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EVENT HIGHLIGHTS
 

Dr. Henry Hsu, Director, Division of Biostatistics for CBER at the FDA has joined the speaking faculty and will be presenting on The Regulatory Landscape & Involvement:  An Overview of Existing Regulations/Guidance/Recommendations for Establishing and Executing a DMC. 
   
 
  3rd Data Monitoring Committees Conference

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  EVENT DESCRIPTION
 

 

 RAVE REVIEWS

"ExL’s DMC Conference expanded my knowledge of the processes and procedures associated with DMC services and gave me insight into regulatory compliance issues."
- Rhonda Rusinski, RN, BSN, Drug Safety Manager, ICON Clinical Research

"The conference was timely, informative and among the best I've attended."
- Martin Rose, Vice President, Medical Affairs, Otsuka

"Excellent information was presented."
- Martha Sanchez, Associate Director, Pharmacovigilance, Genzyme

 "Great presentations.  Great speakers."
- Sasan Sabrdaran, Associate Director, Drug Safety & Risk Management, InterMune, Inc.

The industry has seen a recent increase in the usage of Data Monitoring Committees (aka Data Safety Monitoring Boards) to gain independent assessment of interim trial safety, efficacy and integrity.  DMCs offer an opportunity for a team of experts, independent from the trial sponsor, to examine the interim clinical data and make unbiased recommendations for the continuation, alteration and termination of the trial.  Incorporating DMCs into trial design and conduct adds additional protection against proceeding with an unsafe product or futile trial design which mitigates risk to subjects, optimizes resource utilization for the sponsor by reassuring study integrity and protects the public from access to unsafe products. 

ExL has incorporated the feedback from the first and second DMC conferences and focused the 3rd DMC conference on case study examples demonstrating practical information, best practices and lessons learned. 

I look forward to seeing you in February. 

Kristen Hunter
Conference Director
khunter@exlpharma.com

Who should Attend

Executives from Drug, Biologic and Medical Device Companies working in any of the following departments:

  • Statistics/Biostatistics/Biometrics
  • Clinical Operations/Development/Research
  • Safety & Risk Management/Operations
  • Pharmacovigilance
  • Epidemiology
  • Data Management
  • Medical Affairs
  • Regulatory Affairs

Conference is also of interest to:

  • Statistical Analysis Companies
  • Data Management Services
  • Contract Research Organizations
  • IRBs
  • Law Firms
  • Statisticians
  • Anyone who currently is, or may be selected, to serve on a Data Monitoring Committee