A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU.
Regulations for CMC of veterinary pharmaceuticals are complex and are regularly updated, making pharmaceutical product development challenging. Information presented in the CMC section (Part 2) of the veterinary pharmaceutical dossier enables you to demonstrate successful pharmaceutical development and support post approval change management.
This course is designed to guide you through the essential steps in the development of the formulation and manufacturing process, in a manner that will ensure regulatory compliance for clinical trial applications and marketing authorization applications. Requirements for a range of veterinary dosage forms will be addressed with reference to guidance and legislation applied by EU regulators. Pharmaceutical development, manufacturing activities and the content of the CMC (Part 2) regulatory submission will be covered with consideration of VICH and EU provisions.
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Suitability - Who should attend?
Benefits of attending
- Understand the EU regulatory framework governing CMC aspects of veterinary pharmaceutical development
- Gain a detailed review of product development steps to fulfill requirements for Development Pharmaceutics
- Confirm the manufacturing and stability protocol to meet EU regulatory expectations
- Review the impact of the CMC data package on post-approval change management
- Learn from experienced CMC regulatory experts and gain an understanding of the complexities and opportunities in the development of veterinary pharmaceutical products
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