When: 16 May 2022
Time: 9.00-12.30 GMT
The Veterinary Medicines Regulation requires a number of changes to the SPC, labelling and package leaflet (product information) for veterinary medicines. This workshop will cover the legislative requirements and practicalities, as well as offering an opportunity for discussion with both industry professionals and regulators.
During this workshop, we will cover:
- What is changing?
o QRD template v.9
- Timelines for change (transitional arrangements)
- What is still in development for labelling requirements?
Professionals working in European veterinary medicines regulatory affairs or placing products on the European market:
- At all levels of experience
- Involved with originator or generic products
Veterinary Regulatory Affairs Team Leader
European Medicines Agency
In 2001, Emily began her career in veterinary regulatory affairs within the consultancy Cyton Biosciences, eventually heading up their regulatory projects team.
She joined the European Medicines Agency in 2009 to take up the role of CMDv Secretary and project manager for post-authorisation procedures, including variations, renewals and referrals. In 2017, Emily took over as Head of the Veterinary Regulatory and Organisational Support Service until 2020, managing post-authorisation activities, CVMP & CMDv secretariats, validation of incoming product applications and provision of regulatory advice.
Having gained experience in managing that multi-disciplinary Service, Emily has now formed a specialised regulatory affairs team within the EMA’s Veterinary Division and is enjoying this expert role during the implementation of the Veterinary Medicines Regulation.
Alongside her regulatory expertise, Emily has specialist knowledge of product information and labelling and has led on the 2021 revision of the QRD template.
HPRA (The Health Product Regulatory Authority)
Rhona McHugh graduated with a BSc and PhD in Pharmacology from University College Dublin before working, for a number of years, as a product development scientist in the immunodiagnostics industry.
Rhona has over 11 years’ experience as a pharmaceutical assessor of veterinary medicinal products (including immunological, pharmaceutical and homeopathic assessment) serving as a national and European expert in the review of pharmaceutical regulatory submissions and policy for the HPRA and EMA.
She has served as the Irish representative for the Co-Ordination group for mutual recognition and decentralised procedures - veterinary (CMDv) since February 2018.
This course offers 2.5 CPD hours for successful completion. To learn why CPD is important visit our Lifelong Learning page.
How do I register?
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