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Two-part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates

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Overview 

Continuing Education credit or Certificate Program units are not available for Archived Webinars.


Are you confident that your Pharmacovigilance operations are meeting the EU’s expectations for compliance?

Did you miss this DIA webinar in July 2012?

Back by popular demand DIA would once again like to provide the pharmaceutical and biotech industry a chance to hear from global experts on the impact of the new Pharmacovigilance legislation that came into effect in July 2012 across the EU as a result of changes set out in:

·         Regulation (EU) No1235/2010 

·         Directive 2010/84/EU 

The legislation was underpinned by an EC Implementing Measures Regulation and a series of modules on Good Pharmacovigilance Practice. 


The implementation of the new EU legislation is ongoing.  Does your company understand the processes needed to perform adequate benefit-risk assessment? 


This is the webinar your entire Pharmacovigilance team cannot afford to miss. Your product could suffer significant consequences if your company does not have the proper systems and processes in place.  In just two 90 minute sessions attendees gained a better understanding of how to work to meet EU standards and are better prepared to implement regulatory requirements for signaling and risk managementThis webinar also addressed the new requirements described in the ICH guideline E2C (R2), periodic benefit-risk evaluation report (PBRER).  Periodic Benefit Risk Evaluation Report

 



Archived Webinar available for purchase through May 1, 2014

Featured Topics 

This two-part webinar series is designed to give pharmaceutical and biologic companies operating in the EU an introduction to the new European Pharmacovigilance requirements and provide important updates.  The webinars will address the following topics:
Part 1:

  • EU regulatory framework
  • Ongoing timeframe for implementation of the new legislation
  • GVP modules and implementing measures
  • PV System Master File (PSMF)
  • Audit and inspection
  • ADR reporting
  • The Pharmacovigilance Risk Assessment Committee (PRAC)

Part 2:

  • Risk Management Plans: risk assessment and risk minimization
  • Periodic Safety Update Reports/ Periodic benefit-risk evaluation report
  • Signal management
  • Post authorization studies of safety (PASS) and efficacy (PAES)
  • Implications for international harmonization

Who Should Attend 

  • Drug safety and Pharmacovigilance
  • Regulatory affairs
  • Clinical development
  • Executives (including C-Level) with any legal responsibility for drug safety
  • Benefit-Risk management
  • Market Access
  • Post-approval studies

Learning Objectives 

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

  • Discuss the new EU regulatory requirements for drug safety
  • Describe how to process adverse events to meet EU requirements
  • Explain what to expect in a European PV inspection
  • Describe the differences between the old PSUR and the new PBRER

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM - 8:00PM ET
CustomerService@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Registration Fees 

Other Fees

Government (Full Time) Individual
$225.00
Charitable Nonprofit/Academia Individual
$275.00
Group Site
$999.00
Group Plus
$1195.00

Member

Member Individual
$350.00

Non-Member

NonMember Individual
$395.00
Registration Fees for Additional Offerings
Part 2: Impact of the New EU PV Legislation - Standard Rate
$0.00
Group Discounts

  • 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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