Public Policy / Health Care Compliance / Regulatory Law - What's on tap at DIA2012?

48th Annual Meeting
June 24-28, 2012
Philadelphia, PA
Pennsylvania Convention Center

Public Policy / Health Care Compliance / Regulatory Law - What's on tap at DIA2012?

Civil and Criminal Liability from Clinical Trials
This interactive forum will use case studies to highlight some real-life legal and regulatory issues that affect sponsors, investigators, and IRBs in the conduct of clinical trials. The forum will touch upon legal and regulatory issues regarding such things as conflicts of interest, enrolling non-English-speaking subjects, and enrollment incentives.


Clinical Trials on Trial: Potential Legal Liability Arising from Clinical Trials
In this workshop, experienced lawyers will conduct a mock trial involving issues that may arise in clinical trial lawsuits. The mock trial will include opening statements and closing arguments, as well as realistic direct and cross-examination of the primary witnesses in the case, including video evidence. At its conclusion, the lawyers will entertain questions about the mock trial. **Due to workshop format, seating will be limited and will be available on a first come, first served basis. The Pennsylvania Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this event will not be recorded.


Drug Rediscovery as an Innovative Tool to Meet Unmet Medical Needs
Drug Rediscovery is the science dealing with the use of old active substances to develop new treatments. This session focuses on the benefits and challenges of drug rediscovery.


Emerging Development and Policy Trends in the Economics of the Biopharmaceutical Industry
The implications of industry practices and public policies for R&D productivity and the incentives to innovate will be examined.


Emerging Role of the Patient Voice on Drug Policy in Japan
Patients and lay people in Japan now form one of the major groups that support current drug development, safety, supply, and regulatory affairs. This session will discuss recent change and the significant effect of the patient voice on drug policy and the progress of the amendment of the Pharmaceutical Affairs Law.


International Cooperation Among Regulatory Agencies
Since 2004, regulators, such as the EMA, Health Canada, and the US FDA, have extended harmonization actions to include exchanges of information and personnel to discuss product development and policy matters in joint closed sessions. Industry began to take notice that regulatory decision-making had become global. This session will include updates on strategic activities sponsored by the EMA, Health Canada, and the US FDA.

Legal Aspects of Clinical Trial Compliance
This session will provide a broad-based review of the various laws and regulations that impact clinical trials. This discussion will focus primarily on issues including the Foreign Corrupt Practices Act, False Claims Act, anti-kickback laws, determination of fair market value, and HIPAA. There will also be a discussion on the non-FDA governmental organizations that may get involved in clinical trial compliance including HHS and the US Attorney's Office.



Meeting the Therapeutic Needs of Older Patients: A Sustainable Collaborative Approach
Regulators will discuss how to facilitate the implementation of affordable development programs for unmet therapeutic needs of older patients, in line with the existing regulatory guidance for geriatric medicines.

Policy and Enforcement Trends: Are Regulators and Industry Heading in the Right Direction?
This forum will explore policy and enforcement trends and explore issues addressing questions related to the issue of whether regulators/industry are heading in the right direction. As globalization and collaboration become more relevant, can we do better?

Regulatory Capacity Building from 360 Degrees
Regulatory capacity building is a critical activity to ensure the global access and supply of safe and effective pharmaceuticals. Health authorities, nonprofit entities, and international organizations priorities and activities will be presented.

Product Liability in the US and the EU
In this session, an overview will be given of both legislation and case law with respect to product liability on both sides of the Atlantic. The session will provide hands-on information for advice to clients and will discuss current case law.