The RAPS Fellow
Posted 01 April 2010 | By
The Regulatory Affairs Professionals Society (RAPS) was established in 1976 with the mission of developing and nurturing the emerging healthcare product regulatory profession. A key building block of the new profession was put into place in 1990 when RAPS introduced the Regulatory Affairs Certification (RAC). The development of the RAC was based upon extensive research on the scope of practice and specific activities of professionals with three to five years of regulatory experience, the target for this professional credential. This research has been replicated and updated several times, with studies extended to professionals involved with the European, US and Canadian regulatory systems. More recently, another category of certification, the General Scope, was introduced to test knowledge and critical thinking skills related to the general scope of practice of regulatory professionals throughout the product lifecycle, with reference to global standards from ICH, GHTF, WHO and ISO.