26 - 28 April, 2010, CCT Venues, Canary Wharf, London
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We’re delighted to announce the dates for the forthcoming Successful eCTD Lifecycle Management conference taking place on the 27th-28th April, 2010 in London.
This conference is designed to explore the planning, application and filing of eCTD submissions; highlighting the challenges that are faced and the latest regulatory guidelines. Case studies from key industry players as well as crucial insights from the regulatory authorities will allow attendees the opportunity to discuss key challenges they are facing with eCTD and gain advice from both peers and regulators alike.
David Wheeler Business Relations Manager MHRA
Dr Stephan Jarmann Business Project Manager, Marketing Authorisation Swissmedic - Swiss Agency for Therapeutic Products
Mattias Boman Information Administrator, Registration and Information Management Unit, Medical Products Agency Sweden
David Obranovic Manager Electronic Submissions, JAZMP Slovenia
Lidija Makarova Senior Expert, Registration Department of Human Medicines Latvian State Agency of Medicines
Csaba Harasztior Head of Coordination Unit, The National Institute of Pharmacy Hungary (Pending Final Confirmation)
Dr. Klaus Menges Division Strategy and Planning, Scientific Quality Assurance and Process Organisation BfArM
Ensuring eCTD Readiness for Centralised, DCP and MRP Procedures Both Now and in the Future: Roche, H. Lundbeck A/S, Pfizer and Solvay Pharmaceuticals give you insight on the next steps forward and how oyu, as a business can prepare
Keep in Line with Regulations by Gaining Clarity Over the Current Regulatory Status in Western and Eastern Europe: Gain unprecedented access to 6 key regulatory bodies in order to understand the latest shifts in regulations both now and in the future and get your questions answered
Successfully Planning for PIM and Transfer of Legacy Products to eCTD To Ensure a Smooth Transition in Preparation for Changes in Guidance: EFPIA discuss the changing landscape for PIM and the steps that need to be taken for you to ensure a smooth transition
ICH CTD-Q resurrection and new guidance going forward: AstraZeneca show you how to use these Q&A opportunities to your advantage and how to avoid the pitfalls that can occur
Very valuable, learned a lot, inspired
Very eye-opening as to what others are doing in this area.
Great mix of presenters covering a comprehensive range of topics-well done. Superb networking opportunity.
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