Developing Medicines for Companion Animals in the EU

This In-house course will provide a comprehensive introduction to the entire development programme for companion animal medicines.

In-house Training and Consultancy Services

This In-house course has been designed to demonstrate how pharmaceutical, pharmacological, toxicological, pharmacological, safety risk assessments, clinical development, and regulatory submissions. An important part of the course will be devoted to working on case studies in the workshop sessions.

Your next step is to call us now on +44 (0)20 7749 4730 or email us at info@management.forum.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme - Day one

Introduction and Objectives of the Course

EU Regulatory Framework

  • Understanding the regulatory objectives
  • EU legal framework
  • Legal base of regulatory procedures and dossier requirements

Assessing Development Candidates

  • New chemical entities and older products

Introduction to Workshop

  • Objectives of the workshop and review case studies
  • Planning approach to workshop and workshop teams

Product Development

  • Physical and chemical characteristics of the drug substance
  • Process development
  • Requisites of an ideal product
  • Formulation development
  • Optimising performance of problem drug substances
  • Analytical development and setting specifications
  • Stability testing

Process Scale up and Validation

  • Effect of product type
  • Facilities/Personnel
  • Regulatory issues

Workshop: Understanding How to “Block Out Studies”

  • Pharmaceutical studies
  • Toxicological studies
  • Pharmacokinetic studies
  • Clinical studies

Sample programme - Day two

The Toxicological Package

  • The objective of Part III
  • The data required

User Safety: Risk Assessment

  • Reviewing toxicology studies
  • Setting the scenario
  • Risk assessment
  • Risk management

Pharmacokinetics and Bioequivalence

  • Role of pharmacokinetic studies in product development
  • Bioequivalence studies
  • Exemptions from bioequivalence studies

Environmental Risk Assessment

  • Phase I Assessment

Workshop Session

Workshop Session….continued

Planning Pre-Clinical and Clinical Development

  • Preparing pilot batches
  • PKs and target animal tolerance
  • Approaches to dose selection
  • Clinical trial applications

EU Regulatory Strategies and Procedures

  • Full and abbreviated applications
  • Generic applications
  • Centralised Procedure
  • Decentralised, MRP and National Procedures

Sample programme - Day three

Clinical Development

  • Selecting a dose
  • Field studies
    • Multi-centred
    • Controlled
    • Randomised
    • Blinded
  • Efficacy guidelines

Target Species Tolerance

  • VICH guideline
  • Field safety

Minor Use and Minor Species (MUMS)

  • What are minor species?
  • What are minor uses?
  • Approaches to preparation of clinical data

Final Workshop Session

Workshop Presentations

  • Presentation by each team
  • Review and discussion

Writing and Managing the Regulatory Submission

  • Writing the dossier
  • Summary of Product Characteristics and labelling
  • Working with Writers of Detailed and Critical Summaries
  • Managing the Regulatory Submission

Recommended trainer

Dr. 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.

Bespoke training

We can customise this course to meet the requirements of your organisation. Contact us to discuss your training requirements.

Previous customers include...

  • Abbott Animal Health
  • aniMedica GmbH
  • Bayer
  • Bayer Animal Health GmbH
  • Boehringer Ingelheim Animal Health GmbH
  • Boehringer Ingelheim Pharma GmbH & Co KG
  • Boehringer Ingelheim Vetmedica GmbH
  • CEVA Sante Animale
  • Cyton Biosciences Ltd
  • Dechra Veterinary Products
  • Dyntec s.r.o.
  • Elanco Animal Health
  • Eli lilly & Co Ltd
  • Eli Lilly & Company Limited/Elanco Animal Health
  • Eli Lilly Benelux SA
  • Hifarmax Lda
  • Merial SAS
  • MSD AH Innovation GmbH
  • National Veterinary Institute
  • Norbrook Laboratories Ltd
  • Novartis Animal Health Inc
  • Novartis Animal Health UK Ltd
  • Novartis Pharmaceuticals UK Ltd
  • Orion Corporation Orion Pharma
  • Rotam Sub-Saharan Africa
  • Triveritas Limited
  • Vetcare Oy
  • Veterinary Medicines Directorate
  • Virbac Laboratories
  • Zoetis Belgium SA