Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials 2012

February 28, 2012(Ended)

Online Webinar

Regulatory Perspectives of Clinical Project Management: Meeting FDA Requirements for Clinical Trials 2012

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

Prices *

299-1199 US Dollar

Exhibition

No exhibition

Organization

ComplianceOnline

Website

www.complianceonline.com/ecommerce/control/trainin...

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