This session will include the key principles of labelling as defined by the guidelines on label requirements of the FDA and NA within the EU. However, as these guidelines can and will change in the near future due to harmonization, this presentation will also enclose data presented on public websites as of July 2015.
Why Should You Attend:
Where can you find information on label requirements for veterinary medicine products (VMPs) on public authority websites of the FDA and in the EU?
How to gain an overview of the exemptions per country in labelling in the US and EU?
Which text is authorized for use on these labels and where can I find this?
How to create a label?
Who Will Benefit:
Healthcare providers interested in exploring and marketing the field of VMPs
New regulatory affairs officers
Administrative managers and officers in charge of labelling VMPs
Regulatory compliance associates and managers
Regulatory affairs consultants
Dr. AMT Tolkamp, DVM, is the director of Vet-Online Consultancy and consultant in regulatory affairs and pharmacovigilance veterinary medicines within the EU since 2012. She graduated in veterinary medicines at the University of Utrecht in 2001 and conducted her research at the University of Utrecht on pharma kinetics of currently authorized veterinary medicines for horses and dogs.
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