PharmiWeb.com - Global Pharma News & Resources
23-Apr-2020 - 24-Apr-2020

EU Clinical Trial Regulation: Overview and Implementation

  • Location:
    • The Rembrandt Hotel
    • Thurloe Place
    • London
    • Greater London
    • SW7 2RS
    • United Kingdom
  • View on a map

Course overview

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC). Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a new

clinical trial database and portal. Guidelines for enacting the new Regulation are also being prepared in a number of areas including inspection, investigational medicinal products and trial documentation. This course will provide an essential understanding to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU. The course will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, CROs and study sites.

Benefits of attending:

  • Gain an overview of the Clinical Trial Regulation and changes for trials in the EU
  • Review how the new Regulation differs from the previous Clinical Trials Directive
  • Be updated on the Clinical Trial Regulation Delegated Acts and other implementation documents
  • Discuss the new EU clinical trial authorisation process, including considerations for the UK

Key topics to be covered include:

  • Implications of having a regulation instead of a directive
  • Clinical trial transparency
  • Clinical trial authorisation process
  • Co-sponsorship
  • Safety reporting
  • Trials with authorised medicinal products
  • Risk-based considerations
  • Non-EU sponsors
  • Requirements for managing investigational medicinal products
  • Clinical trials conducted on children
  • Regulatory inspection

Who should attend?

This event is ideal for anyone requiring an update on the EU Clinical Trial Regulation (536/2014) The course is relevant for those working in regulatory, clinical research, clinical operations, project management, pharmacovigilance, quality assurance (GCP auditors), vendor/CRO professionals, study sites and other professionals in pharmaceutical and biotechnology organisations conducting trials with drugs, biologics or combination products.

It will also be of interest to those departments who liaise with/support clinical trial personnel, and all other professionals who want to know more about this important new Regulation.