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Essentials of European Regulatory Affairs (Online Course)

The Organisation for Professionals in Regulatory Affairs
Course summary
340 GBP excl. VAT
English
Full time
Online courses
Next available date: Enquire for more information - Online courses

Course description

Essentials of European Regulatory Affairs (Online Course)

The world of Regulatory Affairs can be a confusing and complex place, particularly if you have no formal industry background. This online course will provide you with a clear and concise understanding of the role played by regulatory affairs in obtaining and maintaining Marketing Authorisations for pharmaceutical and medical device products.

Suitability - Who should attend?

Our first online Essentials course for new recruits, PAs, administrators, support staff, agency staff and students in regulatory affairs.

Outcome / Qualification etc.

What you will learn

  • Regulatory Affairs: what is it and why is it needed?
  • The role of the Regulatory Affairs Professional within the company
  • The role of the Regulatory Affairs Professional – working with external Regulatory agencies and other bodies
  • The European legislative framework
  • How pharmaceuticals are controlled
  • The contents of a basic application dossier
  • Basic data requirements
  • Overview of drug development
  • Overview of clinical trials
  • Marketing Authorisation Applications
  • European procedures
  • Post-licensing Labels and leaflets
  • Variations

Once you have completed the course you will receive a completion certificate.

Training Course Content

Course modules:

  1. What is Regulatory Affairs?
  2. Regulatory control of clinical trials
  3. Marketing Authorisation Applications
  4. European application procedures
  5. Post-Authorisation activity

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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