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Pharmacovigilance and Global Harmonization Updates

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Overview 

Continuing Education credits are not available for the archived offering.
This archived webinar is available for purchase through July 23, 2015.
Duration: 1 hour 29 minutes


In this webinar, speakers from Japan, Europe and the US will explore how various ICH regions are working to implement global harmonization practices in the areas of drug safety and risk management.  While many concepts of pharmacovigilance are now shared globally, regional interpretations of those concepts can vary.  The speakers will explore the implications of differences in reporting formats, clinical trial reporting requirements, and the lack of standardization of label safety information.  They will also discuss the challenges associated with implementing and adopting global harmonization practices within a company.  Finally, they will explore how the expansion of ICH is expected to benefit industry, regulators and patients and how this expansion will help to promote faster access to innovative medicines across the globe.

Who Should Attend 

Intermediate to Advanced Clinical Safety Professionals who are involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Clinical Research
  • Data Analysis
  • Pharmacoepidemiology
  • Medical Information
  • Health Outcomes

Learning Objectives 

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

  • Describe harmonization efforts, updates and legislation within the EU, US and Japan
  • Discuss the challenges and implications of adopting global harmonization strategies within an organization
  • Explain how the expansion of ICH participation is expected to benefit patients and improve their access to innovative medicines and therapies

Contact Information 

Printable Registration Form

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

For Information on Archived Webinars
Carolyn Callahan
Phone +1.215.442.6194
Fax +1.215.442.6199
Carolyn.Callahan@diahome.org

Technical Requirements 

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Link: http://www.webex.com/lp/jointest/

Presenter(s) 

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Agenda  

Day 1 Thursday, Jul 24, 2014

  • 10:00AM - 11:59PM

    Pharmacovigilance and Global Harmonization Updates

    Speaker(s):

    • Richard F. Kingham
      Partner
      Covington & Burling, United States
    • Expansion of ICH Harmonization Activities
      Justina A. Molzon, JD, MSc, RPh
      Associate Director for International Programs, Office of Strategic Program CDER
      FDA, United States
    • Asian Perspective on Harmonization
      Stewart Geary, MD
      Senior Vice President, Chief Medical Officer
      Eisai Co., Ltd., Japan
    • Moira Daniels, MBA
      VP, Head Global Patient Safety Services, PACE
      PAREXEL International, United Kingdom

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Charitable Nonprofit/Academia Member Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Individual
$350.00
Registration Information

Printable Registration Form

  • Individual registration is a license for ONE internet login allowing one viewer.
  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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