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New Good Pharmacovigilance Practice (GVP) Documents in Canada

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Overview 

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


In this webinar the presenters will highlight the following:
Key content of GUI-0102
Key changes in GUI-063 and POL 0041
What the industry can expect in the future

As part of Health Canada’s mandate to maximize the safety, quality and efficacy of health products, Health Canada implemented on August 1, 2004 an inspection program for Good Pharmacovigilance Practices (GVP) (previously known as Post-Market Reporting Compliance). The GVP inspection program is intended to verify that manufacturers, including Market Authorization Holders (MAH) and importers, meet the requirements of sections C.01.016 to C.01.020, C.08.007 (h) and C.08.008 (c) of the Food and Drug Regulations.

To ensure the uniform application of these requirements and to help industry to comply, the Inspectorate program released, on February 11, 2013, the new guidance document entitled Good Pharmacovigilance Practice (GVP) Guidelines (GUI-0102),  the revised documents entitled Risk Classification of GVP Observations (GUI-0063) and the Inspection Strategy for GVP for drugs (POL-0041).  The document Good Pharmacovigilance Practice (GVP) Guidelines (GUI-0102) outlines the interpretations of the regulations with respect to the adverse drug reaction and post-approval reporting requirements (or GVP).


Archived Webinar Available through July 31, 2014

Who Should Attend 

Professionals involved in:

  • Pharmacovigilance and drug safety
  • Regulatory Affairs
  • Medical Information
  • Quality Assurance/Quality Control

Learning Objectives 

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

  • Identify Health Canada's expectations for pharmacovigilance systems which will be assessed during GVP inspections
  • Discuss how Health Canada attributes risk classification to GVP inspection observations
  • Describe how Health Canada schedules and conducts GVP inspections

Contact Information 

Questions on Archived Webinar
Jessica Culp
DIA North America
Phone +1.215.442.6132
Fax +1.215.442.6199
Jessica.Culp@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Presenter(s) 

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Agenda  

Day 1 Thursday, Jul 18, 2013

  • 7:00AM - 11:59PM

    New Good Pharmacovigilance Practice (GVP) Documents in Canada

    Speaker(s):

    • New Good Pharmacovigilance Practices (GVP) Documents in Canada - A webinar on the GVP Guidelines, Risk Classification of GVP Observations and Inspection Strategy for GVP
      Sophie Lafrance
      Compliance Officer, HPFB Inspectorate
      Health Canada, Canada
    • New Good Pharmacovigilance Practice (GVP) Documents in Canada
      Rita Cassola, RPh
      Executive Director, PV
      Certus PV, Canada

Registration Fees 

Other Fees

Government (Full Time) Individual
$125.00
Charitable Nonprofit/Academia Individual
$175.00
Group Site
$799.00
Group Plus
$995.00

Member

Member Individual
$250.00

Non-Member

NonMember Individual
$295.00
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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