TOPRA 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.
In 2004, a 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 Chair of this Leadership Team serves as Regional Development Director in the Board of Directors. Similar to the BOD, the North America Leadership Team can call on expert members in a North America consultation Group for guidance on future directions.
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 Team has crafted a plan that includes conducting membership drives, producing regional programming and developing strategic alliances that support this vision. A series of teleconferences and/or face to face meetings are arranged throughout the year to manage these aims.
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. Further membership drives and regional seminars provide an opportunity for networking and reach out to prospective members.
Recent Activities
TOPRA organized for the 1st time in the US its very successful Basics of European Regulatory Affairs course. It was brought as a one-day foundation course for regulatory professionals and support staff in Regulatory Affairs and other related areas such as Medical, Manufacturing, Marketing etc. with a need to know European Regulatory Affairs. Nineteen delegates attended the 1st session on the 19th of April at Octagon Research Solutions, Inc., in Wayne, Pennsylvania. Due to the eruption of a volcano on Iceland, resulting in limited intercontinental travel between Europe and the USA, the other sessions were rescheduled in June in North Carolina and California with approximately 30 delegates in each location.
Delegates received a free TOPRA membership until 1 January 2011 (Regulatory Rapporteur and InTouch Online only).
In collaboration with the Organization of Regulatory and Clinical Associates (ORCA) a ½ day workshop was held on Wednesday 23 June in Seattle. This program provided a review of key EU regulatory development considerations, including the Scientic Advice and the Pediatric Development processes, an update on EMA/FDA joint initiatives, with Dr. Hilde Boone, EMA Liaison at the FDA as speaker. Also a view from industry perspective and a panel discussion were on the agenda.
On Thursday 24 June, a networking event was held in San Diego. Dr. Hilde Boone, EMA Liaison at the FDA, provided a general overview of the activities of the EMA and its plans for the future, a comprehensive overview of the collaboration between EMA and FDA throughout the product lifecycle, and specific examples of the collaboration between the two agencies on items such as Pediatrics, Scienti¬fic Advice and Inspections.
Upcoming Activities
The September 2010 issue of the Regulatory Rapporteur will be a North America special and the North America Leadership Team has approached several colleagues in the regulatory profession to contribute a North American specific item. If you are interested to contribute in any future publication, please contact TOPRA North America by e-mail (toprana@topra.org).
Preparations are also ongoing for a contribution in the form of a session during the 2010 TOPRA Annual Symposium in London (4 through 6 October, London, UK). The provisional topic of the session is: Globalization of pharmaceutical regulations – what do the agencies discuss behind closed doors?
In addition, TOPRA continues its collaboration with AAPS for the AAPS/FIP 2010 Pharmaceutical Sciences World Congress. TOPRA as a supportive organization for this congress chairs 2 mini-symposia sessions with representatives from Japan, Europe and US health authorities and industry on the topics of globalization and pharmacovigilance. See http://www.pswc2010.org/ for more information and preliminary and at a later stage complete program
Further, collaborations with other regional organizations, for various activities will also be planned for the rest of 2010.
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 (toprana@topra.org), or via the TOPRA Head Office in London (UK).
North America
Board Representitive
Carlos Langezaal
Officers of the Regional Development Group
- Carlos Langezaal (Chair)
- Gillian Ivers-Read (Membership, Business Ops)
- Chris Griffett (Membership)
- Susanne Dorn (Education Management/Conferences)
- Lynda Wight (Executive Director; TOPRA Head Office)
- Roland Cooke (Device Representative)
- Monique Garrett (Publications & Publicity Representative)
- Nancy Chew (Member at large)
- Aman Khera (Canada Representative)
- Dawn Spark (Canada Representative)
- Paul Larocque (Canada Representative & Correspondent for Regulatory Rapporteur)
Last updated: 30 June 2010.
