Veterinary Pharmaceutical Submissions in the EU (European Union)

by IPI Academy Training Claim Listing

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.

£1499

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img Duration

2 Days

Course 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; 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.

This course forms part of our selection of Animal Health training courses, designed to keep you up to date with the latest regulations surrounding veterinary medicines, animal feeds, and industry best practices.

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 preparing critical expert report

  • 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 registration of veterinary medicines.

This course will cover:

  • Day 1

  • Day 2

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

  • London Branch

    10-12 Rivington Street, London

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