Regulatory Affairs


Course Description

Regulatory Affairs (RA) are a department in the pharmaceutical industry which plays a major role in protecting the human health by ensuring safety, efficacy and quality of pharmaceutical products. It acts as the interface between the pharmaceutical company and the government regulatory authority.

Their strategic involvement starts from the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labelling and advertising, and post-market surveillance.

They are responsible for keeping track of the ever-changing regulatory guidelines from all the countries in which a company wishes to distribute its products, advise on the legal and scientific restraints and requirements, and collect, collate and evaluate scientific data.

Our training program provide fundamentals of regulatory affairs, Regulatory document preparation and submission process which help the student to make a career path in Regulatory affairs industry. 

Course Duration

20 Hours

Mode of training

Online Training through Skype / Team Viewer

Placements

The Healthcare Chronicle consulting team will be supported for student placements, after successful completion of the course.

Course Modules