Regulatory Affairs and Intellectual Property Rights

Regulatory affairs are a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. The companies responsible for the discovery, testing, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare.

Intellectual property rights refer to the general term for the assignment of property rights through patents, copyrights and trademarks. These property rights allow the holder to exercise a monopoly on the use of the item for a specified period. By restricting imitation and duplication, monopoly power is conferred, but the social costs of monopoly power may be offset by the social benefits of higher levels of creative activity encouraged by the monopoly earnings.

 

  • Track 1-1 Pharmaceuticals
  • Track 2-2 Medical devices
  • Track 3-3 Patent infringement
  • Track 4-4 Biologics and Biotechnology
  • Track 5-5 in-vitro diagnostics
  • Track 6-6 Nutritional products

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