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 and Upcoming Activities
On the 9th of April 2008, a TOPRA/Octagon Networking event was held in Basking Ridge, New Jersey. Teresa Perney, PhD, and Ajay Acharya, BS from Schering Plough gave an overview of the implications and future directions of the EU Clinical Trial Directive. For their presentation, please click here.
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 will be published in the December 2008 Regulatory Rapporteur, as well as a presentation to TOPRA’s Advisory Council. 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).
November 13th 2008 TOPRA hosts 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, is Hot topics from the European Commission. For the handout, which includes a brief background on the EU legislative system, please click here.
For early 2009, the TOPRA NALT is looking into a networking event with LifeSciences BC, in the Vancouver area. Additional networking events around that same time on the West/North West Coast of the US will be posted here as dates are set.
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)
- Jacqui Dombroski (Education Management)
- Susanne Dorn (Education Management/Conferences)
- Lynda Wight (Executive Director; TOPRA Head Office)
- Roland Cooke (Device Representative)
- Monique Garrett (Publications & Publicity Representative)
- Sybille Schoepf-Ward (Member at large)
- Aman Khera (Canada Representative)
- Dawn Spark (Canada Representative)
Last updated: 10 November 2008.
