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Drug Safety and Adverse Drug Reaction Reporting Workshop

November 29, 2019 @ 9:00 am - 5:00 pm

Drug Safety and Adverse Drug Reaction Reporting Workshop

Register for 3 Days online

Dates Available

April 22, 29 & May 6, 2020

Time

10:00 a.m. – 12:00 p.m.

Cost

CAD $585.00 + HST

Location

Online

Live interactive and instructor led


This workshop will explain the importance of adverse drug reactions, the Canadian MEdEffect Scheme, the source of adverse drug reaction reports and the differences between serious and non-serious events. Ina addition, a MedEffet form will be completed in class.

Day 1

  • Introduction
  • What is Pharmacovigilance and why it's important
  • The WHO and drug safety
  • ICH and drug safety
  • Learning the terminology
  • The regulatory landscape (US and EU) with a focus on Canada

Register for Day 1 online

Day 2

  • Pre and Post-market Adverse Event collection, assessment and reporting
  • The expedited regulatory reporting process
  • Sources for Drug Safety Information
  • Criteria for reporting ADRs, and required assessments
  • Drug product life cycle

Register for Day 2 online

Day 3

  • Coding of ADRs
  • CIOMS and MedWATCH
  • Reporting process in clinical trials
  • Reporting timeframe
  • Introduction to PSUR/PBRERs
  • Regulatory Guidelines
  • Introduction to signal detection and processing
  • Introduction to risk management

Register for Day 3 online

Certificate of Attendance and Course Material

  • All participants will receive a certificate of attendance upon completion of the course.
  • The participants will be receiving specially prepared course manual.

Note: Registration closes one week prior to the start of workshop.

Details

Date:
November 29, 2019
Time:
9:00 am - 5:00 pm

Venue

AAPS Training Center
200 Consumers Road, Suite 200
Toronto, Ontario M2J 4R4 Canada
Phone:
416-502-2277

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