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Informa

Practical Development of a Veterinary Pharmaceutical (EU)

2 - 3 May 2018

Radisson Blu Edwardian Grafton, London

 This practical 2-day course has been designed to give you a comprehensive overview of the requirements that need to be met when developing a new veterinary pharmaceutical product.

Over two days this course will explore all aspects of veterinary medicine product development with handy hints and tips to meet the quality, safety and efficacy requirements from development through to the registration of your new product in the EU.

 

  • Understand how to successfully apply the latest regulatory requirements to a veterinary drug development programme
  • Consolidate the theory, with a practical workshop on planning a new product development
  • Learn how best to seek advice on a novel product development
  • Expedite the regulatory process by learning how to collate data in an effective dossier
  • Choose the right submission procedure to support your application

Dr Mel Munro

Dr Mel Munro has worked in the regulation of animal health medicinal products since 2002. In her currently role at the veterinary product development consultancy group, Triveritas, she is responsible for all aspects of veterinary vaccine and biopharmaceutical product development. Mel spends most of her time providing strategic and expert regulatory advice on all aspects of new product developments - taking ideas from proof of concept all the way through to Marketing Authorisation. In addition to providing regulatory strategy she also has extensive experience in the preparation of documents and dossiers for regulatory submissions and runs regulatory procedures on behalf of clients. Over her career she has been involved in the successful development of broad range of veterinary medicinal products ranging from conventional to high-tech.

 

Dr Andrew Hewitt MRCVS

Dr Andrew Hewitt is a veterinarian who has been working in Veterinary Medicine Product Development in a clinical and regulatory capacity since 2007.  In his current role with global animal health product development CRO Triveritas, Andrew manages regulatory affairs projects covering all aspects of product development and maintenance from early proof of concept right through to post authorisation work.  Andrew also acts a back up Qualified Person for Pharmacovigilance (QPPV), delivering pharmacovigilance services for Triveritas and its clients. Taking advantage of previous experience as a clinical practitioner in the UK and investigator and monitor on clinical trials, Andrew brings a broad range of knowledge to regulatory projects and has a particular interest in strategic regulatory planning. 


This course has been specifically designed for those working in the development of new veterinary medicinal products

  • Regulatory Affairs
  • Document Management
  • Project Managers in Regulatory Affairs
  • Research & Development

The course gave a clear overview of the different submission procedures and the requirements to be followed in the content of the dossier. The availability of the trainers for questions was great.


Regulatory Affairs Manager, Merial