The Quality Colloquim - The Leading Forum on Health Care Quality Enhancement and Medical Error Reduction

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Symposium Overview
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 together representatives and advisors from government and the world's leading drugmakers to share strategies for regaining consumer confidence in today's medicines.

The FDA Regulatory and Compliance Symposium

- a unique three-day, high-level forum in one of the world's most famous academic settings - will help drugmakers prepare for the full impact of the many changes flowing from the FDA and Congress, while clarifying many of the uncertainties. The Symposium will also provide practical solutions to the challenges and risks faced throughout the product life cycle - from the drug pipeline to manufacturing to patient delivery.

Choose from multiple tracks!

On Day 2 of the Symposium, select the tracks that best meet your needs. Each one features a powerful line up of industry experts, thought leaders and policymakers. Choose from three morning tracks: Drug Safety and Risk Management; Advertising, Promotion and Compliance; or Where the FDA and CMS Meet. Choose from two afternoon tracks: Drug and Device Development and Clinical Trials, or Compliance and FDA Enforcement.

Location:

The Symposium takes place on the campus of Harvard University, the oldest institution of higher learning in the U.S., established in 1636. Classes are held in Annenberg Hall, Sanders Theatre and the Science Center.

Who Should Attend:

Senior executives, compliance officers 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 describe best industry practices for managing drug safety risks
  • To examine the latest changes at the FDA - including new people, policies and priorities - and prepare for more changes to come
  • To share ideas and discuss specific successful strategies for reducing risks throughout the life cycle of a product - from development to delivery, from bench to bedside
  • To meet heightened FDA expectations for pharmacovigilance
  • To implement proven techniques for internal compliance and risk auditing
  • To benchmark risk management strategies against several of the top pharmaceutical and biologic companies in the world
Symposium Sponsors:

FDAnews is the premier provider of global regulatory, legislative, and business news and information for professionals in industries regulated by the FDA and European Medicines Agency. Pharma and device professionals rely on FDAnews' conferences, print and electronic newsletters, and books to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
www.FDANews.com.

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.
www.HHPR.org.

Health Affairs is the leading journal of health policy thought and research. Health Affairs is a multidisciplinary journal covering a wide range of health issues, including access to care, health spending, quality, Medicare, Medicaid, prescription drug coverage and costs, physician practice, nursing trends, mental health, malpractice and health law, insurance reform, hospitals, global health, and disparities in healthcare, among others.
www.HealthAffairs.org.



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