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Veterinary Pharmaceutical Submissions in the EU (European Union) 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.

13-14 Dec 2022

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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.

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

Maximum Residue Limits (MRLs) - Safety and residue data requirements

  • MRL dossier: safety file (pharmacology and toxicological studies)
  • MRL dossier: residue file (metabolism and residue studies)

Pharmacokinetics and bioequivalence

Workshop session

Planning a dossier to contain:

  • Pharmaceutical development studies
  • Toxicological, pharmacokinetic, metabolism and residue studies
  • Pre-clinical and clinical studies

Part III of the marketing authorisation application

  • Pharmacology and toxicology studies
  • User safety risk assessment
  • Setting the scenario
  • Risk assessment and management
  • Environmental risk assessment
  • Phase I and II assessments
  • Residue depletion studies
  • Setting the withdrawal period

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

Presenters

Andrew Hewitt (More...)

Dr Andrew Hewitt is a veterinarian with over 14 years of experience in Veterinary Medicinal Product development in a clinical and regulatory capacity. In his current position as Senior Advisor for Veterinary Product Development at knoell, Andrew manages all aspects of regulatory input in product development and registration, from early proof of concept right through to post authorisation work. Taking advantage of previous his previous role as a clinical practitioner in the UK, and investigator and monitor on clinical trials, Andrew brings a broad range of clinical and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets, Andrew has a particular interest in strategic regulatory planning during product development.

Dave Parry (More...)

David Parry is a chemist with over 14 years of experience in in veterinary medicinal product development and registration. In his current position as CMC team leader at knoell, David works with manufacturers in developing formulations and the commercial manufacturing process. Taking advantage of his previous roles in pharmaceutical research and development and process development, David brings a broad range of chemistry, manufacturing and regulatory knowledge to projects. With extensive experience interacting with regulatory authorities in most major global animal health markets and working with contract manufacturing organisations, David is involved with all aspects of regulatory support from early stage development through to post approval product maintenance.

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NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate
  • 40% off the 3rd delegate
  • 50% off the 4th delegate
13-14 Dec 2022
Live webinar
09:00-16:30
UK (London)
13-14 Dec 2022
Live webinar
09:00-16:30
UK (London)
GBP 1,199 999
EUR 1,719 1,439
USD 1,942 1,630
Until 8 Nov*
Enrol now
to attend
Live webinar

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. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

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.

Contact us

You may also be interested in

Previous customers include...

  • Animalcare Ltd
  • Bayer SpA
  • Beaphar B.V.
  • Benchmark Animal Health
  • Benchmark Vaccines Ltd
  • Boehringer Ingelheim Animal Health GmbH
  • Cargill R and D Centre Europe
  • Cross Vetpharm Group Ltd
  • Cyton Biosciences Ltd.
  • DANISH INST FOOD AND VET RESEARCH
  • DP Consulting
  • Eco Animal Health Ltd
  • Elanco Animal Health
  • Eli Lilly & Company Ltd
  • FATRO S.p.A.
  • Fort Dodge Animal Health
  • Hifarmax, Produtos e Serviços Veterinários, Lda.
  • Huvepharma
  • Interchemie werken De Adelaar BV
  • KUBUS SA
  • MASTERFOODS
  • Merial SAS
  • Norbrook Laboratories Ltd.
  • Orion Corporation
  • Pfizer Limited
  • SELBRUHA Kft.
  • SEQ Limited
  • Tiflovet Ltd
  • VETOQUINOL UK LTD
  • Zoetis B.V.

I enjoyed the event and even through a virtual platform it was very personable. Overall very happy with the large volume of information provided. My aspirations from the meeting were met as I wanted an overall understanding of the regulations.

Brendan Moran, Technical Director, Hygeia, Dec 21

[Particularly liked]: The speaker and his ability to share the information.
The complex structure of the course.
The workshop prepared for us

Daniel Pepa, Jr. Manager GRA Pharma Vetcare, B. Braun Melsungen AG, Dec 21

the content was very useful to continue investigating further, the workshop was quite nice also

Karine Tanan, Principal Scientist, Scientific and Regulatory Affairs, Cargill R and D Centre Europe, Dec 21

Great speaker, tremendous experience. I am extremely satisfied with the level of information and knowledge acquired throughout the last 2 days. I would definitely recommend this course and this format to all stakeholders approaching the Veterinary Pharmaceutical Submissions in the EU.

Alessio Giannelli, Regulatory Science Liaison, Inovet, Mar 21

I was overall happy with the webinar. Julian was very clear and ready to answer any question throughout the webinar.

Veronica Nannetti, DVM Regulatory Department, Fatro Spa, Mar 21

Very friendly speaker.

Edouard Timsit, chef de projet recherche - ruminant, CEVA SANTE ANIMAL , Nov 20

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

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

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

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

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