Medical Device Link.

Originally Published MX July/August 2004

INDUSTRY ASSOCIATIONS

Each year, TOPRA runs more than 40 courses designed to provide structured and flexible continuing education in regulatory affairs. The organization's courses can be grouped into the following four categories.

Foundation Training. TOPRA's introductory courses are widely regarded by industry and regulatory agencies as the most comprehensive of their kind. They are designed for those new to regulatory affairs who wish to acquire an entry-level understanding. More than 50 speakers and facilitators, all respected authorities in their fields, present at these residential courses, which are offered twice a year and last 5–6 days. In addition, the organization offers a program of one-day basic courses that provide support and administrative staff with the fundamentals they need to understand their role in the regulatory process.

Continuing Professional Training. TOPRA's continuing regulatory education and development program builds on the foundation offered by its introductory courses. The program consists of a series of one-day interactive workshops on eight core topics relevant to the pharmaceutical and allied industries, which run over a two-year cycle. The courses are designed to provide comprehensive coverage of both the theory and practice of international regulatory affairs. Each of the core topics is covered in two separate but complementary workshops, which are structured around lectures and interactive group sessions and are often based on case studies.

The organization also offers professionals in regulatory affairs workshops, which are designed to help regulatory professionals apply their knowledge in a cross-functional environment. The workshops make use of a program of case studies that take professionals through the regulatory process from drug discovery to postapproval activities.

Current Awareness. Acting as a refresher course for managers moving into a new area, or an update on the latest regulatory issues, TOPRA offers a current awareness program of one-day conferences and review meetings. Together with the organization's prestigious annual symposium, the current awareness program offers the best way for regulatory professionals to remain at the cutting edge.

MSc and Postgraduate Diploma. TOPRA's master of science (MSc) in regulatory affairs was the world's first such program. Over the past 15 years, it has become recognized as the gold-standard educational qualification for the regulatory affairs profession. The degree course is taught by an internationally recognized panel of lecturers, and attracts students from Europe, the United States, Central and Eastern Europe, Australia, the Middle East, and Asia.

The degree program is formatted as a series of part-time, modular courses designed to meet the postgraduate educational and vocational needs of personnel employed in the field of regulatory affairs in the pharmaceutical and allied industries. The program includes 13 modules, 5 of which are offered each academic year. TOPRA organizes and operates the MSc and associated diploma programs, which are accredited through the University of Wales (Cardiff, UK).

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