Regulatory professionals play critical roles in the health product lifecycle, from development through postapproval. The regulatory professional’s job is to keep track of the ever-changing regulations in all of the regions or countries in which the company wishes to distribute its products. Regulatory professionals are responsible for presenting registration documents to regulatory agencies and carrying out all subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned.
Regulatory professionals also advise on legal and scientific constraints and requirements, and collect, collate and evaluate the scientific data generated by research and development colleagues. They give strategic and technical advice at the highest levels in their companies, making important contributions both commercially and scientifically to the success of a development program and the company overall. Regulatory is a dynamic discipline that brings the individual into contact with almost all of a company’s various departments and disciplines.
This course discusses the evolution of the regulatory profession and the professional’s roles and responsibilities. It also briefly outlines the critical events and their impact for each product lifecycle stage for drugs, biologics and medical devices.