Medical Device Link.

Originally Published EMDM March/April 2004

INDUSTRY NEWS

Designed to meet the needs of regulatory officials in the healthcare arena worldwide, The Organisation for Professionals in Regulatory Affairs (TOPRA) was officially launched in January. Current members of the British Institute of Regulatory Affairs and the European Society of Regulatory Affairs are automatically members of the organization, which claims to have more than 2700 members in 45 countries.

TOPRA offers adherents an international education and training programme, career development assistance, and a number of industry resources. In addition to foundation training for those new to the field, the organization offers an MSc degree and postgraduate diploma, which are validated by the University of Wales.

Its Web site, www.topra.org, will provide a stream of regulatory news, a comprehensive database of regulatory links, and a careers section. (Several pages were still under construction at the time of writing.) It will also feature a so-called regulatory calculator. Restricted to members, the device will allow users to “plan their next EC application and advise management with confidence,” according to TOPRA.

In February, the organization announced the creation of an advisory council. The members, who will serve a two-year term and meet twice a year, will provide strategic direction. They include Rolf Bass from the Office for Registration of Medicinal Products, Poland; Daniel Brasseur, chairman of the Committee for Proprietary Medicinal Products (London); Philippe Brunet, Director-General Enterprise at the European Commission; David Jeffreys, head of devices at the UK Medicines and Healthcare Products Regulatory Agency; and Tamas Paal, Director-General at the National Institute of Pharmacy, Hungary.
For more information, go to the TOPRA Web site at www.topra.org. 

Norbert Sparrow

Copyright ©2004 European Medical Device Manufacturer