22/9 Regulatory networking and information meeting

TOPRA in Denmark and Sweden inbjuder till nätverksträff i Köpenhamn på temat Regulatory networking and information meeting

The Danish Medicines Agency – New organisation and Activities

and

Clinical Trials, Phase I studies – Challenges with First in Man trials

This evening is an ideal opportunity to hear Thomas Senderovitz, new Director General at DMA talk about the new organisation and its activities. The meeting will also address clinical trial applications from the agency perspective and challenges with performing Phase I (FIM) studies. Networking among regulatory professionals, sharing regulatory challenges among each other is key to our daily work. The meeting provides the perfect opportunity to meet with colleagues in Denmark and Sweden from the regulatory environment in a relaxed, informal and sociable setting.

Agenda:

18:00 – 18:30 Light refreshments (sandwiches and drinks)

18:30 – 18:35 Welcome – Introduction Margareth Jorvid (TOPRA volunteer)

18:35 – 19:20 The Danish Medicines Agency, Thomas Senderovitz

19.20 – 19.30 Questions & Answers, Short break

19:45 – 20:05 Clinical studies – Regulatory requirement, Lene Grej (Danish Medicines Agency)

20:05 – 20:25 Challenges with performing Phase I studies, Richard Torstenson (Novo Nordisk A/S)

20:25 – 20:35 Questions, Answers and Discussions

20:35 – 20:50 Regulatory networking, TOPRA news, Margareth Jorvid (Methra Uppsala AB, LSM group)

20:50 – 21:00 Networking, summing up and closing

http://www.topra.org/