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Veterinary clinical trial agreements in the EU: a guide to key provisions

Animal health companies that wish to conduct veterinary clinical trials in the EU should be aware of aware of the VICH Guidelines Good Clinical Practice (GCP) principles. The VICH is a trilateral agreement between the US, Europe and Japan that is aimed at harmonizing technical requirements for veterinary product registration. Although the guideline is not binding, it is intended to facilitate the mutual acceptance of clinical data by the EU, US and Japanese regulatory authorities. Susan Clements, an associate at the law firm Hogan & Hartson LLP in Brussels, Belgium, provides some indicators on negotiating clinical veterinary trial agreements.



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