Two-Day Online Training on Regulatory Requirements for Clinical Trials (January 27-28, 2022) – | Business and finance

DUBLIN – (BUSINESS WIRE) – January 10, 2022–

Are you up to date with regulatory requirements for clinical research?

Do you understand the impact and the new requirements of the European regulation on clinical trials?

This course will guide you through the main regulatory requirements and guidelines for clinical research in Europe, including the new EU regulation on clinical trials and the CTIS (Clinical Trial Information System) which will come into force on January 31, 2022. Major US requirements that impact on-going testing in Europe will also be briefly discussed.

The interactive program will highlight the most important of these key requirements and changes and their likely impact on current and future trials for pharmaceutical and biotechnology companies and study sites.

The main topics to cover include:

  • EU regulation on clinical trials (536/2014)
  • The new clinical trial information system
  • Comparison of the regulation on clinical trials with the European directive on clinical trials
  • Clinical trial authorization
  • Complexities of conducting pediatric trials
  • Requirements for the management of investigational drugs
  • Legal aspects of clinical trials
  • Pharmacovigilance requirements
  • ICH GCP R3 Update
  • Regulatory inspections
  • Benefits of participating
  • Decipher the framework of regulations and guidelines for clinical trials in Europe
  • Get an update on the new European Clinical Trials Regulation 536/2014
  • Review major FDA requirements
  • Understanding clinical trial authorizations: regulatory and ethical approval
  • Evaluate the most important legal aspects of clinical trials
  • Make sure you comply with pharmacovigilance and adverse event reporting

Laura Wood, Senior Press Director

For EST office hours, call 1-917-300-0470

For USA / CAN call toll free 1-800-526-8630

For GMT office hours, call + 353-1-416-8900


SOURCE: Research and markets

Copyright Business Wire 2022.

PUB: 01/10/2022 06:46 AM / DISC: 01/10/2022 06:46 AM

Copyright Business Wire 2022.

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