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

We’re delighted to announce the dates for the forthcoming 2nd Successful eCTD Lifecycle Management conference taking place on the 14th and 15th September 2010 in Prague.

Ensuring eCTD readiness is now critical for all businesses wishing to gain first time market approval, with more and more regulators moving to this as the preferred if not only accepted format for regulatory submissions, this is more imperative now than it has ever been. Understanding what the regulators are doing is key, and that is why Pharma IQ’s 2nd Successful eCTD Lifecycle Management will bring together key regulators not only from Eastern Europe but also much further afield to ensure compliance for your business.

The first Eastern European Successful Lifecycle Management Forum

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.

  • Benchmark your current strategies against 12 industry leading representatives, and take away key messages to improve your implementation processes
  • Ensure 100% compliance by incorporating the latest national eCTD regulatory changes with representation from 6 leading regulators
  • Mitigate the risks and ensure your company is prepared for PIM Implementation: Key insights from Andrew Marr, EFPIA and Lynsey Flitton, Pfizer
  • Understand how to roll out a global strategy to your local authority representatives to ensure compliance to local regulations, exclusive representation from GSK, Zentiva, Novartis and Many More!

17 internationally renowned experts share best practices and lessons learnt, 6 international regulatory bodies include:

Dr Klaus Menges
Division Strategy and Planning - Unit Scientific Quality Assurance and Process Organisation
Federal Institute for Drugs and Medical Devices, Bfarm

Germany

Karin Grondahl
Head of Unit, Registration and Information Management
Sweden Medical Agency

swadish

Dr Claudia Zerobin Kleist
MHA, Case Manager
Swiss Agency for Therapeutic Products (Swissmedic)

swiss

Jostein Øksne
Technical Contact for eSubmissions
Norwegian Medicines Agency

Norwegian

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

latvia



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