Comparing US Requirements with European Legislation

 

Comparing US Requirements with European Legislation

Regulatory Courses

You want to see the difference between the legislation in European and the United States? Find it out in this one-day training showing, back to back, the variation between the FDA Code of Federal Regulation 21 (CFR21) and the European counterparts.

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20 Sep 2012 Brussels English
1 250,00 €
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Full description

This one day course is designed for everyone currently managing clinical trials for the FDA or need to understand the differences in US and EU requirements of performing clinical trials. Information is focused on fundamental topics in the USA and in Europe and what is substantially different between them. Specific forms required by the FDA will be explained and include those for investigator commitment and safety forms.

Who should attend?

Everyone involved in 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.

Trainers
  • Update on European Regulations for Clinical Trials
  • Understanding Investigator Obligations in the US, FDA Form 1572 , Financial Disclosure Form
  • 21 CFR Part 56 - Institutional Review Boards and Human Subject Protection - HIPAA and Informed consent - Safety Reporting
  • European Regulations on Human Subject Protection
  • To review European Regulatory Requirements for Clinical Trials
  • To comprehend differences between American and European Requirements on Human Subject
  • Protection and Investigator’s obligations
  • To understand differences between ICH GCP, US & EU regulations

 

Workshops
  • Quiz