This course will provide a comprehensive overview of the regulatory landscape relevant to the pharmaceutical and biotechnology industries. The focus of the course is on providing an understanding of the principles governing drug development and approval, as well as key aspects of regulatory compliance. It also includes ICH guidelines, CTD and eCTD modules, introduction to DMF, ASMF, and CMC, process validation, and product quality.
Upon finishing this course, you will be able to:
- Understand the principles governing drug development and approval
- Understand the key aspects of regulatory compliance
- Write regulatory documents to communicate a company’s policies.
- Create a Regulatory Strategy that aligns with company goals and interests.
- Market pharmaceutical products in different countries with the proper licensing.
- Take on the role of entry-level Regulatory Affairs professional with ease.
Who Should Attend
This training is for pharmaceutical and biotech business professionals who are involved in regulatory affairs, such as QA/QC, R&D, production, and marketing. Students (B. Pharma/ M. Pharma/ B.Sc./M.) with a background in the pharmaceutical and healthcare sector..