Regulatory Affairs Course
Thalidomide disaster, Elixir Sulfanilamide Incident and many other such instances demonstrated as a tragic lesson for developing stringent rules and regulations. Regulatory Affairs is a profession which has developed from the desire to protect public health, by controlling the safety and efficacy of healthcare products. It is involved throughout the lifecycle of a product i.e. from the synthesis of the active moiety to marketing to post approval activities. Most healthcare industries have specialist departments of Regulatory Affairs professionals.
Role of Regulatory Affairs Professional:
- To keep track of the ever changing rule/guidance
- Preparation and submission of Registration documents to various regulatory agencies
- To give strategic and technical support to R&D, QA/QC, Production and Marketing departments etc.
Thrilled by Bermuda Triangle mystery, then come and learn CTD Triangle.
- Diff. Regulatory bodies of diff. countries
- Regulatory Challenges
- Regulatory Affairs in India