Course content
Day1:
• Introduction into GMP
• GMP-Infrastructure: Planning, Construction, and Approval
• Regulatory aspects of vaccine development in the context of GMP production requirements
• Practical session: CMC sections of IMPD, IND, CTG
Day2:
• Analytical Method development (Case study)
• A CMOs perspective on GMP process translation
• GMP facility tour
Learning Outcomes
Deeper insight into the requirements for GMP-production of vaccines or other drug substances.
Who should apply
Scientists involved or interested in vaccine R&D and manufacturing projects.
Minimal requirements
Self-assessment of “GMP-status” provided in application form.
Accommodation
Accommodation will be provided. Travel Costs are not included.
Comments
* Due to COVID19 related delays call and training modules' schedule may be subject to change.
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