Description

Regulatory Courses

You want to see the difference between the legislations in Europe and the United States? Discover them in this eLearning course showing, back to back, the variation between the European regulatory requirements and the FDA Code of Federal Regulation 21 (CFR21) counterparts.

It is an interactive approach to review and comprehend European and North-American regulatory requirements of clinical trials.

This eLearning course is designed for everyone currently managing clinical trials for the FDA or who needs to understand the differences in EU and US requirements of performing clinical trials. Information is focused on fundamental topics in Europe and in the USA and what is substantially different between them. Specific forms required by the authorities are explained and include those for investigator commitment and safety forms.
Interactive quizzes and exercises for self-assessment are included to provide a better understanding of each part of the course. You will be able to test your comprehension with a final grading assessment. All ECCRT eLearning courses include a touchpoint with the trainer to discuss open questions from any student. Continuous interactivity with the trainer and fellow students is also encouraged through the ECCRT Virtual Campus Discussion Forum.

Course time
At your own pace; the course will remain available online for you for 3 months after you register for it. --------------------- Course Credits: 6 hours
Who should attend
  • Everyone involved in international clinical research (pharmaceutical companies, Contract Research Organisations (CROs), investigators, site personnel, ethics committee members, etc
  • People from clinical research, regulatory affairs and pharmacovigilance departments within the pharmaceutical industry.
Programme highlights
  • Regulatory Framework in EU and in US,
  • Update on European Legislative requirements for Clinical Trials,
  • Submission Process and Timelines,
  • Institutional Review Boards/Independent Ethic Committees (21 CFR Part 56 - Institutional Review Boards - HIPAA and Informed consent),
  • Protection of Study Subjects (Rules on Subject Protection),
  • Understanding Investigator Obligations (FDA Form 1572, Financial Disclosure Form),
  • Safety Reporting Rules,
  • Public Registration of Clinical Trial Protocols and Clinical Trial Results,
  • Inspections
  • Comparison ICH-GCP versus EU and US requirements

 

Learning Objectives
  • Have an overview European and North-American legislation in general and in particular of regulatory documents for Clinical Trials,
  • Comprehend the rules in Europe and in the USA with regards protection of human study subjects, investigator’s obligations, and safety reporting in clinical trials,
  • Know how and when to use mandatory clinical trial forms in Europe and in the USA,
  • Understand similarities and differences between ICH-GCP, EU & US clinical trial responsibilities.

 

Competencies

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

  • Scientific Concepts & Research Design (1)
  • Ethical & Participants Safety Considerations (4)
  • Investigational Product Development and Regulation (5)
  • Clinical Studies Operations (GCPs or ISO 14155) (5)
  • Study and Site Management (0)
  • Data Management and Informatics (1)
  • 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
* Book now and learn at your own pace within the next 3 months
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.
500,00 € excl. VAT (if applicable)