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Management Forum

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.

18 March 2024
+ 5 November 2024 »

from £549

Need help?  Enrol or reserve

  • Format: Live online

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

Enrol or reserve

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

Enrol or reserve

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.

More details

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.

 

 

 

More details

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

18 March 2024

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
05:00-12:45 New York (UTC-04)
Course code 14304

  • GBP 649
  • EUR 929
  • USD 1,049

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Not ready to book yet?

for 7 days, no obligation

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

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* 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.

United Kingdom

  • Dechra Ltd
  • Dechra Pharmaceuticals plc

Austria

  • Delacon Biotechnik GmbH

Finland

  • Orion Pharma

Netherlands

  • Dechra Veterinary Products

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy