top of page
Requirements of GMP Production
M12
Course Goals
Requirements for GMP-production of vaccines or other drug substances regarding technical, analytical and regulatory aspects.
Timeline
Application Deadline:
18 July 2021
Course Dates:
08-09 November 2021 (2days)
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
How to apply>>
Kindly note that not all courses are open for application submission, check open calls to know which for which courses you can apply for at the moment.
Be the first to know about the upcoming application calls, follow European Vaccine Initiative on Twitter and LinkedIn or subscribe to TRANSVAC Newsletter
bottom of page