Working Through Veterinary Drug Development in the EU and USA

This practical four day course provides a comprehensive understanding of a veterinary medicine development in the EU and USA.

3-6 Jun 2019

GBP 2,399
EUR 3,359
USD 3,743

Book now

Course overview

This course provides a comprehensive understanding of how to develop a veterinary medicine in the EU and USA. The development of a veterinary medicine is complex, time consuming and expensive. It requires teamwork from individuals with different scientific training and a wide range of skills. Everyone involved must be aware of the main stages in the development programme and be able to relate his or her responsibilities to the expertise and needs of the scientists and commercial members of the team. Furthermore, different approaches taken by the regulatory authorities in the European Union and the USA mean that a comprehensive development programme must be designed in order for the product to be commercialised in both the American and European regions.

This course has been designed to demonstrate how pharmaceutical, pharmacological, toxicological and clinical investigations and regulatory management are brought together in the development programme. It will take the participants through all the stages in the development of a veterinary medicinal product for which a marketing authorisation is sought in the European Union and the USA. Presentations will cover pharmaceutical and process development, toxicological, pharmacological, residues and environmental studies, safety risk assessments, clinical development, regulatory and marketing input and project management. An important part of the programme will be devoted to working on case studies in the workshop sessions.

Gain a comprehensive understanding of the processes for the EU and USA, including:

  • EU and US regulatory frameworks, strategies and procedures n MRLs Parts A & B; MAA Parts IIIA & IIIB
  • US FDA approach to HFS studies
  • User safety risk assessment in the EU
  • Planning pre-clinical and clinical development
  • Environmental risk assessment Phases I and II n EU and US target animal safety
  • Minor use and minor species (MUMS)
  • Writing and managing regulatory submissions

Please note that this event has been changed from five days to four days.

Who should attend

This course has been designed for anyone who has limited experience in only one of the disciplines in veterinary medicine development, such as pharmaceutical or analytical development, clinical trials, regulatory affairs or quality assurance. Anyone learning the role of project manager, as well as more experienced personnel seeking to review special problems encountered in product development, will benefit from the comprehensive programme delivered by experienced professionals.

Previous delegates who have benefited from this course include clinical scientists, pharmaceutical scientists, marketing managers and personnel from regulatory affairs, R&D and development.

Programme - Day 1

Day 1

Introduction and objectives of course

EU regulatory framework for regulation of veterinary medicines

US regulatory framework for regulation of veterinary drugs

EU and USA: differences and similarities

The global development programmes

USA regulatory strategies and procedures

EU regulatory strategies and procedures

Introduction to workshop – session 1

Programme - Day 2

Day 2

MRLs Part A safety and MAA Part IIIA

USA FDA approach to HFS studies

MRLs Part B residues and MAA Part IIIB

FDA evaluation of consumer safety

Environmental risk assessment Phases I and II

User safety risk assessment in the EU

Workshop session 2

Programme - Day 3

Day 3

Pharmacokinetics and bioequivalence

EU and US clinical development

EU and US clinical development (continued)

EU and US target animal safety

Minor use and minor species (MUMS)

Workshop session 3

Programme - Day 4

Day 4

Workshop presentations

Pharmaceutical development and the CMC package

Managing the USA regulatory submission

Writing and managing the EU regulatory submission

Closing remarks

Presenters

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.

David Petrick

Dr David Petrick has over 30 years’ experience in bringing novel animal health products to the marketplace. During his professional career he has worked in Regulatory Affairs and Product Development for both American Cyanamid Company and Schering-Plough Animal Health.
In 2004 he founded the Delta Consortium Regulatory Consulting Limited, serving as a consultant in Regulatory Affairs for animal health companies. In 2009 he joined Triveritas and was a part of the opening of Triveritas, USA. In 2004 Dr Petrick joined Velcera, a venture capital funded animal health company and was the Executive Vice President of Research Development and Regulatory Affairs. Velcera was sold to a major pharmaceutical company in 2010.
He holds a degree in veterinary medicine from the University of Pennsylvania, and a law degree from Seton Hall University. He is a member of the American Veterinary Medical Association, the American Bar Association, the New Jersey Bar Association and the New Jersey Bar.

Book now

3-6 Jun 2019
3-6 Jun 2019 Rembrandt Hotel, London GBP 2,399.00
EUR 3,359.00
USD 3,743.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Bayer Animal Health GmbH
  • Bayer New Zealand Ltd
  • Bela-Pharm GmbH & Co. KG
  • Benchmark Animal Health Ltd
  • BI Vetmedica GmbH
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Boehringer Ingelheim RCV GmbH & Co KG
  • Boehringer Ingelheim Vetmedica GmbH
  • Boehringer-Ingelheim Danmark A/S
  • Carus Animal Health Limited
  • Ceva Animal Health
  • Cyton Biosciences Ltd
  • Dechra
  • Dechra Development
  • Dechra Ltd
  • Elanco Animal Health
  • GAB Consulting GmbH
  • MSD Animal Health Innovation
  • MSD Animal Health Innovation GmbH
  • National Drug Authority
  • Norbrook Laboratories Ltd
  • Novartis Animal Health Inc
  • Novartis Animal Health UK Ltd
  • Novartis Animal Health US Inc
  • Novus Spain SA
  • Pharmaq AS
  • Royal Veterinary College
  • Sumitomo Chemical
  • Veterinary Medicines Directorate

Very well organised. Great venue. Well planned, interesting content.

Rich Irvine, Veterinary Surgeon, Carus Animal Health Limited

Really good, I would recommend it

Daniel Rodes, , Merial SAS

Extremely professional, could not find better qualified speakers. Definitely a masterclass

Ludovic Pelligand, Associate Professor in Clinical Pharmacology and Anaesthesia, Royal Veterinary College

The course was put together very well in its entirety - location, accommodations, course length and content, speakers

Jean Dory, Manager, Dechra Development

Excellent - kept dry subject matter interesting and interactive. Well planned and excellent speakers with lots of real life experience

Melissa Coffman, Clinical Manager, Ceva Animal Health

Overall it was very good course

Pinalee Nanda, Regulatory Affairs Specialist, Bayer New Zealand Ltd

Pretty good, lot of information and workshop session is very important!

Aurelie Lopez, Data Management and Biostatistics Manager, CEVA Sante Animale

Very interesting course, enriching, speakers know a lot what they are talking about and can answer all questions. Really good!

Marine Porri, Project Formulation Manager, Ceva Sante Animale Sa

The course provided a fantastic learning experience. The course materials were varied, so that everyone was able to learn something. The speakers are quite knowledgeable, and encouraged questions. It was easy to see that they actually wanted us to learn, and that goes a long way. The course was well organized, and I really enjoyed the out of class activities, specifically the theater trip. Overall, a really great learning experience and I would highly recommend it to anyone.

Kelsey Biegun, Regulatory Affairs Officer, Dechra Ltd

Great speakers, great quality of the talks, great discussions, perfect operations team, feel-good atmosphere

Claudia Boehm, Veterinarian - Head of Laboratory, Bayer Animal Health GmbH

Very good, easy to understand

Naomi Isaka, Live Stock Clinical Development Manager, CEVA Sante Animale

Very interesting course, enriching, speakers know a lot what they are talking about and can answer all questions. Really good!

Marine Porri, Project Formulation Manager, Ceva Sante Animale Sa

The course was really good content. All the speakers had vast knowledge on the subjects and were happy to answer any questions.

Susan Scanlan, Regulatory Affairs Manager, Dechra Ltd

Very interesting course, enriching, speakers know a lot what they are talking about and can answer all questions. Really good!

Marine Porri, Project Formulation Manager, Ceva Sante Animale Sa

Excellent choice of subjects covering the area indicated in the title of the course. I appreciate very much the presence of (almost) all speakers during all of the lectures, which enabled questions and discussions. Individual lectures complemented one another favourably without unnecessary duplication, which indicated cooperation of speakers in the preparation of the entire course.

Magdalena Dettwiler, Safety Manager, Senior Research Scientist, Elanco Animal Health