Gain market authorisation first time through submission readiness, regulatory compliance and optimised lifecycle management

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.

7 Key Regulatory Insights From Both Western and Eastern Europe:

David Wheeler
Business Relations Manager
MHRA

UK

Dr Stephan Jarmann
Business Project Manager, Marketing Authorisation
Swissmedic - Swiss Agency for Therapeutic Products

swiss

Mattias Boman
Information Administrator, Registration and Information Management Unit, Medical Products Agency
Sweden

swadish

David Obranovic
Manager Electronic Submissions, JAZMP
Slovenia

Slovenian-flag

Lidija Makarova
Senior Expert, Registration Department of Human Medicines
Latvian State Agency of Medicines

latvia

Csaba Harasztior
Head of Coordination Unit, The National Institute of Pharmacy
Hungary (Pending Final Confirmation)

Hungary

Dr. Klaus Menges
Division Strategy and Planning, Scientific Quality Assurance and Process Organisation
BfArM

Germany

Key Issues to be Discussed at Successful eCTD Lifecycle Management 2010 Include:

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

Testimonials

Very valuable, learned a lot, inspired
Novartis Pharma AG
Very eye-opening as to what others are doing in this area.
GlaxoSmithKline
Great mix of presenters covering a comprehensive range of topics-well done. Superb networking opportunity.
Pfizer
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