DUBLIN–(BUSINESS WIRE)–The “A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products Training Course (Nov 4, 2025)” training has been added to ResearchAndMarkets.com’s offering.
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.
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
Certifications:
- CPD: 6 hours for your records
- Certificate of completion
Who Should Attend:
This course will be beneficial to personnel in the following departments and roles:
- Regulatory affairs
- Quality assurance and manufacturing
- Research and development
- CMC technical writers
Key Topics Covered:
EU CMC guidelines for veterinary pharmaceuticals
- EU legal requirements for CMC
- EMA CMC guidelines
- EMA Scientific Advice for CMC
Development requirements for the active substance
- New substance: process development and production of clinical and regulatory batches
- Supplier qualification
- Transfer of test methods
- Setting the specification
Development pharmaceutics – part 1 – formulation and analytical development
- Dosage form selection
- Excipient selection and compatibility
- Preliminary stability
- Antimicrobial preservatives and antioxidants
- Packaging selection
- Analytical method development and validation
Development pharmaceutics – part 2 – process development
- Quality by Design
- Scale-up pilot scale to engineering batch
- Developing in-process controls
- Selection of sterilization method
- Process validation protocol
Manufacturing and stability considerations for EU regulations
- Scheduling for submission batches
- Stability protocol
- Bracketing and matrixing
Part 2 – dossier and expert report preparation
- Data requirements for the Part 2 dossier
- Presentation of the CMC development package
- Specification for starting materials
- Specification for dosage form
- Method validation
- Shelf life and in-use shelf life
For more information about this training visit https://www.researchandmarkets.com/r/rdysj7
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