Drug Information Association Logo

Regulatory Requirements for the Conduct of Clinical Trials in Europe

| Online

« Back to Listing


This course, a Thomson Reuters Cortellis Regulatory Online Learning module, examines European clinical trials legislation. The course explores the legal basis, roles of parties involved, and procedures for recruiting and protecting subjects. It describes the regulatory requirements to initiate, amend, and conclude a clinical trial. Participants also learn the procedures to request ethics committees’ opinions and competent authorities’ authorizations. The course concludes with a discussion on adverse reaction reporting during clinical trials.

Featured Topics 

  • European clinical trials legislation
  • European clinical trials regulations
  • Reporting adverse reactions during European clinical trials

Who Should Attend 

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Learning Objectives 

Participants who complete this course should be able to:

  • Understand who is involved in a clinical trial
  • Determine if an activity is a clinical trial
  • Identify the documents authorities require
  • Describe the procedures for recruiting and protecting trial subjects
  • Recognize the procedures to request an Ethics Committee's opinion and Competent Authority's authorization
  • Describe amendments to clinical trials
  • Understand the criteria for considering a trial to be complete
  • Clarify adverse reactions reporting

The module takes an average of 1.5 hours to complete.

Contact Information 

Linda Belmont, DIA
Phone +

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

« Back to Listing Back To Top