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
24-25 Mar 2020
& 18-19 Nov 2020
Obtaining a marketing authorisation for a veterinary medicine can be a costly and time-consuming process and this practical two-day course will equip participants with the key information to achieve a successful application.
The programme will take delegates through all of the constituent parts of the application for marketing authorisation for a veterinary medicinal product 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 programme will be devoted to working on case studies in the workshop sessions and there will be ample opportunity for discussion throughout the two days with the expert trainer and fellow professionals.
Benefits of attending:
Personnel working in the following departments:
• Regulatory affairs
• Research and development
• Clinical trials
The course will also be valuable to those seeking to review special problems encountered in the registrations of veterinary medicines.
Introduction and objectives of the course
EU regulatory framework
Part II: Pharmaceutical data requirements
Planning 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
Detailed and critical summaries on safety and residues
Part IV: Pre-clinical data
Part IV: Clinical data and clinical detailed and critical summaries
EU regulatory strategies and procedures
Writing the regulatory submission
Further details for the above meetings will be available in due course, in the meantime if you have any queries please click here to email us
Dr Julian Braidwood 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. A tailored start to finish service takes client projects from proof of concept through to multi-national registrations.