Regulatory approval time lines should be a key focus for all Generic companies, even more important than development time lines. Companies must understand a poorly written application could potentially cost them 12-18 months of time on the market.
Average ANDA approval times are approaching 34 months, most blame the FDA. But is this the case? We don't think so.
The FDA receives applications from a vast array of companies, many from overseas. Custopharm has reviewed documents from over 35 companies, many of the applications we see are 'data dumps' to the FDA. Too much information is submitted to the FDA reviewers which clogs up the system and wastes the reviewers time. Another critical issue is how the ANDA is written, every company has a different style of formatting the application, this also adds time to the review. Language barriers can create confusion to the reviewer, this adds additional questions to the sponsor of the application. Last but not least, many applications are not complete which creates additional cycles of review adding to the work load of the FDA reviewer.
For more information please click here: CUSTOpharm: 'Well written' eCTD Gateway ANDA filings most efficient
31 July 2011
eCTD translation
The shift towards electronic submissions isn't easy - not for pharma companies, nor for translators. While pharmaceutical companies typically struggle with getting management support and managing timelines for the conversion to eCTD, many translators are dealing with more fundamental questions like: What is eCTD? Do I need to work in XML? Which modules require translation?
For More information please click here: eCTD translation
For More information please click here: eCTD translation
EMA is organising a workshop on electronic drug information for prescribing in EU (e-spc)
The European Medicines Agency is seeking expressions of interest from software development companies in a workshop on the future of electronic prescribing in the European Union.
The workshop, taking place at the Agency on Wednesday 5 October, will bring together members of the Agency's electronic summary of product characteristics (e-SPC) project. This includes doctors, drug buyers, patients, health-technology-assessment bodies, specialists in the safety of medicines, experts in quality monitoring of healthcare, regulators and the pharmaceutical industry.
For More Information please click here: EMA is organising a workshop on electronic drug information for prescribing in EU (e-spc)
The workshop, taking place at the Agency on Wednesday 5 October, will bring together members of the Agency's electronic summary of product characteristics (e-SPC) project. This includes doctors, drug buyers, patients, health-technology-assessment bodies, specialists in the safety of medicines, experts in quality monitoring of healthcare, regulators and the pharmaceutical industry.
For More Information please click here: EMA is organising a workshop on electronic drug information for prescribing in EU (e-spc)
Exalon: EU CMDh introduces pilot phase for Type IA "supergrouping"
The EU Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CDMh) has announced a 6-months pilot phase starting on 1st August 2011 allowing marketing authorisation holders to submit grouped type IA variations including more than one Reference Member State (RMS) and to give instructions to marketing authorisation holders for the submission of such variations (see CMDh meeting report from July 2011). (Note: Up to now, grouping of type IA or IAIN variations of different Marketing Authorisations (MA) in acc. to article 8 of Commission Regulation (EC) No 1234/2008 was to be performed per RMS - in case different RMS were assigned in the application procedures of the individual MAs).
The corresponding CMDh "Best Practice Guide for the submission and processing of variations in the Mutual Recognition Procedure" has already been updated to revision 14 correspondingly. The updates concern exclusively chapter 6 of the Best Practice Guide dealing with the submission of grouped variation applications.
For More information please click here: Exalon: EU CMDh introduces pilot phase for Type IA "supergrouping"
The corresponding CMDh "Best Practice Guide for the submission and processing of variations in the Mutual Recognition Procedure" has already been updated to revision 14 correspondingly. The updates concern exclusively chapter 6 of the Best Practice Guide dealing with the submission of grouped variation applications.
For More information please click here: Exalon: EU CMDh introduces pilot phase for Type IA "supergrouping"
Mission3 Clinical Trial Management Solutions Products Services Clients About Us eCTD Publishing – is it a Publishing Problem, or an Enterprise Content Management problem? - By Gabor Fari – Director of Life Science Solutions, Microsoft Corporation
eCTD Publishing – is it a Publishing Problem, or an Enterprise Content Management problem?
By Gabor Fari – Director of Life Science Solutions, Microsoft Corporation
The issue of whether submission management is more of a publishing problem or an Enterprise Content Management (ECM) problem is an issue that is near and dear to my heart. I remember about 10 years ago, when I was working for another ECM vendor, our customers started asking us about eCTD Publishing tools, and whether we would support them. I started digging some more into the eCTD problem space, and what it meant for companies. I realized that the eCTD challenge also brought a real opportunity for innovation. When looked at from an ECM perspective, eCTD is all about lifecycle management and metadata management. Therefore, I came to the conclusion that this is not really a publishing problem. A publication is merely an output from the ECM system: a collection of documents or artifacts that are arranged according to certain rules and output via a delivery mechanism. ECM systems have been used almost from the beginning for publishing compound documents, and the eCTD is merely a form of this. The XML backbone of the eCTD contains the publishing rules.
Unfortunately, two things happened in the industry: first of all most of the people in the Life Sciences industry charged with implementing eCTD Publishing systems have a long publishing background, all the way back to when paper was the preferred media, and they did not realize the potential benefits of the paradigm shift. Second, there was a flurry of activity on the part of vendors to deliver these eCTD publishing tools, while the ECM vendors were content to focus on the repository aspect of eCTD. All the eCTD tool vendors were focused on integrating with the legacy ECM tools, and on an approach that I would characterize as ‘pull’ (wherein the content to be published was pulled into the publication from the ECM repository) rather than a ‘push’ approach (wherein the publication was directly assembled within the ECM system). This approach brought several major challenges with it; the two biggest ones were link management and lifecycle management. The first is a thorny problem, which was initially addressed via very ‘kluge’ approaches, such as setting the links in the ECM system, and then exporting the whole document hierarchy to a file system, otherwise the links would break. Most of the link management problems have been resolved by today – 10 years later! But it is still largely a kluge process, and the market consolidation is a good indication that the market cannot sustain more than a few eCTD vendors, as opposed to well over a dozen when the shift to eCTD started.
For More Information please click here: Mission3 Clinical Trial Management Solutions Products Services Clients About Us eCTD Publishing – is it a Publishing Problem, or an Enterprise Content Management problem? - By Gabor Fari – Director of Life Science Solutions, Microsoft Corporation
By Gabor Fari – Director of Life Science Solutions, Microsoft Corporation
The issue of whether submission management is more of a publishing problem or an Enterprise Content Management (ECM) problem is an issue that is near and dear to my heart. I remember about 10 years ago, when I was working for another ECM vendor, our customers started asking us about eCTD Publishing tools, and whether we would support them. I started digging some more into the eCTD problem space, and what it meant for companies. I realized that the eCTD challenge also brought a real opportunity for innovation. When looked at from an ECM perspective, eCTD is all about lifecycle management and metadata management. Therefore, I came to the conclusion that this is not really a publishing problem. A publication is merely an output from the ECM system: a collection of documents or artifacts that are arranged according to certain rules and output via a delivery mechanism. ECM systems have been used almost from the beginning for publishing compound documents, and the eCTD is merely a form of this. The XML backbone of the eCTD contains the publishing rules.
Unfortunately, two things happened in the industry: first of all most of the people in the Life Sciences industry charged with implementing eCTD Publishing systems have a long publishing background, all the way back to when paper was the preferred media, and they did not realize the potential benefits of the paradigm shift. Second, there was a flurry of activity on the part of vendors to deliver these eCTD publishing tools, while the ECM vendors were content to focus on the repository aspect of eCTD. All the eCTD tool vendors were focused on integrating with the legacy ECM tools, and on an approach that I would characterize as ‘pull’ (wherein the content to be published was pulled into the publication from the ECM repository) rather than a ‘push’ approach (wherein the publication was directly assembled within the ECM system). This approach brought several major challenges with it; the two biggest ones were link management and lifecycle management. The first is a thorny problem, which was initially addressed via very ‘kluge’ approaches, such as setting the links in the ECM system, and then exporting the whole document hierarchy to a file system, otherwise the links would break. Most of the link management problems have been resolved by today – 10 years later! But it is still largely a kluge process, and the market consolidation is a good indication that the market cannot sustain more than a few eCTD vendors, as opposed to well over a dozen when the shift to eCTD started.
For More Information please click here: Mission3 Clinical Trial Management Solutions Products Services Clients About Us eCTD Publishing – is it a Publishing Problem, or an Enterprise Content Management problem? - By Gabor Fari – Director of Life Science Solutions, Microsoft Corporation
Register today for GlobalSubmit's quarterly e-newsletter sharing regulatory info and eCTD updates!
eSubmission Digest: The GlobalSubmit Industry Newsletter please click the following to register.
Link: GlobalSubmit's quarterly e-newsletter
Link: GlobalSubmit's quarterly e-newsletter
CDSCO issues guidance on trial approvals with an eye on e-submissions
India’s Central drugs standard control organisation (CDSCO) has issued new draft guidance of clinical trials and new drug approvals that pave the way for potential electronic submissions.
The document, available here , covers the requirements for approval of trials, new drugs and details the CDSCO’s review process under Rule 122A, 122B, 122DA,122DAA,122E and Schedule-Y of the Drugs and Cosmetics Rule.
The organisation said that: “This guidance will help the industry to submit the required documents in a more realistic manner, which in turn will also help reviewer of CDSCO to review such application in systematic manner.
“It is apparent that this structured application with comprehensive and rational contents will help the CDSCO to review and take necessary actions in a better way and would also ease the preparation of electronic submissions, which may happen in the near future at CDSCO.”
For More Information please click here: CDSCO issues guidance on trial approvals with an eye on e-submissions
The document, available here , covers the requirements for approval of trials, new drugs and details the CDSCO’s review process under Rule 122A, 122B, 122DA,122DAA,122E and Schedule-Y of the Drugs and Cosmetics Rule.
The organisation said that: “This guidance will help the industry to submit the required documents in a more realistic manner, which in turn will also help reviewer of CDSCO to review such application in systematic manner.
“It is apparent that this structured application with comprehensive and rational contents will help the CDSCO to review and take necessary actions in a better way and would also ease the preparation of electronic submissions, which may happen in the near future at CDSCO.”
For More Information please click here: CDSCO issues guidance on trial approvals with an eye on e-submissions
Job: Senior Manager of Regulatory Operations (eCTDs)- Holland. Great Salary, Global Pharma!
Senior Manager of Regulatory Operations (eCTDs)- Holland. Great Salary, Global Pharma!
If you or anyone you know might be interested in these roles please contact Reesa Berry on +441483228190 or email reesa.berry@m3pharma.com
Candidates must be European citizens or have valid working visas for working in Europe.
If you or anyone you know might be interested in these roles please contact Reesa Berry on +441483228190 or email reesa.berry@m3pharma.com
Candidates must be European citizens or have valid working visas for working in Europe.
20 July 2011
Sweden Medical Products Agency - Practical guidance for submissions
Practical guidance for submissions
1. Application for marketing authorisation
Please consider the CMDh recommendations for the cover letter and preferably use the published template (see link to the right).
1.1. Electronic submissions on CD/DVD
Electronic-only submissions (eCTD, NeeS or VNeeS format) are strongly encouraged. A filled “Confirmation of transition to electronic-only submissions” should be submitted together with extension applications to clarify that all future submissions also for other strengths and forms of the product applied for will be submitted electronic only.
The criteria for accepting electronic submissions as originals in all procedures are that the current ICH and EU specifications and the EU eCTD harmonised guidance or the EU NeeS harmonised guidance are followed. The submissions have to pass the technical validation at the MPA.
If the submission requires more than one CD, a DVD is preferred. The CD/DVD should be packed adequately to prevent damage. Each CD/DVD should be properly labelled in accordance with current EU guidance.
The applicant is responsible for checking the CD/DVD for viruses.
Avoid submitting documents in several different formats, unless they are so called working documents.
All submissions, whether entirely on paper or on CD/DVD, should have a paper cover letter with submission subject clearly stated. Original signature is not needed. If in electronic format, the cover letter should also be included on the CD/DVD.
For More information please click here: Sweden Medical Products Agency - Practical guidance for submissions
1. Application for marketing authorisation
Please consider the CMDh recommendations for the cover letter and preferably use the published template (see link to the right).
1.1. Electronic submissions on CD/DVD
Electronic-only submissions (eCTD, NeeS or VNeeS format) are strongly encouraged. A filled “Confirmation of transition to electronic-only submissions” should be submitted together with extension applications to clarify that all future submissions also for other strengths and forms of the product applied for will be submitted electronic only.
The criteria for accepting electronic submissions as originals in all procedures are that the current ICH and EU specifications and the EU eCTD harmonised guidance or the EU NeeS harmonised guidance are followed. The submissions have to pass the technical validation at the MPA.
If the submission requires more than one CD, a DVD is preferred. The CD/DVD should be packed adequately to prevent damage. Each CD/DVD should be properly labelled in accordance with current EU guidance.
The applicant is responsible for checking the CD/DVD for viruses.
Avoid submitting documents in several different formats, unless they are so called working documents.
All submissions, whether entirely on paper or on CD/DVD, should have a paper cover letter with submission subject clearly stated. Original signature is not needed. If in electronic format, the cover letter should also be included on the CD/DVD.
For More information please click here: Sweden Medical Products Agency - Practical guidance for submissions
18 July 2011
THE eCTD SUMMIT: EU: eCTD Validation Criteria 3.0
As some of you may already know, the European region is going to put new validation criteria into effect in September 2011.
The new criteria can be found on the eSubmission web site at the following link: http://esubmission.emea.europa.eu/
What is this going to mean for validation tools and eCTD validation for the European region?
For one, the previous priority levels of A, B, and C have been removed, and have been replaced by Pass, Fail, and Best Practice.
For the Pass/Fail checks, any eCTD that fails to pass all checks will be returned to the applicant for fixing and resubmission. Additionally, according to the new criteria, the Best Practice checks are now strongly recommended.
From the Best Practice description found in the Validate Criteria 3.0 document:
“The applicant should make every effort to address these areas before the eCTD is submitted to the agency. The applicant should be prepared to include justification for any Best Practice criteria not met in the submission cover letter/reviewer’s guide.”
The most critical point to take away from this change to the priority levels is that now all tests must pass. Yes, eCTDs that fail to pass Best Practice checks will be accepted during technical validation, and may not even be checked, but based on the previous statement, it is clear that the European authorities are really pushing for clean eCTD submissions.
Another item new to the criteria is an indication that a validate check can only be performed in the context of other eCTDs in the lifecycle. This indication has been set on checks which relate to operations and submissions in other sequences. For example, “11.9: The leaf referenced by the modified file must exist in a previously submitted sequence within the same eCTD application”. If you were only validating one sequence that has a leaf modifying a leaf in a different sequence, then this check could not be fully completed unless the other sequence was present during the validation. In this case, validation tools should indicate if the other sequence was present or not when the checks were done.
For more information please click here: THE eCTD SUMMIT: EU: eCTD Validation Criteria 3.0
The new criteria can be found on the eSubmission web site at the following link: http://esubmission.emea.europa.eu/
What is this going to mean for validation tools and eCTD validation for the European region?
For one, the previous priority levels of A, B, and C have been removed, and have been replaced by Pass, Fail, and Best Practice.
For the Pass/Fail checks, any eCTD that fails to pass all checks will be returned to the applicant for fixing and resubmission. Additionally, according to the new criteria, the Best Practice checks are now strongly recommended.
From the Best Practice description found in the Validate Criteria 3.0 document:
“The applicant should make every effort to address these areas before the eCTD is submitted to the agency. The applicant should be prepared to include justification for any Best Practice criteria not met in the submission cover letter/reviewer’s guide.”
The most critical point to take away from this change to the priority levels is that now all tests must pass. Yes, eCTDs that fail to pass Best Practice checks will be accepted during technical validation, and may not even be checked, but based on the previous statement, it is clear that the European authorities are really pushing for clean eCTD submissions.
Another item new to the criteria is an indication that a validate check can only be performed in the context of other eCTDs in the lifecycle. This indication has been set on checks which relate to operations and submissions in other sequences. For example, “11.9: The leaf referenced by the modified file must exist in a previously submitted sequence within the same eCTD application”. If you were only validating one sequence that has a leaf modifying a leaf in a different sequence, then this check could not be fully completed unless the other sequence was present during the validation. In this case, validation tools should indicate if the other sequence was present or not when the checks were done.
For more information please click here: THE eCTD SUMMIT: EU: eCTD Validation Criteria 3.0
DIA:12th Conference on European Electronic Document Management/ EDM - Zurich, Switzerland.
DIA:12th Conference on European Electronic Document Management/ EDM - Zurich, Switzerland.
Location:
Swissôtel Zurich
Am Marktplatz Oerlikon
8050 Zurich
Switzerland
Interest Area(s):
Clinical Data Management/ eClinical,CMC,Clinical Research,Document Management/ eSubmissions,IT/Validation,Medical Writing,Strategic Planning,Quality Assurance/Quality Control,Regulatory Affairs
Overview:
For the past few decades, as we moved from paper-based content to electronic files, we have kept a clear distinction between documents and data, and the context in which this content was used. Data was managed in structured databases, analysed, then transferred manually, and documents were recreated over and over again and stored in eDM systems.
Today this separation is slowly disappearing as new technologies, such as XML, bring documents, data and other forms of information together in one melting point. This evolution is welcome and opens new perspectives in areas such as collaboration, reuse, review, analysis and records management. It also creates new challenges and pharmaceutical professionals will need to revise their view and practices and gradually move from traditional data and document management to information and content management.
DIA has always been in the forefront of new ideas and technologies and will once more offer a privileged forum for discussing, understanding and addressing the new challenges of information management.
For more information click here: DIA:12th Conference on European Electronic Document Management/ EDM - Zurich, Switzerland
Location:
Swissôtel Zurich
Am Marktplatz Oerlikon
8050 Zurich
Switzerland
Interest Area(s):
Clinical Data Management/ eClinical,CMC,Clinical Research,Document Management/ eSubmissions,IT/Validation,Medical Writing,Strategic Planning,Quality Assurance/Quality Control,Regulatory Affairs
Overview:
For the past few decades, as we moved from paper-based content to electronic files, we have kept a clear distinction between documents and data, and the context in which this content was used. Data was managed in structured databases, analysed, then transferred manually, and documents were recreated over and over again and stored in eDM systems.
Today this separation is slowly disappearing as new technologies, such as XML, bring documents, data and other forms of information together in one melting point. This evolution is welcome and opens new perspectives in areas such as collaboration, reuse, review, analysis and records management. It also creates new challenges and pharmaceutical professionals will need to revise their view and practices and gradually move from traditional data and document management to information and content management.
DIA has always been in the forefront of new ideas and technologies and will once more offer a privileged forum for discussing, understanding and addressing the new challenges of information management.
For more information click here: DIA:12th Conference on European Electronic Document Management/ EDM - Zurich, Switzerland
Regulatory Document Management with Microsoft SharePoint 2010 and NextDocs
The full set of documents that ultimately comprise an eCTD submission need to be managed through a complete lifecycle, from creation through submission. In addition to ensuring compliance with 21 CFR Part 11, a broad set of users need to have access to create, review, approve and update each document. During this session you will see how SharePoint 2010 can be used to address the complete set of requirements for managing regulatory documents in a life sciences environment.
This on-line session will include a complete demonstration of a system built on SharePoint 2010 and using the DIA Reference Model for managing regulatory documents and the associated metadata. Key topics that will be addressed: – How SharePoint 2010 can address the complete set of 21 CFR Part 11 requirements including digital signatures, extended audit trails, and version control – The role of the DIA Reference Model in simplifying and standardizing the organization of regulatory documents – How SharePoint can act as a unified repository for managing all regulatory documents through their entire life cycle from creation through submission – Integrating SharePoint 2010 with eCTD assembly and publishing solution
For more information and free video click here: Regulatory Document Management with Microsoft SharePoint 2010 and NextDocs
This on-line session will include a complete demonstration of a system built on SharePoint 2010 and using the DIA Reference Model for managing regulatory documents and the associated metadata. Key topics that will be addressed: – How SharePoint 2010 can address the complete set of 21 CFR Part 11 requirements including digital signatures, extended audit trails, and version control – The role of the DIA Reference Model in simplifying and standardizing the organization of regulatory documents – How SharePoint can act as a unified repository for managing all regulatory documents through their entire life cycle from creation through submission – Integrating SharePoint 2010 with eCTD assembly and publishing solution
For more information and free video click here: Regulatory Document Management with Microsoft SharePoint 2010 and NextDocs
It’ll be an XML world
Steve Ballmer, the CEO of Microsoft, proclaimed back in March of 2001. Eight years later, we're still waiting.
Sure, XML has made some inroads. For instance, as of late 2005, FDA requires that all US-marketed package inserts be submitted in XML format. So far, the goal for most organizations was solely to implement systems and/or processes to achieve compliance with Structured Product Labeling. By and large, though, drug and device companies are still publishing (and thus translating) content in unstructured formats.
This is a shame, for both manufacturers and translation companies. Use of XML would offer the opportunity to reduce turnaround times through reduced analysis time and a generally simpler process flow (fewer steps, fewer technical issues). It would allow translators to focus on linguistic work without the distraction of desktop publishing tasks (focus on core competency).
For More information Please click here: It’ll be an XML world
Sure, XML has made some inroads. For instance, as of late 2005, FDA requires that all US-marketed package inserts be submitted in XML format. So far, the goal for most organizations was solely to implement systems and/or processes to achieve compliance with Structured Product Labeling. By and large, though, drug and device companies are still publishing (and thus translating) content in unstructured formats.
This is a shame, for both manufacturers and translation companies. Use of XML would offer the opportunity to reduce turnaround times through reduced analysis time and a generally simpler process flow (fewer steps, fewer technical issues). It would allow translators to focus on linguistic work without the distraction of desktop publishing tasks (focus on core competency).
For More information Please click here: It’ll be an XML world
DIA Europe: Training Course for eCTD - Submissions in Switzerland
Since January 2010, Swissmedic accepts electronic-only submissions in eCTD-format. This course will offer insight into the compilation of the eCTD, share experience and best practice gained during eCTD submissions in Switzerland, and the eCTD review process. The focus will be on practical experience gained in preparing and submitting eCTDs to Swissmedic.
Hotel Courtyard Marriott Zurich, Zurich, Switzerland
Dec 8 2011 9:00AM - 5:00PM
Registration:
DIA EUROPE
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL, SWITZERLAND
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52
E-mail:diaeurope@diahome.org
For More information please click here: DIA Europe: Training Course for eCTD - Submissions in Switzerland
Hotel Courtyard Marriott Zurich, Zurich, Switzerland
Dec 8 2011 9:00AM - 5:00PM
Registration:
DIA EUROPE
ELISABETHENANLAGE 25, POSTFACH
4002 BASEL, SWITZERLAND
PHONE: +41 61 225 51 51
FAX: +41 61 225 51 52
E-mail:diaeurope@diahome.org
For More information please click here: DIA Europe: Training Course for eCTD - Submissions in Switzerland
CUSTOpharm: New eCTD Software Looking for Beta Testers
A new easy to use eCTD software is entering the final phases of beta testing and we are looking for volunteers to evaluate and provide input crucial to the finalization and completion of the software.
This software is based on the principles that software should be easy to pick up and use and therefore does not require extensive training and is designed to be "Mac" like in its ease of use. However, if anybody needs instructions we are more than happy to help.
Currently, we are looking for volunteers to evaluate the capabilities of the software and make recommendations as to how to improve it. Ideal beta testers would be regulatory consultants working on a variety of submissions types for the US market; however direct pharmaceutical employees are requested to register as well. This is a rare opportunity to use an eCTD software package at no cost.
For More Information please click here: CUSTOpharm: New eCTD Software Looking for Beta Testers
This software is based on the principles that software should be easy to pick up and use and therefore does not require extensive training and is designed to be "Mac" like in its ease of use. However, if anybody needs instructions we are more than happy to help.
Currently, we are looking for volunteers to evaluate the capabilities of the software and make recommendations as to how to improve it. Ideal beta testers would be regulatory consultants working on a variety of submissions types for the US market; however direct pharmaceutical employees are requested to register as well. This is a rare opportunity to use an eCTD software package at no cost.
For More Information please click here: CUSTOpharm: New eCTD Software Looking for Beta Testers
A Case Study for a Global Submission eArchiving System - By Mauricha F. Marcussen
A Case Study for a Global Submission eArchiving System - By Mauricha F. Marcussen, Senior Consultant, Edward S. Tripp and Associates, Inc.
Please click here to find the presentation: A Case Study for a Global Submission eArchiving System - By Mauricha F. Marcussen
Please click here to find the presentation: A Case Study for a Global Submission eArchiving System - By Mauricha F. Marcussen
15 July 2011
CSC : CDISC Data Standards and Your Regulatory Submission: It's Time to Implement - Complementary Webinar
CDISC Data Standards and Your Regulatory Submission: It's Time to Implement
Thursday, July 28, 2011, 8:00 am pacific time / 11:00 am eastern time / 13.00 BST
Interchange Standards Consortium (CDISC) data standards for all regulatory applications delivered to the agency. In fact, on July 21, 2004, the FDA issued a press release announcing that the CDISC Study Data Tabulation Model (SDTM) was the preferred method for submission of source data to the Center for Drug Evaluation and Research (CDER).1 Analysis data used in the clinical statistical review also is being standardized, and CDISC released the Analysis Data Model (ADaM) implementation guide V1.0 in late 2009. The ramifications of these data standards are far-reaching for sponsors. The FDA is now considering a rule change that would mandate the submission of data in these standard formats for all new marketing applications. In addition to the FDA, other government organizations such as the National Cancer Institute and the National Institutes of Health actively incorporating these standards. Unfortunately, even in 2011, only a very small percentage of sponsors are developing and submitting the SDTM and ADaM.
Trend and Opportunities
In this informative and complimentary Webinar, CSC subject-matter expert Gregory Ridge will discuss CDISC's history, the FDA's usage of data standards and sponsor implementation strategies across both the SDTM and ADaM. The conversion of legacy source data to CDISC data standards is a costly proposition in terms of time and resources. Topics included will be the development of a submission data plan and gaining an understanding of the source-to-CDISC conversion process. The discussion will also focus on development of the supportive metadata required in a CDISC submission, commonly called the define.xml.
Key Learnings
Industry Trends: Learn about the history of CDISC and how its standards are utilized at the FDA. Examine the most current metrics on how sponsors are dealing with migration to CDISC and how partner organizations can assist in the development and validation of a company's submission package.
Success Factors: Understand the process of conversion of legacy source data to CDISC models. Discover what's required to migrate a company's submission data package from legacy to state of the art.
Risk and Reward: Determine the strategy that best suits a company's data submission needs. Recognize the current regulatory landscape, and develop a submission plan that best mitigates the company's risks.
A Complete Solution: Learn about all of the components of an electronic submission and how they integrate with a company's dossier. Understand the challenges that must be met to develop a CDISC data package, and learn the costs - in terms of both financing and resources - associated with it.
About the Presenter
Gregory Ridge is group leader of the Regulatory Data Standards and Integration organization at CSC. He has 20 years of pharmaceutical programming experience. His CSC team has developed multiple successful CDISC data packages for clients in a variety of therapeutic areas. Prior to joining CSC, Greg was associate director of clinical programming at sanofi-aventis for 14 years, leading the oncology and cardiovascular therapeutic areas. His teams successfully submitted nine CDISC-compliant submissions to the FDA by utilizing multiple release versions of the SDTM and ADaM.
Please click here to Register this webinar: CSC : CDISC Data Standards and Your Regulatory Submission: It's Time to Implement - Complementary Webinar
Thursday, July 28, 2011, 8:00 am pacific time / 11:00 am eastern time / 13.00 BST
Interchange Standards Consortium (CDISC) data standards for all regulatory applications delivered to the agency. In fact, on July 21, 2004, the FDA issued a press release announcing that the CDISC Study Data Tabulation Model (SDTM) was the preferred method for submission of source data to the Center for Drug Evaluation and Research (CDER).1 Analysis data used in the clinical statistical review also is being standardized, and CDISC released the Analysis Data Model (ADaM) implementation guide V1.0 in late 2009. The ramifications of these data standards are far-reaching for sponsors. The FDA is now considering a rule change that would mandate the submission of data in these standard formats for all new marketing applications. In addition to the FDA, other government organizations such as the National Cancer Institute and the National Institutes of Health actively incorporating these standards. Unfortunately, even in 2011, only a very small percentage of sponsors are developing and submitting the SDTM and ADaM.
Trend and Opportunities
In this informative and complimentary Webinar, CSC subject-matter expert Gregory Ridge will discuss CDISC's history, the FDA's usage of data standards and sponsor implementation strategies across both the SDTM and ADaM. The conversion of legacy source data to CDISC data standards is a costly proposition in terms of time and resources. Topics included will be the development of a submission data plan and gaining an understanding of the source-to-CDISC conversion process. The discussion will also focus on development of the supportive metadata required in a CDISC submission, commonly called the define.xml.
Key Learnings
Industry Trends: Learn about the history of CDISC and how its standards are utilized at the FDA. Examine the most current metrics on how sponsors are dealing with migration to CDISC and how partner organizations can assist in the development and validation of a company's submission package.
Success Factors: Understand the process of conversion of legacy source data to CDISC models. Discover what's required to migrate a company's submission data package from legacy to state of the art.
Risk and Reward: Determine the strategy that best suits a company's data submission needs. Recognize the current regulatory landscape, and develop a submission plan that best mitigates the company's risks.
A Complete Solution: Learn about all of the components of an electronic submission and how they integrate with a company's dossier. Understand the challenges that must be met to develop a CDISC data package, and learn the costs - in terms of both financing and resources - associated with it.
About the Presenter
Gregory Ridge is group leader of the Regulatory Data Standards and Integration organization at CSC. He has 20 years of pharmaceutical programming experience. His CSC team has developed multiple successful CDISC data packages for clients in a variety of therapeutic areas. Prior to joining CSC, Greg was associate director of clinical programming at sanofi-aventis for 14 years, leading the oncology and cardiovascular therapeutic areas. His teams successfully submitted nine CDISC-compliant submissions to the FDA by utilizing multiple release versions of the SDTM and ADaM.
Please click here to Register this webinar: CSC : CDISC Data Standards and Your Regulatory Submission: It's Time to Implement - Complementary Webinar
AAMI News: E-Submissions Coming for Manufacturers
Hospitals aren’t the only ones that are moving to electronic records. Manufacturers face that change, too, and they need to prepare to submit their medical device applications to regulators electronically, standards experts say.
“The message here is that e-submissions are coming,” said Bernie Liebler, director of technology and regulatory affairs for Advanced Medical Technology Association (AdvaMed), a Washington, DC-based trade group representing device manufacturers. “The pharmaceutical industry is pushing for e-submission standards that can also be used for devices.”
The healthcare informatics standards organization Health Level Seven International (HL7) is creating such a standard, one that will include guidelines on how to submit applications electronically for regulated drugs and medical devices to authorities around the world.
Liebler, who spoke during a May 23 webinar sponsored by AdvaMed on e-submissions, called for the formation of an international working group of device manufacturers to help develop the standard.
For more information please click here: AAMI News: E-Submissions Coming for Manufacturers
“The message here is that e-submissions are coming,” said Bernie Liebler, director of technology and regulatory affairs for Advanced Medical Technology Association (AdvaMed), a Washington, DC-based trade group representing device manufacturers. “The pharmaceutical industry is pushing for e-submission standards that can also be used for devices.”
The healthcare informatics standards organization Health Level Seven International (HL7) is creating such a standard, one that will include guidelines on how to submit applications electronically for regulated drugs and medical devices to authorities around the world.
Liebler, who spoke during a May 23 webinar sponsored by AdvaMed on e-submissions, called for the formation of an international working group of device manufacturers to help develop the standard.
For more information please click here: AAMI News: E-Submissions Coming for Manufacturers
14 July 2011
e-submissions look scary?
Electronic records are everywhere these days - healthcare providers, patients, and now event manufacturers face that change. More and more pharmaceutical and medical device companies are preparing to submit applications to regulators electronically.
The healthcare IT standards organization Health Level Seven International (HL7) is creating a standard that will include guidelines on how to submit applications electronically for regulated drugs and medical devices to authorities around the world.
The most recent issue of AAMI News reports that HL7 plans to test the regulated product submission (RPS) in the fall of 2011, and the International Organization of Standardization plans to adopt the standard as early as 2013.
For More Information please click here: e-submissions look scary?
The healthcare IT standards organization Health Level Seven International (HL7) is creating a standard that will include guidelines on how to submit applications electronically for regulated drugs and medical devices to authorities around the world.
The most recent issue of AAMI News reports that HL7 plans to test the regulated product submission (RPS) in the fall of 2011, and the International Organization of Standardization plans to adopt the standard as early as 2013.
For More Information please click here: e-submissions look scary?
EXTEDO Webinar - The New EU Validation Criteria and EURSvalidator 2.0
EXTEDO is Hosting a Complimentary Webinar!
The New EU Validation Criteria and EURSvalidator 2.0
During this webinar Dr. Gerhard Neurauter (Director Regulatory Competence Center at EXTEDO) will provide an overview of the changes in the EU validation criteria and will show you how to validate your submission according to the new rules with EXTEDO's EURSvalidator 2.0. The following topics will be covered during the webinar:
•History and roadmap of EURSvalidator
•EURSvalidator 2.0 - What's new
•Reports and documentation
•The new validation criteria for eCTD and NEES
•Implementation of the new validation criteria in EURSvalidator
•Best practice: Switching from eCTD validation criteria 2.1 to 3.1
•Live demo of EURSvalidator 2.0
•Update of the validation library of eCTDmanager / EURS is Yours with EURSvalidator
To Register the Webinar Please Click here: EXTEDO Webinar - The New EU Validation Criteria and EURSvalidator 2.0
The New EU Validation Criteria and EURSvalidator 2.0
During this webinar Dr. Gerhard Neurauter (Director Regulatory Competence Center at EXTEDO) will provide an overview of the changes in the EU validation criteria and will show you how to validate your submission according to the new rules with EXTEDO's EURSvalidator 2.0. The following topics will be covered during the webinar:
•History and roadmap of EURSvalidator
•EURSvalidator 2.0 - What's new
•Reports and documentation
•The new validation criteria for eCTD and NEES
•Implementation of the new validation criteria in EURSvalidator
•Best practice: Switching from eCTD validation criteria 2.1 to 3.1
•Live demo of EURSvalidator 2.0
•Update of the validation library of eCTDmanager / EURS is Yours with EURSvalidator
To Register the Webinar Please Click here: EXTEDO Webinar - The New EU Validation Criteria and EURSvalidator 2.0
Exalon: TIGes updates clarification on the new EU eCTD validation criteria
The Telematic Implementation Group for electronic submission and ICH Implementation (TIGes) has updated the clarification document on the draft eCTD validation criteria 3.1 that will come into force in September this year. The initial version of the clarification document was published in June (see our related News article)
In the updated version, additional clarification concerning the usage of eCTD style sheets is provided. As reported by TIGes, "several agencies noticed that for some eCTD submissions the style sheets provided by the eCTD building tools do not produce the correct MD5 checksum".
The TIGes confirms now that only the official style sheets are allowed in the eCTD as validated by correct MD5 checksums. (Note: Official style sheets for Module 2 - Module 5 are released by ICH; the regional EU Module 1 style sheet is part of the regional EU Module 1 package as released by TIGes - original MD5 checksums are provided on the download pages).
For More Information Click here: Exalon: TIGes updates clarification on the new EU eCTD validation criteria
In the updated version, additional clarification concerning the usage of eCTD style sheets is provided. As reported by TIGes, "several agencies noticed that for some eCTD submissions the style sheets provided by the eCTD building tools do not produce the correct MD5 checksum".
The TIGes confirms now that only the official style sheets are allowed in the eCTD as validated by correct MD5 checksums. (Note: Official style sheets for Module 2 - Module 5 are released by ICH; the regional EU Module 1 style sheet is part of the regional EU Module 1 package as released by TIGes - original MD5 checksums are provided on the download pages).
For More Information Click here: Exalon: TIGes updates clarification on the new EU eCTD validation criteria
NextDocs: Using SharePoint 2010 with NextDocs as a Complete Quality Management System - Webinar Slides
NextDocs: Using SharePoint 2010 with NextDocs as a Complete Quality Management System - Webinar Slides
Webinar Slides Can view by clicking the below weblink: NextDocs QMS Webinar Slides
Recorder Webinar Can hear by clicking the below weblink: NextDocs QMS Webinar Record
Webinar Slides Can view by clicking the below weblink: NextDocs QMS Webinar Slides
Recorder Webinar Can hear by clicking the below weblink: NextDocs QMS Webinar Record
eCTD Publishing Specialist (Contract/Freelance) - Regulatory Affairs - UK South/South East - Negotiable daily rate.
One of the client is looking for a talented individual to join their exisitng successful team on a contract/freelance agreement. The role is a pivitol part of the team. Please see an outline of the role below or look at our website - www.morganprestwich.com
Person Spec:
•Experience with NEES, eCTD and Paper Submissions
•Knowledge of European procedures (Centralised, Decentralised and Mutual Recognition)
•Good written and communication skills
•Use of docuBridge or similar publishing tool
•A confident user of MS Office, Adobe Acrobat and ISI Toolbox (Preferable)
•General understanding of regulatory affairs
RESPONSIBILITIES
•Maintain well established infrastructure for electronic submissions and eCTD.
•Make sure that the published regulatory submission is in accordance with the relevant guidelines ICH M2 (eCTD Specification), ICH M4 (Q, E, S, Organisation CTD), EU Module 1 Specification etc.) and contains all necessary navigation tools like bookmarks and hyperlinks which provide essential navigational aids for the reviewer.
•Communicate with regulatory agencies (EMA, local competent authorities) with respect to electronic regulatory submissions, answer technical queries, resolve technical issues (with relevant IT support).
•Responsible for the preparation of the same eCTD submissions for planned MAAs (e.g. Computer Validation testing by EMA).
To apply
Please send your CV to Greg Bell - greg.bell@morganprestwich.com or call me on 01737 22 66 44 to discuss this and othe positions further.
Person Spec:
•Experience with NEES, eCTD and Paper Submissions
•Knowledge of European procedures (Centralised, Decentralised and Mutual Recognition)
•Good written and communication skills
•Use of docuBridge or similar publishing tool
•A confident user of MS Office, Adobe Acrobat and ISI Toolbox (Preferable)
•General understanding of regulatory affairs
RESPONSIBILITIES
•Maintain well established infrastructure for electronic submissions and eCTD.
•Make sure that the published regulatory submission is in accordance with the relevant guidelines ICH M2 (eCTD Specification), ICH M4 (Q, E, S, Organisation CTD), EU Module 1 Specification etc.) and contains all necessary navigation tools like bookmarks and hyperlinks which provide essential navigational aids for the reviewer.
•Communicate with regulatory agencies (EMA, local competent authorities) with respect to electronic regulatory submissions, answer technical queries, resolve technical issues (with relevant IT support).
•Responsible for the preparation of the same eCTD submissions for planned MAAs (e.g. Computer Validation testing by EMA).
To apply
Please send your CV to Greg Bell - greg.bell@morganprestwich.com or call me on 01737 22 66 44 to discuss this and othe positions further.
Regulatory Affairs eCTD Publishing Specialist ~ 10 -12 Month Contract ~ Surrey ~ July Start !!
Independent consultancy with office throughout Europe who deliver a highly professional service to the Pharmaceutical industry encompassing Regulatory Affairs, PVG, Health Economic Evaluation and QA.
They have a requirement for a Regulatory Affairs eCTD publishing specialist, the position can accommodate some home working but will be mainly office based at my clients offices in Surrey therefore I cannot accept applications from candidates who cannot commute to Surrey.
Suitable Candidates will have experience in the following,
-Experience with NEES, eCTD and Paper Submissions
-Knowledge of European procedures (Centralised, Decentralised and Mutual Recognition)
-Good written and communication skills
-Use of docuBridge or similar publishing tool
-A confident user of MS Office, Adobe Acrobat and ISI Toolbox (Preferable)
-General understanding of regulatory affairs
RESPONSIBILITIES
-Maintain well established infrastructure for electronic submissions and eCTD.
-Make sure that the published regulatory submission is in accordance with the relevant guidelines ICH M2 (eCTD Specification), ICH M4 (Q, E, S, Organisation CTD), EU Module 1 Specification etc.) and contains all necessary navigation tools like bookmarks and hyperlinks which provide essential navigational aids for the reviewer.
-Communicate with regulatory agencies (EMA, local competent authorities) with respect to electronic regulatory submissions, answer technical queries, resolve technical issues (with relevant IT support).
A full job description is available on application.
Kind regards
Paul Duffy
Manager ~ Contracts Division
Specialist Contract Pharmaceutical Recruitment
+44 (0) 1293 77 66 44
paul@barringtonjames.com
Click Here for www.barringtonjames.com
IF YOU ARE CURRENTLY CONTRACTING OR INTERESTED IN CONTRACT OPPORTUNITIES THEN PLEASE VISIT OUR LINKEDIN GROUP
“THE PHARMACEUTICAL CONTRACTOR AND FREELANCE NETWORK”
They have a requirement for a Regulatory Affairs eCTD publishing specialist, the position can accommodate some home working but will be mainly office based at my clients offices in Surrey therefore I cannot accept applications from candidates who cannot commute to Surrey.
Suitable Candidates will have experience in the following,
-Experience with NEES, eCTD and Paper Submissions
-Knowledge of European procedures (Centralised, Decentralised and Mutual Recognition)
-Good written and communication skills
-Use of docuBridge or similar publishing tool
-A confident user of MS Office, Adobe Acrobat and ISI Toolbox (Preferable)
-General understanding of regulatory affairs
RESPONSIBILITIES
-Maintain well established infrastructure for electronic submissions and eCTD.
-Make sure that the published regulatory submission is in accordance with the relevant guidelines ICH M2 (eCTD Specification), ICH M4 (Q, E, S, Organisation CTD), EU Module 1 Specification etc.) and contains all necessary navigation tools like bookmarks and hyperlinks which provide essential navigational aids for the reviewer.
-Communicate with regulatory agencies (EMA, local competent authorities) with respect to electronic regulatory submissions, answer technical queries, resolve technical issues (with relevant IT support).
A full job description is available on application.
Kind regards
Paul Duffy
Manager ~ Contracts Division
Specialist Contract Pharmaceutical Recruitment
+44 (0) 1293 77 66 44
paul@barringtonjames.com
Click Here for www.barringtonjames.com
IF YOU ARE CURRENTLY CONTRACTING OR INTERESTED IN CONTRACT OPPORTUNITIES THEN PLEASE VISIT OUR LINKEDIN GROUP
“THE PHARMACEUTICAL CONTRACTOR AND FREELANCE NETWORK”
Danish Medicines Agency: Electronic clinical trial Applications (e-CTA) Do not meet Format Requirements
Electronic clinical trial applications do not meet format requirements
A month ago, the Danish Medicines Agency announced that it is possible to submit clinical trial applications electronically, and we are happy to see that many have taken advantage of this possibility.
Unfortunately, we receive quite many applications that do not comply with the requested format. The most common error that we see is that several files are submitted in various formats (PDF, Word and emails).
This delays the start-up phase of our review, and we therefore call attention to the description of the requested format.
In the event that it is not possible to submit one PDF file with bookmarks, we accept the submission of separate PDF files for each of the submitted documents with unambiguous file names (e.g. "Cover letter", "Protocol", "EudraCT application form", etc.).
If you use Eudralink to submit several files, please send them in one ZIP file.
For More Information Please click here: Danish Medicines Agency e-CTA
A month ago, the Danish Medicines Agency announced that it is possible to submit clinical trial applications electronically, and we are happy to see that many have taken advantage of this possibility.
Unfortunately, we receive quite many applications that do not comply with the requested format. The most common error that we see is that several files are submitted in various formats (PDF, Word and emails).
This delays the start-up phase of our review, and we therefore call attention to the description of the requested format.
In the event that it is not possible to submit one PDF file with bookmarks, we accept the submission of separate PDF files for each of the submitted documents with unambiguous file names (e.g. "Cover letter", "Protocol", "EudraCT application form", etc.).
If you use Eudralink to submit several files, please send them in one ZIP file.
For More Information Please click here: Danish Medicines Agency e-CTA
13 July 2011
Cato Research & GlobalSubmit: Reasons to Switch to eCTD By Evan M. Richardson - Webinar Slides
Reasons to Switch to eCTD
13 July 2011
Evan M. Richardson, B.S., R.A.C.
Associate Director, Regulatory Operations
Cato Research Ltd.
Please click here to view or download the slides: Webinar Slides
13 July 2011
Evan M. Richardson, B.S., R.A.C.
Associate Director, Regulatory Operations
Cato Research Ltd.
Please click here to view or download the slides: Webinar Slides
11 July 2011
FDA's Drug-Approval Rate for 2011 on Pace to Exceed 2010
WASHINGTON—The Food and Drug Administration has approved 20 new drugs so far this year, just one short of the total for all of 2010, according to a top agency official.
The pace likely puts the FDA on track to approve more new types of drugs in 2011 than the previous few years.
In testimony before the House Energy and Commerce's health subcommittee, Janet Woodcock, the head of the FDA's drug division, responded to some lawmakers concerns that a tougher safety stance taken by the agency was slowing down the pace of drug approvals and hurting the pharmaceutical and biotech industry.
FDA's drug approval figures involve drugs or biologics—which are made from living cells—that are considered new types of products. They don't include approvals granted for new formulations or new uses of existing drugs as well as vaccines.
Ms. Woodcock explained the agency meets more than 90% of deadlines that are part of the drug-review process. She also said so-called first cycle approvals are at a 20-year high with and said more than two-thirds of new drugs being approved within the six-to-10-month time frames given to new drug applications. In other cases companies are asked to submit more information, which prompts additional reviews, or drugs are rejected.
For More Information please use the below weblink: The Wall Street Journal - FDA's Drug-Approval Rate for 2011 on Pace to Exceed 2010
The pace likely puts the FDA on track to approve more new types of drugs in 2011 than the previous few years.
In testimony before the House Energy and Commerce's health subcommittee, Janet Woodcock, the head of the FDA's drug division, responded to some lawmakers concerns that a tougher safety stance taken by the agency was slowing down the pace of drug approvals and hurting the pharmaceutical and biotech industry.
FDA's drug approval figures involve drugs or biologics—which are made from living cells—that are considered new types of products. They don't include approvals granted for new formulations or new uses of existing drugs as well as vaccines.
Ms. Woodcock explained the agency meets more than 90% of deadlines that are part of the drug-review process. She also said so-called first cycle approvals are at a 20-year high with and said more than two-thirds of new drugs being approved within the six-to-10-month time frames given to new drug applications. In other cases companies are asked to submit more information, which prompts additional reviews, or drugs are rejected.
For More Information please use the below weblink: The Wall Street Journal - FDA's Drug-Approval Rate for 2011 on Pace to Exceed 2010
NextDocs:Using SharePoint 2010 with NextDocs as a Complete Quality Management System (QMS) - COMPLIMENTARY WEBINAR On July 12, 2011
A complete quality management system (QMS) includes solutions for CAPA, Deviations, Complaint Management and more, all operating as components of an integrated, closed-loop system. This is exactly what you will see during this one-hour online session.
Managing quality processes in accordance with 21 CFR Part 11 and related regulatory requirements involve collecting and documenting critical activities and incidents, and ensuring that appropriate notifications and actions follow.
During this session you will see a solution based on SharePoint 2010 including the ability to collect the required documentation, manage it in a compliant manner, notify the correct individuals and launch the required corrective or preventative processes. The result is an integrated, closed loop quality management system.
This one-hour session will cover:
An overview of SharePoint 2010 in the context of managing quality processes in a life sciences environment
A demonstration of a complete Deviation >> CAPA cycle, including initial documentation, notifications to the correct parties and generation of a resulting corrective action.
A discussion of how SharePoint 2010 addresses regulatory requirements for managing quality processes
For More information and Register to the webinar please use the below mentioned weblink: NextDocs Quality Management System - COMPLIMENTARY WEBINAR
Managing quality processes in accordance with 21 CFR Part 11 and related regulatory requirements involve collecting and documenting critical activities and incidents, and ensuring that appropriate notifications and actions follow.
During this session you will see a solution based on SharePoint 2010 including the ability to collect the required documentation, manage it in a compliant manner, notify the correct individuals and launch the required corrective or preventative processes. The result is an integrated, closed loop quality management system.
This one-hour session will cover:
An overview of SharePoint 2010 in the context of managing quality processes in a life sciences environment
A demonstration of a complete Deviation >> CAPA cycle, including initial documentation, notifications to the correct parties and generation of a resulting corrective action.
A discussion of how SharePoint 2010 addresses regulatory requirements for managing quality processes
For More information and Register to the webinar please use the below mentioned weblink: NextDocs Quality Management System - COMPLIMENTARY WEBINAR
10 July 2011
NextDocs Corporation: NextDocs Compliance with Key European Regulations - By Kathie Clark, Director, Product Management
Unlike the U.S. Food and Drug Administration, European Health Authorities do not have a single document that defines the authorities‟ position on electronic records and electronic signatures. That is, there is no single document that is the equivalent of Code of Federal Regulations, Title 21 - Food and Drugs, Part 11 - Electronic Records; Electronic Signatures.
NextDocs has been asked to provide a response to specific regulations that cover aspects of electronic records and electronic signatures. This paper provides a response to the requirements of four specific regulations.
Please use the following web link to read or download the white Paper: NextDocs Corporation: NextDocs Compliance with Key European Regulations
NextDocs has been asked to provide a response to specific regulations that cover aspects of electronic records and electronic signatures. This paper provides a response to the requirements of four specific regulations.
Please use the following web link to read or download the white Paper: NextDocs Corporation: NextDocs Compliance with Key European Regulations
06 July 2011
Regulatory Submission Publisher II - Job Opening in US
This position will be responsible for publishing electronic/paper regulatory submissions for US, European and rest of the world filings by working with Regulatory Affairs and project teams. If you possess 3 years of pharmaceutical/biotech industry experience with a minimum of 2 years of experience with publishing electronic/paper regulatory submissions.
Expert knowledge and experience with publishing eCTD submissions, and you're interested in working for an innovator in biotecnology, please contact me. Phone: +1 866-203-8227 x6606, or email:Sharon.Thornton@rightthinginc.com.
Expert knowledge and experience with publishing eCTD submissions, and you're interested in working for an innovator in biotecnology, please contact me. Phone: +1 866-203-8227 x6606, or email:Sharon.Thornton@rightthinginc.com.
DIA: Electronic Submissions 2011: 10th Anniversary Conference: Moving into the Next Generation of Electronic Submission Standards
Title:
Electronic Submissions 2011: 10th Anniversary Conference: Moving into the Next Generation of Electronic Submission Standards
Date(s) And Time(s):
Nov 16 2011 8:30AM - Nov 17 2011 5:00PM
Location:
The Westin San Diego Hotel
400 West Broadway
San Diego, CA 92101
Interest Area(s):
Regulatory Affairs,Document Management/ eSubmissions,IT/Validation,Medical Writing,Clinical Data Management/ eClinical,Project Management,Clinical Research
For more information about the conference please click here: DIA Electronic Submissions 2011: 10th Anniversary Conference
Electronic Submissions 2011: 10th Anniversary Conference: Moving into the Next Generation of Electronic Submission Standards
Date(s) And Time(s):
Nov 16 2011 8:30AM - Nov 17 2011 5:00PM
Location:
The Westin San Diego Hotel
400 West Broadway
San Diego, CA 92101
Interest Area(s):
Regulatory Affairs,Document Management/ eSubmissions,IT/Validation,Medical Writing,Clinical Data Management/ eClinical,Project Management,Clinical Research
For more information about the conference please click here: DIA Electronic Submissions 2011: 10th Anniversary Conference
Andrew Marr assesses the impact of the EMA announcement on Medicinal Product Information
Andrew Marr assesses the impact of the of the EMA announcement of 1 July 2011 on the mandatory provision of medicinal product information (EVMPD) by 2 July 2012. This article originally appeared on www.regulatoryaffairspharma.com.
Please click here to find more information: Andrew Marr assesses the impact of the EMA announcement on Medicinal Product Information
Please click here to find more information: Andrew Marr assesses the impact of the EMA announcement on Medicinal Product Information
AEMPS: Spanish Medicines Agency Released Version 2.0 of the National eSubmission Guidance
AEMPS: Spanish Medicines Agency Released Version 2.0 of the National eSubmission Guidance.
For More information about the Guidance please click here: AEMPS eSubmission Guidance
For More information about the Guidance please click here: AEMPS eSubmission Guidance
FDA: Updated Study Data Specification Guidance (Version 1.6)
The U.S. Food and Drug Administration (FDA) has released an updated version 1.6 of the "Study Data Specifications" used for submitting animal and human study datasets in electronic format.
The new version 1.6, version date 2011-06-22, includes now specifications for general toxicology and carcinogenicity data tabulation datasets. The corresponding "Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies" has just been released by CDISC as final version 3.0. (SEND IG 3.0). The SEND IG 3.0 is now referenced in the Study Data Specification 1.6 as Implementation Guide for which corresponding SDTM datasets are accepted by CDER starting with June 22, 2011.
For More Information Please click here: FDA: Updated Study Data Specification Guidance (Version 1.6)
The new version 1.6, version date 2011-06-22, includes now specifications for general toxicology and carcinogenicity data tabulation datasets. The corresponding "Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies" has just been released by CDISC as final version 3.0. (SEND IG 3.0). The SEND IG 3.0 is now referenced in the Study Data Specification 1.6 as Implementation Guide for which corresponding SDTM datasets are accepted by CDER starting with June 22, 2011.
For More Information Please click here: FDA: Updated Study Data Specification Guidance (Version 1.6)
05 July 2011
GlobalSubmit IT & IS Team Webinar :FDA views an electronic submission
upcoming web demonstration to discover the advantages of using GlobalSubmit 2010.
•See how the FDA views electronic submissions
•Build your application as the FDA sees it
•Cut days off the time it takes to quality check bookmarks and hyperlinks
•Improve your communications both internally and with the Agency
•Improve your team’s efficiency and meet important deadlines
•Reduce your risk of technical rejections
To Register the webinar click here: GlobalSubmit IT & IS Team Webinar :FDA views an electronic submission
•See how the FDA views electronic submissions
•Build your application as the FDA sees it
•Cut days off the time it takes to quality check bookmarks and hyperlinks
•Improve your communications both internally and with the Agency
•Improve your team’s efficiency and meet important deadlines
•Reduce your risk of technical rejections
To Register the webinar click here: GlobalSubmit IT & IS Team Webinar :FDA views an electronic submission
Apex Regulatory Blogspot: How to file eCTD in MRP/DCP - One decision already made?
When filing a new eCTD using the Mutual Recognition or Decentralised Procedure, you need to be aware of the following question:
“When an application refers to multiple strengths or dosage forms, should I create one eCTD covering ALL strengths and dosage forms, or should I create one eCTD for EACH?”
This is no concern under the centralised procedure, where one eCTD will be submitted to cover all dosage forms and strengths: i.e. there’s no room for discretion.The advantages and disadvantages of both approaches are discussed in the TIGes guidance, but can be summarised as follows:
For More Information please click here:Apex Regulatory Blogspot: How to file eCTD in MRP/DCP - One decision already made?
“When an application refers to multiple strengths or dosage forms, should I create one eCTD covering ALL strengths and dosage forms, or should I create one eCTD for EACH?”
This is no concern under the centralised procedure, where one eCTD will be submitted to cover all dosage forms and strengths: i.e. there’s no room for discretion.The advantages and disadvantages of both approaches are discussed in the TIGes guidance, but can be summarised as follows:
For More Information please click here:Apex Regulatory Blogspot: How to file eCTD in MRP/DCP - One decision already made?
02 July 2011
European Medicines Agency (EMA) publishes format for submission of information on medicines
Due to the new pharmacovigilance legislation implementation marketing authorisation holders (Pharmaceutical Companies) needs to submit electronic submission of information on medicinal products for human use to the European Medicines Agency.
The format shows the types of information that companies will need to submit to the Agency by the legal deadline of 2 July 2012.
For More Information please clikc here: EMA New format for submission of information on medicines
The format shows the types of information that companies will need to submit to the Agency by the legal deadline of 2 July 2012.
For More Information please clikc here: EMA New format for submission of information on medicines
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