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.
BENEFITS OF ATTENDING
Understand the EU Regulatory Framework
Learn the Pharmaceutical Data Requirements
Know how to Comply with the Safety Requirements
Review the User Safety Risk Assessment
Consider the Environmental Risk Assessment
Receive Guidance on the ‘Safety’ Detailed and Critcal Summary
Consider the Pre-Clinical and Clinical Requirements
Take away Regulatory Strategies and Procedures
Know how to Write the Regulatory Submission
Personnel working in the following departments: Regulatory Affairs, Research and Development and Clinical Trials and Marketing. It will also be valuable to those seeking to review special problems encountered in the registrations of veterinary medicines. There will be ample opportunity for discussion during the proceedings.
09.30 Introduction and Objectives of the course
09.45 EU Regulatory Framework
10.45 Refreshments
11.00 Part II: Pharmaceutical Data Requirements
12.15 Discussion
12.30 Lunch
13.30 Workshop session
Planning a dossier to contain:
14.45 Part IIIA: Consumer and Environmental Safety Data Requirements
15.15 User Safety Risk Assessment
15.45 Refreshments
16.00 Pharmacokinetics and Bioequivalence
17.00 End of Day One
09.00 Environmental Risk Assessment
09.30 Part IIIB Residues
10.15 Safety and Residues’ Detailed and Critical Summaries
10.30 Refreshments
10.45 Part IV Pre-Clinical Data
11.15 Part IV Clinical Data and ‘Clinical’ Detailed and Critical Summary
11.45 EU Regulatory Strategies and Procedures
12.30 Lunch
14.00 Workshop Session
15.00 Refreshments
15.15 Workshop Presentations
15.45 Writing the Regulatory Submission
16.45 Discussion
17.00 End of Course
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 |
“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
“I'm very satisfied with the course overall!”
Renée Alberda, Supervisor Regulatory Affairs, Kepro B.V.
“Great speaker, easy to listen to. Good sense of humour. ”
Pauline Schipper, Associate Regulatory Affairs Manager, Zoetis B.V.
“Excellent speaker”
Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG
“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
“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