The Leading Forum on the Law, Regulation and Ethics of Medical Research in the United States

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Overview

THE FOURTH ANNUAL MEDICAL RESEARCH SUMMIT: THE LEADING FORUM ON THE LAW, REGULATION AND ETHICS OF MEDICAL RESEARCH IN THE UNITED STATES

Facing an increasingly complex environment affecting clinical research activities, the research community and the healthcare industry have come under increased scrutiny from federal regulators and the public. Key challenges for all entities involved in the research enterprise include the adequacy of compliance with federal regulatory requirements for human subject research and the responsibilities of research sponsors and investigators. At the same time, increased federal and commercial support for biomedical research has led to an era of unparalleled growth in clinical research and the need for clinical studies to confirm the efficacy of new drugs and therapies.

The Medical Research Summit is an annual conference focusing on issues relating to medical research and compliance concerns. This will be the fourth Medical Research Summit and will take place in Baltimore, MD at the Baltimore Marriott Waterfront Hotel.

The Summit is now recognized as one of the preeminent conferences in the country for professionals involved in medical research. Highlights for the Summit include plenary sessions by leading experts as well as instructive and comprehensive workshops designed to provide the most up to date approaches to managing medical research initiatives with regard to the current and future legal, regulatory and ethical context.

Plan now to attend the Fourth Annual Medical Research Summit!!!

SPECIAL THANKS TO THE SUMMIT CO CHAIRS FOR THE PAST FOUR YEARS:

  • Robert M. "Skip" Nelson, M.D., Ph.D., Associate Professor of Anesthesia and Pediatrics, and Chair, Committee for the Protection of Human Subjects, The Children's Hospital of Philadelphia, Philadelphia, PA
  • Tom Puglisi, Ph.D., Global Pharmaceutical & Health Sciences Group, PricewaterhouseCoopers, and Former Director of Human Subject Protections, Office for Human Subjects Research Protections, Washington DC
  • Michele Russell-Einhorn, Esq., Associate General Counsel, J. Craig Venter Science Foundation, and Former Director of Regulatory Affairs Office for Human Research Protection, Washington DC.

Who Should Attend

  • Chief Executive Officers
  • Chief Operating Officers
  • Chief Technology Officers
  • Chief Financial Officers
  • Clinical Investigators
  • Clinical Research Monitors
  • Compliance Officers
  • Contract Researchers
  • Health Law Attorneys
  • Medical Directors
  • Physicians
  • Managed Care Professionals
  • Medical Group Managers
  • Data Managers
  • Ethics Officers
  • Health Insurance Executives
  • Consultants
  • Government Agency Employees
  • Health Administration Faculty
  • Risk Managers
  • Pharmacists
  • Quality Assurance Professionals
  • Registered Nurses
  • Long Term Care Professionals
  • Billing and Coding Professionals
  • Third Party Billing Professionals

Goals & Objectives

  • To provide an overview of medical research initiatives in the United States
  • To establish the legal and regulatory context for medical research
  • To analyze the ethical implications of medical research and the appropriate institutional approaches to addressing these ethical issues
  • To investigate through case studies strategies to comply with legal, regulatory and ethical constraints on medical research initiatives
Prerequisites: There are no prerequisites for this educational activity.


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