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Breakout Session 5B: Technical Regulatory Challenges (Standards, Quality Control)
Session Chair(s)
Felipe Dolz, DVM, PhD
Head of Regulatory Affairs
Merial, a Sanofi Company, United States
At the global level, there are a multitude of issues associated with product standards, testing, and quality assurance/quality control related to the regulation and global distribution of veterinary pharmaceuticals and biologics. This breakout session will use recent examples of issues faced with the development, testing and distribution of products that have the potential to contribute to food security and sustainability. Using a set of focused questions participants will discuss issues such as:
1) the challenges of developing efficacious products for new and emerging diseases where basic research has not yet fully defined the pathogenesis of the agent;
2) Needs to achieve effective quality control of products in the market, using an example relating to international standards and quality control
Speaker(s)
Rapporteur
Samata Veluvolu
Animal Health Institute, United States
Manager, Regulatory Affairs
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