Course Goals 

Requirements for GMP-production of vaccines or other drug substances regarding technical, analytical and regulatory aspects.

Timeline 

Organiser

Fraunhofer IME,
Aachen Germany

Nr of Participants: max 15

Contact

Holger Spiegel holger.spiegel@ime.fraunhofer.de

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.

Weblink

NA

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