The Successful eCTD Lifecycle Management Series Moves to Eastern Europe



Pharma IQ News
06/22/2010


After the brilliant feedback from the first Successful eCTD Lifecycle Management conference, that took place in London earlier this year, Pharma IQ is proud to announce the 2nd Successful eCTD Lifecycle Management conference taking place in Prague on the 14th and 15th of September. The conference provides a valuable opportunity for those working within regulatory affairs, dossier management and e-submissions to learn from key regulatory bodies and other professionals working with eCTD.

A speaker from Bayer Healthcare had this to say; "Fantastic opportunity to meet many of the European regulators and to get their latest updates. Presentations covered solutions for in-house publishing and outsourcing possibilities as well as future initiatives - very informative."

With Eastern Europe being an area where pharmaceutical companies are still looking to adopt new solutions to support their transition to the eCTD format, Pharma IQ eCTD Lifecycle Management decided it was time to move the conference closer to this growing market.

Sarah Haynes, Conference Director; “Having spoken with a large number of regulatory professionals and regulators in my research, it is clear that this is a challenging area for all and is not something that can be easily avoided. This is your chance to hear from thought leaders and uncover the latest regulations and thinking surrounding eCTD, both now and in the not to distant future.”

Delegates to the conference in September will hear from 6 key regulatory bodies;

• Dr Klaus Menges, Division Strategy and Planning – Unit Scientific Quality Assurance and Process Organisation, Federal Institute for Drugs and Medical Devices, Bfarm
• Karin Grondahl, Head of Unit, Registration and Information Management, Sweden Medical Agency
• Dr Claudia Zerobin Kleist, MHA, Case Manager, Swiss Agency for Therapeutic Products (Swissmedic)
• Jostein Øksne, Technical Contact for eSubmissions, Norwegian Medicines Agency
• Ivana Sinova, State Institute of Drug Control, Czech Republic
• Lidija Makarova, Senior Expert, Registration Department of Human Medicines, Latvian State Agency of Medicines


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Editors Notes. IQPC has an established reputation for delivering the highest standard of industry specific conferences, seminars and internal training programmes. We aim to keep business executives up-to date with the forefront of their industries’ trends, technological developments and regulatory landscape.

For any more information please contact: Sarah Haynes, +44 (0)20 7368 9300
sarah.haynes@iqpc.co.uk or visit www.ectdevent.com.