Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials 2015

  • 10 Feb 2015
  • Webinar

Description

Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials 2015 is a webinar that covers topics such as:

  • Regulatory responsibilities of the clinical project manager
  • Overview of FDA requirements for clinical trials under an IND or IDE application
  • Addressing adverse events and safety reporting
  • An ideal clinical trial protocol and processes to amend it
  • Managing investigational products: stability, storage, accountability, and expiry
  • Management of randomization, blinding, unblinding, and DSMB review
  • Recruitment strategies
  • IRB review and review of the IRB processes by sponsors
  • When and how to seek regulatory clarification
  • What and what documents not to submit to FDA
  • Corrective and Preventive Actions (CAPA) for clinical trial projects
  • Risk management: Key techniques in risk reduction, assessment, addressing, training and communication
  • Challenges of large-scale and international clinical trials
  • Do`s and don`ts of investigator meetings

Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials 2015 brings together Clinical research associates, Clinical Project Managers, Principal Investigators and sub investigators, Clinical coordinators, Regulatory Vice Presidents, Directors and Managers, IRB personnel and Attorneys – In-house or Outside Counsel.

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Important

Please, check "Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device, Medical laboratories, Pharma
Technology: Biotechnology

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