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Access to Unapproved Drugs through Compassionate Use

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Overview 

This course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes the legal mechanisms and regulated programs for allowing access to unapproved pharmaceuticals for compassionate use in the EU, United States, Canada, and Australia. It examines EU compassionate use programs by reviewing the differences in the member states’ programs. It then discusses US compassionate use programs by focusing on unapproved drugs potentially available for treatment. The course concludes with in-depth reviews of Canada’s Special Access Programme and Australia’s Special Access Scheme.

Featured Topics 

  • Accessing unapproved pharmaceuticals for compassionate use in the EU, United States, Canada, and Australia
  • US compassionate use
  • EU compassionate use
  • Canada Special Access Programme
  • Australia Special Access Scheme

Who Should Attend 

Professionals and experts in the pharmaceutical, biotechnology, and medical device fields

Learning Objectives 

Participants who complete this course should be able to:

  • Define the legal basis for compassionate use programmes in the European Union
  • Address the different national Member States compassionate use programmes
  • Explain when an unapproved drug may be made available for treatment use in the United States
  • Describe the purpose of the Special Access Programme in Canada
  • Define the purpose of the Special Access Scheme in Australia
  • Understand how requests are processed
  • Explain the responsibilities of the prescriber, applicant, and sponsor

The module takes an average of one hour to complete.

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Individual
$495.00
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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