A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products Training Course

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. This course is designed to guide you through the essential steps in development of the formulation and manufacturing process, in a manner that will ensure regulatory compliance for clinical trial applications and marketing authorisation applications.

5 November 2024 »
from £549

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Overview

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.

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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

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

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The A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products course will cover:

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 preservative 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

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Dave Parry
knoell Animal Health

David Parry is a chemist with over 14 years of experience in 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.

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Craig Evans
Knoell

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.

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NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

5 November 2024

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
04:00-11:45 New York (UTC-05)
Course code 14329

GBP 549 649
EUR 789 929
USD 893 1,049

Until 01 Oct

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.