Course Details

Biocon JSS AHER Certificate Program in Global Regulatory Affairs is a 16-week course focused on offering domain specific skills taught by the faculty of JSS AHER with experience of offering this content for the past 20 years at postgraduate level.

During the program, students will undergo experiential learning with Biocon Regulatory Science department, case studies will be conducted by Subject Matter Experts, and hands-on training in making e-CTD, eSUGAM filings and 356h submission. Students will also get an opportunity to visit JSS Hospital to understand clinical trial proceedings. Lastly, they will be provided training in professional writing and speaking skills to augment their success in regulatory space.

16 weeks program comprises of theory, experiential learning, and hands on training in the following areas:

  • Introduction to Regulatory Affairs
  • Overview of Pharmaceutical markets and regulations
  • GMP and GLP
  • Intellectual Property and Intellectual Property Rights
  • Regulated Markets like USA, European Union, and Japan
  • ROW Markers like India, ASPAC (China, South Korea, Malaysia, Singapore), LATAM (Mexico, Columbia, Brazil), and Emerging markets like Africa (Tanzania and South Africa) and Middle East (any 2 countries)
  • USA, European Union, and India
  • Clinical Drug Development Process
  • Clinical Research Related Guidelines
  • ICH Guidelines
  • US-FDA Guidance
  • Basics like introduction, product lifecycle of medical devices, risk-based classification, and essential principles of medical devices and IVDs, and differences between medical devices, IVDs and Combination Products from pharmaceuticals
  • USA
  • European Union
  • Ethics
  • Quality
  • Documentation in pharmaceutical industry
  • Dossier and submission
  • Audits
  • Inspections
  • Product lifecycle management
  • Emerging Technologies