BEGIN:VCALENDAR VERSION:2.0 X-WR-CALNAME;VALUE=TEXT:"Post-Trial Responsibilities Conference: Ethics and Implementation: PRODID:-//Harvard events data//EN BEGIN:VEVENT UID:event_213501_0 SUMMARY:"Post-Trial Responsibilities Conference: Ethics and Implementation: DESCRIPTION:

Click here to register for this day-long event.

The MRCT Center at Harvard and the Petrie-Flom Center at Harvard Law School are proud to co-host the Post-Trial Responsibilities Conference: Ethics and Implementation.

Background

Law, policy, and guidance in regard to post-trial access can be vague, conflicting, and lacking in concrete solutions. Questions relating to this notion include:

What types of interventions should be included within post-trial access obligations?
What is a reasonable duration for provision of post-trial access?
What is the mission and purpose of various stakeholders in the conduct of clinical research and how do these roles intersect with post-trial access obligations?

Discussion of Solutions to Post-Trial Access

This conference will bring together diverse, global stakeholders to address and develop consensus around:

articulating and understanding the range of perspectives relating to post-trial access
implications of the 2013 Declaration of Helsinki revisions (and other guidance on post-trial access) for clinical research sponsors, investigators, and other stakeholders in the U.S. and abroad
drawing lessons from successful and unsuccessful attempts to implement post-trial access policies
potential scenarios and practical solutions for post-trial access to medicines that may inform policy in this important area moving forward

Session I: Setting the Stage (Moderator: Glenn Cohen): To introduce current ethical and regulatory approaches to “post-trial access,” as well as key controversies with speeches by global regulators.

Session II: Important Perspectives (Moderator: Barbara Bierer): To convey the range of stakeholder perspectives and current approaches to the post-trial access issue from sponsors, regulators, patients, and investigators, and identify areas of convergence and divergence with speakers from government, industry and non-profit

Session III: Potential Models and Case Studies of Post-Trial Access (Moderator: TBD): To better understand real world experiences with post-trial access, including both successes and failures, and to more clearly articulate and assess the complexities involved with speakers from government, industry and non-government organizations

LOCATION:Harvard Law School, Wasserstein Hall, Milstein West AB, 1585 Massachusetts Ave., Cambridge STATUS:CONFIRMED DTSTART:20140924T113000Z DTEND:20140924T213000Z END:VEVENT END:VCALENDAR