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Complimentary - Risk-Based Monitoring: Regulatory Expectation and Operational Application

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Overview 



This Solution Provider Webinar is brought to you by DIA in cooperation with Covance, Inc.

This complimentary archive is available for viewing through May 14, 2015.
Archive duration: 1 hour 29 minutes


The application of Risk-Based Monitoring (RBM) is a hot topic across the industry yet the final Agency guidance, released in August of 2013, has led to more questions within pharmaceutical companies and CROs on how to transition this newly revised guidance into processes for implementation.

Within this session we will examine regulatory (the visionaries’) and industry (the implementers’) viewpoints and how together we can explore practical approaches in translating the latest expectations in to real life clinical trial conduct.  An emphasis will be placed on how to balance resources, quality of data and design, technology, risk awareness, different aspects surrounding the transformative impact to process, as well as barriers to RBM adoption.



Who Should Attend 

  • Operations and Project Management
  • Regulatory
  • Procurement
  • Clinical Safety and Pharmacovigilance
  • Therapeutic and Portfolio Heads

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Discuss the FDA’s Final Guidance on Risk-Based Monitoring and its purpose
  • Discuss examples of approaches to translate regulatory expectations into actual clinical trial conduct
  • Describe the different implementation strategies organizations may pursue with respect to RBM

Special Offers 

Registration for a Solution Provider Archived Webinar is FREE! Sign up by clicking on the Register Online button.

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Questions about archived webinars
Carolyn Callahan
Phone +1.215.442.61894
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Thursday, May 15, 2014

  • 12:30PM - 11:59PM

    Complimentary - Risk-Based Monitoring: Regulatory Expectation and Operational Application

    Speaker(s):

    • Risk-Based Monitoring: Regulatory Expectation and Opperational Application
      Ben Dudley
      Executive Director, Alliance Management, Clinical Development Services
      Covance Inc., United Kingdom
    • Risk-Based Monitoring – Regulatory Expectations
      Jonathan S. Helfgott, MS
      Associate Director for Risk Science (Acting), OSI, OC, CDER
      FDA, United States

Registration Fees 

Other Fees

Complimentary
$0.00
Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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