Rare Disease Collaboration Summit: Managing Compassionate Access
Hear directly from FDA on how to manage compassionate access requests for orphan drugs!
Requests for compassionate access to orphan drugs are perhaps the greatest ethical and business dilemma that you face. The rise of social media has massively broadened public awareness and activism, with the intense attention given to Chimerix’s brincidofovir being only the most recent high-profile case. In all circumstances you must be guided by steady ethical and safety considerations.
ExL Pharma’s Rare Disease Collaboration Summit, August 12-13, Philadelphia, is pleased to offer an exclusive FDA keynote address that tackles these difficult decisions. Here you will learn how to boost public understanding of the potential risks and tradeoffs, construct trial protocols around compassionate access requests to gain more disease natural history data – and much more!
REGISTER HERE to reserve your seat today!
DOWNLOAD the Full Brochure.
Featured Sessions Include:
KEYNOTE: Regulatory Perspective on Compassionate Access Requests for Pre-Approval Orphan Drugs
Richard Klein, Director, Patient Liaison Program, Office of Health and Constituent Affairs, FDA.
KEYNOTE: Manage, Select, and Learn From Patient Compassionate Access Requests
Murad Husain, VP, Regulatory Affairs, PTC THERAPEUTICS.
• Over 24 expert speakers from pharma, patient advocate, and government sectors focus on developing long-lasting partnerships in order to overcome clinical challenges and secure regulatory approval and market access for orphan drugs. Set working-group relationships that outlast the meeting!
• An in-depth intensive workshop examining how to guarantee access to rare disease patients during clinical trials
• Exclusive case studies comparing and contrasting the ideal strategies for pharma / patient partnerships given the differing sizes and resources of patient populations and advocacy groups
• Up-to-date best practice for ensuring continued access to rare drugs amidst the changes brought about by healthcare reform
• Vital understanding on how to handle compassionate access requests in a manner that protects your patients, your business model, and your public reputation.
Register online and SAVE 20% by using our Discount Code C484ODB.
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