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 100) 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
In October 2008, several NALT members attended TOPRA’s 2008 annual symposium in Budapest, and supported the organization by providing reporting support for several sessions, which were published in the December 2008 Regulatory Rapporteur.
During the October 2008 TOPRA Advisory Board meeting held after the symposium, the TOPRA North America Regional Representative, Carlos Langezaal, PhD, presented the TOPRA NALT goals, vision and plans for 2008/2009.
The TOPRA NALT was also very pleased that it was able to facilitate one of the sessions at the Annual Symposium in collaboration with the American Association of Pharmaceutical Scientists (AAPS).
On November 13th 2008 TOPRA hosted a table at the North Carolina Regulatory Affairs Forum (NCRAF) Annual Roundtable Dinner. The Topic presented by the TOPRA North America Regional Representative, Carlos Langezaal, PhD, was “Hot topics from the European Commission.”
The April 2009 Regulatory Rapporteur issue had as a special feature an update on North America, with various contributions focusing on some of the key initiatives from the US FDA. These included amongst others Focus articles on drug safety, medication safety and patient safety, a review of the new draft FDA guidance on genotoxic and carcinogenic impurities, and an insight in the interdisciplinary review team for QT studies in the FDA.
TOPRA North America organised a workshop/networking event roadshow along the West Coast of Canada and the US.
On Tuesday April 21, LifeSciences BC and TOPRA held a joint workshop focusing on European and Canadian regulatory requirements for clinical trials for pharmaceuticals, in Vancouver. The next day, Wednesday April 22, the Organization of Regulatory and Clinical Associates (ORCA) and TOPRA co-sponsored an ORCA Special Monthly Meeting on Clinical Trial Updates for EU and Canada in Seattle.
Speakers at both events included Professor Tamas Paal, President of the Operative Board to the Director-General, National Institute of Pharmacy, Hungary, and Dr Norman Viner, Unit Head, Clinical Trial Applications, Biologics & Genetic Therapies Directorate,
Health Canada.
They provided an overview of the procedures for obtaining regulatory approval for clinical trials in their jurisdictions and discussed current and upcoming issues and amendments to clinical trials regulations. Professor Paal also provided insight into the latest proposals for new pharmaceutical legislation in Europe, as well as reviewed recent changes that have significantly altered the European regulatory arena for running clinical trials. These included the December 2008 “Pharmaceutical Package” of new legislation.
On Thursday April 23, TOPRA held its inaugural meeting at Halozyme Therapeutics, Inc. conference center in San Diego. Professor Tamas Paal presented an update on European legislation.
Upcoming Activities
Preparations are ongoing for a parallel break-out session with an update from the US FDA and industry during the TOPRA 2009 Annual Symposium. In addition, TOPRA continues its collaboration with AAPS for their 2009 Annual Meeting and the AAPS/FIP 2010 Pharmaceutical Sciences World Congress. Further, collaborations with other regional organizations, for various activities will also be planned for the rest of 2009 and 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.
Click here to view the North America Forum
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)
- Elisabet Lifante-Gali (Member at large)
- Aman Khera (Canada Representative)
- Dawn Spark (Canada Representative)
- Paul Larocque (Canada Representative & Correspondent for Regulatory Rapporteur)
Last updated: 30 June 2009.
