BfArM - Federal Institute for Drugs and Medical Devices

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Innovation Office Date: 04. August 2023 Topics: About BfArM Type: Article

Innovation Office

FAQ and Glossary Date: 06. June 2023 Topics: About BfArM Type: Article

FAQ and Glossary

About Us Date: 06. June 2023 Topics: About BfArM Type: Article

About Us

Statistics Date: 06. June 2023 Topics: About BfArM Type: Article

Statistics

Scientific Advice and Pre-submission Meeting Date: 10. March 2023 Topics: About BfArM Type: Article

Scientific Advice may be provided at any time before or after the initial authorisation of the medicinal product, and may cover a variety of questions related to the planning of the development programme.

What is ICMJE? Date: 15. February 2023 Topics: About BfArM Type: FAQ

The International Committee of Medical Journal Editors (ICMJE) is a union of the publishers of leading international medical journals which set guidelines for the publication of clinical trials. The ICMJE includes journals like JAMA, New England …

Which trials can/should be registered with the DRKS? Date: 03. February 2023 Topics: About BfArM Type: FAQ

Formal criteria:

  • the existence of a vote by an Ethics Committee of the European Union or Switzerland in German or English. Votes in other languages require an official translation in addition.

Additional criteria:

  • study on humans
  • health issues such …