Course description
Regulatory Affairs For Veterinary Medicines
This 2-day practical course is designed for the regulatory professional to give a complete guide to the regulatory guidelines surrounding the authorisation of veterinary medicinal products in the EU. As the market for veterinary medicinal products grows, so too do the requirements for regulatory compliance. The course will provide you with the fundamental regulatory knowledge to unpick the complexity of the system and apply your knowledge to achieve fast product approval and effective product maintenance.
The optional 1-day course is aimed at professionals working in pharmacovigilance (PV) or those wanting to discover more about post market safety activities for veterinary medicines. On this 1-day course you will examine the PV requirements for veterinary medicines, discover how to manage adverse events and learn how to prepare and submit Periodic Safety Update Reports (PSUR).
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Suitability - Who should attend?
This course has been specifically designed for those working in the development of new veterinary medicinal products
- Regulatory Affairs
- Document Management
- Project Managers in Regulatory Affairs
- Research & Development
Outcome / Qualification etc.
Regulatory Affairs For Veterinary Medicines
Training Course Content
- Understand and successfully apply the latest directive to your marketing authorisations
- Choose the right submission procedure to support your application
- Establish your veterinary pharmacovigilance reporting systems
- Comply with the latest regulations for packaging and labelling of veterinary medicinal products
- Learn how to maintain your marketing authorisation with a practical guide to variations
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 5
Very enjoyable course with trainers that clearly know their stuff. Time given to ask questions was great.
The course definitely covered my needs. It was interactive and provided additional information.