Presented by
Management Forum
Presentations will cover the regulatory framework, pharmaceutical, toxicological and pharmacological data, safety risk assessments, pre-clinical and clinical data, critical expert reports and regulatory submissions.
★★★★★ "[Particularly liked]: The speaker and his ability to share the information. The complex structure ... more (20)"
12-13 December 2023
+ 4-5 March 2024, 26-27 November 2024 »
from £1099
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; critical expert reports 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:
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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.
Planning a dossier to contain:
12-13 Dec 2023
4-5 Mar 2024
26-27 Nov 2024
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.
12-13 Dec 2023
4-5 Mar 2024
26-27 Nov 2024
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.
26-27 Nov 2024
Colin McLean has over 30 years of experience in in veterinary medicinal product development and registration. He previously managed the Animal Health Product Development team for a global CRO, conducting both pre-clinical and clinical regulatory studies. In his current position as Global Clinical Team leader at knoell Colin is responsible for the conduct of clinical trial within knoell animal health. Colin has a broad range of regulatory and practical GCPv and GLP knowledge.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
12-13 December 2023
Classroom
Rembrandt Hotel
London
08:30-16:30 UK (London)
Course code 12734
Optional £195/€280/$320 per night
Not ready to book yet?
for 7 days, no obligation
4-5 March 2024
Live online
09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 13545
Until 29 Jan
Not ready to book yet?
for 7 days, no obligation
26-27 November 2024
Classroom
Rembrandt Hotel
London
08:30-16:30 UK (London)
Course code 14095
Optional £195/€280/$320 per night
Until 22 Oct
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Excellent presentation with very useful content and information. Great speakers with brilliant experience who were always available to respond any question.
Mar 6 2023
Karen Vásquez Cruz
Regulatory Affairs Officer, Hygeia Chemicals Limited
Mar 6 2023
The overall opinion is that the webinar was great.
Johanna Axling
Product manager, FarmPharma
Dec 6 2021
[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 6 2021
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 6 2021
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
Mar 3 2021
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 3 2021
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
Nov 18 2020
Very friendly speaker.
Edouard Timsit
chef de projet recherche - ruminant, CEVA SANTE ANIMAL
May 22 2019
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
Nov 26 2019
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.
May 22 2019
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
Nov 26 2019
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.
Apr 25 2018
Great speaker, easy to listen to. Good sense of humour.
Pauline Schipper
Associate Regulatory Affairs Manager, Zoetis B.V.
Apr 25 2018
I'm very satisfied with the course overall!
Renée Alberda
Supervisor Regulatory Affairs, Kepro B.V.
Apr 25 2018
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
Nov 28 2017
Excellent speaker
Sandra Lickova
Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG
Nov 28 2017
Excellent speaker with interesting and entertaining stories from his own experience.
Marie Lovoll
Research Director, VESO
Nov 28 2017
Brilliant speaker
Sandra Lickova
Product Development & Regulatory Affairs Manager, Dr. E. Graeub AG
Dec 1 2016
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 1 2016
Very good
Renate Makovska
Food & Veterinary Service
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2 days
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: