Training Needs In Regulatory Science For The Biopharmaceutical Industry

For regulatory affairs professionals as well as newly hired scientists, a solid grasp of regulatory science is needed to succeed in pharmaceutical R&D.

The pharmaceutical, biotechnology, and medical device research and development industries are among the most highly regulated in the country. While small companies engaged in early research and development usually do not have an individual designated to handle regulatory affairs, every pharmaceutical research and development company worth its salt has an individual or department devoted to regulatory affairs. The regulatory affairs professional is the primary communication link between the company and worldwide regulatory agencies such as the US Food and Drug Administration (FDA; Rockville, MD). In addition, he or she serves as the primary communicator of the seemingly endless list of laws, regulations, guidelines, and guidances from these regulatory agencies, and as the interpreter of these documents to the other members of the company's research, development, manufacturing, and compliance staff. As a consequence of successfully fulfilling his or her responsibilities, the regulatory affairs professional interacts with the vast majority of the other departments within the company.The regulatory affairs professional not only must read and understand each regulation, but must have an appreciation of its place in the regulatory "milieu". This requires that he or she have a thorough understanding of the history of the FDA and of a particular regulatory document, as well as an appreciation for the evolution of the regulatory process on a worldwide basis. It is imperative to have an understanding of not only the words contained in a regulatory document, but the intended result envisioned by the individuals who drafted this regulatory document. Also, in order to adequately interpret this regulatory document to colleagues, the regulatory professional must have a clear understanding of the organization, procedures, and resources of his or her own company. Over the years, a number of organizations, such as the Regulatory Affairs Professional Society (RAPS), the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and international organizations like the European Society of Regulatory Affairs, have taken an increasing role in providing educational meetings for the regulatory affairs professional.As an alternative, one can attend a growing number of meetings presented by commercial training companies, such as Parexel-Barnett and the Pharmaceutical Education and Research Institute (PERI).

Source:Nature Biotechnology