Cooperation Among Regulators: Impact on Stakeholders

Hear Firsthand from FDA Commissioner Hamburg, EMA Executive Director Rasi, and Health Canada Assistant Deputy Minister Glover             View Commissioner Hamburg at Last Year's Annual Meeting Cooperation Among Regulators: Impact on Stakeholders Monday, June 24 Hear views on important issues from the leaders of three of the most influential drug regulatory agencies: The Health Products and Food Branch of Health Canada, the European Medicines Agency, and the U.S. Food and Drug Administration. Join the regulators as they discuss current actions in public policy resulting from interagency actions and strategic communication. Speakers: Chairpersons: Paul Glover, MBA Assistant Deputy Minister of the Health Products and Food Branch Health Canada Marie Allison Dray, MA, MBA President International Regulatory Affairs Group LLC Margaret A. Hamburg, MD Commissioner, FDA  Murray M. Lumpkin, MD, MSc Commissioner's Senior Advisor and Representative for Global Issues, OC, FDA Guido Rasi, MD Executive Director European Medicines Agency European Union Late Breaker Sessions Collaborating to Streamline Drug Development: Are We Making Progress? Wednesday, June 26 In this forum, leaders of two of the best known initiatives – TransCelerate Biopharma Inc (TransCelerate) and the Clinical Trials Transformation Initiative (CTTI) – will provide a status report on current projects, with additional perspectives provided by representatives of the FDA, CROs, and research sites. TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology Wednesday, June 26 TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically and uses adaptive onsite monitoring to further support subject safety and data quality. White Paper Showcase features the following two opportunities... Stay Tuned, More to Come! Next Generation Medical Information Call Center Tuesday, June 25 This session will discuss best practices for building a next generation medical information call center that expediently and efficiently delivers medical information on a global scale. We will discuss how advanced technology can enable and enhance critical patient and provider relationships.   Learning to Share-Sharing To Learn: How an Industry Learns to Honor it’s Volunteers Monday, June 24 This session will discuss the potential value of data sharing initiatives and what hurdles need to addressed to successfully create one. Learn what components are needed and how best to support or participate in this next step in the evolution of clinical research.   Coming Soon! Innovation Theater Schedule to be Announced - Stay Tuned!   Overview | Agenda | Register Online Keynote Speaker Preconference Tutorials Hotel & Travel Exhibiting Daniel Kraft, MD Executive Director, FutureMed Register for 2 half-day or 1 full-day tutorial, save $100 on your registration Book within the DIA Room Block, get special perks! 90% of the hall is SOLD. Reserve your booth today!

Physicians call for improvements to country's public health system to protect US residents

American College of Physicians policy paper, 'Strengthening the Public Health Infrastructure,' calls for adequate resource allocation and funding

(New Orleans) A call for an improved public health infrastructure that works collaboratively with physicians in order to ensure the public's safety and health was made today by the American College of Physicians (ACP). The action was highlighted by the release of a new policy paper, Strengthening the Public Health Infrastructure, at Internal Medicine 2012, ACP's annual scientific meeting in New Orleans.

"This paper points out that strengthening the public health infrastructure is imperative to ensure that the appropriate health care services are available to meet the population's health care needs and to respond to public health emergencies," said Virginia L. Hood, MBBS, MPH, MACP, president of ACP. "A strong public health infrastructure provides the capacity to prepare for and respond to both acute and chronic threats to the nation's health, yet ill-advised budget cuts at the federal, state and local levels pose a grave threat to the health of U.S. residents."

ACP's paper makes the case for adequate investments in public health, which is the practice of preventing diseases and promoting good health within groups of people. Public health depends on an underlying foundation, or infrastructure, to support the planning, delivery, and evaluation of public health activities and practices. Public health works to protect and improve the health of communities through education, policy development, promotion of healthy lifestyles, and research. It concentrates on the health of the population, rather than care of the individual patient, although these are becoming more intertwined as non-communicable diseases are becoming a priority focus for both population and patient-directed care.

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Physicians call for improvements to country's public health system to protect US residents

If Obamacare falls, MassDevice

http://www.massdevice.com/blogs/massdevice/if-obamacare-falls

Until last week, the government's confidence on the constitutionality of the Patient Protection and Affordable Care Act (PPACA) seemed all but certain. Now, they're not so sure it might stand.
Of course, most American's are wondering: "Okay, if it gets repealed, then what?"
First, it is unlikely things will change right away. Many of the changes we've seen in health care with funding of the electronic medical record and forcing the collaboration between doctors and hospitals were created by the earlier economic "Stimulus" package funding, not the PPACA...

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.