#  "Post-Trial Responsibilities Conference: Ethics and Implementation: 

 



####  calendar\_today Date and Time 

 **September 24, 2014** 

 07:30AM - 05:30PM EDT 

####  pin\_drop Location 

 **Harvard Law School, Wasserstein Hall, Milstein West AB, 1585 Massachusetts Ave., Cambridge**  



 

 



 

[Click here](https://events.r20.constantcontact.com/register/eventReg?llr=niba49lab&oeidk=a07e99xekt272ca4975) 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



 

 



 

 

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