TOPRA in North America
The vision of TOPRA North America is to be the organisation for professionals involved in all aspects of global healthcare regulatory affairs.
The TOPRA North America Leadership Team (NALT) was formed to create and implement a TOPRA organization, recognized in North America, aimed at optimizing value for TOPRA members, and aligned to the existing TOPRA international core structures.
The aim of the TOPRA North America Leadership Team is to enhance knowledge of and awareness of TOPRA in North America, to expand membership, and to become the most important source for European Regulatory Affairs information in North America.
The University of Wisconsin and TOPRA organised a highly successful webinar series entitled An Overview of US and EU Regulatory Processes, which ran over four weeks in October and November 2013.
TOPRA in North America Update - Winter 2012/2013
Read the latest newsletter from TOPRA in North America, including an interview with Dr Sabine Haubenreisser about her role as European Medicines Agency liaison official at FDA and an update on the wide-ranging implications of PDUFA.
Networking Event 25 September 2012
The TOPRA North America Leadership Team conducted a networking event on 25 September 2012 in East Hanover, New Jersey. The event was held on the Novartis Pharmaceuticals Corporation campus and approximately 60 regulatory professionals from the region were in attendance.
The 'Hot Topics' agenda attracted a broad audience and resulted in a lively discussion. Below are links to the presentations.
- Introduction to TOPRA - Patricia Duchene
- Presentation 1: PDUFA V - Rob Kowalski, Senior Vice President, Global Head Drug Regulatory Affairs & US Head of Development, Novartis Corporation, USA
- Presentation 2: Biosimilars - Mark Goldberger, Divisional Vice-President Regulatory Policy and Intelligence, Abbott, USA
- Presentation 3: Companion Diagnostics - Allison Nance, Executive Director, Regulatory Affairs, Celgene Corporation, USA
- Presentation 4: The European Pharmacovigilance legislation - Sharon Olmstead, Global Head, Development and Regulatory Policy, Novartis Corporation, USA
Networking Event 17 May 2012
Below are presentations and supporting documents from the networking event on 17 May 2012 in New Jersey. These resources will provide a good example of the quality of content and the depth of expertise that is available to you through our popular networking events.
- Presentation 1: FDA - Future Landscape and Drivers of Change Florence Houn, Vice President, Regulatory Affairs, Celgene, USA
- Presentation 2: What Health Authorities Discuss Behind Closed Doors– Carlos Langezaal, Director of Global Regulatory Affairs, Eisai and former Chair of TOPRA NALT
- Reference requested during the Q&A session: Accelerated Approval of Oncology Products: The Food and Drug Administration Experience
If you are interested in contributing to the North America Leadership Team, our publications or programs, please contact TOPRA North America by e-mail: firstname.lastname@example.org
If you would like to understand the practical implications of European legislation, please consider becoming a member of TOPRA. Either visit http://www.topra.org or contact the TOPRA office via e-mail at: email@example.com
TOPRA In North America can be contacted at firstname.lastname@example.org, or via TOPRA Head Office in London (UK).
Members of the North America Leadership Team
The North America Leadership team expanded in 2012 to include representatives in various pharmaceutical, biotechnology and device regions.
- Lynda Wight (Executive Director; TOPRA Head Office)
- Patricia Duchene (NALT Chair from January 2013)
- Monique Garrett (former Chair, East Coast Representative)
- Carlos Langezaal (former Chair, member at large)
- Gillian Ivers-Read (Membership, Business Ops)
- Chris Griffett (Membership)
- Malcolm Lloyd-Smith (West Coast Representative)
- Aman Khera (Canada Representative)
- Patricia Anderson (Canada Representative)
- Nanci McClellan (NA Editorial Team Liaison)
- Nancy Chew (North Carolina Representative)
- Alix Alderman (Midwest Representative)
- Roland Cooke (Device Representative)
- Susan Yule (West Coast Representative)
- Sara Snow (Massachusetts Representative)
- Ken VanLuvanee (East Coast Representative)
- Mauricha Marcussen (Midwest Representative)
- Mary Celine Scott (West Coast Representative)