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Course summary
2 days
English
Online courses

Course description

European Regulatory Procedures

A course designed for individuals involved in developing European regulatory strategies for projects or wishing to gain the knowledge and skills to contribute to regulatory strategies.

The course is intended to bring the theory and practice of running and working with the EU procedures to life, illustrated with real life examples and case studies.

Suitability - Who should attend?

Suitable for

  • Those who wish to progress from the introductory course level
  • More experienced professionals changing area or moving into European submissions
  • Allied professionals for example: Clinical professionals who want to understand the regulatory procedures better and project managerswho want to understand the regulatory procedures better.

Outcome / Qualification etc.

Benefits to participants

  • Meet and learn from experts in the field from both industry and agency
  • Learn by doing - participate in case studies and interactive sessions
  • Build a network to support the rest of your career
  • Gain a firm understanding of the European Regulatory System for medicinal products, developing strategies and HTA
  • Get practical application of European procedures – an increased focus on the practicalities

Training Course Content

Day One

  • Case study introduction
  • Overview of the European Regulations
  • Developing your Global Filing Strategy
  • Developing Strategy for Filing Non-NCEs
  • Decentralised and Mutual Recognition Procedures
  • Finalising your European Regulatory Strategy

Day Two

  • Introduction
  • Key EU Regional Considerations
  • Centralised Procedure - The Details
  • New MAAs in the Centralised Procedure – Theory versus Reality
  • Working Effectively with Regulators – Regulators Perspective
  • Agency perspective on strategic and practical considerations

Expenses

The full tuition price for Members is 925 GBP. The price for Non-members is 1095 GBP

About provider

The Organisation for Professionals in Regulatory Affairs

The Organisation for Professionals in Regulatory Affairs (TOPRA)

The Organisation for Professionals in Regulatory Affairs (TOPRA) has encouraged excellence in the area of regulatory affairs for pharmaceuticals, veterinary medicines and medical devices since 1978. TOPRA's mission is to represent and promote the profession of healthcare regulatory affairs globally....


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Contact info

The Organisation for Professionals in Regulatory Affairs

3 Harbour Exchange, 6th Floor
E14 9GE London

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