When: 25 November 2021
Time: 9.00 - 12.30 GMT
Overview
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
We’ll have time for an open live Q&A session at the end of the webinar to answer any questions.
Learning objectives
During this workshop, we will cover:
- Procedure for the selection of the reference VMPs for SPC harmonisation and designation of the RMSs
- Procedure for the SPC harmonisation of the reference VMPs
- Procedure for the SPC harmonisation of generics and hybrids
- Harmonisation of part II and subsequent MRP transfer
Target Audience
Anyone working in veterinary regulatory affairs in Europe or placing products on the market in Europe who need, therefore, to comply with the Veterinary Medicines Regulation from January 2022. This could be relatively junior professionals or senior people as both will be working with the VMR for the first time. This will be relevant for people working on originator products or generics.
Programme
You can check out the workshop programme here.
Speakers
Dries Minne
Head of the veterinary division
FAMHP Belgium
In 2003, Dries began as Regulatory Affairs Officer within Pfizer.
He then decided to join Federal Agency for Medicines and Health Products (FAMHP) in 2004 where he took up the role of project manager for veterinary medicinal products, starting his career in veterinary medicines with this. Since 2010, Dries became the head of the veterinary division, where is in charge of coordination of the activities of the division.
Through his role and expertise, Dries is also a Belgium CMDv member, while also being a QRD-vet and NtA Vet delegate. He also chairs the CMDv Legislation working group and of Belgian veterinary borderline commission.
Marco Hoyer
MSD
Marco Hoyer holds a degree in Veterinary Medicine by the University of Leipzig. In 1995, he started working as a Scientific Director at Scantox Germany. Marco has over 20 years experience in the industry and has worked in several companies in leading positions. Since 2003, Marco has joined MSD Animal Health Innovation as a Regulatory Affairs Associate Director.
Marco is also a member of the Regulatory Procedures Working Group at European Veterinary Industry Association (AHE).
Elsa Vecino
Technical Director
Access VetMed
Elsa Vecino holds a degree in Veterinary Medicine by the Autonomous University of Barcelona. She started working as a companion animals’ veterinary practitioner. In the last 15 years, Elsa has been working for EU-industry associations on the veterinary and public health sectors, holding top-management positions in policy/regulatory areas.
Since 2011, she is Technical Director at Access VetMed (former EGGVP), the association of the European industry of generic and added-value veterinary medicines. In her position, Elsa deals with a variety of responsibilities including the follow up of veterinary pharmaceutical policy and being the interface with academia, pharmaceutical industry, regulators, competent authorities, stakeholders and EU/national institutions, among others.
Erik Waterdrinker
Regulatory Affairs Expert
Erik graduated as a biologist from the Nice Sophia Antipolis University in 1991 with a master’s degree and joined Virbac as a Scientific Assistant to participate in the then new and fast growing field of Regulatory Affairs. He held various regulatory affairs positions covering pharmaceutical and non pharmaceutical products, lifecycle and new product developments and more recently specialising in European procedures.
Erik is currently Chair of the Animal Health Europe Regulatory Procedure Working group.
CPD
This course offers 3 CPD hours for successful completion. To learn why CPD is important visit our Lifelong Learning page.
How do I register?
Prices
| Type |
Member |
Non-member |
| Standard |
£70 + VAT |
£90 + VAT |
Discounted Places
A limited number of discounted places are available at the rates below for those:
Please email meetings@topra.org for a discount code before making your booking.
Terms and conditions
By purchasing this webinar, you are agreeing to the terms and conditions.