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Veterinary Pharmaceutical Submissions in the EU
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
Course Overview
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:
- 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 detailed and critical summaries on safety
- Consider the pre-clinical and clinical requirements
- Take away regulatory strategies and procedures
- Acquire the skills to write the regulatory submission
Who should attend?
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.
Programme Day One
Introduction and objectives of the course
EU regulatory framework
- Understanding the regulatory objectives
- EU legal framework
- Legal base of regulatory procedures and dossier requirements
Part II: Pharmaceutical data requirements
- Formulation and analytical data
- Manufacturing process
- Stability studies
Workshop session
Planning a dossier to contain:
- Pharmaceutical development studies
- Toxicological, pharmacokinetic, metabolism and residue studies
- Pre-clinical and clinical studies
Part IIIA: Consumer and environmental safety data requirements
- The toxicological package
- Maximum residue limits dossier: safety file
- Part IIIA of the marketing authorisation application
User safety risk assessment
- Reviewing toxicology studies
- Setting the scenario
- Risk assessment and management
Pharmacokinetics and bioequivalence
Programme Day Two
Environmental risk assessment
- Phase I and II assessments
Part IIIB: Residues
- Metabolism and residue studies
- Maximum residue limits dossier: residues file
- Withdrawal period
- Part IIIB of the marketing authorisation application
Detailed and critical summaries on safety and residues
Part IV: Pre-clinical data
- Pharmacodynamics and pharmacokinetics
- Target species tolerance
- Resistance
Part IV: Clinical data and clinical detailed and critical summaries
- Clinical trials
- Clinical detailed and critical summaries
EU regulatory strategies and procedures
- Full and abbreviated applications
- Generic applications
- Centralised procedure
- Decentralised, MRP and national procedures
Workshop session
Workshop presentations
- Presentation by each team
- Review and discussion
Writing the regulatory submission
- Writing the dossier
- Summary of product characteristics and labelling
- Working with writers of detailed and critical summaries
Discussion session
You might also be interested in
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
Presenter
Julian Braidwood
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.
Book now
| 24-25 Mar 2020 | |||
| 24-25 Mar 2020 | Holiday Inn London - Kensington Forum, London | GBP 1,399.00 EUR 1,959.00 USD 2,182.00 + VAT @ 20.00% |
Enrol now |
| 18-19 Nov 2020 | |||
| 18-19 Nov 2020 | Rembrandt Hotel, London | GBP 1,399.00 EUR 1,959.00 USD 2,182.00 + VAT @ 20.00% |
Enrol now |
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Previous customers include...
- aniMedica GmbH
- Beaphar B.V.
- Ceva Salute Animale SPA
- Chanelle Pharmaceutical Manufacturing Ltd.
- Cross Vetpharm Group Ltd
- Cyton Biosciences Ltd
- Cyton Biosciences Ltd.
- Danisco (UK) Limited
- DANISH INST FOOD AND VET RESEARCH
- Dopharma Research BV
- DP Consulting
- ECO Animal Health Limited
- Elanco Animal Health
- GALDERMA R & D
- Interchemie werken De Adelaar BV
- Jacobsen Pharma & MedTech Advice A/S
- Klifovet A.G.
- MASTERFOODS
- Medicines and Medical Devices Agency of Serbia
- MSD Animal Health SRL
- Nippon Zenyaku Kogyo Co., Ltd.
- Novartis Animal Health Canada
- Novartis Animal Health Inc
- Novartis Animal Health UK Ltd
- Pfizer Limited
- Swissmedic
- Tiflovet Ltd
- Vana GmbH
- VESO
- Vetoquinol SA
“The very complex theme was presented in an exciting, motivating and relaxed way. Connections were presented in a comprehensible way”
Heike Luckow, Regulatory Affairs, Bela-Pharm GmbH & Co. KG
“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.
“I'm very satisfied with the course overall!”
Renée Alberda, Supervisor Regulatory Affairs, Kepro B.V.
“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
“Brilliant 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