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Risk Management Plans and Drug Utilization Studies in Canada

Oct 27 2014 1:30PM - Oct 27 2014 5:00PM | Ottawa Marriott Hotel 100 Kent Street Ottawa, ON K1P5R7 CANADA

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Overview 

Regulators around the world have expanded their investment and policy frameworks in the development of tools to assess both pre- and post-market safety evidence. These efforts have expanded with the implementation of a number of International Conference on Harmonisation (ICH) guidelines including ICH E2E Guideline. The tutorial is intended to provide participants with an overview of the 2014 Health Canada Draft Guidance Document entitled: “Risk Management Plans and Follow-up Commitments.” Additionally the assessment of benefit-risk of medicines needs careful consideration concerning their patterns of utilization; a component that is increasingly becoming an integral component of risk management planning. The course will therefore provide a training on Drug Utilization Studies (DUS) in addition to a discussion of alternative options in situations where full DUS are not feasible.

Learning Objectives 

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

  • Explain Health Canada expectations in relations to Risk Management Plans
  • Discuss main principles and limitations of DUS
  • Explain Health Canada expectations of DUS
  • Recognize situations where alternatives can be considered when full DUS are not attainable

Contact Information 

Registration Questions
Customer Service Department
Toll Free: 1.888.257.6457
Phone: +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

For  More Information:
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1.215.442.6199
Rachel.Minnick@diahome.org

Jessica McGrory, In-company Training Manager
Phone +1.215.442.6182
Fax +1.215.442.6199
Jessica.McGrory@diahome.org

Instructor(s) 

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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.

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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