Webinar on “Risk-Based Monitoring: A Pathway to Efficient Quality Management” : 2nd May 2013 ; 11:00 – 12:00 hrs US EST

Pharmaceutical Regulatory Affairs

Part I: Risk-Based Monitoring – Putting into Context

After issuance of the guidance document by FDA on – ‘A Risk Based Approach to Monitoring’ and EMA Reflection Paper on – ‘Risk Based Quality Management in Clinical Trials’, the drug / device development companies, CROs are actively embarking   on this paradigm shift in clinical research which has opened an enhanced path to efficient quality management of clinical trial process.  The implementation of risk-based study specific monitoring strategies, plans will be a critical component for every study sponsor to ensure high quality and integrity of data, enhance human subject protection, reduce cost and eliminate inefficiencies across clinical trial process.  Thorough  identification  and evaluation of  risks to critical study data , processes and thereby designing appropriate monitoring plan with a balance of  centralized  &  onsite monitoring   will maximize the effectiveness of  risk based monitoring.   As the industry is abuzz with the concept of risk-based monitoring and sponsors, CROs are looking into implementing it into operations, this webinar organized by MakroCare will provide more insight on this new approach.

Key Topics:
Part I : Risk-Based Monitoring – Putting into Context

  • Regulatory requirements
  • Broad review of risk based activities
  • Study level risk management
  • Risk-based monitoring – Adding value to your operations


Jane Tucker
Independent Risk Management Consultant and Trainer, UK


Sue Fitzpatrick
Head of Education and Training
The Institute of Clinical Research, UK



Ashok K. Ghone, PhD
VP, Global Services
MakroCare, USA


Date & Time :
Date : Thursday, 2nd May 2013
Time : 11:00 – 12:00 hrs US EST /16:00 – 17:00 hrs UK BST

Cost : None

Click Here to Register for Webinar or sent an e-mail to webinar@makrocare.com

For More Information Click Here

Part II : Risk-Based Monitoring: Putting into Practice
(on 5th June 2013; details will be shared later)

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