TOPRA in North America
Overview and Summary of Activities
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 TOPRA North America Leadership Team stays in contact with its members located in North America (around 150) via the TOPRA publications, such as the Regulatory Rapporteur and In Touch. In addition, we have begun to distribute a quarterly electronic newsletter (The TOPRA North America UPDATE) that is specifically targeted to North American members.
2012 North American Events and Activities
Education
The TOPRA North American Leadership Team is conducting The Essentials of European Regulatory Affairs course in June. The course addresses the following topics:
• European Institutions and the European Legislative framework
• European Clinical Trial Processes and Procedures
• European Marketing Authorisation Processes and Procedures
• The European system for classification of Post Approval Amendments (Variations) and associated procedures
• Advertising, Labelling and Leaflets in the European Union
The course will be offered at the following locations/dates:
June 4, 2012 Eisai, Woodcliff Lake, New Jersey
June 7, 2012 Eisai, Research Triangle Park, North Carolina
To learn more about the course or to register, please visit: http://www.topra.org/essentialsna
Networking
We are planning a networking event for Regulatory professionals at Novartis in East Hanover, New Jersey on September 25th, 2012. Presenters and topics will be announced shortly.
Below are presentations and supporting documents from our last networking event 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.
Presentations
- 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: toprana@topra.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: topra@topra.org
Contact
TOPRA North America can be contacted by e-mail at: toprana@topra.org, or via the TOPRA Head Office in London (UK).
North America
Board Representative
Monique Garrett
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.
Two of our members have received TOPRA’s Distinguished Service Award recognizing their ongoing support and exceptional efforts in supporting the goals of TOPRA
• Lynda Wight (Executive Director; TOPRA Head Office)
• Monique Garrett (NALT Chair)
• *Carlos Langezaal (former Chair, member at large)
• Gillian Ivers-Read (Membership, Business Ops)
• Chris Griffett (Membership)
• Malcolm Lloyd-Smith (West Coast Representative)
• *Patricia Duchene (Publications & Publicity Representative)
• Aman Khera (Canada Representative)
• Patricia Anderson (Canada Representative)
• Nancy Chew (North Carolina Representative)
• Alix Alderman (Midwest Representative)
• Roland Cooke (Device Representative)
• Susan Yule (West Coast Representative)
• Sara Snow (Massachusetts Representative)
• Nanci McClellan (Canada Representative)
* Recipients of TOPRA Distinguished Service Award
Last updated: April 25, 2012
