Presented by
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.
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
- Veterinary Pharmaceutical Submissions in the EU
- A Practical Approach to Veterinary Vaccine Development and Registration in the EU
- The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA
- Practical Implementation of GCP in Veterinary Field Studies
- A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
- Registration of Veterinary Pharmaceuticals in China
- Animal Feed and Feed Additive Registration in China and Thailand
Course 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
This 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
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.
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.
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
Not ready to book yet?
for 7 days, no obligation
1 May 2025
Live online
09:00-16:45 UK (London) (UTC+01)
10:00-17:45 Paris (UTC+02)
04:00-11:45 New York (UTC-04)
Course code 14600
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 27 Mar
- 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
Not ready to book yet?
for 7 days, no obligation
4 November 2025
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 15040
- GBP 549 649
- EUR 789 929
- USD 893 1,049
Until 30 Sep
- 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
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; and apply only when booking multiple delegates on the same date.
Netherlands
- Alcomed BV
- Dechra Veterinary Products
- DOPHARMA RESEARCH B.V.
- Pharma Laboratory Services BV
- PHARMA LS
United Kingdom
- Dechra Limited
- Dechra Ltd
- Dechra Pharmaceuticals plc
Austria
- Delacon Biotechnik GmbH
Finland
- Orion Pharma
Germany
- Boehringer Ingelheim Vetmedica GmbH
