Pharmacovigilance - A Blueprint for Risk Management©
The Seventeenth Annual Training Course in Pharmacovigilance

November 4, 2011 at the Delta Ottawa Hotel & Suites

Leave bandaid solutions at home! For 21st century life science industry knowledge workers this is a must attend course dealing with the latest developments in drug safety management. Risk free - and can only benefit your career and company

Program for this Special One-Day Course:

The Continuum of Risk/Benefit Assessment
Risk management via Pharmacovigilance Planning; Pharmacovigilance competency

How & Why drug safety data management is regulated
The scientific basis of ADR regulations; introduction to CIOMS; ICH

Regulations for safety data management:

  • Postmarket regulations (Canadian, FDA, EU); ICH-E2D & E2E
  • Periodic Safety Update Reports (ICH-E2C)
  • Comparisons with FDA and EU proposals.

Case Report Management

Case report assessment:

  • Types of ADRs; looking for signals.
  • Determining "seriousness" and "expectedness".
  • Canadian ADR reporting guidelines as a tool for report management.
  • Follow-up procedures.

Causality Assessment

Various assessment methods used in safety data management; individual case reports vs. data sets.

Case Studies
Participants will be given individual case reports to assess;to be reviewed in the afternoon session.

Risk Management - Tools in Pharmacovigilance

Benefits and limitations of Pharmacoepidemiology studies

Safety Department Audits

Principles of Pharmacovigilance related to audits; experiences of FDA and EU Audits

Faculty includes:

  • W. C. Appel, Ph.D., Principal, Kusuri Canada Corp.
  • Jacqueline Conant, MSc., Assoc. Director, Medical Information & Pharmacovigilance, Regulatory Affairs, Apotex Inc.
  • Alain Rohan, M.D., MPH, Director, International Pharmacovigilance, 3M Pharmaceuticals, St. Paul, Minnesota
  • Invited Speaker from the Canada Vigilance, Marketed Health Products Directorate


Pharmacovigilance Stewardship - Training Canada's Future Leaders.™

To Register Contact us: Phone or fax (613) 523-5993

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