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

Apr 29 2014 11:00AM - Apr 29 2014 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


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 and Technical Support Day of Event
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

Agenda Details
Maureen Lamplugh, Content Lead
Phone +1.215.442.6115
Fax +1.215.442.6199
Maureen.Lamplugh@diahome.org

Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
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

Presenter(s) 

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Continuing Education 



Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 1 Elective Units
• Regulatory Affairs Certificate Program: 1 Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Good Pharmacovigilance Practice IACET 1.50 0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Tuesday, May 13, 2014.
Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for participation in the archived version of the webinar.

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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