This symposium focuses on the quality and regulatory requirements for fish vaccines with a particular emphasis on the work of the European Pharmacopoeia and on improving the development of study methods and quality control testing such as batch potency testing, the use of alternative in vitro methods, 3Rs and consistency of production. It provides an overview on how this field is likely to evolve in the near future and the main challenges that lie ahead.
The main programme topics include:
- A summary of current regulatory requirements;
- The work of the Ph. Eur., its Groups of Experts and a focus on Ph. Eur. monographs for fish vaccines;
- The safety and efficacy of fish vaccines and in particular the design of studies;
- 3Rs approaches and alternative test methods for the quality control of fish vaccines;
- Viewpoints from manufacturer’s and authorities
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This symposium is aimed at those involved in the quality of fish vaccines, be it in R&D, manufacturing, regulatory affairs, quality control, quality assurance or similar functions in both industry and regulatory authorities.
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- Session 1 General Overview on Current Legal Requirements
- Session 2a: Batch Potency Test – Point of View of Manufacturers
- Session 2b: Batch Potency Test – Point of View of Academia
- Session 2c: Batch Potency Test – Point of View of Authorities
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