Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 30 n° 318

Two Day Course: Veterinary Pharmaceutical Submissions in the EU

Posted by fidest press agency su lunedì, 14 maggio 2018

The “Veterinary Pharmaceutical Submissions in the EU” conference has been added to ResearchAndMarkets.com’s offering.Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Detailed and Critical Summaries and regulatory submissions. This practical two-day In-house course will take participants through all of the constituent parts of the application for marketing authorisation for a veterinary medicinal product for which a marketing authorisation is sought in the European Union, including the Maximum Residue Limits dossier.Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, Detailed and Critical Summaries and regulatory submissions. An important part of the course will be devoted to working on case studies in the workshop sessions. The course will provide a comprehensive introduction to the entire regulatory dossier for a veterinary medicinal product in the European Union.

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