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Life Science Compassionate Access Summit

Life Science Compassionate Access Summit

Categories

Date of beginning

Monday, 18 March 2019

Duration

2 days

City

Philadelphia

Country

USA

Contact

Emily Schriver

E-Mail

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Memo

In today’s transparent clinical trial environment, HCP receive constant communication about trials and can offer an alternative treatment under expanded access, also known as compassionate use. Compassionate Access is a special exception made for the use of investigational drugs, biologics or medical devices used on patients during extenuating circumstances on an individual basis. As a life science organization and medical expert, it is your obligation to review fast and fairly to approve this request to send to regulators in the nation for regulators to ship the drug to the physicians. These responsibilities will ensure patient safety and expanded access capabilities, to execute a proper program that is compliant. At ExL’s Life Science Compassionate Access Summit, attendees will be able to join industry leaders to explore compassionate use departments, compliance, market access, and understand the ethics of regulatory affairs to advance public health and widen the application within the life science industry. Top Five Reasons to Attend1. Examine best practices to implement, integrate, and enhance fair patient enrollment criteria and practices for an Expanded Access Program2. Implement EAPs to support patient access from a stakeholders standpoint3. Review industry trends and the use of Real-World Data in an Expanded Access Program4. Discuss the benefits and challenges of the new legislative “Right to Try” bill5. Explore how to enhance all factors and address regulatory, ethical, and management aspects of an EAP program Time: 9:00 am - 5:00 pm Venue details: Sonesta Philadelphia Downtown Rittenhouse Square,1800 Market Street, Philadelphia,19103,USA