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AAPS WORKSHOP on Strategic Management of CMC Dossiers in the eCTD Format: What CMC Professionals Need to Know Now!
March 10-11, 2009
Sheraton Inner Harbor Hotel
Baltimore, MD
Attention all CMC Professionals!
Join us for a two-day workshop that will jump start your ability to develop and manage eCTD submissions, all while interacting with fellow Industry colleagues, representatives from global Health Authorities, and CMC eCTD experts. This workshop covers topics of interest for CMC Regulatory Submission Strategists and Technical Writers, with the following learning objectives:
- WHAT is an electronic CTD?
- WHY an eCTD is not the same as an electronic version of paper.
- Tools and technology – what exactly is in the ICH M2 guidance?
- UNDERSTAND the critical decisions to be made BEFORE the submission authoring process begins.
- AVOID common mistakes that complicate post-approval change management.
- LEARN from case studies presented by industry peers about successes and pitfalls during eCTD implementation.
- HEAR from various Global Health Authorities on the electronic submission standards and latest expectations for industry.
- WHY your authoring strategy, submission templates and internal review processes may need to change.
By the end of the meeting participants should have a better understanding of:
- The benefits and flexibility of the eCTD submission process for managing quality data and agency commitments throughout the product lifecycle;
- Available Global and regional eCTD guidances and their current interpretations related to chemistry, manufacturing and controls for regulatory processes;
- Authoring and dossier assembly strategies for developing robust quality modules of eCTD submissions that enable efficient lifecycle processes; and
- Current, pending and future opportunities and challenges in managing the quality modules of the eCTD submission process throughout a product lifecycle.
Detailed Program Information (PDF)
For copies of speaker’s presentations, please contact Megan Reese.
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