'The Pink Sheet' Announces Practical Clinical Trials Audio Conference: July 20th.

CHEVY CHASE, Md. & ARLINGTON, Va. -- Drug & Device Dialogue, produced by FDC Reports, Inc., publisher of "The Pink Sheet" and "The Gray Sheet," in partnership with Polidais LLC, today announces a new audio conference:

"Trials and Tribulations: Randomized Trials Vs. Practical Clinical Studies for Drugs and Devices" - a 90-minute, interactive web-based audio conference for pharmaceutical and medical technology professionals.

Tuesday, July 20, 2004
1:00-2:30 pm (Eastern Time)
http://www.fdcreports.com/dialogue

Bringing together leading government and industry insiders for a lively, online symposium, this Drug & Device Dialogue event will explore the advantages and challenges of conducting practical clinical studies - comparing new and existing therapies - versus more traditional randomized, placebo controlled trials of drugs and medical devices.

Learn from the following experts as they discuss emerging trends that will alter the healthcare industry:

--Sean Tunis, Chief Medical Officer, Centers for Medicare & Medicaid Services

--David Feigal, former director of FDA's Center for Devices & Radiological Health

--Kathy Buto, VP-Health Policy & Government Affairs, Johnson & Johnson

--Susan Alpert, VP, Chief Quality & Regulatory Officer, Medtronic

Information on the speakers is available at www.fdcreports.com/dialogue.

What You Will Learn:

--CMS' evolving thinking on data requirements for coverage.

--Implications for clinical trial design and protocol development.

--Strategies to address both FDA approval and CMS coverage.

--Differing approaches for drugs and devices.

--Efforts to improve FDA-CMS communications.

--How should you prepare for changes in policy?

Who Should Participate:

--Drug and medical device executives

--Regulatory consultants

--Reimbursement specialists

--Pharmaceutical and med tech attorneys

Drug & Device Dialogue online symposiums feature high-quality audio presentations over the Internet or telephone, complemented by synchronized slide presentations, background materials and user-friendly Q&A.

Registration:

Single registrant access is $395; each additional registrant is $325. Academic and non-profit rates available. For more information or to register, visit www.fdcreports.com/dialogue or call 800-332-2181.

For more information, please visit www.fdcreports.com/dialogue.

FDC Reports, Inc. is a division of the Elsevier Company. Elsevier is a world-leading publisher of scientific, technical and medical information products and services. Working in partnership with the global science and health communities, the company publishes more than 1,800 journals and 2,200 new books per year, in addition to offering a suite of innovative electronic products, such as ScienceDirect (www.sciencedirect.com) and MD Consult (www.mdconsult.com) bibliographic databases, online reference works and subject specific portals.

Polidais LLC is a public affairs firm that organizes and expresses knowledge on health policy. It provides research, policy analysis, policy positioning, and communications services in the fields of health care, science, and technological innovation. Its mission is to help organizations sharpen ideas, base them upon sound research and analysis, and convey them to key audiences.