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DIA Canadian Pharmacovigilance & Risk Management

Oct 2 2014 8:00AM - Oct 2 2014 4:30PM | DoubleTree by Hilton Hotel Toronto Downtown 108 Chestnut Street Toronto, ON M5G 1R3 Canada

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Overview 

Tutorial: October 1, 2014
Pharmacovigilance and Risk Management Planning


This inaugural meeting will provide new insights into the current issues and associated challenges impacting drug safety in Canada. Top pharmaceutical, biotechnology, and regulatory thought leaders will discuss new and updated legislation; patient safety, medical errors, and adverse reporting; operational challenges of implementing Benefit-risk analyses and risk management plans; and much more.

This meeting will focus on:

  • Mandatory Reporting
  • Benefit-Risk Review
  • Draft Guidance Document for Preparing a Post-Market Benefit-Risk Assessment
  • Good Pharmacovigilance Practice (GVP) Inspection Guidelines and Policy
  • Canada Vigilance Project (eReporting)
  • Periodic Benefit Risk Evaluation Reports (PBRERs) and Periodic Safety Update Reports (PSURs)
  • Preparation of Risk Management Plans (RMPs)
  • Development Safety Update Reports (DSURs)

Who Should Attend 

Professionals who are involved in:

  • Drug Safety/Pharmacovigilance
  • Risk Management
  • Medical Product Safety Assessment
  • Regulatory Affairs
  • Clinical Research
  • Data Analysis
  • Pharmacoepidemiology
  • Medical Information
  • Health Outcomes

Learning Objectives 

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

  • Describe the current Canadian regulatory framework for pharmacovigilance
  • Describe operational challenges of implementing Benefit-risk analyses and risk management plans

Special Offers 

Group Discounts Available!
Register 3 and Get the 4th FREE!

 

Hotel & Travel 

DoubleTree by Hilton Hotel Toronto Downtown  A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until August 29, 2014, or until room block is filled).  Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel.  Contact information for Travel Planners is as follows: Attendees can follow this link or call:  +1.212.532.1660 or 1.800.221.3531 in the U.S. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #14018.

Standard Room Rate $195
Hotel Address: 108 Chestnut St, Toronto, ON M5G 1R3, Canada

PLEASE READ
Warning: Unauthorized Solicitation

The most convenient airport is Toronto Pearson International Airport and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Printable Registration Form

Registration Questions
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
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199
Carrie.Dunn@diahome.org

Event Logistics
Stephanie Ritter, Event Planner
Phone +1.215.442.6149
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

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 up to 1.0 CEUs for the 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
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 4 Elective Units
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
• Regulatory Affairs Certificate Program: 4 Elective Units
For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Pharmacovigilance and Risk Management Planning ACPE 3.25 0.325
Pharmacovigilance and Risk Management Planning IACET 3.25 0.300
DIA Canadian Pharmacovigilance & Risk Management IACET 6.75 0.700

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 attend the program and tutorial, if applicable, sign in at the DIA registration desk each day of the program, and complete the on-line 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. Transcript will be available for credit requests on Thursday, October 16, 2014.

Program Committee 

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Agenda  

Tutorials Wednesday, Oct 01, 2014

  • 1:00PM - 4:30PM

    Pharmacovigilance and Risk Management Planning

    This tutorial will focus on the practical aspects of managing biopharmaceutical product risks in the context of a product’s benefits.

Day 1 Thursday, Oct 02, 2014

  • 7:30AM - 8:00AM

    Registration and Continental Breakfast
  • 8:00AM - 8:10AM

    Welcome and Opening Remarks
  • 8:10AM - 8:30AM

    Keynote Address - Update on the Impacts of Pharmacovigilance & Drug Safety Legislation

    Speaker(s):

    • David K. Lee
      Director, Office of Legislative and Regulatory Modernization
      Health Canada, Canada
  • 8:30AM - 10:00AM

    Session 1 - Health Canada Update


    Session Chair(s):

    • Rita Cassola, RPh
      Executive Director, PV
      Certus PV, Canada

    Session 1 - Health Canada Update

    Speaker(s):

    • Draft Guidance Document for Preparing a Post-Market Benefit-Risk Assessment
      Matthew P LeBrun, MS
      Scientific Evaluator
      Health Canada, Canada
    • Inspections
      Katarina Susnjar
      Regulatory Compliance Specialist- Inspectorate Program
      Health Canada, Canada
    • Risk Management Plan Draft Guidance
      Rania Mouchantaf, PhD
      Scientific Evaluator
      Health Canada, Canada
  • 10:00AM - 10:30AM

    Morning Refreshment Break
  • 10:30AM - 12:00PM

    Session 2 - Special Product Areas


    Session Chair(s):

    • Anne Tomalin, RAC
      President
      Therapeutic Products Inc, Canada

    Session 2 - Special Product Areas

    Speaker(s):

    • Canadian Medical Devices Sentinel Network (CMDSNet)
      Colleen Turpin
      Regulatory Project Manager
      Health Canada, Canada
    • NHP & OTC: Monitoring Literature
      Stephanie Jack, MSc
      Acting Scientific Manager, Marketed Health Products Dictorate
      Health Canada, Canada
    • Generics
      Bruce W. Valliant
      Director, Medical Affairs
      Teva Canada Limited, Canada
  • 12:00PM - 1:00PM

    Luncheon
  • 1:00PM - 2:00PM

    Session 3 - eReporting


    Session Chair(s):

    • Rebecca A. Noel, DrPH, MPH
      Senior Research Scientist, Global Patient Safety
      Eli Lilly and Company, United States

    Session 3 - eReporting

    Speaker(s):

    • Health Canada Update
      Bill Wilson
      Business Lead, Canada Vigilance Project
      Health Canada , Canada
    • Implementation
      Marcia Bailey, BSN
      Sr. Specialist, Pharmacovigilance and Medical Information
      Otsuka Canada Pharmaceutical Inc., Canada
  • 2:00PM - 2:45PM

    Session 4 - Medication Errors & Patient Safety


    Session Chair(s):

    • Rebecca A. Noel, DrPH, MPH
      Senior Research Scientist, Global Patient Safety
      Eli Lilly and Company, United States

    Session 4 - Medication Errors & Patient Safety

    Speaker(s):

    • Labels & Packaging
      Margaret Zimmerman
      Manager, Policy & Partnership
      Health Canada(MHPD), Canada
  • 2:45PM - 3:00PM

    Afternoon Refreshment Break
  • 3:00PM - 4:00PM

    Session 5 - Signal Detection and Real-World Data


    Session Chair(s):

    • Marc F. Poitras, PhD, MBA
      Scientific Manager
      Health Canada, Canada

    Session 5 - Signal Detection and Real-World Data

    Speaker(s):

    • Drug Utilization Studies
      Yola Moride, PhD, FISPE
      Professor, Faculty of Pharmacy
      University of Montreal, Faculty of Pharmacy, Canada
    • Evolving Nature of Evidence in Pharmacovigilance to Inform on Regulatory Decisions
      Rania Mouchantaf, PhD
      Scientific Evaluator
      Health Canada, Canada
  • 4:00PM - 4:30PM

    Closing Remarks

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$580.00
Member Government
$435.00
Member Industry
$965.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$805.00
NonMember Government
$660.00
NonMember Industry
$1190.00
Registration Fees for Additional Offerings
Pharmacovigilance and Risk Management Planning - Tutorial Rate
$405.00
Group Discounts

Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia. To take advantage of this offer, please print a registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

Register Online

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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