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Hotel Novotel Paris Charenton

Oct 14, 2014 8:00 AM - Oct 15, 2014 5:45 PM

3-5 place des Marseillais, 94227 Charenton Le Pont, Paris, France

How to prepare for your meeting with Health Authorities

Speakers

Gabriele  Disselhoff, PHD

Gabriele Disselhoff, PHD

Managing Director, CRQS, Germany

Dr. Disselhoff is a consultant to Pharmaceutical Industry, specializing in Strategic Regulatory Affairs, Quality Management, Organizational Development and Change Management. She has almost 30 years of experience in Pharmaceutical Industry in Regulatory Affairs, Quality Management and Clinical Research.

Truus  Janse-de Hoog, PHARMD, MSC

Truus Janse-de Hoog, PHARMD, MSC

Senior former Staff Member of the Medicines Evaluation Board , Netherlands

Truus Janse-de Hoog, Pharm D, retired recently after having served the Dutch Medicines Evaluation Board (MEB) for nearly 25 years. Truus has extensive international experience serving two terms as chair of Coordination group for human medicines (CMDh) (2005-2008; 2008-2011). From 2006 to 2013 she served as co-chair of the joint HMA/EMA Taskforce on Transparency.

Stefan  Schwoch, PHD, RPH

Stefan Schwoch, PHD, RPH

VP Global Regulatory Affairs EMEA, Eli Lilly and Company Limited, United Kingdom

Stefan is currently VP, Global RA-Regional Regulatory Leader-EMEA at Eli Lilly dividing his office time between Lilly’s Bracknell, UK and Bad Homburg, Germany. Stefan has leadership responsibilities for all of Lilly’s regulatory activities in EU, UK, CH, Middle East and Africa for both marketed & development products. He represents Lilly’s regulatory function on various internal governance committees including for global product labelling and international product development strategies. Stefan also represents the company at the EFPIA Innovation Board Sponsored Committee. After studying pharmacy at Johannes Gutenberg University, Mainz, D, he completed his PhD with honors from Ruprecht-Karls-University Heidelberg, Heidelberg, D.

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