Regulatory Affairs Certification (RAC) Drugs
The RAC Drugs requires knowledge of the full product development and lifecycle for pharmaceutical and medicinal and related products, APIs, biologics and biotechnology products. Knowledge of US FDA requirements (30%). European regulations and guidance from the European Commission, EMA, and competent authorities (30%). Globally applicable regulatory practices* (40%). (*ICH, IGDRP (Generics) and WHO guidelines and standards). Critical thinking and analytical skills. Regulatory Affairs Certification (RAC), is the leading post-academic professional credential for regulatory professionals in the healthcare product sector. It is intended for individuals employed in regulatory agencies, industry, consultancies and other settings involved with the regulation of healthcare products. Regulatory Affairs Certification tests expertise in two sectors, pharmaceuticals and medical devices, and candidates may choose whether to take the RAC Drugs exam or the RAC Devices exam. All candidates who pass an RAC exam will be recognized by the RAC program and will be eligible to put ‘RAC’ after their name.