A Practical Approach to Developing CMC Packaging for Veterinary Pharmaceutical Products in the EU: 1 Day Virtual Training Course - May 1, 2025 & On-Demand - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products Training Course" 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:

• 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

Speakers:

Dave Parry

knoell Animal Health

David Parry is a chemist with over 14 years of experience in veterinary medicinal product development and registration. In his current position as CMC team leader at knoell, David works with manufacturers in developing formulations and the commercial manufacturing process. Taking advantage of his previous roles in pharmaceutical research and development and process development, David brings a broad range of chemistry, manufacturing and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets and working with contract manufacturing organisations, David is involved with all aspects of regulatory support from early stage development through to post approval product maintenance.

Craig Evans

knoell Animal Health

Craig Evans is a chemist with over 13 years experience in the veterinary medicines field, working on everything from initial registrations to post-approval activities including change controls captured with variations. Craig works directly with multiple pharmaceutical companies, providing expert knowledge relating to a variety of areas of veterinary medicines. Craig has in depth knowledge of CMC activities, and has an excellent working understanding of Regulatory Guidelines in the EU.

For more information about this conference visit https://www.researchandmarkets.com/r/ha6l8y

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