In the name of the Program Planning Committee, please be warmly invited to join the inaugural PDA Europe Aseptic Animal Health Conference!
Manufacturers of products for veterinary use face specific challenges. Due to lower product prices compared to human pharma products, it is crucial that cost efficiency is considered in the design of manufacturing processes. The GxP regulations for animal health products today are nearly as strict as we know from human pharma. Also, veterinary products need to be available for a large number of different species.
The EU has officially adopted a new legislation on veterinary medicines applicable in all EU countries from 28 January 2022. The new regulation brings significant changes to the way animal medicines are regulated in the market authorization process but also in manufacturing, distribution, retail and controls. These changes are considered to stimulate innovation and to improve the availability of animal medicines. Another main area of the new regulation is to address public health risks arising from antibiotic resistance.
Regulatory representatives and industry experts will join discussions not only on on challenges associated with the implementation of the new Veterinary Medicines Regulation but also on the the revised Annex 1. Attendees will also hear their expert insights on the Mutual Recognition Agreement between US and Europe.
Relevant topics such as Animal Vaccines and advanced therapies for livestock but also companion animals will be complemented by sessions focusing on Quality & Data Integrity or Considerations for Global Aseptic Manufacture.
Be sure to join us in The Hague this October!
Mai X. Huynh,