Life Science Compassionate Access Summit – Life Science Compassionate Access Summit



Andra Stratton,
Chief Executive Officer,

Alison Bateman-House,
Research Assistant Professor, Division of Medical Ethics,

John Caminis,
Therapeutic Area Head: Gastroenterology, Endocrinology and Metabolism, Global Drug Safety,

Chitra Edwin,
Senior Vice President of Regulatory Affairs and Compliance,

Ross Goldstein,
Director, Medical Affairs,

Jill McNair,
Senior Director, Patient Engagement,

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 Attend

  1. Examine best practices to implement, integrate, and enhance fair patient enrollment criteria and practices for an Expanded Access Program
  2. Implement EAPs to support patient access from a stakeholders standpoint
  3. Review industry trends and the use of Real-World Data in an Expanded Access Program
  4. Discuss the benefits and challenges of the new legislative “Right to Try” bill
  5. Explore how to enhance all factors and address regulatory, ethical, and management aspects of an EAP program

Who Should Attend

This conference is designed for representatives from pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:

  • Pricing and Reimbursement
  • Expanded Access/Compassionate Use/Compassionate Access
  • Early Access
  • Pharmacovigilance
  • Patient Support/Engagement
  • Patient Advocacy
  • Patient Experience
  • Medical Affairs
  • Regulatory Affairs
  • Clinical Affairs
  • Managed Markets
  • Global Market Access
  • Named Patient Programs
  • Market Access
  • Safety
  • Legal
  • Rare Disease Products
  • Off-Label Products

This conference is also of interest to:

  • Healthcare Agencies
  • Private Equity Firms
  • Medical-Legal Regulatory
  • Market Access Consulting
  • Law Firms
  • CRO Partners
  • Regulatory Affairs and Compliance Partners
Startdate: 2019-03-18
End Date 2019-03-19

Performer: ExL Events
Address : Life Science Compassionate Access Summit