Description

Regulatory Courses
Part of a STAR Programme

Clinical Research is one of the most regulated industries in the world. Not a surprise, as we are dealing with research involving human beings. Therefore, safeguarding study participant’s rights, wellbeing and safety is of utmost importance. This is why before starting a clinical trial, you need to obtain appropriate approvals. Authorities and Ethics Committees play a major role in this approval process. 

This ½-day course is designed to provide basic understanding of the current regulatory requirements for Clinical Trials for people who have limited or no background in these matters.

Clinical Research is one of the most regulated industries in the world. Not a surprise, as we are dealing with research involving human beings. Therefore safeguarding study participant’s rights, wellbeing and safety is of utmost importance. This is why before starting a clinical trial, you need to obtain appropriate approvals. Authorities and Ethics Committees play a major role in this approval process.

This ½ day course is designed to provide basic understanding of the current regulatory requirements for Clinical Trials for people who have limited or no background in these matters.

Course time
13h00 - 17h00
Who should attend

People starting in the clinical research field in operational roles as well as people in other domains, who want to have a clear and basic understanding of clinical trial rules.

Programme highlights
  • Clinical trials
    • Why & When
    • Difference with regular medical practice
  • Rules for clinical research:
    • History (tragic mistakes)
    • Declaration of Helsinki
    • ICH-Good Clinical Practice
    • Legal framework
  • Definitions and frequently used abbreviations (plus exercise)
  • Getting the approval for starting a clinical trial
    • Process
    • Documents
Learning Objectives
  • Understand the basic concepts of and obtain a clear view on the clinical research regulations and how they came to existence
  • Be able to identify what is needed in order to get the required approvals to start a clinical study
  • Get familiar with terminology and abbreviations

 

Competencies

This course covers competencies that are part of the ECCRT Competency Framework

  • Scientific Concepts & Research Design (0)
  • Ethical & Participants Safety Considerations (2)
  • Investigational Product Development and Regulation (6)
  • Clinical Studies Operations (GCPs or ISO 14155) (0)
  • Study and Site Management (0)
  • Data Management and Informatics (0)
  • Leadership and Professionalism (0)
  • Communication (0)
  • Teamwork (0)
  • Business acumen (0)

Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained

Book a course

Date Lang Location
 
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.
300,00 € excl. VAT (if applicable)

Testimonials

Chiara Zavattaro
July 2018
Company
Janssen

The trainer was FANTASTIC. She knew a lot, was extremely friendly, and was open to reply (and she knew the answer to) any question on the topic