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 our
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
- Examine best practices to implement, integrate, and enhance fair patient enrollment criteria and practices for an Expanded Access Program
- Implement EAPs to support patient access from a stakeholders standpoint
- Review industry trends and the use of Real-World Data in an Expanded Access Program
- Discuss the benefits and challenges of the new legislative "Right to Try" bill
- 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
Speakers
- Alison Bateman House, Research Assistant Professor, Division of Medical Ethics, NYU LANGONE HEALTH
- John Caminis, Therapeutic Area Head: Gastroenterology, Endocrinology, and Metabolism, Global Drug Safety, SHIARE
- Chitra Edwin, Senior Vice President of Regulatory Affairs and Compliance, SPOTLIGHT INNOVATION
- Karen Frascello, Vice President, Pre-Approval Access Programs, CALIGOR COGHLAN
- Ross Goldstein, Director, Medical Affairs, RETROPHIN
- Lubna Jamal, Real-World Evidence Consultant, PROGENICS
- Richard Klein, Former Director, Patient Liaison Program, FDA
- Jill McNair, Senior Director, Patient Engagement, CENTER FOR INFORMATION & STUDY CLINICAL RESEARCH PARTICIPATION (CISCRP)
- Stefan Ochalski, Vice President, Regulatory Affairs, TAIHO ONCOLOGY
- Andra Stratton, Chief Executive Officer, LIPODSTROPHY UNITED
- June Wasser, Executive Director/CEO, REAGAN U-DALL FOUNDATION FOR THE FDA
- Kevin Weatherwax, Manager MICHR/IND/IDE Investigator Assitance Program, MIAP, UNIVERSITY OF MICHIGAN HEALTH SYSTEM
Please fill in your name and email to receive the Summit Agenda of this event.
Venue
Sonesta Philadelphia Downtown Rittenhouse Square
1800 Market St, 19103
Philadelphia, PA, USA
Venue
Sonesta Philadelphia Rittenhouse Square1800 Market Street
Philadelphia, PA 19103
Explore
the comfort and fresh, contemporary vibe at the all-new Sonesta
Philadelphia. A premier choice among hotels in Philadelphia, enjoy
spacious, modern accommodations and luxurious amenities while staying in
the heart of downtown and only steps away from Rittenhouse Square.
To make reservations, guests can call 1-800-SONESTA (766-3782) and request the negotiated rate for ExL's December Meetings.
To make reservations online
Click HereThe group rate is available until November 15, 2018. Please book your room early as rooms available at this rate are limited.
