Regulatory professionals play a critical role in the healthcare product lifecycle, from concept through marketing. The regulatory affairs professional’s job is to keep track of the ever-changing regulation in all of the regions in which the company wishes to distribute its products. They 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.
Additionally, regulatory professionals advise on the 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 level in their companies, making an important contribution both commercially and scientifically to the success of a development program and the company overall.
This course will discuss 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 stage of the product lifecycle for drugs, biologics and medical devices.
Learning Objectives
Upon completion of this course, participants should be able to:
- Discuss the history and evolution of the regulatory profession
- Outline the role of the regulatory professional
- Explain what is involved in each product lifecycle stage and the players involved
Target Audience
This course is designed for individuals with limited or no experience in the regulatory profession and those with some experience in related fields or functional areas who want to increase their knowledge and skills pertaining to the regulatory field.