Requirements of GMP Production
Requirements for GMP-production of vaccines or other drug substances regarding technical, analytical and regulatory aspects.
18 July 2021
08-09 November 2021 (2days)
Nr of Participants: max 15
Holger Spiegel firstname.lastname@example.org
• 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
• Analytical Method development (Case study)
• A CMOs perspective on GMP process translation
• GMP facility tour
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.
Self-assessment of “GMP-status” provided in application form.
Accommodation will be provided. Travel Costs are not included.
* Due to COVID19 related delays call and training modules' schedule may be subject to change.