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Veterinary Pharmaceutical Submissions in the EU Training Course
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.
Details
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.
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
Programme
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
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
Writing the regulatory submission
- Writing the dossier
- Summary of product characteristics and labelling
- Working with writers of detailed and critical summaries
Presenter
Julian Braidwood (More...)
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
Book now
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18-19 Nov 2020 Live webinar |
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18-19 Nov 2020 Live webinar |
GBP 1,199.00 EUR 1,719.00 USD 1,942.00 + VAT @ 20.00% |
Enrol now
to attend Live webinar |
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16-17 Mar 2021 Live webinar |
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16-17 Mar 2021 Live webinar |
GBP 999.00 EUR 1,439.00 USD 1,630.00 Until 2 Feb 21* |
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to attend Live webinar |
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18-19 Mar 2021 Face-to-face, (venue not yet confirmed) |
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18-19 Mar 2021 Face-to-face (venue not yet confirmed) |
GBP 1,199.00 EUR 1,679.00 USD 1,870.00 Until 4 Feb 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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6-7 Dec 2021 Live webinar |
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6-7 Dec 2021 Live webinar |
GBP 999.00 EUR 1,439.00 USD 1,630.00 Until 25 Oct 21* |
Enrol now
to attend Live webinar |
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8-9 Dec 2021 Face-to-face, (venue not yet confirmed) |
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8-9 Dec 2021 Face-to-face (venue not yet confirmed) |
GBP 1,199.00 EUR 1,679.00 USD 1,870.00 Until 27 Oct 21* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code
Customised in-house training
We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.
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- Working Through Veterinary Drug Development in the EU and USA
- A Practical Approach to Veterinary Vaccine Development and Registration in the EU
- Project Management for Pharma Professionals
- Introduction to Veterinary Pharmacovigilance
- Registration of Veterinary Vaccines in the USA and Canada
- Advanced Veterinary Pharmacovigilance
- Positive Persuading and Influencing Skills for Pharma Professionals
Previous customers include...
- Bayer SpA
- Beaphar B.V.
- Boehringer Ingelheim Vetmedica GmbH
- CEVA Sante Animale
- Chanelle Pharmaceutical Manufacturing Ltd.
- DANISH INST FOOD AND VET RESEARCH
- Diamond BioPharm Ltd
- Eco Animal Health Ltd
- FATRO S.p.A.
- Food & Veterinary Service
- Indukern SA
- Jacobsen Pharma & MedTech Advice A/S
- Janssen Pharmaceutica NV
- Kepro B.V.
- Leo Animal Health As
- MASTERFOODS
- Medicines and Medical Devices Agency of Serbia
- Merial
- Merial SAS
- Nippon Zenyaku Kogyo Co., Ltd.
- NOAH ltd
- Norbrook Laboratories Ltd.
- Pfizer Limited
- SELBRUHA Kft.
- SEQ Limited
- Vana GmbH
- Vetcare Oy
- Veterinary Medicines Directorate
- Zoetis B.V.
- ZOOPAN S.A.
“This course teaches you the essentials of EU veterinary regulatory affairs and enables you to understand the different strategies and how to achieve a successful registration through the excellent content, presentation and speaker who knows to inspire you with his enthusiasm and easy-to-follow way of teaching. Thank you Julian!. I particularly liked the workshop, during which i learnt a lot. ”
Rachael Benjamin, Regulatory Affairs Officer, Beaphar B.V., Nov 19
“Very interesting content and program, presented in a clear, pleasant and appealing way. The workshops were well prepared and very helpful and the speaker was always available to help with any questions.”
Marlene Delgado, QPPV, ZOOPAN S.A., Nov 19
“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, May 19
“A comprehensive course to understand the basis for the registration of animal medicines in EU. Great speaker, easy to listen to. ”
Ludovique Van Gastel, Scientific Writer, Galderma R&D, May 19
“I'm very satisfied with the course overall!”
Renée Alberda, Supervisor Regulatory Affairs, Kepro B.V., Apr 18
“Great speaker, easy to listen to. Good sense of humour. ”
Pauline Schipper, Associate Regulatory Affairs Manager, Zoetis B.V., Apr 18
“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, Apr 18
“Brilliant speaker”
Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG, Nov 17
“Excellent speaker with interesting and entertaining stories from his own experience.”
Marie Lovoll, Research Director, VESO, Nov 17
“Excellent speaker”
Sandra Lickova, Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG, Nov 17
“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, Dec 16
“Very good”
Renate Makovska, Food & Veterinary Service, Dec 16