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Good Pharmacovigilance Practice: How Good has it Proven to be for Industry?

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Overview 

Continuing Education credits are not available for the archived offering.
This archived webinar is available for purchase through November 1, 2014.
Duration: 1 hour 28 minutes


The new good pharmacovigilance practices (GVP) regulations have been undergoing implementation since July 2012. GVP are a set of measures to facilitate the performance of pharmacovigilance in the EU. GVP applies to marketing-authorization holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorized centrally via EMA as well as medicines authorized at the national level.

Approaching the two-year anniversary, this webinar will examine how industry has adapted and the real-world impacts of the legislation on Pharmacovigilance (PV) organizations and their processes. The dissolution of Volume 9A, into 16 separate modules, has had far-reaching affects across global PV organizations. The release schedule of the modules and the subsequent revisions has made implementation challenging. Some modules are process and/or organizationally driven, with minimal or no technology implications, whereas others have obvious impacts across both safety systems plus other clinical and regulatory applications.  Some of the downstream affects are still either emerging and/or yet to be fully understood. 

This webinar will examine the state-of-play, to assess whether the perceived implications have been realized versus the actual, and on-going, adjustments to organizations, processes and technology that have proved necessary for the adoption of GVP.

Who Should Attend 

Intermediate to Advanced Clinical Safety Professionals who are involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Pharmacoepidemiology
  • Medical Information

Learning Objectives 

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

  • Discuss the activities that have taken place in the past two years in relation to the implementation of the new EU PV Legislation
  • Describe key impacting changes including the challenges and solutions to implementing the EU PV Legislation
  • Identify what is to come as well as what to be ready for in relation to the new EU PV Legislation

Contact Information 

Printable Registration Form

Registration Questions
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Phone +1.215.442.6100
Fax +1.215.442.6199
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Questions about Archived Webinars
Carolyn Callahan
Phone +1.215.442.6194
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 Tuesday, Apr 29, 2014

  • 11:00AM - 11:59PM

    Good Pharmacovigilance Practice: How Good has it Proven to be for Industry?

    Speaker(s):

    • Betsy Wolfish
      Specialist Master
      Deloitte Consulting LLP, United States
    • Simoni Lopes Brand
      Global Head, PV Policy and Compliance
      F.Hoffmann-La Roche Ltd., Switzerland
    • Fiona Maini, MS
      Senior Manager, Management Consulting
      Deloitte Ltd, United Kingdom
    • Kelly Lyn Traverso
      Specialist Master
      Deloitte Consulting LLP, United States

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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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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