University of AntwerpContact : Peter DELPUTTE, Professore-mail : peter.delputte@uantwerpen.be
Keywords : Vaccine development, Vaccine manufacturing, Vaccine quality, Vaccine evaluation, Vaccine standards, GMP, Vaccine regulation, Vaccine licensing, Vaccine prequalification programme, International supply chains
Aims of “Vaccine manufacturing & quality control process”:
This course will be designed in close collaboration with our industrial partners
Vaccine manufacturing and quality control
- Vaccine manufacturing: from working seed to filling and packaging
- Examples of vaccine production: viral and bacterial vaccines, recombinant protein vaccines
- GMP considerations
- Industry and new technologies: antigen sparing, cell-culture, thermostability
- Quality control and quality assurance: supply chain protection, monitoring and testing
Vaccine regulatory approval processes
- Laws, regulations, guidances
- CTD format: content and review
- From development to licensure: examples of EU, US and international procedures
- Approval, variations and renewals
- Specific requirements: pediatric population, risk management
- Role of supranational organisations in vaccine approval and distribution: WHO prequalification and article 58
The tutorials will involve the study of articles or patents covering various topics of this course. Technological monitoring of different subjects in these areas will be conducted in groups and presented during specific sessions
Speakers:
Karin Hardt, Christophe Saillez, Alberta Di Pasquale.
Learning outcomes:
Explain vaccine manufacturing principles, rules and regulations related to vaccine development, manufacturing, assessment and release, explain regulatory process for vaccine review and approval, explain role of supranational organisation in vaccine registration and surveillance and how the expedited procedure fits into the existing legal framework for licensing of vaccines
Updated on April 9, 2019
