Industry-Academia Meet on Pharmaceutical Regulatory Affairs

September 26-30, 2022 | 10:00 AM – 3:00 PM

Venue – Picaso Hall, Chitkara University, Punjab

Organized by: Department of Science and Technology (GoI) sponsored Chitkara University Technology Enabling Centre

The prime objective was to support pharma sector MSMEs in meeting ethical and regulatory compliance through academic partnerships.

Following is a list of topics that were covered in the meet.

1. Documentation and general principles involved in regulatory writing and submission to USFDA, EU, and CDSCO.
2. Understanding the stages of regulatory filing
3. Insights into filing and strategy in eCTD/QbD paradigms
4. Regulations and legislation for medical devices
5. Concept of Total Quality Management
6. Intellectual property rights in the pharma sector
7. Regulatory requirements for cosmetics
8. Ethical conduct and regulatory approval of clinical research.