When: March 29
Time: 10 to 11 CEST
About the LIVE Q&A
On March 29, members of the Regulatory team will have a LIVE Q&A session to answer all your questions regarding the new Veterinary Regulation. Send in your questions in advance!!
Good to know:
• When you register, you get instant access to our video presentation and pdf.
• The LIVE Q&A will be executed with the Zoom platform and questions can be sent in advance or anonymous during the live event.
• The Live Q&A will be conducted by our Regulatory team including Sara Bradshaw, Marit Erlien, and Regulatory experts LINK Medical
Our team of experts goes over the New Veterinary Medicinal Products Regulation 2019/6, changes to MA applications, it also reviews the product information (label, package leaflet, and SPC), MAJOR change to the variation system, variation not requiring assessment (VNRA), the change of product name, the variation requiring assessment (VRA), the Union Product Database (UPD) as well as other updates and Pharmacovigilance.
About the speakers:
Marit has more than 15 years of international experience within Regulatory Affairs in the Pharmaceutical Industry. Her regulatory expertise is within veterinary and human medicine, working extensively within CMC, and pre-and post-marketing activities, Marit also has leadership experience through roles as advisor, mentor, and project leader.
Sara worked in the regulatory department in the Swedish Medical Products Agency for over 5 years. Her expertise lies foremost with Regulatory Affairs post-marketing; variations, product information, and labeling. She was the Swedish representative of the CMDh/CMDv Working party on Variation Regulations and was involved in the implementation of the VMP Regulation – variations, both nationally and in Europe.
About LINK Medical
- LINK Medical is a full-service contract research organization (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe.
- LINK Medical has 200± employees providing expert guidance across every aspect of a project – all from ONE source.
- LINK Medical has one of the largest full-service regulatory teams in the Nordics
- LINK Medical has regulatory specialists present in all Nordic countries.
- LINK Medical handles over 6500 regulatory projects per year, ranging from single tasks to larger projects for small and big companies in all of Northern Europe.
- Navigating The New Veterinary Medicinal Products Regulation
- Clinical Trial Regulation (CTR) EU No 536/2014
- Marketing Compliance
- Medical device
- Ethical marketing: The rules of medicinal product promotion – Article
- LINK Medical broadens its regulatory consulting business in Sweden to help more companies navigate the regulatory framework- Article
- LINK Medical expands its regulatory services team, strengthening its IMPD & CMC capabilities -Press Release