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Essentials of European Pharmaceutical Regulatory Affairs

The Organisation for Professionals in Regulatory Affairs
Course summary
1 day
580 GBP excl. VAT
English
Online courses
Next available date: 06/08/2020 - Online courses

Course description

Essentials of European Pharmaceutical Regulatory Affairs

This course will provide a basic, comprehensive grounding in pharmaceuticalregulatory affairs in a relaxed and interactive environment.

This popular course provides an opportunity that on-the-job learning doesn't: network and learn from a variety of experts, including your fellow participants.By attending this course, you will:

  • Get a clear understanding of the roles played by regulatory affairs professionals obtaining and maintaining marketing authorisation for medicines
  • Learn the key steps involved in developing new pharmaceuticals
  • Gain an overview of EU legislative framework and regulatory procedures
  • Get insights about the strategies needed to be applied by regulatory affairs professionals to obtain best results for their organisations and stakeholders
  • Understand life-cycle management procedures including variations, the essentials of clinical trials and importance of labeling

Suitability - Who should attend?

Suitable for

This course is designed for those:

  • Who are new to regulatory affairs
  • Who wish to move into the profession
  • From related professions (law, pharmaceutical manufacturing, marketing and sales, healthcare, administration, project management)
  • Who would gain by obtaining better insight about the world of their partners in regulatory affairs
  • Those who work in regulatory authorities and those in the regulatory sector

Outcome / Qualification etc.

Benefits to participants

  • Get a complete grounding in regulatory affairs in just one day
  • Be taught by regulatory affairs experts with extensive practical examples
  • Understand the regulatory affairs sector and find out for yourself how you can maximise your performance, either as a regulatory professional or working alongside regulatory colleagues
  • Build a network to support the rest of your career

Training Course Content

  • Introduction
  • Setting the Scene
  • Overview of Drug Development
  • Regulatory Control of Clinical Trials
  • Marketing Authorisation Applications
  • Product Information (Labelling)
  • SmPC game
  • European Marketing Authorisation Procedures
  • Marketing Authorisation Strategy
  • Post- Authorisation Activities
  • Review
  • Millionaire Quiz

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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