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Rarely has the life science industry been met with so many major changes and uncertainties with such far-reaching consequences to drug development, manufacturing, monitoring and marketing. And rarely has there been a greater need to bring leaders from the FDA and Congress together with thought leaders from industry and outside experts to share strategies for regaining consumer confidence in today's medicines.

Who Should Attend:

Senior executives and managers of pharmaceutical companies, especially those responsible for the oversight of:

  • Regulatory affairs
  • Pharmacovigilance
  • Drug manufacturing
  • Quality management systems
  • Medical affairs
  • Clinical research
  • Risk management
  • Labeling
  • Legal affairs
  • Sales and marketing
Learning Objectives:
  • To examine the latest changes at the FDA--including new people, policies and priorities--and prepare for more changes to come
  • To hear directly from FDA's top leaders the agency's priorities and programs for drug safety, REMS, Safe Use, comparative effectiveness, health outcomes, and other key initiatives
  • To formulate ideas and discuss specific successful strategies for reducing risks throughout the life cycle of a product--from development to delivery
  • To understand the impact of new guidance, new enforcement trends, and recent changes in federal preemption
  • To hear directly from Congressional leaders, key staff, and outside experts how healthcare reform is likely to impact the FDA and industry
Symposium Media Partners:

The Harvard Health Policy Review is dedicated to broadening awareness of health policy issues and aims to educate people about healthcare policy and to stimulate thinking about the pressing healthcare questions facing the nation and the world. The HHPR is published by Exploring Policy in Health Care at Harvard and is supported by the University-wide Interfaculty Initiative in Health Policy.

Health Affairs is the leading journal of health policy thought and research. The journal was founded in 1981 under the aegis of Project HOPE, a nonprofit international health education organization. Health Affairs explores health policy issues of current concern in both domestic and international spheres.

Rx Compliance Report is the only news source devoted exclusively to the government’s crackdown on pharmaceutical sales and marketing practices. This 12-page bi-weekly newsletter uncovers emerging investigations and offers practical firsthand advice on implementing effective compliance programs. Rx Compliance Report focuses on the state and federal agencies leading these fraud and abuse investigations including the U.S. Dept. of Justice, the HHS OIG, state Attorneys General, state Medicaid Fraud Control Units, and other federal agencies.

Overview | Agenda/Faculty Materials | Brochure | Promotional Opportunities
Administration | Speaking Proposals | Past Events | Contact Us | Home

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