IPQ: Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections

Incomplete or inaccurate facility information on NDA/ANDA form 356h cover letters are causing decisions on conducting preapproval inspections (PAIs) to be delayed or tabled, FDA field managers are reporting.

The cover letter problem was highlighted by PAI managers at their September meeting at the agency’s White Oak headquarters in Maryland. FDA has been receiving about 110-140 NDAs per year with each referencing, on average, six to eight establishments. A little more than half are foreign facilities.

Addressing PAI issues at an Xavier University/FDA Global Outsourcing Conference in Cincinnati in early October, Cincinnati District Investigator and Drug Preapproval Manager Kathleen Culver focused heavily on the September discussions regarding deficiencies being found in NDA/ANDA cover letters and the impact it is having on inspection planning.

To find more information please click here: IPQ: Incomplete NDA/ANDA Cover Letters Are Causing FDA to Delay Preapproval Inspections

GxP Perspectives: eCTD as Required Format for FDA Submissions

he electronic Common Technical Document (eCTD) is due to become a requirement in the immediate future (immediate in the FDA sense of the word). By 2017 FDA will have made the transition from paper to electronic submissions complete. Hopefully, the transition of most types of recordkeeping will also make the transition to electronic format. After the initial investment, this should cut the time and cost of bringing new health products to market. What do you need to know about eCTD? That’s the topic of Kathie Clark’s Guest Commentary.

Five Steps to Become eCTD Ready, by Kathie Clark

In FDA’s PDUFA V Commitment Letter 8-31-2011, the agency announced their intention of issuing draft guidance for required electronic submissions in eCTD format by December 31, 2012, with final guidance no more than 12 months after the close of the public comment period. Twenty-four months after publication of the final guidance, electronic submissions will be required for all new NDA and BLA submissions (originals, supplements and amendments) with a few specified exceptions.

Although many in industry were aware that the agency was preparing legislation to mandate eCTD, others have long been postponing moving to electronic submissions until FDA “pulled the trigger.” The good news is that FDA’s timeline still allows plenty of time for an orderly move to eCTD if plans are put in place now.

Here are some key steps to move to being eCTD-ready:

1. Get educated. If you are fortunate enough to have one or more team members with real experience in eCTD from a former employer, consider whether they can lead education and process transformation efforts needed to be eCTD-ready. However, be realistic about whether their day jobs allow for these activities. If you need help, consider sending employees for training – or better yet, bring in a knowledgeable consultant to educate your team and help them establish a plan for eCTD readiness. If you have more than a few employees who need training, it’s probably a more cost-effective approach, plus education can be tailored to the context of your submissions, taking into account what types of drugs or biologics you produce, whether generics are involved, which authorities you submit to, whether you will outsource or produce submissions in-house, and many other factors.

2. Understand and act on steps needed to make your source documents eCTD-ready. If you have been submitting paper eCTDs, you may not have been concerned about the quality or granularity of your PDF source documents. For more detail, see my recent article Five key steps for e-submission ready documents to avoid pre-submission rework on the Applied Clinical Trials website. It’s important to understand that you must produce submission-ready documents even if you plan to outsource submission preparation.

To find more information please click here: GxP Perspectives: eCTD as Required Format for FDA Submissions

EXTEDO Free Webinar: how EXTEDO's Pharmacovigilance Database and Reporting Solution can Simplify Drug Safety Management

Agenda for Webinar on November 7th

Speaker, Dr. Reinhard Nibler, will discuss drug safety issues and how EXTEDO's PcVmanager can help simplify the compliance process.

During the one hour webinar Dr. Nibler will cover the following topics:

PcVmanager - the All in One Pharmacovigilance Database System

Case creation, case import and follow-up: The basics of e-Pharmacovigilance Workflow: The different steps of case processing
Submission: Paper or electronic, U.S. or European Union - How to be prepared for all filing requirements
Search and Query: Get what you need quickly
Reports: Depict your results clearly

EXTEDO's PcVmanager is a drug safety management software solution based on the E2B and MedDRA standards that enables you to classify, create, review, submit, and maintain pharmacovigilance data and adverse event reports. PcVmanager helps you manage the life cycle of mandatory SUSAR and ICSR reports to the EMA (European Medicines Agency) and the NCAs via our integrated E2B gateway, as well as all reported Serious Adverse Events (SAE) for an overall safety re-evaluation.

PcVmanager fulfills the Adverse Events Reporting System (AERS) requirements of electronic submissions, streamlining the certificate controlled communication process using the FDA gateway and getting "real-time" acknowledgement of submissions.

A variety of regions are supported through different report formats, like MedWatch or CIOMS.

Duration - 60 minutes

Registration

Please note that there will be two presentation times on November 7th!

Starting Time for Session 1

3:00 p.m. European Time
2:00 p.m. UK Time
9:00 a.m. US East Coast Time (New York, EST)

Register for Session 1 please click here

EXTEDO Free Webinar: how EXTEDO's Pharmacovigilance Database and Reporting Solution can Simplify Drug Safety Management - Session 1


Starting Time for Session 2

8:30 p.m. European Time
7:30 p.m. UK Time
2:30 p.m. US East Coast Time (New York, EST)

Register for Session 2 please click here

EXTEDO Free Webinar: how EXTEDO's Pharmacovigilance Database and Reporting Solution can Simplify Drug Safety Management - Session 2

ETICS (A Project of the IRISS Forum) - ETICS Phase 1 Results Made Public

The reports created by the 3 regional ETICS teams were written in such a way that the identity of participants is encoded. A single comprehensive report for each region was issued. These are now being made available to the public and can be viewed or downloaded below.

The ETICS Team invites developers of new tools or established vendors who are making major changes to their tools to use the materials provided here as a test bed for confirming the correct operation of these tools.

The sample eCTDs along with the detailed description of the intentional error in each sample and the expected outcome provides software developers with the resources they need to evaluate the compliance of their tools.

Sponsors may wish to use these same resources to test the tools that they currently use or perhaps are evaluating.

To find more information and download the sample submission please click here:
ETICS (A Project of the IRISS Forum) - ETICS Phase 1 Results Made Public

Swissmedic: Electronic exchange of ICSRs

The European Medicines Agency (EMA) and other therapeutic products agencies in Australia, the USA and Singapore (TGA, FDA, HSA) currently accept reports of suspected adverse events of pharmaceuticals (individual case safety reports - ICSRs) electronically for direct processing in their databases. But Swissmedic does not yet have this facility.

Swissmedic has now launched a project in a bid to implement this international standard in the automatic electronic exchange of ICSRs between Swissmedic and the licence holders. The quality assurance requirements when exchanging ICSRs should in particular be met by means of a gateway.

The FPE-I project involves the development and implementation of a gateway for exchanging (sending and receiving) ICSRs electronically in E2B format along with an electronic acknowledgement that the reports have been received (ACK-log).

Within the scope of this project, the test and pilot phases are being carried out in collaboration with pharmaceutical companies involved in the Pharmacovigilance Interassociation Working Group (« interverbandliche Arbeitsgruppe Pharmacovigilance ») and guidelines are being drafted for the therapeutic products industry.

It will probably be possible to start exchanging ICSRs electronically between Swissmedic and the therapeutic products industry by the autumn 2012.

If you have any questions about the FPE-I (gateway) project, please write to pvgateway@swissmedic.ch.

Licence holders that have signed up to take part in the pilot phase can find all relevant information at (https://spextranet.admin.ch)
Back to overview Overview Pharmacovigilance

To find more information please click here: Swissmedic: Electronic exchange of ICSRs

EU CMDh to issue newly revised draft on automatic validation of eSubmissions

EU CMDh to issue newly revised draft on automatic validation of eSubmissions after consultation period ends.

To find more information please click here: EU CMDh to issue newly revised draft on automatic validation of eSubmissions

THE eCTD SUMMIT: Transitioning from Paper to eCTD - Updated Information

According to FDA, you can start with sequence number 0000 or you can use any other sequence number. Your software should allow you to change the sequence number from the default to any number, so I recommend that you continue with the sequence numbering you’ve been using in your paper submissions. From experience, I can tell you that this will avoid the logistical complications that crop up when you restart the sequence numbering at 0000 for your first eCTD submission.

UPDATE: Thanks to Missy Fussell of Allegro Solutions for updated information regarding sequence numbering. The post has been updated to incorporate the information she provided.

Please find more information by clicking the following weblink:
THE eCTD SUMMIT: Transitioning from Paper to eCTD - Updated Information

Six Questions to Ask Before Investing in a Digital Identity or Digital Signature Solution

Some people say that the answer to life is in the nature of the questions we ask. I believe the same is true when it comes to making good business decisions.

In a world that is going digital faster than it knows how to control the technology and its endless uses, asking the right questions can help avoid the kinds of decisions that deliver less than optimal results.

This is especially true when selecting digital identity and signature solutions.

We need to inquire about regulatory acceptance and the ability for a digital identity to be used in the world at large – not merely within the confined space of an individual company or the closed world of a slightly larger community.

The reality is that each of us and our respective employers exists in an ever-expanding cyber-community of other companies, government agencies, academia, CROs, etc. We need to be able to exchange and sign electronic information securely, seamlessly, and with full knowledge that the identity on the other end of the screen is truly who he or she asserts to be.

Digital identities and digital signing solutions that are compliant with the SAFE-BioPharma digital identity and digital signature standard provide distinct advantages over other commercially available digital signature solutions.

When evaluating any digital identity or digital signature solution, ask these questions. The answers will help determine if you’re about to get full value for this important decision.

To find more information please click here: Six Questions to Ask Before Investing in a Digital Identity or Digital Signature Solution

FDA: Federal Register Docket published - Draft Documents to Support Submission of an Electronic Common Technical Document (The eCTD Backbone Files Specification for Module 1 version 2.0) - Submit either electronic or written comments

FDA: Federal Register Docket published - Draft Documents to Support Submission of an Electronic Common Technical Document (The eCTD Backbone Files Specification for Module 1 version 2.0) - Submit either electronic or written comments The Food and Drug Administration (FDA) is announcing the availability of the following draft versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications entitled "The eCTD Backbone Files Specification for Module 1, version 2.0" (which includes the U.S. regional document type definition, version 3.0) and
"Comprehensive Table of Contents Headings and Hierarchy, version 2.0." Supporting technical files are also being made available on the Agency Web site. These draft documents represent FDA's major updates to Module 1 of the eCTD, which contains regional information.

DATES: Submit either electronic or written comments on the draft documents by [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER].

ADDRESSES: Submit written requests for single copies of the documents to the

Division of Drug Information,
Center for Drug Evaluation and Research (CDER).
Food and Drug Administration (FDA),
10903 New Hampshire Ave.,
Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002.

To find more information please click here: FDA: Federal Register Docket published - Draft Documents to Support Submission of an Electronic Common Technical Document (The eCTD Backbone Files Specification for Module 1 version 2.0) - Submit either electronic or written comments

THE eCTD SUMMIT: Webinar Recap: Understanding the New FDA Validation Criteria – Q&A

Q: FDA forms have PDF security. Is this a problem in validation, and if so, how should it be dealt with?
A: Any file in the forms sections will not be validated again PDF checks; for example, PDF security. Forms have special validation; for example, ensuring that the application number is correct.

Q: Some ICH regions have provided free validation tools as a collaborative effort between agency and vendor. Does FDA/GlobalSubmit have any plans to provide a free validation tool to industry?
A: Currently neither GlobalSubmit nor the FDA has plans to provide free validation tools to the industry.

Q: When will the new FDA Validation criteria version 2.0 be implemented at the agency? The FDA website says November 2011. Is this still the timeframe?
A: No, the tentative date is February 2012.

Q: How do we get a list of validation errors from the FDA from each of our submissions?
A:You should request the validation errors from your Project Manager.

To find more Q&A information please click here: THE eCTD SUMMIT: Webinar Recap: Understanding the New FDA Validation Criteria – Q&A

Ask CATO: Pre-IND Submissions in eCTD Format

Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission. However, since FDA assigns a Pre-IND number, which ultimately becomes the IND number, and Module 1 includes at least two places that are appropriate for including Pre-IND documents (either Module 1.12.1 or Module 1.6 for meeting-related documents), we should be able to make these submissions in eCTD format as well. Doing so would allow us to ease into the use of eCTD format, which would be especially useful when working with sponsors who are new to the eCTD format.

So, I recently asked the CDER Electronic Submissions team if it is possible to make Pre-IND submissions in eCTD format. As usual, I received a quick and helpful reply to my query, this time from Regulatory Information Specialist Valerie Gooding.

“Yes, it is possible to submit Pre-IND correspondence in eCTD format.”

She noted that the submission type in the Regional Metadata should be set to “Presubmission,” for any Pre-IND submissions. The initial IND that eventually follows follows should be set as the “Original Application,” regardless of the sequence number.

She confirmed that all Pre-IND meeting-related correspondence should be included in the appropriate Module 1.6 subsections instead of Module 1.12.1

To find more information click here: Ask CATO: Pre-IND Submissions in eCTD Format

EMA: Submission of Type IA, Type IAin and Quality Type IB variations in December 2011

EMA will be closed between 23 December 2011 and 2 January 2012 (inclusive).

Marketing Authorisation Holders are therefore advised, where possible, not to submit Type IA and Type IAin variation applications to the EMA after 28 November 2011 because the 30-day timeframe for the Agency to acknowledge the validity of the submitted Type IA and Type IA in variation(s) (see article 14 of Commission Regulation (EC) No 1234/2008) would coincide with the official closure of the EMA. Marketing Authorisation Holders intending to apply for Quality Type IB variations in December 2011 are encouraged to liaise with the EMA prior to their submission.

CSC Launches Total Regulatory Solution Strategy and Portfolio

Uniquely holistic, integrated, end-to-end product and services suite addresses the increasing demands of regulatory submissions management, transforming efficiency and speed to market for life sciences organisations.

CSC Life Sciences has unveiled its vision and solution portfolio for complete, end-to-end regulatory submissions management. CSC’s Total Regulatory Solution (TRS) is unique in the industry, being the only proposition to offer cradle-to-grave business process automation and management across the entire regulatory operations process.

In December 2010, CSC boosted its respected regulatory content management solution and services portfolio with the strategic acquisition of ISI, the leading provider of electronic publishing solutions to the life sciences industry. CSC TRS is the resulting, end-to-end software and regulatory services proposition, providing complete control and visibility across the creation, review, approval, consumption and exchange of regulated content as well as of other, associated mission-critical documents.

The acquisition also brought together two highly regarded managed-services businesses, giving life sciences organisations access to comprehensive support across their regulatory operations activities from a single global service provider.

“Today the regulatory landscape is more challenging than ever, as authorities implement new initiatives designed to ensure product quality and patient safety. Requirements include greater transparency and traceability, as well as the adoption of consistent processes for managing regulatory submissions, which must now be published electronically,” said Marty Magazzolo, Global Practice Director, Life Sciences Software Solutions Group at CSC.

To find more information please click here: CSC Launches Total Regulatory Solution Strategy and Portfolio

GlobalSubmit: Webinar Recap: Understanding the New FDA Validation Criteria

GlobalSubmit recently held an educational webinar on the Understanding the New FDA Validation Criteria.

The webinar was to provide an overview of the US FDA’s draft version of the new “Specification for eCTD Validation Criteria,” which outlines many of the new error conditions that the FDA will be checking for in the next version of its validation software. During the webinar, facilitated by Daniel Clark, Sr. Manager, Strategic Regulatory Innovation, Novo Nordisk Inc., GlobalSubmit’s CTO Jason Rock discussed the more important changes to the criteria, when the new validation criteria will go into effect, best practices for ensuring your application is free of technical errors, and more.

To find more information and to download the webinar slides please click the weblink:
GlobalSubmit: Webinar Recap: Understanding the New FDA Validation Criteria

FDA: CDRH's eMDR (Electronic Medical Device Reporting) Sep. 30th 2011 Webinar Recording Posted

The recording of CDRH's eMDR (electronic medical device reporting) webinar held on September 30th, 2011 has been posted on the eMDR webinar website. This presentation differs slightly from the previous three in that the there is a greater focus on implementation of an eMDR solution and an added presentation on event and evaluation codes.

To find the recorded webinar please click here: FDA: CDRH's eMDR (Electronic Medical Device Reporting) Sep. 30th 2011 Webinar Recording Posted

EXTEDO and ProductLife: Electronic PharmacoVigilancy (ePV): The new EMA guidance on EVMPD (July 2011), will we meet the July 2012 deadline? – A Complimentary Webinar

EXTEDO & ProductLife invite you to our next complimentary webinar on 27th October.

During this webinar, They will target the following questions:

But how MAH will face this major step toward ePV?
Have we a clear understanding on the information required on our products and how collect this information?
How are we going to meet the deadlines in 2012, internally, outsourced, a mix?
Are our IT systems ready?

To find more information and Registration please click here: EXTEDO and ProductLife: Electronic PharmacoVigilancy (ePV): The new EMA guidance on EVMPD (July 2011), will we meet the July 2012 deadline? – A Complimentary Webinar

eCTD indexer 1.4 Beta: Free Download

eCTD indexer 1.4 Beta – A free Tool to help us to generate eCTD XML backbones

The eCTD indexer was designed as an Open Source and accessible program that can generate the XML backbones.

eu-regional.xml and index.xml are required for submission of registration dossiers in the eCTD format. In order to use this software you need a basic understanding of XML.

To find more information about eCTD Indexer and download please click here:
eCTD indexer 1.4 Beta

eCTD Publisher - Long contract based Job

Currently looking for an eCTD Publisher for a year long contract based in Brussels.

Contact: ktierney@peglobal.net or 00353 21 4297900

Building the eCTD 2013 – eCTD Conference - January 2013 (No final dates) London, United Kingdom

Building the eCTD is a conference that covers topics such as:

Challenges of adopting the eCTD
Publishing and delivering regulatory submissions
Manage and Track multiple agency submissions
Regulatory requirements and the agency communications

Building the eCTD brings together delegates involved in Dossier Management, Regulatory Affairs, Data Management, Document Management, Electronic Publishing/ Submissions, Compliance, EDMS and IT/IS.

To find more information please click here: Building the eCTD 2013 – eCTD Conference - January 2013 (No final dates) London, United Kingdom

GlobalSubmit: eSubmission Digest: The GlobalSubmit Industry Newsletter

Thank you for your interest in our quarterly newsletter - eSubmission Digest.

To be added to our mailing list, please complete our very brief registration form by clicking the "Register Now" button below.

To Register Please click the following web link: GlobalSubmit: eSubmission Digest: The GlobalSubmit Industry Newsletter

eCTD Tips: Multiple eCTD Sequences in One Day?

I recently encountered a situation in which a sponsor needed to provide responses to multiple Information Request Letters to FDA before the end of the day in order for FDA to meet a decision deadline. Unfortunately, some of the responses were immediately available, while others might take until the end of the day to prepare.

I let our RPM know that it might be late in the day before all of the necessary information was available and therefore it would be close to the end of the workday before we could file a submission with our responses. She asked if I could go ahead and submit the information we already had in had, and then send in a second submission later in the day with the remaining information.

In my experience, the review divisions at FDA are not always up to speed with the latest procedures for eCTD submissions, and I was under the impression that the ESG will only accept once sequence per application per day. In fact, that “rule” was part of the institutional knowledge in my company. So, with the clock still ticking, I sent a quick email explaining the situation to the CDER eSubs team and asked whether or not we could submit more than one sequence in a day.

For more information click the below mentioned weblink: eCTD Tips: Multiple eCTD Sequences in One Day?

COI PharmaSuite: eCTD rent instead of buy

Smaller companies and pharmaceutical service will especially benefit from rental solutions, say the experts at COI GmbH in Erlangen. The specialists in the field refer to pharmaceutical / life science while at the lower cost compared to the full investment in special software.

The COI PharmaSuite offers the user the full functionality for drug approval and GxP documentation. At the same time, the financial contribution depends only on the number of clients. The user benefits from low monthly charges. Companies that do not require daily software for drug approval, or shrink from the expense of purchasing and maintenance.

To find more information click here: COI PharmaSuite: eCTD rent instead of buy

The Medical Products Agency (MPA) encourages applicants to use eSubmissions - Additional Administrative Guidance Issued

Electronic-only submissions within the MRP, DCP, and NP are accepted in eCTD or NeeS-format for human medical products and in VNeeS -format for veterinary medical products. If an application is made in an electronic format, subsequent submissions for that product are expected in the same format (unless upgraded from NeeS to eCTD).

Current guidelines for electronic submission must be followed (see Validation below). Please observe that also PDFs not included in the structure (e.g. mock-ups) have to be in PDF version 1.4 or above (preferably 1.4 or 1.7).

For identifying purposes, a paper copy of the cover letter included in the electronic submission should always be attached to the CD/DVD, but an original signature is not needed. The application form can be submitted in electronic format only.

Generally, signatures are not needed to be included (scanned) within the electronic submission.

If the application concerns an extension of a MA, the form “Confirmation for electronic-only submissions” (see Transition to an electronic format) should be attached in order to confirm that documentation for previously approved or submitted strengths and forms of the product will now be handled in electronic format only.

To find more information click the below mentioned web link
The Medical Products Agency (MPA) encourages applicants to use eSubmissions - Additional Administrative Guidance Issued

Senior eCTD Publisher Job - UK - Swindon - 12 months maternity cover

Job Title: Senior Regulatory Publisher


II. Basic Function:

The preparation, publishing, submission, maintenance, tracking and operational organization of any kind of paper and/or electronic submission for one or more regulatory projects and serving as regulatory publishing representative on project teams.

To work closely with business development resources to promote the service and generate new leads and opportunities.

III. Specific Activities, and Responsibilities:

o To lead and assist regulatory consultants in the preparation (assembly, publishing, printing and dispatching) of the regulatory dossier.
o Provide consultation, education and advice on the submission publishing process to internal consultants and external clients.
o Participate in regulatory project teams and interface with regulatory and clinical consultants to ensure timely submission of dossiers.
o Provide submission readiness assessments to submission project managers using system reports.
o Assist consultants with submission support through archiving submission related material and correspondence to and from Health Authorities.
o Ensure that submission standards are maintained and are readily available to the end users.
o To support the preparation and execution of IQ/OQ and PQ as required in support of software version updates.
o To maintain controlled documents in compliance with local and corporate policy and procedural requirements to include document management support for new Policies, SOPs and Forms, Change Control, Periodic Reviews and obsolete documents.
o To support continuous improvement of systems under Regulatory Publishing control to ensure system robustness, reliability and cost effectiveness and which meet the current and ongoing needs of the group and its clients.
o To ensure that you maintain a high level of current knowledge of eCTD and submission standards and other business systems and processes through personal development and training
o To provide a primary contact for consultants, clients and compliance groups with regards to eCTD, DMS/ Documentum and Compliance Wire applications
o To write clear concise SOP’s, reports and memos to a high technical standard as required.
o To make effective training presentations as required.
o To work closely with business development resources to promote the service and generate new leads and opportunities.

IV. Knowledge Requirements:

Education or Equivalent: (Minimum required to perform job)

• Degree qualified
• 2-3 years regulatory publishing experience using any eCTD system and DMS
• Evidence of ongoing IT skills training

V. Contact Information
Julie Cooper
Julie@mosaicrecruitment.co.uk

DIA: Are You Prepared to Move into the Next Generation of Electronic Submission Standards?

Now that DDMAC submissions will be accepted in eCTD format by FDA in 2012, there are many challenges that befall both industry and agency to comply with and scale-up their operations in support of the new guidance. This year’s conference will feature collaborative working sessions on specific topics and ICH modules that will give you the opportunity to interact and share ways to overcome the challenges you face.

Electronic Submissions 2011
Tutorials: November 15
Conference: November 16-17
The Westin San Diego Hotel, San Diego, CA

To find more information and Registration click here: DIA: Are You Prepared to Move into the Next Generation of Electronic Submission Standards?

GlobalSubmit: Free Educational Webinar on Understanding the New FDA Validation Criteria on Thursday, October 20th at 11:00am EDT

The US FDA recently posted a draft version of a new “Specification for eCTD Validation Criteria,” outlining many of the new error conditions that the FDA will be checking for in the next version of its validation software. With the FDA getting tougher on technical issues, it is critical that your application is not only structured correctly, but also free of technical errors, especially high severity errors. Most importantly, it must be ready for review by the agency upon submission. Based on the current quality of the submissions the FDA receives, many can expect to receive a technical rejection. This can cost a sponsor anywhere from 4 days to 1 week of delayed approval time and tens of thousands of dollars (possibly much more depending on the expected product revenue), not to mention the man hours spent correcting the issue.

That’s why GlobalSubmit is offering a free educational webinar on Understanding the New FDA Validation Criteria on Thursday, October 20th at 11:00am EDT.

During this discussion, we will focus on some of the more important changes to the criteria, when the new validation criteria will go into effect, best practices for ensuring your application is free of technical errors, and more.

Top 3 Learning Objectives:

Understand why there are new validation criteria

Understand how the FDA uses these validation criteria

Learn how the new validation criteria affects you

To find more information and Registration please click the below mentioned weblink
GlobalSubmit: Free Educational Webinar on Understanding the New FDA Validation Criteria on Thursday, October 20th at 11:00am EDT

Mission3: Move Into the Fast Lane with eTMF - Educational webinar

An educational webinar to inform attendees about the benefit of eTMF and getting them out from under the pile of regulatory binders. Occurring October 21st at 10am PST.

To registeration and more information click here: Mission3: Move Into the Fast Lane with eTMF - Educational webinar

Companies Need To Prepare Themeslves For The Big Data Challenge

With transactional data volumes reaching billions a day, Big Data is a big concern for business. Thus, Big Data is also big business for technology providers working to address the associated requirements, costs and long-term ramifications of the data explosion/deluge. There’s an entirely new market building rapidly around Big Data to address challenges like capture, storage, search, sharing, analytics and visualizing, among others.

A May 2011 McKinsey Global Institute report estimated that nearly all sectors in the U.S. economy had at least an average of 200 terabytes of stored data by 2009 – and that was two years ago and already twice the size of Walmart’s data warehouse in 1999 – per company with more than 1,000 employees. How quickly data volumes have moved beyond gigabytes to terabytes, and they will only continue to increase.

Such large volumes of data used to be generated predominately as a result of human-driven interaction: texting, online retail purchases, stock trades and so on. But in the new digital age, more and more data is now machine-generated. It is this machine-generated data, ranging from Call Detail Records (CDRs) and automated stock trades to smart meter sensors, security monitoring appliances, and test and measurement devices, that is expected to form the bulk of data growth into the future.

To find more information click here: Companies Need To Prepare Themeslves For The Big Data Challenge

Seminar: Points to note eCTD application and Practices in Tokyo - Japan

Point change and the utilization of internal processes and outsourcing for the creation of eCTD, the process of applying for eCTD real good explanation of experienced teachers?


Point of course

If the NDA went on eCTD, approval Attachment (CTD) eliminates the need for attachment of the third part of the fifth part in the big pharmaceutical companies have had the benefits, one can create an entirely eCTD One challenge that is. Point change and the utilization of internal processes and outsourcing for the creation of eCTD, doing commentary for the application process for the actual eCTD. Furthermore, QC is performed to explain and support eCTD ER / ES will need when applying for eCTD.

Knowledge can be learned

Such as the idea of ​​ER / ES Considerations when outsourcing considerations when creating eCTD eCTD application process to build house / outline of how to proceed · eCTD eCTD implementation project.

Program

1. NDA and the current review

(A) MHLW and PMDA
(B) of the examination and approval flow (c) query and response characteristics of the items (d) public information after approval

2. eCTD and is

(A) the history of the eCTD (b) Structure of eCTD (c) creating a flow of eCTD (d) Regulatory Considerations for eCTD applications

3. Preparing to apply for eCTD

(A) corresponds ER / ES (b) Considerations for the introduction of eCTD (c) implementation procedures eCTD (d) factors when deciding to outsource their creation and

4. apply quality assurance related to the eCTD

(A) QA and QC
(B) the selection of outside contractors (c) ensure the quality of the eCTD

5. Question and answer session

To find more information about the webinar click here: Seminar: Points to note eCTD application and Practices in Tokyo - Japan

CUSTOpharmBlog: FDA eCTD ANDA Submission Statistics

100% of Original ANDAs being submitted are in CTD format (eCTD+paper CTD+Gateway).

Approximately 95% (or more) of original submissions are now electronic.

Gateway submissions have continued to surge tremendously 58=(2008) 178=(2009) 411=(2010) 611=(2011).

RTR's as a percent of submissions is about 17% (data is incomplete as all of FY 2011 submissions have not been reviewed) FY 2008=15%, FY 2009=9%, FY 2010=14%.

FDA currently has approximately 2500 ANDA's under review.

FDA currently has approximately 4900 CMC Supplements under review.

To find more information click here: CUSTOpharmBlog: FDA eCTD ANDA Submission Statistics

Update report on the Agency’s EU Telematics: Operations report

Management Board meeting 6 October 2011

Background note

As agreed by the Management Board on 19 December 2002, the European Medicines Agency (the Agency) presents regular status and progress reports on Eudra Telematics implementation at each meeting.

Matters for consideration

This is the 31st report, covering the period from 1 January 2011 to 31 August 2011.
On this occasion, following the review by the Management Board Telematics Committee (MBTC), the reporting format has been changed in such that two reports are presented instead of one: The first report addresses the operational aspects and is attached below; the second report addresses projects and is presented for discussion under point 7bis. The reason for this division is that the reporting period for projects will not necessarily be the same as the reporting period for operations. Consequently, this new approach provides the timeliest information
on both topics.

To find more information click here: Update report on the Agency’s EU Telematics: Operations report

THE eCTD SUMMIT: Regulatory Submissions Made Easy, Part II - By Matthew J. Neal

Today’s entry was provided by Matthew J. Neal, Director of Knowledge Management & Innovation in Global Regulatory Affairs & Safety at Amgen, Inc. in Thousand Oaks, CA. He led the Regulatory Operations group there for seven years and managed submissions for GSK in Philadelphia, PA for 7 years before that.

So, last time, I told you about assembling a team of believers. Those believers are the “customers” you serve on both sides of the fence in regulatory operations. Not only are you getting documents from all the different members of the extended filing team (Regulatory, CMC, Pre-Clinical, etc.), but you’re then serving a different master in your health authority. If you need to review, please read the previous post.

This time, I want to focus on getting the most out of the tools and process which drives your efficiency. Getting to the heart of the matter, operations functions of all shapes and sizes exist – and so do solutions to meet those needs. While it is true that you can create a valid eCTD with some very simple and inexpensive software tools, there is no way I would want to do it by those means.

To find more information click here: THE eCTD SUMMIT: Regulatory Submissions Made Easy, Part II - By Matthew J. Neal

Five key steps for e-submission ready documents to avoid pre-submission rework - By Kathie Clark

It's been said that a new drug application is 100,000 pages (or more) in support of a label. While this might be a simplified view, it does provide some idea of the scope and challenges involved in preparing the enormous body of documentation that is needed to convince a regulatory authority that a product is safe and effective.

In taking a closer look at the required documentation, it's easy to see that a number of challenges await those responsible for assembling the submission:

Administrative and prescribing information. Agencies require a variety of forms, which may be locked down PDF fillable forms, XML forms, or scanned paper. Correspondence and certifications are required that may originate from a variety of different sources. Labeling required in a submission may take several forms ranging from MS Word documents showing tracked changes for draft labeling to XML (e.g., FDA's Structured Product Information).

Summaries and overviews. Because the documents depend on being able to analyze and reference final documents in other parts of the submission, the ability to finalize them depends on the other documents being available and stable.

Quality documents. In this area, the submission publisher must locate the correct content taking into account document versions and specific authority requirements. For example, different stability documents and compendial excipients may apply in different parts of the world, despite the harmonization goals of the International Council on Harmonization. Other challenges include the need to include scanned content such as batch records as well as manufacturing documents that may be subject to late modifications during manufacturing scale-up.

Nonclinical reports. Because the nonclinical program is so lengthy for most products, reports may be needed that were created five years ago or even earlier. The reports were often created by contract research organizations (CROs) or by scientists no longer working on the drug project. These factors often contribute to difficulties in locating reports and in issues related to the fact that they were not created to current standards.

Clinical reports. Clinical reports represent the largest portion of submission content, averaging around two-thirds of an application. In this area, the publisher must work with study reports that may not have been formatted in accordance with agency requirements, or that many exist in many small pieces. In the United States, a large volume of case report forms and SAS datasets must be assembled in accordance with their own specifications.

In the world of paper submissions, the assembly process was complicated, but largely free of technical compliance requirements. In other words, the publisher could take documents in many formats, assemble and print them, with the main concern being the appearance of the final paper product. If a problem was found, often a replacement page could be slipped in at the last moment.

Now, electronic submissions standards place many technical requirements on the individual documents included in a submission, resulting in a new set of quality assurance responsibilities that sometimes fall on a documentation group, but more often end up with the regulatory publisher.


To find more information please use the below mentioned weblink
Five key steps for e-submission ready documents to avoid pre-submission rework - By Kathie Clark

Exalon: Belgian FAGG revokes previously released bug fixed version 2.9.b of the NeeS checker

The Belgian Federal Agency for Medicines and Health Products (FAGG) has revoke the previously released version v.2.9.b (see our related News Article from September) of the "NeeS checker".

Quotation: "Because of bug in Checker v.2.9., this version was replaced with the previous one, Checker v.2.9.a.) Please uninstall checker 2.9.b before re-installing checker 2.9.a"

To find more information please click here: Exalon: Belgian FAGG revokes previously released bug fixed version 2.9.b of the NeeS checker

GlobalSubmit: Free White Paper: FDA Review Process, A Technical Look

In this white paper, GlobalSubmit covers the full FDA review process to help you create an application that is technically sound, structured correctly, and most importantly, is ready for agency review.

To receiver free copy, please complete GlobalSubmit registration form by clicking the below mentioned web link.

GlobalSubmit: Free White Paper: FDA Review Process, A Technical Look

NextDocs and Extedo: INTEGRATED REGULATORY COMPLIANCE MANAGEMENT From Concept to Real World - Germany - Half-Day Complimentary Workshop

NextDocs and EXTEDO invite you to a half-day workshop covering the hot topics of eCTD / electronic submissions and document management.

Experts from the leading service and solution providers will share their experience through presentations and live demos. Chance to get See first-hand how easily documents and submissions can be managed using EXTEDO eCTDmanager integrated with the SharePoint-based Document Management System from NextDocs.

When: Thursday, November 10th , 2011 - 13:30 PM - 17:30 PM

Where: FOM University of Applied Sciences
Room A03
Arnulfstrasse 30 - about 100m from “Hauptbahnhof” / Main Station
80335 Munich

To find more more information Registration for this webinar click below mentioned weblink

NextDocs and Extedo: INTEGRATED REGULATORY COMPLIANCE MANAGEMENT From Concept to Real World - Germany - Half-Day Complimentary Workshop

Ask Cato: Health Canada Increases Acceptance of eCTD Electronic-only Filings

Late last week, Health Canada (HC) announced that it is further expanding its acceptance of regulatory submissions in the eCTD electronic-only format. In addition the submission types already accepted in eCTD electronic-only format (including those added to the list earlier this year), HC will now also accept these submission types:

■ Request for Priority Review Status: New Drug Submissions (PRNDS) and Supplement toa New Drug Submission (PRSNDS)
■ Pre-Submission Meeting Information
■ Drug Identification Number Application (DINA)
■ Drug Identification Number Application – Biologic (DINB)

To find more information please click the below mentioned weblink

Ask Cato: Health Canada Increases Acceptance of eCTD Electronic-only Filings

FXConferences: Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD)

The European Medicines Agency (EMA) recently announced that Marketing Authorisation Holders will have to provide medicinal product information for all authorised products in the European Union by July 2, 2012. This means an additional 400,000 records will need to be added to the Eudravigilance Medicinal Product Dictionary in less than 12 months, and information for 100,000 previously submitted products will need to be updated to meet new data and document requirements. This massive undertaking will impact every company with a medicinal product registered in the EU.

For More information click here: FXConferences: Complying with EMA's New Mandatory Requirements for Medicinal Product Information (EVMPD)

Exalon: Health Canada increases scope of submissions being accepted in eCTD electronic-only filing format

Health Canada has further increased it's scope of submissions that are accepted in eCTD-only format. In addition to the announcement in May this year (see our previous News Article) the following submission types are accepted in eCTD-only format (requiring only the cover letter to be submitted as paper original in addition):

Request for Priority Review Status:

New Drug Submissions (PRNDS) and Supplement to a New Drug Submission (PRSNDS): The Clinical Assessment Package filed to support a Priority Review Request should be currently filed as leaf elements under the m1-2-8-other-application-information subheading, at this time. When the related submission is filed, the priority review acceptance letter should also be filed under the m1-2-8-other-application-information subheading.

Pre-Submission Meeting Information:

As for the PRNDS and PRSNDS, the corresponding information should be currently filed as leaf elements under the m1-2-8-other-application-information subheading. For all leaf files provided as part of the Pre-Submission Meeting Package, the operation attribute in the leaf element should be “new”, with the possible exception of the Life Cycle Management (LCM) table. When a document is revised in relation to the pre-submission meeting, the operation attribute should be “replace”. Please note: Sponsors may be required to provide printed copies of the Pre-Submission Meeting Package, upon request.

For More information click here: Exalon: Health Canada increases scope of submissions being accepted in eCTD electronic-only filing format

Pharmalot: Why Contract Research Organizations Are Hot

With more drugmakers outsourcing more trials to contract research organizations, few should be surprised that the CRO sector is generating investor interest. The attention-grabbing deal announced yesterday in which two private equity firms - Carlyle Group and Hellman & Friedman - agreed to pay $3.9 billion in cash to buy Pharmaceutical Product Development is no random bet.

Might there more be more such acquisitions? Clearly, CROs are on the radar screen. Why? For one thing, prices are rising. A survey by RW Baird analyst Eric Coldwell found 42 percent of drugmakers say prices rose in this year’s second quarter, up from one-third in the first quarter. The backdrop is a projected 3.6 percent to 8 percent growth in R&D budgets, on average, among drugmakers and biotechs.

Large and mid-sized drugmakers reported fewer price decreases, while small firms, which include biotechs, reported more price decreases in the his most recent survey. Howeve, the magnitude of price decreases was flat to lower across the board. “The vast majority of internal pharma staff surveyed believe that they are spending the same, or more, per unit of outsourced work today than in the recent past,” Coldwell writes in an investor note.

For More information click here: Pharmalot: Why Contract Research Organizations Are Hot

The FDA eCTD M1 Specification (Draft guidance - only for Review Not for Implementation) Shared by Antoinette in box.net

The FDA eCTD M1 Specification (Draft guidance - only for Review Not for Implementation) Shared by Antoinette Azevedo box.net

Please note that this document is not yet officially posted by FDA.

To view or download the document document please use the below weblink.

The FDA eCTD M1 Specification (Draft guidance - only for Review Not for Implementation) Shared by Antoinette in box.net

Health Canada Update: Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) electronic-only filing format

Health Canada is pleased to announce an increase in the types of submissions being accepted in the electronic-only filing format for a subset of eCTD submissions.

The measures outlined in this Notice are effective immediately since they do not impose an obligation but rather provide more options for submission sponsors. Sponsors are encouraged to compile submissions using the most recent Guidance Documents and Notices.

This Notice is meant to be read in conjunction with the Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format. The guidance will be changed to reflect this Notice at a future date.

It is Health Canada's intention to continue to broaden the eCTD electronic-only scope and future plans include those submissions currently filed in the eCTD hybrid filing format.

To find more information please use the below mentioned weblink

Health Canada Update: Increased Scope of Submissions being accepted in Electronic Common Technical Document (eCTD) electronic-only filing format