An Overview of Recent Developments in Clinical Trial Registries

Fri, May 9 12:00 pm – 2:00 pm

TO REGISTER

Email your name, title and company to register@massbio.org. Please include "5/9 CT" in the subject line.

This event is free of charge and open to MBC Member companies and their employees only.

For more information on Membership, contact Lori Gold at lori.gold@massbio.org or 617-674-5149

Registration closes at approximately 3pm one day prior to a scheduled meeting. Unless a meeting is closed due to capacity you may attend as a walk-in registrant.

This meeting will be held at the MBC Offices, located on the ninth floor of One Cambridge Center, Cambridge, MA 02142.

Topic Overview

The MBC Clinical Trials Committee is pleased to invite you to a forum on Patient Registries.

There has been much in the news about the ever-increasing reliance on post-marketing registries to satisfy a growing list of regulatory, safety, and reimbursement commitments. These external demands have broadened the number of stakeholders within sponsor organizations, each with a distinct expectation of what a registry will deliver for them.

Topics for discussion include:

  • Types of registries (e.g. which are mandated?), including case studies
  • Deciding between a trial or registry
  • Registry best practices
  • Monitoring and auditing of registries

  • Invited Speakers

  • Flora Sandra Siami, MPH, RAC, Director, Regulatory Affairs, New England Research Institutes, Inc,
  • Rebecca H. Li, Ph.D., Vice President, Clinical Research, from New England Research Institutes, Inc
  • Neal Mantick, MS, Director of Registries from Abt Bio-Pharma Solutions, Inc