Exalon:EU: Updated requirements from CMDh on electronic and paper submissions for MRP/DCP or National procedure

CMDh has released an updated version of the "Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for New Applications within MRP, DCP or National procedures", document CMDh/085/2008/Rev8, version date July 2011.

Compared to the previous revision 7 released in October 2010, only slight modifications were introduced:

Some footnotes were removed from Table 1 (electronic-only submissions) for the entries of Cyprus and Sweden. For Cyprus, entries were added in Table 3 (paper submissions) for the provision of electronic copies of the Product Information and Module 2 documents in MS Word format.

For More Information Please click here: Exalon:EU: Updated requirements from CMDh on electronic and paper submissions for MRP/DCP or National procedure

MasterControl: How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market –White Paper.

This white paper will discuss common challenges pertaining to document control encountered by most drug companies from the preclinical stage through the post-market phase, and how the MasterControl™ GxP process and document management software solution addresses such challenges to accelerate time to market and improve product quality.

Please click here to find more information: MasterControl: How Effective Document Management Helps Pharmaceutical Companies Accelerate Time to Market –White Paper.

CDISC: Medical Device Standard - Webinar Slides

CDISC: Medical Device Standard - Webinar Slides

To download the slides please click here: CDISC: Medical Device Standard - Webinar Slides download

Use of PDF File Format 1.7 (PDF Version 1.7) for Regulatory esubmissions

PDF (Portable Document Format) as a preferred format for regulatory esubmission in the pharmaceutical and biotechnology industry. Since 1999, the Adobe Acrobat Portable Document Format (PDF) is the building block of regulatory electronic submissions. All regulatory agencies those who are accepting PDF documents they have very strict requirements for the format and setting within PDF files.

Regulatory Agencies including FDA, and EMA published PDF Specification guidance. According to the guidance PDF files should be in File Format 1.4 (PDF version 1.4). Pharmaceutical and Biotechnological industry following the same and they are submitting there documents in PDF 1.4v to Regulatory agencies.

Recently ICH ESTRI (The International Conference on Harmonisation Electronic Standards for the Transfer of Regulatory Information) they have answered the question related to use of PDF version 1.7 documents for esubmissions they are recommending pharmaceutical industry and Regulatory agencies (Regional Authorities) to use PDF version 1.7 documents for regulatory submissions.

FDA Thoughts about use of PDF File Format 1.7

According to FDA esubmission team Currently FDA CDER accepting PDF 1.7 version documents However FDA working with PDF specifications they will be updating their PDF Specification document over the summer to reflect this change to PDF 1.7v, but the change is in fact active now. If sponsor will receive any validation error for using 1.7v PDF they can ignore the error. FDA we will not reject any esubmission based on PDF version of the document.

EMA Thoughts about use of PDF File Format 1.7

There is no any information about use of PDF version 1.7 from EMA. Even in the new EU Validation Criteria version 3.1 document (EU Validation Criteria version 3.0 will be effect from 1st Sep 2011) says PDF documents should be in 1.4v only.

However the EU Module 1 specification guidance being updated and will be published 31st of August 2011. It will clarify the use PDF v1.7 documents.

Swissmdic Thoughts about use of PDF File Format 1.7

According to Swissmedic eSubmission team the current Swiss eCTD validation criteria v1.1 and the Guidance for Industry on Providing Regulatory Information in eCTD Format v1.2 require PDF v1.4 documents, Swissmedic will not apply more tight restrictions than EU does in this respect. Therefore Swissmedic will accept PDF v1.7 as well and will change its requirements accordingly. Swissmedic will implement the same requirements as the EU has, which are based on

• The new EU validation criteria v3.1 to be implemented by EU on September 1, 2011
• The ICH Q&A document v1.20 dated June 16, 2011
• The ESTRI file format recommendation dated April 5, 2011

According to the current Swiss eCTD validation criteria v1.1 and the Guidance for Industry on Providing Regulatory Information in eCTD Format v1.2, the use of PDF v1.7 is not allowed and, as the validation engines still validate based on this, the use of PDF v1.7 will be apparent as B5 error during technical validation. As Swissmedic will now accept PDF v1.7 in spite of the current requirements, Swissmedic will expect sponsors to explicitly declare the use of PDF v1.7 documents by using the form 'FO Technical Validation'.

Health Canada Thoughts about use of PDF File Format 1.7

According to Health Canada guidance document, Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format, technical requirements for eCTD submissions can be found in section 4.1- file formats. It states the following:

The following components should be provided in both PDF (Adobe Acrobat, version 5.0, 6.0, or 7.0) and word-processed format:

• PM;
• Quality Overall Summary (QOS);
• Certified Product Information Document (CPID);
• Comprehensive Summary: Bioequivalence (CS:BE); and
• Responses to SDNs, Clarifaxes, NONs, and NODs.

Health Canada will accept higher version of PDF documents, Sponsor can use PDF v1.7 documents for Health Canada esubmissions.

Features of PDF version 1.7

The PDF 1.7 specification includes all of the functionality previously documented in the Adobe PDF Specifications for versions 1.0 through 1.6. The PDF 1.7 was approved by ISO Technical Committee 171 in January 2008 and published as ISO 32000-1:2008 on July 1, 2008. ISO 32000-1:2008 is the first ISO standard for the full function PDF.

In the PDF version1.7 new features includes increased presentation of 3D artwork; XFA 2.4 rich text elements and attributes; multiple file attachments (portable collections); document requirements for a PDF consumer application; new string types: PDFDocEncoded string, ASCII string, byte string; PKCS#7 with SHA384, SHA512 and RIPEMD160.

Exalon: Finnish Medicines Agency reports high percentage of electronic submissions received in the first year

The Finnish Medicines Agency (FIMEA) reports that the acceptance of electronic drug regulatory submissions in Finland has been widely embraced by applicants. Although FIMEA does accept drug regulatory dossiers in electronic format only for about 1 year, more than 80 percent of drug regulatory submissions submitted in the first half of 2011 were provided in electronic format.


However, FIMEA has concerns regarding the high number of NeeS dossiers received, as the NeeS format provides significant disadvantages compared to eCTD. According to the FIMEA, applications in NeeS format "are frequently low in quality, highly resource intensive and problematic in terms of future life-cycle management".

Of particular concern is also the fact that fresh NeeS applications continue to be submitted, event though the usage of eCTD format is highly preferred by the agency.

For More Information please click here: Exalon: Finnish Medicines Agency reports high percentage of electronic submissions received in the first year

EMA News: New validation criteria for electronic submissions from 1 September 2011

The European Medicines Agency is informing pharmaceutical companies that a new version of the validation criteria for electronic applications for human medicines is coming into effect on Thursday 1 September.

The Agency will be applying new electronic common technical document (eCTD) validation criteria (version 3.1) upon technical validation of all eCTD sequences received from this date. The Agency has agreed the new criteria with regulatory authorities in European Union (EU) Member States.

The Agency advises applicants to familiarise themselves with the new criteria. Applications that do not adhere to the new requirements will lead to a negative technical validation.

For More Information Please click here: EMA News: New validation criteria for electronic submissions from 1 September 2011

ICH Reports on Latest Activities (Electronic standards)

ICH’s M2 Expert Working Group, which was established in 1994 “to facilitate international electronic communication by evaluating and recommending, open and non-proprietary— to the extent possible—Electronic Standards for the Transfer of Regulatory Information (ESTRI) that will meet the requirements of the pharmaceutical companies and regulatory authorities.” The group works on standardizing electronic communications including the use of the common technical document (CTD). In 2010, ICH moved responsibility for the electronic common technical document (eCTRD) to a new committee called the M8 Expert Working Group. The M8 group is working to develop framework for developing technical solutions in relations to ICH E2B (Re) (clinical data safety management) and M5 (data elements and drug dictionaries).

For More Information please click here: ICH Reports on Latest Activities (Electronic standards)

Apex Regulatory's Blog : PDF Hyperlinking within the eCTD

The use of hypertext links in eCTD submissions to aid navigation within and between PDF documents is commonplace. Along with the use of bookmarks, links can play a vital role in accelerating and facilitating the eCTD review process. Whilst an eCTD will not necessarily fail technical validation if hyperlinks aren’t created correctly, validation tools should still show errors where this is the case, reporting a failure to comply with eCTD best practice rules.

eCTD Validation Criteria v3.0 (which will come into force September of this year) states that:

“The applicant should make every effort to address these areas [failure to comply with best practice criteria] 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 best practice criteria address some of the link formatting issues which any eCTD publisher will face. These will be addressed in the sections which follow.

When to link

The use of links within and between documents submitted in eCTD format is an important consideration for any submission publisher. There is no absolute rule set in stone which determines how many links should be created in any document, but the eCTD spec. v3.2.2 states that:

“Hypertext links throughout the document to support annotations, related sections, references, appendices, tables, or figures that are not located on the same page are helpful and improve navigation efficiency.”

The purpose of hypertext links, then, is to help the reviewer navigate through and between documents, and so this should always be in the mind of the publisher. Links to sections on the same page, for example, might not help the reviewer at all, and so such linking is merely an unnecessary waste of time.

For More Information click here: Apex Regulatory's Blog : PDF Hyperlinking within the eCTD

FDA: CDER Small Business Assistance Industry Workshop: Clinical Trials and Electronic Submissions

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) is announcing an industry workshop entitled ‘‘CDER Small Business Assistance – Clinical Trials and Electronic Submissions.” This two day event will be held in two California locations consecutively. The first workshop will be held in Los Angeles, CA, on September 26-27, 2011, followed by a second in San Francisco, CA, on September 28-29, 2011.

Location(s):

•Los Angeles, CA, September 26-27, 20111
•San Francisco, CA, September 28-29, 20112

Meeting Information

These meetings will not be taped or webcast.There is no fee to register for this meeting. Participants will receive confirmation of registration via e-mail.
As there are limited seats available, please notify us of cancellations one week in advance of the meeting. If you require special accommodations due to a disability, please contact CAPT Brenda Stodart at 301-796-3400, at CDERSmallBusiness@fda.hhs.gov at least 7 days in advance of the meeting.The purpose of this workshop is to educate the small pharmaceutical industry on FDA regulations and requirements as they pertain to different stages of the drug development process. CDER hopes to expand our outreach and encourage maximum attendance by offering the workshop in two separate locations.

Topics to be presented include:

•Clinical trial design - the phased approach and the staged approach
•FDA's Bioresearch Monitoring (BIMO) Inspection Program
•Challenges to conducting clinical research in the 21st century
•Practical concerns of electronic source documentation
•Different types of pharmacokinetic studies conducted during drug development
•Importance of bioequivalence studies
•Strategic Quality for Clinical Trials
•FDA inspection process
•eCTD (electronic Common Technical Document)
•ESG ( Electronic Submissions Gateway)
•eDRLS ( electronic Drug Registration and Listing)

For More Information please click here: FDA: CDER Small Business Assistance Industry Workshop: Clinical Trials and Electronic Submissions

LIQUENT COMPLIMENTARY WEBINAR SERIES: COMPLYING WITH THE EMA NEW PHARMACOVIGILANCE LEGISLATION

LIQUENT COMPLIMENTARY WEBINAR SERIES: COMPLYING WITH THE EMA NEW PHARMACOVIGILANCE LEGISLATION - Co-presented with Andrew Marr, Managing Director, Marr Consultancy Ltd.

TUESDAY, SEPTEMBER 13th
10:00-11:00 am EST
15:00-16:00 pm GMT

European Medicines Agency (EMA) has announced new requirements in support of the new EU pharmacovigilance legislation that will require the submission of medicinal product information for all authorized products in Europe with a deadline of 2 July 2012. This webinar will provide an overview of the changes related to EVMPD and ISO IDMP standards, timelines for implementation, and how LIQUENT can help ensure your compliance with the new legislation

Key Topics That will be covered:

•More details on the EMA announcement regarding EVMPD and ISO IDMP standards and the latest timelines for implementation

•What this means to you and what should you be doing in preparation

•How LIQUENT InSight® and Regulatory Services can help ensure your compliance with the new legislation.

•LIQUENT InSight® Platform's ability to automate generation of the automation of EVMPD XML message submission and the processing of the acknowledgement.

Please click here to register the webinar: LIQUENT COMPLIMENTARY WEBINAR SERIES: COMPLYING WITH THE EMA NEW PHARMACOVIGILANCE LEGISLATION

CSC: Complimentary Webinar: NeeS Publishing Made Easy - August 31st 2011, 10 am AEST

ISIToolBox, the industry's trusted standard for creating submission-ready documentation, slashes the time spent on manually intensive document processing tasks. The latest version of ISIToolBox includes eSubmission tools that facilitate simple and cost-effective processing of documents for both the electronic Common Technical Document and non-eCTD electronic submission standards; the latter has been adopted as an interim measure by agencies in Europe and Australia. Attend our complimenatry webinar to learn how ISIToolBox can help your team publish applications in NeeS format with ease.

To Register the webinar please click here: CSC: Complimentary Webinar: NeeS Publishing Made Easy - August 31st 2011, 10 am AEST

NextDocs: Managing Clinical Documents and Processes with SharePoint 2010 - Webinar Slides

Please click here to view the webinar: NextDocs: Managing Clinical Documents and Processes with SharePoint 2010 - Webinar Slides

48 Things Medical Writers Need for Clinical Study Reports (CSRs)

Contract medical writers sometimes find themselves hired to write a clinical study report (CSR) (or clinical trial report (CTR)) before their client has prepared all of the information needed for the report. This leads to frustration and causes delays in the CSR’s development. In turn, delayed CSR completion can extend the actual submission date of the product’s eCTD/marketing application-because CSRs are required content. Thus, the very painful result of delayed CSR preparation is the sponsor’s loss of considerable revenue for every day that the marketing application’s approval is delayed.

Stack of cashClearly, writing the CSR promptly, on study completion, is the wise course of action. Doing this can reduce the cost of generating the CSR, compared with writing the CSR months or even years after the study is closed. And one of the most effective things the sponsor can do to prepare for prompt CSR completion is to have the items listed below available when the medical writer begins drafting the CSR.

The items in this list include some documents and tools that must be available for CSR completion. However, some items are optional. Other items are needed only in specific circumstances, such as when specific clinical trial designs are used. This checklist applies to full-length CSRs that document the execution and completion of clinical studies of drug and biologic investigational products.

All documents listed here should be provided to the medical writer in electronic format, assuming the CSR will eventually be included in an electronic regulatory submission. If the documents are available only as hard copies, those should be scanned for incorporation into the CSR. If the writer only receives hard copies of the documents they need to work with, the cost of the CSR will be much higher than if they are given electronic copies. This is because the writer will have to scan the hard copies to convert them into electronic files in order to incorporate them into the CSR, which is a time-consuming activity.

For More Information please click here: 48 Things Medical Writers Need for Clinical Study Reports (CSRs)

THE eCTD SUMMIT:Regulatory Submissions Made Easy, Part I

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.

Did that title catch you? Did you think I was going to reveal the secrets of pulling together millions of pages of data, reports, and information into a cohesive, user-friendly, searchable, and (one could argue) beautiful unit commonly called the eCTD? Well, sorry. There is no way to do it easily. In the upcoming several part series, I hope to take you through some of the things that I think will lead to a better experience navigating the unbelievable complexity that surrounds regulatory submissions. There’s a lot of science in there – good thing the publishers don’t have to actually read it.

Hopefully some of these tips and comments will help you not only make your submissions better, but also give you some idea of how to explain your job at parties.

First order of business, make sure that the extended team (by this, I mean everyone – the Regulatory liaison, the CMC rep, the pre-clinical teams, the regulatory writers, the senior leaders that chose the submission date randomly 2-3 years ago) understands that you will be the last one to touch their stuff and without you, the submission does not go to the agency. Also, make sure they understand that rushing it out the door may lead to it not getting filed at all. Do not be afraid to stand your ground, but choose your battles wisely. You may only get away with one threat per filing – so make sure it’s real. You are the gatekeeper. With great power comes great responsibility.

For More Information click here: THE eCTD SUMMIT:Regulatory Submissions Made Easy, Part I

FDA CDER Small Business Webinar: "FDA Electronic Submissions Gateway (ESG)"

CDER's Small Business Assistance Program introduces a new webinar, "FDA Electronic Submissions Gateway (ESG)" which will focus on the Webtrader. The Webtrader function is commonly used for delivering drug registration and listing submissions, as well as other guidance compliant electronic submissions to the Agency.

This presentation will be given by Michael B. Fauntleroy, Agency Program Manager for the implementation of FDA's Electronic Submissions Gateway (ESG).

When: Tuesday August 16, 2011, 11:00 AM (EDT)

It is recommended that you register and obtain your password prior to the day of the event. You can register at: https://collaboration.fda.gov/sba6/event/registration.html
Web Address for viewing: https://collaboration.fda.gov/sba6/event/registration_login.html

Dial-in number: 1-212-287-1629 or 800-857-9682

Participant Code: 6794 (Participants will be asked to enter the code verbally)

Regulatory submissions in Latin America

Latin America is getting a lot of attention among pharmaceutical companies. Brazil and Mexico are already among the top ten ex-US markets. At the same time, diverse regulatory requirements across these markets create significant obstacles to efficient development and registration of new drugs. Some efforts are being made to harmonize submissions across the continent but complete harmonization is still a ways off.

Because of this lack of harmonization, it can be difficult to obtain information on the local requirements across Latin America. The following three presentations touch on different aspects of the drug submissions process and, together, provide a fairly complete picture.

For More information click here: Regulatory submissions in Latin America

National Organization for Medicines (Greek agency): Instructions for Submitting Dossiers in electronic format via Google Translate

The National Medicines Agency (EMEA) in an effort to facilitate, for practical reasons, the procedures for approval, amendment and renewal of registration of Pharmaceutical and Biological products for human and veterinary use and to reduce the volume of paper you receive, manage, archive and destroy, seek the cooperation of the companies concerned and is prior to any submission to take into account the following guidelines:

Pharmaceutical and Biological Products for Human Use

The requirements for filing on paper limited to submission of Modules 1, 2, and 3 in accordance with current standards.In addition, we recommend the above be submitted in electronic format (e-CTD, or non-e-CTD) to three (3) copies.
Note that the documentation concerning the non-clinical (Module 4) and clinical part (Module 5, for example, clinical efficacy studies, safety, bioequivalence etc.) recommended be submitted only in electronic form (e-CTD or non e-CTD) and not on paper, unless specifically requested.

Notice to Applicants http://ec.europa.eu/enterprise/pharmaceuticals/eudralex For filing for approval, amendment and renewal based on the e-CTD is recommended to follow the instructions on the website of the Notice to Applicants http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm # 2b and on the website EMEA ( www.emea.europa.eu ), which have already been posted texts with questions and answers. About the specifications of the e-CTD (for all regions of the world) can be found at the ICH ( http://estri.ich.org/ectd/ ), while information on the specifications of the EU Module 1 can be found at: HTTP : / / ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm
For electronic filing of applications are not compatible with standard e-CTD, ie non e-CTD Electronic Submissions, advised those concerned to follow the instructions posted on the EMEA website http://esubmission.emea.europa.eu and specific document: http://esubmission.emea.europa.eu/doc/eGuidance_Document% 201.4.pdf .

For more information please click here: National Organization for Medicines (Greek agency): Instructions for Submitting Dossiers in electronic format via Google Translate

Apex Regulatory's Blog: Document Granularity within the eCTD Structure

Deciding where a document should begin and end is one of the key considerations when drafting certain documents which are to be submitted as part of an eCTD submission. For the most part, the eCTD structure allows no legroom when deciding where and how to include a document as part of an eCTD. For example, your Cover Letter (section 1.0) and Application Form (section 1.2) cannot be submitted as one merged PDF document in either section.

For More Information Please click here: Apex Regulatory's Blog: Document Granularity within the eCTD Structure

BeckloffAssociate: Preparing for Mandatory eCTD Submissions to FDA by Greg A. Onyszchuk, Ph.D (White Paper)

A race car with no driver and no knowledge of the course will have little chance to complete the race. Similarly, an eCTD publishing system without knowledgeable and expert eCTD publishers, and without viable submission content, may not deliver much value for the sponsor.

For More information about this white paper please click here: BeckloffAssociate: Preparing for Mandatory eCTD Submissions to FDA by Greg A. Onyszchuk, Ph.D (White Paper)

Healtch Canada: Revised Draft Guidance Document: Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format.

Healtch Canada: Revised Draft Guidance Document: Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format.

Health Canada is pleased to announce the release of the revised draft Guidance for Industry:Preparation of Drug Submissions and Applications in the Common Technical Document (CTD)Format for a 60-day comment period. Once final, it will replace the 2003 Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format.

This guidance document will assist sponsors in the preparation of drug submissions and applications in the Common Technical Document (CTD) format developed by the International Conference on Harmonisation (ICH). It defines the regional requirements of submissions in CTD format, found in Modules 1 and 3.

please click here to find more information: Healtch Canada: Revised Draft Guidance Document: Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format.

CfPA: Building the eCTD for FDA Submission

CfPA: Building the eCTD for FDA Submission

New Brunswick, NJ, December 1-2, 2011

This course is intended for Professionals in the Pharmaceutical, Biotech and related fields who are responsible for compilation and submission of electronic applications to FDA.

For more information and Registration please click here: CfPA: Building the eCTD for FDA Submission

Introducing RPS – Taking eCTD To The Next Level - By Joel Finkle, Senior Strategist, Regulatory Informatics, CSC’s

By now, regulatory teams and IT departments within pharma companies have grown used to the precise demands of the FDA and equivalent overseas authorities when it comes to submitting dossiers in support of new drug license applications, amendments and updates, and product labeling. Rates for compliance with the current electronic common technical document (eCTD) standard are impressively high in the United States, which leads the way globally in electronic submissions. The eCTD standard dictates how documentation must be published and structured, to make it as easy as possible for the regulators to review. Unsurprisingly, since the standard originated here, the U.S. market was the first to make it mandatory for pharma companies to use the specification for electronic submissions. Other territories are following suit, but adoption rates across Europe, in particular, vary considerably.

Preparing For What Lies Ahead

The new refined version of the standard offers even greater efficiencies to the pharma industry. eCTD in its original form has been around for a long time now. Version 3.0 was issued in October 2002. Since then there have been only minor tweaks, until the arrival of eCTD version 4, that is — the new regulated product submission (RPS) standard, which aims to take eCTD to the next level.

Pharma organizations should not be alarmed by the emergence of what may at first seem to be further hoops to jump through. Particularly where companies are still in the early stages of eCTD adoption, advance awareness of the RPS specification offers an opportunity to refine processes as they go, knowing that the benefits are likely to outweigh any additional work that has to be done.

The emphasis of the new RPS standard is to build on the original goals of eCTD, adding more flexibility and robust capabilities, in recognition that the original eCTD standard has a number of limitations. The eCTD format is limited to human pharmaceuticals, for example. This has created inefficiencies for regulatory authorities such as the FDA. Currently, there are different electronic standards for each division, and not every division even has an electronic standard. The situation is costly for the FDA, which has to allocate staff to manage and maintain each of those systems. A single system covering all of the divisions — comprising food additives, medical devices, human therapeutics, and veterinary medicines — would simplify things considerably.

There are technical limitations, too, involving tagging and the way additional information is supported by eCTD, with differences emerging between different regions in the way that content gets handled, despite the standard having been designed to be international in scope. Similar restrictions apply to the way documents are managed across the lifecycle of a product, as amendments get made and old information is superseded.

The RPS standard has been in development since June 2007. The refined version, RPS Release 2, was released in January 2010. This has undergone extensive testing by all major user groups — sponsors, agencies, and software vendors — to ensure it meets everyone’s needs.

One change expected with the next release is simplification of the way information changes get made at the metadata level. For example, when an ingredient manufacturer changes its name, the sponsor must revise a vast number of documents, and there are metadata associated with each of those documents. In the current eCTD, there is no way to change the metadata associated with documents — you would have to mark each one as deleted, then add a new section to the submission with new metadata. In RPS, the document can just be marked as revised with the new metadata.

Something that emerged from testing of Release 2 is the need for a common interpretation of the way the RPS model has to work, in order to ensure all systems implement the model the same way, and to avoid scenarios where one agency’s review system might accept something that may be rejected by another. The current goal is to approve Release 2 as an ANSI standard late in 2012, with ISO approval sought immediately following.

For More Information please click here: Introducing RPS – Taking eCTD To The Next Level - By Joel Finkle

Adlib and Pfizer to Provide Webinar on Streamlining Regulatory Submissions to Avoid Rejections

BURLINGTON, ONTARIO, CANADA--(BUSINESS WIRE)--Adlib, the leading expert in Enterprise Content Transformation, today announced a complimentary live webinar titled “Pfizer Streamlines Pharma Submissions” on August 9, 2011, at 11:00 a.m. Eastern. Attendees will learn how Pfizer shortens submission times, improves inefficiencies and reduces time-consuming and error-prone PDF transformation problems. The Adlib Platform provides enterprise-grade, best-of-breed content-to-PDF transformation capabilities for document-intensive and highly regulated industries.

The requirements for Electronic Common Technical Document (eCTD)-compliant submissions are unique and must be applied to documents that are constantly evolving. As an Investigational New Drug Application (IND) or New Drug Application (NDA) submission is prepared, the incorporated documents are continuously under review, endlessly annotated and changing through internal and external improvements. This increases the risk of corrupting the submission, creating errors in post-production re-rendering. The revenue window for pharmaceutical companies is directly linked to the patent clock, so the speed of submission processing can add millions of dollars to a company’s bottom line.

Using an Enterprise Content Transformation solution, Pfizer is able to meet stringent government agency standards and drastically increase efficiency in the submission process while optimizing its revenue window of opportunity. In this webinar, representatives from Adlib and Pfizer will explain how Adlib’s Enterprise Content Transformation platform easily delivers submission-ready PDF renditions through an optimized regulatory submission process, resulting in increased revenue and improved speed-to-market. In addition to Pfizer, Adlib also saves millions of dollars in the submission process for leading pharmaceutical companies such as Bayer, Coley, Eli Lilly, Genentech and OSI.


What: Webinar titled “Pfizer Streamlines Pharma Submissions”

When: August 9, 2011 at 11:00 a.m. Eastern

To register please click here: Adlib and Pfizer to Provide Webinar on Streamlining Regulatory Submissions to Avoid Rejections

Applied Clinical Trials: Common Technical Document Development - Mary Jane Lunsford & Thomas Kalfas

Pharmaceutical and biotechnology companies are finding new innovative approaches to partnering with clinical research organizations (CROs) in order to add expertise to their internal team. In particular, smaller firms are collaborating with CROs in an effort to gain efficiency and cost effectiveness.1 Typically, smaller firms have outsourced a higher proportion of their total clinical research portfolio in order to obtain expertise that falls outside the scope of their core capabilities.2 Successful CRO partnerships can enhance the clinical development process and drug development companies recognize that speed-to-market is essential to gain advantage over their competitors.


One particular area where smaller firms typically depend on CROs is with Common Technical Document (CTD) development. Regulatory submissions are fraught with obstacles to meeting the submission deadlines, but challenges can be anticipated and creative solutions implemented to ensure success. A CRO's experiences with previous regulatory submissions provides historical knowledge of potential pitfalls while offering the sponsor quick resolution to unforeseen barriers (Figure 1).


The first step of the partnership is to clearly define the study-specific information and scope of work between the CRO and the sponsor. This can be easily accomplished using a detailed questionnaire that captures relevant information from each study that will be included in the CTD submission.

For More information please click here: Applied Clinical Trials: Common Technical Document Development - Mary Jane Lunsford & Thomas Kalfas

The eCTD Summit: Coming Soon: New eCTD Validation Criteria for the FDA

The US FDA has posted a draft version of a new “Specification for eCTD Validation Criteria” which can be found here. This document outlines many of the new error conditions that the FDA will be checking for in the next version of the validation software. I will be highlighting some of the more important changes to the criteria.

When is the FDA going to move to the new validation criteria?

The FDA has mentioned various estimated dates and the draft version does mention that the deployment is scheduled for June 2011; however, the new criteria have yet to be formally implemented. The last I’ve heard is that the new criteria is currently under test. The FDA is evaluating the changes, and will be moving to the new version sometime in the next few months. Currently they are still validating with the previous criteria, and using the GlobalSubmit VALIDATE version 4 to do so.

So what are some of the major changes to the criteria?

First off, there has been a lot of work done on cleaning up existing errors. Within the draft guidance, fourteen errors have been removed from the list. This was to clean up redundant checks, a change in the criteria, or the error can no longer be triggered based on the validation tools behavior.

For more information click here: The eCTD Summit: Coming Soon: New eCTD Validation Criteria for the FDA

Understanding submissions

I read an interesting article recently entitled, "Understanding the 505(b)(2) Approval Process." What I found most interesting was the clear and concise explanation of the clinical trial and the submission processes for the FDA. The clinical trial process is not new to me. I've been working with clients to help them with this work for over 10 years. Part of the submission section was new to me.

The basics of the submission process are clear. However, I did not know that there were three separate paths a company could pursue, based on their product – the main one is 505(b)(1). This path is for new drugs. The second one is 505(b)(2). This is for drugs that are not completely new products, yet they are not generics. Drugs chosen for this path may have the same active ingredients as a previously approved drug, but now the drug is formulated in a different delivery mechanism or with a different indication.

For More Information please click here: Understanding submissions

Acrobat for Life Sciences: Creating Linked PDF's Form a set of Word Files by Rick Borstein

Life Sciences organizations often have voluminous numbers of reports and corresponding reference material that need to be prepared for regulatory filings.

Many organizations generate Word and PDF documents which need to be converted in a cross-linked set of documents for submission or for internal use.

Using Microsoft Word, you can create a hyperlink to PDF document easily. Simply select some text in your Word document, right-click and choose hyperlink, then point to a PDF.

For More Information Please click here: Acrobat for Life Sciences: Creating Linked PDF's Form a set of Word Files by Rick Borstein

Updates to the FDA's Study Data Standards Resources page

US FDA updates and expands it's online information about "Study Data Standards" resources.

To find the information please click here: Updates to the FDA's Study Data Standards Resources page

Exalon: Danish Medicines Agency updated information on the format and submission requirements for eCTD / NeeS and paper

The Danish Medicines Agency (DKMA) has restructured the information regarding submission format for paper applications and electronic drug applications in eCTD / NeeS format. In parallel the instructions provided have been more detailed.

Formats still accepted are paper, eCTD and NeeS/VNeeS. The DKMA strongly prefers electronic formats. For human drugs,the eCTD is the preferred format. "Mixed" formats are no longer accepted: With the exception of the cover letter and (for the 1st eCTD submission of a product) the "Confirmation for eCTD submissions", all paper documents provided as supportive information to an electronic application in eCTD / NeeS format will no longer be processed, but destroyed. With regard to electronic applications, the DKMA does now consider applications that include acceptable electronic media (CD/DVD) as electronic submissions, unless the CD/DVD contains supportive working documents to a paper submissions.

For More information click here: Exalon: Danish Medicines Agency updated information on the format and submission requirements for eCTD / NeeS and paper