Correlation between tertiary education and pharmaceutical industry requirements for regulatory affairs pharmacists

Abstract

In the pharmaceutical sector, the health of the public is protected by medicines regulatory authorities who enforce regulatory practices to be executed by pharmaceutical companies. In South Africa, the Medicines Control Council (MCC) describes these practice requirements via guidelines, which are based on the Medicines and Related Substances Control Act 101 of 1965. The Regulatory Affairs Department is often the first point of contact between the regulatory authority and the company. Regulatory affairs pharmacists therefore require broader skill sets than scientific and technical skills. Global expansion of regulatory affairs has resulted in significant skills shortage, for which a lack of education in regulatory affairs is partially responsible. Lack of communication between academia and industry further contributes to this skills shortage. In South Africa, the Pharmacy School curricula are approved by the South African Pharmacy Council (SAPC) in keeping with The Pharmacy Act 53 of 1974. Regulatory practices however, are determined by the Medicines and Related Substances Control Act. The aim of this study was to assess if there are inconsistencies in regulatory affairs between the pharmacy curriculum and job descriptions of regulatory affairs pharmacists, and to determine if graduating pharmacists entering industrial pharmacy are equipped for their role in regulatory affairs. The objectives were to examine regulatory education and regulatory practices in industry to assess deficiencies in the required competencies of a regulatory affairs pharmacist. The appropriate sections in Pharmacy curricula from all eight Pharmacy Schools in South Africa were examined to assess the level to which regulatory affairs is taught, and the job descriptions of regulatory affairs pharmacists were examined to assess the functional competencies required. Survey studies were conducted in the Pharmacy Schools and Pharmaceutical Industry to understand the gaps between what is taught and what is required in industry practice. The results showed that B.Pharm undergraduates were insufficiently prepared for their role in regulatory affairs, once they entered the Pharmaceutical Industry sector. Regulatory Affairs education is covered partially at undergraduate level but in some detail at a post-graduate level, in some Pharmacy Schools. Improvements are required to the current B.Pharm curricula, taking into account the Medicines Act 101 of 1965 and with MCC Guidelines, to accommodate regulatory affairs education. Collaboration between academia and industry has been proposed and employed in other countries and have been shown to be successful, hence this is also recommended for South Africa with most participants expressing a willingness to do so..