MarrConsultancy: Updated assessment of requirements for EVMPD data in Europe – Mandated by 2 July 2012 - Article by Andrew Marr

Andrew Marr has published a new article that further assesses the impact of the revised guidance on EVMPD issued by EMA on 1September 2011 together with key information provided at the EMA’s Information Day on EVMPD held on 22 September 2011.

He re-assessed the impact of the revised guidance on EVMPD issued by EMA on 1September 2011 together with key information provided at the EMA’s Information Day on EVMPD held on 22 September 2011.

To find more information and article please click here: MarrConsultancy: Updated assessment of requirements for EVMPD data in Europe – Mandated by 2 July 2012 - Article by Andrew Marr

FDA: Submit a Sample eCTD or Standardized Data Sample t Sample Submission Process

FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and offer the following steps to help smooth the process. The agency also offers a process for submitting sameple standardized datasets for validation. Sample submissions are tests only and not considered official submissions. They are not reviewed by FDA reviewers at any time. Follow the steps below to submit a sample.

For More Information please click here: FDA: Submit a Sample eCTD or Standardized Data Sample t Sample Submission Process

Fimea (Finnish Medicines Agency) - Updates on Frequently asked questions about electronic submissions

Could you mention some reasons why validation reports results may differ between NCAs and the Applicants?

In some cases the validation report results have been different even though Fimea and the Applicant have used the same validation tool. We have noticed that some times the Applicant has validated the data in their own document management system and, therefore, validated data is not identical to the CD/DVD sent to Fimea. To ensure that both parties are validating exactly the same data, please, validate the actual burned CD/DVD media before sending it to NCAs.

Can you please advice if there is an eCTD validator/checker tool available? As we will like to ensure there are no errors before we submit.

We know two vendors offering free validator tools that include required EU eCTD and NeeS validation criterias. These vendors have also developed eCTD review tools that are used by many NCA in Europa. Fimea uses Extedo’s validator “EURS is Yours”.

For more information click here: Fimea (Finnish Medicines Agency) - Updates on Frequently asked questions about electronic submissions

FDA CDRH : eMDR (Electronic Medical Device Reporting) Webinar - Free and no registration is required

This eMDR webinar being held this Friday (Today) September 30, 2011 at 1:30 PM EDT Please note that participants will not be able to enter the actual meeting until the host has logged in on the day of the event. To join the meeting Friday September 30, 2011.

This Webinar will differ slightly from the previous webinars. Firstly, it will feature a modified overview of eMDR which will hit on concepts relating to implementation of an electronic submission process. Secondly, there will be an added presentation covering how to use the Event Problem Codes and the newly unveiled Manufacturer Evaluation Codes.

You can enter into CDRH eMDR Web Meeting Room by clicking the below mentioned web link

CDRH eMDR Web Meeting Room Link

You can enter as a Guest by using your name or company name.

If you have any questions please feel free to e-mail at eMDR@fda.hhs.gov

Regards
Shakul

EDQM: E-Submissions for CEP Applications - Live Interactive Online Webinar

Programme Overview

This one-hour webinar on eSubmissions for CEP applications will provide an overview of the expectations of EDQM regarding eSubmissions. It will address the different formats (eCTD, NeeS, PDF) accepted, how to prepare a new submission, a revision/renewal application or a response to a request for additional information. Also addressed will be where to find information on eSubmissions.

The live interactive presentation will be given by an EDQM Scientific Officer with experience in the assessment of CEP applications and in electronic submissions. Attendees will gain an understanding of the expectations of EDQM regarding eSubmissions.

Who should attend

This webinar is designed for those working in the areas of CEP e-submissions, regulatory affairs and operations, document or dossier management, information management, information systems, publishing or other professionals responsible for compiling CEP submissions.

Important: Webinar participants located in India and China must register for the first session and can use a TOLL FREE telephone number. All other participants can listen either via VoIP or via a long distance call (chargeable from your service provider).

Date: Tuesday, 8 November 2011
Times : Asian/ European session : 9h00-10h00 CET OR European/American session: 15h00-16h00 CET
Duration: 60 minutes

For More Information please click here: EDQM: E-Submissions for CEP Applications - Live Interactive Online Webinar

IPQ: BLA CMC Problem Areas Include Lack of Transparency in Supplement Cover Letters, FDA Reports

FDA is urging sponsors filing Biologic License Application (BLA) supplements to clearly highlight the significant changes and their scope in the cover letter to expedite the agency review and approval process.

The advice reflects the agency’s experience that supplement filers are not always giving it a clear picture up-front, resulting in significant review delays or a Complete Response (CR) letter indicating that the application is not approvable in its current form.

In turn, providing too much information on aspects of existing facilities that have not changed – for example, through hyperlinks to prior submissions – can also slow down the process as the reviewer must take time determining what has changed and what has not.

For More Information please click here: IPQ: BLA CMC Problem Areas Include Lack of Transparency in Supplement Cover Letters, FDA Reports

Exalon: Belgian FAGG releases bug fixed version 2.9.b of the NeeS checker

The Belgian Federal Agency for Medicines and Health Products (FAGG) has released an updated version v.2.9.b of the NeeS checker.

For More information please click here:Exalon: Belgian FAGG releases bug fixed version 2.9.b of the NeeS checker

EXTEDO: First Regulatory Experts Meeting - on 11th November 2011 in Ottobrunn (near Munich), Germany

Objective of this meeting to develop requirements and options for an efficient approach that will provide your organization a strategic, long term solution for maintaining and submitting medicinal product information.

For More information please click here: EXTEDO: First Regulatory Experts Meeting - on 11th November 2011 in Ottobrunn (near Munich), Germany

ADLIB: European Changes in Regulatory Environment at LORENZ userBridge

From the first shot of espresso in the morning to the last bottle of Barolo at night, this year’s LORENZ userBridge is another winner. Held in the wonderful city of Turin (Torino), Italy the nearly 150 attendees – more than attended last year's twenty-fifth anniversary event – have enjoyed fantastic weather when not attending informative sessions held at the Starhotels Majestic - a suitably romantic venue, given that I have my wife as my traveling companion on this trip (right).

There have been many opportunities during this two-and-a-half-day event to learn about changes in the industry and about Lorenz’s product plans, as well as best practices related to submissions.

Among these was my presentation titled ‘Populating your eCTD - Submission Document Rendering." Follow-up discussions have so far been focused on life sciences requirements like removing same-page hyperlinks from PDFs rendered from source documents.

For More Information please click here: ADLIB: European Changes in Regulatory Environment at LORENZ userBridge

Electronic submission of information on medicines

The 2010 pharmacovigilance legislation required EMA to publish the format for the electronic submission of information on medicinal products for human use by 2 July 2011.

EMA is more or less on track, and the just-released Electronic submission of information on medicines give a good sense of the four-step approach that the agency will take towards implementation:

Phase one: Notification of the electronic submission format
Phase two: Electronic submission by marketing-authorisation holders
Phase three: Processing and validation of the submitted information
Phase four: Update of the format in compliance with the ISO IDMP standards

For More information click here: Electronic submission of information on medicines

Use of Hyperlinks in the Cover Letter for FDA eCTD Submissions

Use of Hyperlinks in the cover letter document – this is another important question as per as Regulatory Operation or Publishing Professional is concerned.

Answer for this question is yes we can use the Hyperlinks in the Cover letter document for eCTD Submissions.

Some of the Pharmaceutical/Biotech companies they are making hyperlinks in the cover letter documents and some of them are not making.

As per as FDA is concerned there is no any specific guidance or standard practice guidance for use of Hyperlinks in eSubmission except Portable Document Format (PDF) Specifications guidance version 2.0.

In this guidance FDA has clearly mentioned “Hypertext links and bookmarks improve navigation through PDF documents. For text, hypertext links throughout the body of the document to supporting annotations, related sections, references, appendices, tables, or figures that are not located on the same page as the narrative text are helpful to improve navigation efficiency.”

FDA eSubmission Team comments regarding use of Hyperlinks in Cover Letter Document
Hyperlinks in the cover letter to other sections of the application are encouraged and can be very helpful to reviewers to Review the submissions.

FDA recommending the sponsor to use Internal Hyperlinks (if there is any need) in the cover letter document however do not include any external hyperlinks (external to the current application) anywhere in the submission.

There are three possible ways for sponsor can make Internal Hyperlinks in the cover letter document.

1) Links within the cover letter document

Example: Page 1 Hyperlinks to Page 2 or 3

2) Create Internal Hyperlinks within the same sequence (For example consider seq 0000)

Example: Cover Document Hyperlinks To Section 1.3.1.1.Change of address Document

3) Create Internal Hyperlinks in the same application but in different sequences (For example consider seq 0001)

Example: Cover Document Hyperlinks To Section 1.3.1.1.Change of address Document

Linking to documents within the same sequence is acceptable and linking to documents in a different sequence in the same application is also acceptable.

However Making External Link is not allowed in the cover letter document. External applies only to linking to a document outside the current application.

For example, a cover letter in ANDA 123456 that links to cover letter in ANDA 456789).

ICH E2B(R3) Expert Working Group has released Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) for consultation.

The E2B(R3) Expert Working Group has finalised the Step 2 ICH Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs), Data Elements and Message Specification which includes the key parts of the updated E2B(R3) Guideline. As there are significant differences between the data models for E2B(R2) and E2B(R3), a Backwards and Forwards Compatibility (BFC) document has been produced as an Appendix to the Implementation Guide to define the compatibility of data elements between the two versions of the specification.

Fore information please click here: ICH E2B(R3) Expert Working Group has released Implementation Guide for Electronic Transmission of Individual Case Safety Reports (ICSRs) for consultation.

FDA CDER Electronic Data Team: SDTM Column Resizing Research - Background and Industry Testing Results

Due to Dataset File Size issue FDA can’t perform the regulatory review on timely manner. The FDA CDER Team conducted internal Quantitative Research on datasets file resize.

The internal research study concluded that significant file size differences exist between both legacy datasets and CDISC datasets, and between different file types used (JMP (.jmp), SAS v7 (.sas7bdat), and Transport v5 (.xpt)).

The have given some recommended action and possible solutions to the sponsors based on their research.

Industries (Sponsor) also involved in this testing through Pharma ERS group.

For more information and download the slides please use the following weblink: FDA CDER Electronic Data Team: SDTM Column Resizing Research - Background and Industry Testing Results

FDA Released Electronic Common Technical Document (eCTD) Module 1for review not for Implementation

FDA released new version of electronic common technical documents (eCTD) Module 1 documents including specification guidance, DTD, style sheets and New Attributes list.

These documents in draft (only for review not for implementation) FDA is working with Sponsors (Pharma/Biotech and Software vendors) Soon they will release the final guidance with some changes.

As per the new draft The Comprehensive Table of Contents Headings and Hierarchy document version 2.0 there are many additions and corrections of sections in module 1.
As per the new the eCTD Backbone Files Specification for Module 1 (Version 2.0), there are many changes in Module 1 specification including new attributes called submission sub-type, submission description, application contact, submission-id, submission unit id etc….

Apart from above mentioned documents FDA has released draft Regional DTD, Style Sheet, Module 1 new attributes list information.

For more information about the documents please navigate to the following FDA webpage.

(Kindly note these documents are only for review not for implementation).

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm253101.htm

LIQUENT and NextDocs: INTEGRATED REGULATORY COMPLIANCE MANAGEMENT - From Document to Submission - Complimentary Webinar

NextDocs and LIQUENT invite you to a complimentary webinar, covering topics of eCTD / electronic submissions and document management.

Experts will share their experience and will demonstrate how LIQUENT InSight® integrated with NextDocs SharePoint-based document management system simplifies document and submission management.

For more information about the Webinar and Registration please click here: LIQUENT and NextDocs: INTEGRATED REGULATORY COMPLIANCE MANAGEMENT - From Document to Submission - Complimentary Webinar

Aris Global: EVMPD - Off to New Horizons - A free Seminar

Learn how Aris Global solutions can help you successfully manage the changes brought about by the new EudraVigilance legislation framework.

For More information and to Register the seminar click here: Aris Global: EVMPD - Off to New Horizons - A free Seminar

Health Canada to stop sending Validation Reports for passed submissions to sponsor and update on current version of validation software

Health Canada announced as of October 1, 2011, Health Canada will no longer be providing the Validation Reports or email notifications for submissions that have passed validation to sponsor. However any submissions that have warnings or fails validation will still have a validation report sent to the sponsor.

The current version of validation software used by Health Canada is:

Software: docuBridge® eCTD Validator 3.0 SP1
Profile: eCTD Validator - Profile HC-SC-2-4

Fore more information click here: Notice - Health Canada to stop sending Validation Reports for passed submissions

Vault Blog: The Document Hunter Pt. 2: Why Life Sciences Document Management Has Failed And 4 Ways to Fix It - By Jennifer Goldsmith

Last post, I wrote about a clinical study project manager whose role had been reduced to nothing more than that of a document hunter. Instead of developing new and innovative means of study report creation, or paving the way for multimedia report review capabilities, she was spending 90% of her time just looking for documents. In my post I explained how life sciences companies got into this mess. The question now is, how do we fix it?


1) Get Back to Basics – First, take a step backwards and determine what is really necessary to improve how we find, manage, and use content today. For years, we added on bells and whistles that were seldom used, often broken, and difficult to maintain. Lesson learned: if it doesn’t help find a document more quickly, manage or share that content more easily, or allow organizations to adapt more rapidly to changing business and regulatory requirements, then it shouldn’t be done.

2) Collaborate in the Cloud – Remember when collaborating on content meant walking down the hall to meet with the team? Today we collaborate across teams, across organizations and across the world. Therefore, we need better, faster, and more secure ways of sharing information without the cost and overhead associated with VPNs, dedicated laptops, and other means of getting vendors and partners behind the firewall. How do we do this? Move to the regulated
cloud. For some time now, organizations have used the cloud to share everything from sensitive financial documentation to biomedical research. The result? Better collaboration that can be set up in minutes, not days, weeks, or even months.

3) For Goodness’ Sake, Make it Easy – When was the last time you heard a document management user exclaim, “I love my 3-day training course on searching!” or “Woo hoo, folder navigation refresher training is next week!” Yes, it’s probably been a while. So why do we still need intense training, 600-page user manuals, and other support mechanisms for our current systems when doing things like ordering a book on Amazon.com or searching with Google is so easy? It’s not that the latter processes are so much simpler; in fact, consumer website processes are actually more complex. It’s that most current document management systems were designed pre-consumer web and are thus often incompatible with a modern user’s behavior. Leveraging the commonly understood and well-proven design and functionality from the consumer web can make systems dramatically easier to use and maintain. In other words, no more 3-day training or 600-page manuals – just log in and go.

For more information please click here: Vault Blog: The Document Hunter Pt. 2: Why Life Sciences Document Management Has Failed And 4 Ways to Fix It - By Jennifer Goldsmith

QUMAS: The Evolution of Document Management in the Pharmaceutical Industry - By Paul Hands and Alan Weintraub

It is often said that a pharmaceutical company produces two products a drug and all the associated information that goes into the research, approval and manufacturing of the drug, In this article we will trace the evolution of document management in the pharmaceutical industry, highlighting the business gains and the subsequent regulations resulting from the movement of a very static set of information to the dynamic nature of electronic documents.

For More Information Please click here: QUMAS: The Evolution of Document Management in the Pharmaceutical Industry - By Paul Hands and Alan Weintraub

EMA: eCTD validation Criteria 3.0 wil be in effect

EMA: eCTD validation Criteria 3.0 wil be in effect from September 2011 for more information please click below weblink

EMA: eCTD validation Criteria 3.0 wil be in effect

IJPRD: Comparative Study of Dossier file submission Process of Drug Product in USA and Europe - Article by Devesh Sharma et al

To find the article please click here

IJPRD: Comparative Study of Dossier file submission Process of Drug Product in USA and Europe - Article by Devesh Sharma et al

GlobalSubmit: Transitioning from Paper to eCTD

Successful adoption of the eCTD involves the strategic assimilation of the right people and the right technology. It requires a clear understanding of the processes and best practices that ensure success. To provide some key insights into eCTD publishing, we asked Evan Richardson, Associate Director of Regulatory Operations, Cato Research to author today’s guest post.

For several years, experts from both industry and FDA have extolled the virtues of eCTD submissions. The message is clearly sinking in; FDA reports that almost 70% of new NDAs and 41% of new INDs are now submitted in eCTD format. There are obviously many benefits to switching from paper to eCTD submissions, but how do you take advantage of them if you’ve already filed your application in paper?

Fortunately, it’s relatively simple to convert your application from paper to eCTD. I’ll use an IND as an example in my explanation below, but the process applies to NDAs or BLAs as well.

Step 1: Check-In with Your FDA Regulatory Project Manager

Before beginning the conversion process, I recommend that you call your assigned Regulatory Project Manager (RPM) at FDA and let him or her know what you’re planning. A close and cordial working relationship with your RPM can be an invaluable asset, and I think it’s always a good idea to keep him/her apprised of any major submissions on the horizon. Almost certainly, your RPM will be very pleased to hear that you plan to convert to eCTD and will offer their blessing on the endeavor. Each FDA review division seems to have its own quirks, so you should also be sure to ask if there are any special concerns that you should keep in mind, just in case.

Step 2: File Your Last Paper Submission

You’ll file one last paper submission to your IND. This submission will consist of only a cover letter and a Form FDA 1571. In the cover letter, you should include a statement similar to the following:

The purpose of this submission is to notify the Division of [Sponsor]’s intention to submit all future submissions to IND xxxxxx in eCTD format through the Electronic Submissions Gateway (ESG). Currently, IND xxxxxx is submitted in paper format; henceforth, all submissions to IND xxxxxx will be in eCTD format (beginning with SN 0000).

(Note the reference to “SN 0000” in the last sentence. I’ll discuss this further later on.)

For More information please click here: GlobalSubmit: Transitioning from Paper to eCTD

NextDocs & Liquent: Integrated Regulatory Compliance Management - From Document to Submission - COMPLIMENTARY WEBINAR

NextDocs and Liquent invite you to a complimentary webinar, covering topics of eCTD / electronic submissions and document management.

Experts will share their experience and will demonstrate how Liquent InSight integrated with NextDocs SharePoint-based document management system simplifies document and submission management.

Sept. 27, 2011. 9 –10 AM ET and Sept. 27, 2011. 1–2 PM ET.

To get more information and Registration please click here: NextDocs & Liquent: Integrated Regulatory Compliance Management - From Document to Submission - COMPLIMENTARY WEBINAR

FXconferences: Using Short Style Guides to Harmonize Writers and Improve the Quality of Electronic Submissions

Many companies have style guides that span over 100 pages and cover everything from the fine points of template use to the details of punctuation preferences. While having these documents is a sign of a well-organized writing group, a smaller, project-specific style sheet of two to 10 pages can be used on large projects that call for cross-departmental work and/or the help of contractors.

For More information please click here: FXconferences: Using Short Style Guides to Harmonize Writers and Improve the Quality of Electronic Submissions

Pharma-IQ: Effective Information Management to Aid Regulatory Submissions: What Do You Do to Make it Work in Practice?

Pharmaceutical companies are placing even more importance on the pharma regulatory aspects of data and information management and how efficiently information is translated to drug market applications. Neil Gow, Head of Records Management for UCB, joins Helen Winsor from Pharma IQ, to discuss the challenges to efficient and effective information management in pharma and biotech.

For more information please click here: Pharma-IQ: Effective Information Management to Aid Regulatory Submissions: What Do You Do to Make it Work in Practice?

CSC: The changing face of regulatory outsourcing - Article - By Paul Chung, CSC Life Sciences.

Hit by a perfect storm of heightened regulatory scrutiny and a tougher business climate, life sciences companies are scrambling to find ways to cut costs and expand revenue. This has led to a growing trend across the life sciences industry as all departments, including research and development, are no longer considering if and when they should outsource, but how much.

In a supercharged business and regulatory climate, life sciences companies large and small are turning to outsourcing vendors to manage tactical tasks and help them adopt best practices. In a constrained business environment, companies are finding that good partnerships bring added efficiencies, the potential for greater market share and the skills and capabilities that enable products to be brought to market more rapidly and maintained well in diverse markets.

There are many reasons why companies turn to outsourcing partners: additional capacity, resource flexibility, cost savings, developing a new capability, process improvement and process standardization, to name a few. Given that regulatory submissions have quiet and busy periods, outsourcing offers a cost-effective and flexible way to manage the peaks and valleys without the need to retain a large in-house staff.

The growth of electronic submissions has encouraged companies to turn to outsourcing partners more frequently to manage product submissions. In part, this is a response to the need for additional resources to support affiliates, but it is also a result of electronic submission standardization that has allowed for greater consistency in how submissions are handled across geographies. It means regulatory practices that once were quite fragmented are more streamlined, allowing vendors to step in and manage clients’ submissions quickly and consistently.

While staff at pharma companies frequently handle such tasks as regulatory submissions, vendors do so day-in and day-out for various clients, thereby developing a level of proficiency that no pharma company could hope to emulate.

To find more information please click here: CSC: The changing face of regulatory outsourcing - Article - By Paul Chung, CSC Life Sciences.

EMA News: European Medicines Agency provides update on electronic submission of information on medicines

The European Medicines Agency has updated the detailed guidance on the electronic submission of information on human medicines to include the XML Schema Definition (XSD). It has also published a set of controlled vocabularies to support the submission process.

Marketing-authorisation holders can now submit XSD-compliant product information on all the medicines authorised or registered in the European Union (EU) using tools developed in-house by pharmaceutical companies or software vendors via the EudraVigilance Gateway.

The detailed guidance is now structured as five separate chapters and annexes on the new page documents for electronic submission of information on medicines. This page also includes controlled vocabularies, XSD schema files and naming conventions. The Agency will add other documents to this page as they become available.

For More information please click here: EMA News: European Medicines Agency provides update on electronic submission of information on medicines

FDA: The Division of Drug Marketing, Advertising, and Communications (DDMAC) does not accept submissions in eCTD format or via the Electronic Secure Gateway (ESG).

CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) does not accept submissions in eCTD format or via the Electronic Secure Gateway at this time. If received, these submissions will be rejected by CDER. For information about submissions to DDMAC.

For more information please click here: FDA: The Division of Drug Marketing, Advertising, and Communications (DDMAC) does not accept submissions in eCTD format or via the Electronic Secure Gateway (ESG).

Exalon: EU: Updated harmonized guidances for eCTD and NeeS released by TIGes

The EU Telematics Implementation Group - electronic submissions (TIGes) has released a new version 2.0 of the "TIGes Harmonised Guidance for eCTD Submissions in the EU" and a new version 3.0 of the corresponding Harmonised Guidance for NeeS (human medicinal products).

Both guidance documents have been changed significantly. Corresponding changes have been detailed in the respective release Notes:

TIGes Harmonised Guidance for eCTD Submissions in the EU, version 2.0, August 2011

Release Notes for TIGes eCTD Guidance – Comparison of version 2.0 with 1.0

TIGes Harmonised Guidance for Non-eCTD electronic Submissions (NeeS) for human medicinal products in the EU, version 3.0, August 2011

Release Notes for EU NeeS Guidance – Comparison of version 3.0 with 2.0

For More information please click here: Exalon: EU: Updated harmonized guidances for eCTD and NeeS released by TIGes

CDISC: Public Review: SDTM Virology Draft Domains

FDA's CDER has recognized a critical need for the development of standards to accommodate the virology data accompanying submissions in multiple therapeutic areas. To address this need, CDER has worked with CDISC to develop a possible solution. Two new SDTM domains to house virologic genotypic (VG) and phenotypic (VP) are proposed. The VG and VP domains are structured as Findings domains that can stand alone or be folded into the constellation of domains called PGx that are currently being drafted. While PGx is designed to house subject-level data, VP and VG are intended to house pathogen-level data.

For More information please click here: CDISC: Public Review: SDTM Virology Draft Domains

Exalon: BE: New version of eSubmission Guideline released by FAHMP

The Belgian Federal Agency for Medicines and Health Products (FAHMP) has released a new version of their national "eSubmission Guidelines" document, version 2.10 which will be in force from today, 01. September 2011.


The new version of the "eSubmission Guidelines" takes into account the new EU eCTD validation criteria 3.1 and NeeS validation criteria 2.1 that are in force since 01. September 2011. Consequently, significant changes have been introduced in the new version:

The previously used Belgian "FAGGeCTDChecker" has been updated. It is now called "NeeS" checker and will no longer be used for eCTD submissions. According to the new eCTD validation criteria 3.1, non-conformity to the recommended file/folder naming convention constitutes a violation against "Best Practice" guidance but will not result in a "Fail" of the corresponding criteria 15.BP2 and 15.BP3. Consequently, such deviations will not automatically lead to a rejection by the FAHMP and should be justified in the cover letter or rewiewer's guide. (Note: This is a change to previous procedures, where electronic submissions in eCTD and NeeS format that did not reach the pre-defined score according to the FAHMP roadmap were rejected)

For More information please click here: Exalon: BE: New version of eSubmission Guideline released by FAHMP

Exalon: New draft EU Module 1 eCTD specification 1.4.1 available for consultation

A new draft version of the EU regional eCTD Module 1 specification, version 1.4.1 has been published by the European Medicines Agency today. The draft includes some additional change requests and Q&A and is open for consultation for a short period until September 07. Among the more prominent proposed changes are:

EU M1 envelope:

New submission type attribute value added in the EU M1 envelope: lou = "Letter of Untertaking"
Clarification for the usage of submission type attribute value "withdrawal" has been added: If application is to be withdrawn during the assessment, the submission type attribute value "supplemental-info" should be used instead.
High-level submission number element value: In case such a high-level number has not been obtained in advance form the relevant authorities (e.g. in the centralized procedure) the corresponding field should be populated as "xxxx". Note: Only required for worksharings and Type IA groupings of more than one MAA.
Tracking number: Additional clarification has been added that the tracking numbers must be delivered in response sequences and updates to facilitate the processing
Additional example values for the "submission-description" element are provided
Many additional information and instructions have been added on the correct usage of the "related-sequence" element.

File / folder system

PDF version 1.7 included as acceptable PDF version
Additional clarification for MS Word files of Product Information is provided: "Track change" versions provided in MS Word format are not required additionally in PDF format.
PIM (1-3-1-pim) has been removed from the file/folder structure in section 1.3.1 "SPC, Labelling and Package Leaflet"
Hyphens have been added as allowed elements in the variable parts of the file names of country-specific parts in Module 1
Supportive documents for M2 - M5 should be placed in the section 1.2 "Application Form". In case or response sequences such supportive documents should be placed within the "Response to Questions" sections.

Others:

Usage of node extensions should be limited to "critical areas". Note: Unfortunately such areas are not explicitly defined. Node extensions are considered helpful to organize granular reports in Module 5 and to organize response documents in response sequences. However, they are not mandatory to use. The FDA does not accept node extensions in eCTD submissions.

Important note: The EU M1 DTD as provided in Appendix 3 of the M1 specification document is currently not affected by the changes proposed in the draft version 1.4.1. Note: The proposed additional submission type element value "lou" for the Letter of Undertaking has not yet been added to the "eu-envelope.mod" file.

The above-mentioned changes are not exhaustive. For details please be referred to the draft version 1.4.1 of the EU M1 eCTD specification, which is available for download from the EMA / TIGes website (see link at the bottom of this article).

To find more information please click here: Exalon: New draft EU Module 1 eCTD specification 1.4.1 available for consultation

eCTD office: Release Announcement: eCTD Office September 2011 - New eCTD 3.1 / NeeS 2.1 Validation Fully Supported

eCTD Office in the latest version includes the following new features:

- Full support for NeeS 2.1 validation criteria.
- Full support for eCTD 3.1 validation criteria.
- NeeS submission publishing for the TGA (Australia)
- Most recently used compilations with customs notes.
- Completely revamped (module) tree searching functionality.
- (Module) tree filtering empowered with actions and leaf flagging.
- Screen Layouts - to quickly reconfigure eCTD Office UI to better reflect your current tasks.
- Various enhancements to make your valid e-submission publishing more user friendly, easier and faster.

For More information Please click here: eCTD office: Release Announcement: eCTD Office September 2011 - New eCTD 3.1 / NeeS 2.1 Validation Fully Supported

The Electronic Common Technical Document (eCTD) - Building Comprehensive Functionality for Effective Implementation - Two-day course - Los Angeles, CA - Oct. 24 & 25, 2011

This two-day course is designed for professionals of the biotechnology and pharmaceutical industries who are currently, or planning to become, involved in the development of regulatory submissions using the electronic Common Technical Document (eCTD). Upon completion of this course, participants will be able to: Develop project plans for the compilation of compliant eCTD submissions (including proper organization and tracking); identify processes employed in preparing CTD/eCTD submissions; understand how to prepare CTD content templates and requirements to generate submission-ready documents; recognize requirements specific to electronic submissions, implications on predicate rules, and differences and similarities across regions; and identify tools and technology used in preparation and review of eCTDs.

To find more information please click here: The Electronic Common Technical Document (eCTD) - Building Comprehensive Functionality for Effective Implementation - Two-day course - Los Angeles, CA - Oct. 24 & 25, 2011

DIA: 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.

Session 1 – eCTD Fundamentals
• eCTD structure and XML backbone
• Envelope information, meta data, and checksums
• Submission ready documents and granularity
• eCTD life cycle
Session 2 – eCTD Submissions in Switzerland
• Swissmedic‘s experiences with eCTD submissions
• Swiss specifications and guidelines
• The Swiss module 1 for eCTD
Session 3 – Case Studies
• Applications according to §13 TPA
• Baseline submissions
• Life cycle management with variations
• Technical correctness
Session 4 – Practical
• eCTD creation and assembly
• Hyperlinking and publishing process
• eCTD life cycle

To find more information please click here: DIA: Training Course for eCTD - Submissions in Switzerland

eCTD Seminar in Japan.

eCTD seminar will going to held in Japan. To find more information about this seminar please click here: eCTD Seminar in Japan.

pipet2pen: Mastering the art of CSR writing - By Ajay K Malik

A clinical study report (CSR) is a “complete” summary of the safety and efficacy data obtained in a clinical study in patients. The investigational drug may be a therapeutic, a prophylactic or a diagnostic agent. A CSR is an “integrated” report since it documents all the information pertaining to a study, including methodology, test article details, patient data and outcome; also attached as appendices are protocol, investigator-related information, sample case report form, tables and figures, statistical methods, statistical reports, etc.

CSRs are generally co-authored, and it’s a team exercise.

« S&P, Ghostwriters and the Ethics Police
Mastering the art of CSR writing

August 30, 2011 by Ajay K Malik

A clinical study report (CSR) is a “complete” summary of the safety and efficacy data obtained in a clinical study in patients. The investigational drug may be a therapeutic, a prophylactic or a diagnostic agent. A CSR is an “integrated” report since it documents all the information pertaining to a study, including methodology, test article details, patient data and outcome; also attached as appendices are protocol, investigator-related information, sample case report form, tables and figures, statistical methods, statistical reports, etc.

CSRs are generally co-authored, and it’s a team exercise.

An eCTD submission or an FDA marketing application may contain multiple CSRs along with clinical summaries and narratives.

Before attempting to assemble a CSR, it is helpful to go through a checklist of items needed to prepare this document. Susan Caldwell on her blog Biotech Ink Blot lists 48 pieces of information that should be available to a medical writer to complete the task.

The design of a CSR is very similar to a peer-reviewed manuscript except that its format is based on the ICH-E3 guidelines and the targeted audience is FDA. ICH-E3 provides a skeleton (template or sections) specifying where each piece of information should go, and the regulatory agency (US FDA, EU, etc.) specifies the format.

Please click here to find more information: pipet2pen: Mastering the art of CSR writing - By Ajay K Malik

EXTEDO: The EU Pharma Package and EXTEDO's PcVmanager Pharmacovigilance DatabasEXTEDO: The EU Pharma Package and EXTEDO's PcVmanager Pharmacovigilance Database - Free Webinare - Free Webinar

Register now for Extedo free webinar on September 12th. Learn more about EXTEDO’s PcVmanager – the All in One Pharmacovigilance Database System.

Please click here: EXTEDO: The EU Pharma Package and EXTEDO's PcVmanager Pharmacovigilance Database - Free Webinar

e-labeling is bound to happen - but not anytime soon

The updated Medical Device Directive opens door to e-labeling or "alternative labeling". According to Jaap Laufer of Emergo Group, we have a glimpse of it coming at some point - but not anytime soon.

There are two problems that stand in the way:

There exists an enormous diversity of languages in Europe. And there is no dominant language - in fact, the moment this would be suggested, the smaller countries would balk.

Internet penetration varies greatly across Europe. Estonia and Holland have achieved almost 100% Internet penetration. On the other hand, across Greece, Portugal, and southern parts of Italy, Internet access can be sporadic. As a result, requiring the use of a computer to read device labeling is unrealistic.

To find more information please click here: e-labeling is bound to happen - but not anytime soon

Exalon:Health Canada releases draft guidance on Preparation of Drug Submissions and Applications in the CTD Format for consultation

Health Canada has released the revised draft guidance "Preparation of Drug Submissions and Applications in the Common Technical Document (CTD) Format" for consultation (click here for the new draft revision). The consultation period will last for 60 days and will end on October 7, 2011. The revised version will replace the 2003 Draft Guidance for Industry: "Preparation of New Drug Submissions in the CTD Format" (click here for the 2003 draft version) as soon as it will be finalized.

The new draft version contains extensive revisions made to the Canadian Module 1 format, allowing "for the CTD format to be used for all submission and application types filed over a product’s lifecycle".

To find more information please click here: Exalon:Health Canada releases draft guidance on Preparation of Drug Submissions and Applications in the CTD Format for consultation

Generic Pharmaceutical Association position on FDA OGD funding

Generic Pharmaceutical Manufacturers endorses user fees to assure ANDA review timelines.

To find more information please click here: Generic Pharmaceutical Association position on FDA OGD funding

FDA: PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017 - Draft

FDA releases PDUFA V Goals and Procedures with timeline mandating eCTD for NDAs/BLAs/commercial INDs.

To find more information please click here: FDA: PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2013 THROUGH 2017 - Draft