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 course will take participants 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.
Benefits of attending:
Personnel working in the following departments:
• Regulatory affairs
• Research and development
• Clinical trials
• Marketing
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
Workshop session
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
‘Safety and residues’ detailed and critical summaries
Part IV: Pre-clinical data
Part IV: Clinical data and ‘clinical’ detailed and critical summaries
EU regulatory strategies and procedures
Workshop session
Workshop presentations
Writing the regulatory submission
Discussion session
Veterinary Pharmaceutical Submissions in the EU
A Practical Approach to Veterinary Vaccine Development and Registration in the EU
Developing Medicines for Companion Animals
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
Julian Braidwood (22-23 May 2019)
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.
| 22-23 May 2019 | |||
| 22-23 May 2019 | Cavendish Hotel, London | GBP 1,399.00 EUR 1,959.00 USD 2,182.00 + VAT @ 20.00% |
Enrol now |
| 26-27 Nov 2019 | |||
| 26-27 Nov 2019 | Cavendish Hotel, London | GBP 1,399.00 EUR 1,959.00 USD 2,182.00 + VAT @ 20.00% |
Enrol now |
“I'm very satisfied with the course overall!”
Renée Alberda, Supervisor Regulatory Affairs, Kepro B.V.
“Very nice presentation and all the 'real life' stories were of added value. Good interesting course with a very nice group. ”
Iris Visser, Regulatory Affairs Officer, Belgica De Weerd BV
“Great speaker, easy to listen to. Good sense of humour. ”
Pauline Schipper, Associate Regulatory Affairs Manager, Zoetis B.V.
“Brilliant speaker”
Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG
“Excellent, very clean, interesting and entertaining stories from speakers own experience ”
Marie Lovoll, Research Director, VESO
“Excellent speaker”
Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG
“Very good”
Renate Makovska, , Food & Veterinary Service
“The content, presentations and speaker was very good - and I got a whole lot out of it”
Mads Thor Madsen, Medical Advisor, DVM, Jacobsen Pharma & MedTech Advice A/S