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Audio conference highlights

December 31, 2009 is just around the corner. Why is this significant? European regulatory authorities are targeting January 1, 2010 for all National Competent Authorities (NCA) to accept eCTD-only submissions for marketing applications. In addition, for Sponsor organizations already filing eCTD submission in Europe, version 1.3 of the EU Module 1 specification for eCTD submissions is effective January 1, 2009. The EU Module 1 specification was revised in May 2008 to include section 1.10, Paediatric Information.

With the multiple filing procedures in Europe, the eCTD presents many interesting challenges. Which filing procedure is most appropriate? Should a Sponsor file individual submissions or combined submissions for the Reference Member State (RMS) and the Concerned Member States (CMS)? Which countries accept eCTD-only submissions, eCTD with a paper copy of one or more modules, or non-eCTD Submissions (NeeS)?

Now is the time for Sponsor organizations to recognize the true value of the eCTD for global regulatory submissions.

This audio conference covers:

• Requirements and concepts of the eCTD.
• An overview of the types of European filing procedures.
• Implication of filing procedure on the eCTD
• EU Module 1 Specifications, v 1.3

About the speaker:

Gina A. Ross has been involved in the pharmaceutical industry for over nine years, and for most of that time has managed the document preparation department for Beckloff Associates, Inc. (BAI), a pharmaceutical research and scientific consulting firm. She was instrumental in implementing the Common Technical Document (CTD) format in her own organization. Beginning in August 2000, she began researching how to implement electronic document management and electronic submission capabilities within BAI. In 2002, she identified an electronic document management system and actively participated in the validation and implementation. BAI submitted its first electronic submission in December 2004.

Since that time, Gina has overseen the submission of multiple electronic submissions, including original submissions, amendments, annual reports, and supplements, and the implementation and validation of eCTD software. Recently, she has managed the submission of several original eCTDs to the Office of Generic Drugs (OGD) and to various divisions within FDA. She has also given numerous presentations on CTD and eCTD implementation.

Who should attend?

• Regulatory Affairs Professionals
• Medical and Scientific Writers
• Document Management/Document Publishers
• Quality Reviewers
• IT personnel
• All Regulatory Submission Professionals

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.