- email:registration@pti-europe.co.uk
- phone:+44 (0) 20 7017 7481
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Regulatory Affairs for Veterinary Medicines
1 - 2 October 2013 , Radisson Blu Edwardian Grafton
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REGULATORY WORKSHOPS
Delegates will elaborate a registration strategy and look at an EU submission in depthGROUP PRACTICE EXERCISE
...PSURs methodology - during this session delegates will examine PSUR preparation processes to optimise and enable drug surveillanceGLOBAL OVERVIEW
...with the latest FDA and CMV developments and guidelinesPRACTICAL UNDERSTANDING
...of the Decentralised and Mutual Recognition procedures for the registration of veterinary medicines in Europe
Regulatory Affairs for Veterinary Medicines
Course Objectives
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. As the market for veterinary products grow, so too do the requirements for regulatory compliance on a global scale. The course will focus on the latest Directive and its impact on your marketing applications in an enlarged Europe.
- 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
- Gain a global overview with the latest FDA and CMV developments and guidelines
What Will You Learn?
Dates and Venues
01 Oct 2013 - 02 Oct 2013
Radisson Blu Edwardian Grafton
Performance & Knowledge Objectives of this Course:
• 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
• Gain a global overview with the latest FDA and CMV developments and guidelines
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