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.
- 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
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.