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LIVE Q&A on the New Veterinary Regulation 2019/6

When: March 29
Time: 10 to 11 CEST

When you register for the Q&A, you automatically get access to the short 16 minute video presentation and pdf. 

About the LIVE Q&A

On March 29, members of the Regulatory teams in Norway, Sweden, and Denmark will have a LIVE Q&A session to answer all your questions regarding the new Veterinary Regulation. Send in your questions in advance.


Presentation overview:

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 Erlien
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 Bradshaw
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.

 

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