This course covers all aspects of drug regulation, from clinical trials to product approval and post-marketing surveillance in different countries. It provides a detailed understanding of DRA objectives, processes, and procedures. It includes ICH, eCTD, MDSAP, DCP, NDA, CMC, etc. The course also includes a 3-month internship at Sunshine Consultancy London Limited to provide you with the opportunity to gain hands-on experience in the regulatory affairs field.
Upon finishing this course, you will be able to:
- Understand the objectives, processes, and procedures of Drug Regulatory Authorities (DRA)
- Understand, define and apply regulatory laws, guidelines, and procedures
- Prepare and submit regulatory documents such as IND, NDA, ANDA, etc.
- Conduct risk-benefit analysis and make sound regulatory decisions
- Prepare for and manage clinical trials
- Communicate effectively with clients, management, and health authorities
- Prepare and submit regulatory documents according to ICH, eCTD, MDSAP, and DCP guidelines
- Gain hands-on experience in the regulatory affairs field through an internship at Sunshine Consultancy London Limited.
- Take on the role of Regulatory Affairs Professional with ease.
Who Should Attend
This course is for professionals who want to take on a leadership role in regulatory affairs. It is also for those who want to specialize in a particular area of regulatory affairs, such as clinical trials, product approval, or post-marketing surveillance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc) with a background in the pharmaceutical and healthcare sector can also attend this course.