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Starting 21 - 22 March 2022
LIVE Online Training Course | 9:30am - 5pm GMT
Starting 21 - 22 March 2022

LIVE Online Training Course | 9:30am - 5pm GMT

Maintain compliance with the Clinical Trials Regulation and ensure the highest ethical standards in your clinical trials

Course Overview

This practical course will take delegates through the essential regulatory requirements for clinical research in Europe including comparisons with key US requirements. The course will also focus on the new Clinical Trial Regulation providing you with practical advice for implementation. The course will highlight the major differences between the Regulation and the Directive. There will also be additional time for delegates to discuss the implications of Brexit on regulatory affairs for clinical trials.

Live Online Training Course

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. 

Over this live online course students will learn through:

  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 10 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions 2 working days prior to the course start date. If you have any questions please contact joanne.driscoll@informa.com.

What will you learn?

Regulatory requirements for clinical trials

Gain a comprehensive overview of the regulatory requirements for carrying out clinical trials

Compliance

Ensure compliance in regulatory requirements for investigational medicinal products, pharmacovigilance and Clinical Trial Data Management including EDC and e-source

Latest insights

Explore recent developments in clinical trial regulations including FDA requirements

Audit preparation

Achieve successful regulatory inspections

EU Clinical Trial Regulation

Gain an understanding of the new EU Clinical Trial Regulation to prepare for the change

Who is this course for?

This course is relevant for anyone involved in clinical trials in Europe, or liaising/supporting research professionals in pharmaceutical, biotechnology CRO/SMO companies.

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.