Introduction

The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonize 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 have also been prepared in a number of areas including inspection, investigational medicinal products and trial documentation.

This webinar will provide an essential overview to help with compliance with the new Regulation and associated implementing acts and other texts for carrying out clinical trials in the EU. The webinar will highlight the most important of these key requirements and changes and how these are likely to impact on trials for biopharmaceutical companies, vendors and study sites.

Area Covered In The Webinar

Understand the new EU Clinical Trial Regulation requirements

Gain an overview of the Clinical Trial Regulation and changes for trials in the EU

Framework of EU clinical trial regulations

Directive vs regulation

Overview of the major new requirements of the regulation including:

  • Non-EU sponsors
  • Transparency
  • Informed consent
  • Co-sponsorship
  • Serious breaches
  • Risk proportionate approaches
  • Summaries of clinical trial results for Laypersons

Clinical Trial Approval

  • Significant changes in EU clinical trial  approval
  • New clinical trial authorization process
  • Substantial modifications

Why should you attend?

  • Understand the new EU Clinical Trial Regulation requirements
  • 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
  • Understand the new EU clinical trial authorization process
  • Share best practice for implementing the new regulation

Who Will Benefit

  • Regulatory
  • clinical research
  • clinical operations
  • pharmacovigilance
  • quality assurance (GCP auditors)
  • vendor/CRO professionals
  • study sites 
  • Other professionals in pharmaceutical and biotechnology organizations 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.

ENROLLMENT OPTIONS

On Demand
ENROLL NOW

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and QA Consultant, Course Director for the MSc Regulatory Affairs, TOP Know More

Dr Laura Brown