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)? What is the timeline for all Reference Member States to accept eCTD submissions? In addition to the challenges of choosing the appropriate filing procedure and submission format, sponsor organizations must also understand the concept of life cycle management for the eCTD and NeeS submissions. Unlike FDA, the EU has specific requirements for tracking the submission life cycle management approach in Module 1, and the approach for life cycle management is dependent upon which filing procedure has been selected.

Understanding what information needs to be provided to the RMS and CMS also represents unique challenges for the eCTD life cycle management. For sponsor organizations considering global submissions, the significance of understanding eCTD life cycle management is critical to ensuring a successful and smooth submission process.

This audio conference covers:

• eCTD life cycle management for the 4 EU submission types
• EU Module 1 eCTD and NeeS requirements
• The implication of filing procedures on the eCTD
• How to understand the EU timeline for eCTD acceptance

About the speaker:

Gina A. Ross has been involved in the pharmaceutical industry for over 9 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 Managers
• Medical Writers
• Quality Assurance Reviewers
• Document Publishers
• IT Personnel

This audio conference is rated General Interest.

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