This In-house coursewill 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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EU Regulatory Framework
Part II: Pharmaceutical Data Requirements
Workshop sessionPlanning a dossier to contain:
Part IIIA: Consumer and Environmental Safety Data Requirements
User Safety Risk Assessment
Pharmacokinetics and Bioequivalence
Environmental Risk Assessment
Part IIIB Residues
Safety and Residues’ Detailed and Critical Summaries
Part IV Pre-Clinical Data
Part IV Clinical Data and ‘Clinical’ Detailed and Critical Summary
EU Regulatory Strategies and Procedures
Writing the Regulatory Submission
Julian qualified as a Veterinary Surgeon and worked in mixed practices before spending fifteen years in R&D and Regulatory departments of five leading Animal Health companies. He has managed clinical trials and regulatory groups, experimental facilities, laboratories, and worked internationally in many countries. Having become an R&D Director within the industry, he formed Triveritas in 2000 which has grown rapidly throughout Europe and North America and has offices in UK, France, Germany, Poland and USA. Triveritas provides specialist contract services to Animal Health and related companies. Triveritas develops veterinary vaccines and medicines by providing comprehensive services in veterinary regulatory affairs, regulatory maintenance, international clinical trials, QA, project/study management, and training.