CDs Include:
PRE-CONFERENCE SESSIONS

• S2 Training for Clinical Research – Samuel Tilden, Carolyn P. Whitmire, Gary Eiland
• S3 Auditing and Monitoring for Grants – Tim Fournier, Phyllis Hall
• S4 The Laws and Regulations Governing Clinical Research 101 – John Steiner, Mark Waxman, Gretchen Brodnicki
• S5 Auditing & Monitoring – Michelle Anderson, Lynda Hilliard
• S6 Human Subjects Protection 101 – Melissa Markey, David Forster

• How CMS’s Anticipated Update to the Clinical Trials NCD Will Affect You – Lisa Murtha, Ryan Meade
• Clinical Trials and the FDA—What You Really Need to Know – Doreen Kezer
• The Enforcement Agenda for Research – Jim Sheehan
• What’s New in Human Subject Protections – Mark Barnes
• Research Misconduct: Recent Developments – Brian D. Bewley
• Off-Label Use of Drugs and the Enforcement Implications – Michael Kendall

• 101 Recent Developments in Clinical Trials and the NCD – Cynthia Boyd, Ryan Meade
• 102 Ethical Conflicts of Interest and Clinical Research: What’s Hot and What’s Not? – Kendra Dimond, Stuart Horowitz
• 103 Common Challenges in Industry—Academia Collaboration – Mark Waxman

• 201 Effort Reporting—the Latest Developments and Recent Cases – Holley Thames Lutz, Terry L. Reeves
• 202 Compliance with Good Clinical Practice Standards—and What’s New with GMP-F – Lisa Murtha, John Steiner
• 203 Clinical Trial Billing—How to Minimize Risk and Maximize Compliance – Mary Schumer, Roger Gopolan
• 204 How to Audit Compliance with Federal Grant Requirements – Matthew Staman

• 301 Informed Consent: The Theory, The Cases, and the Process – Jerry Menikoff
• 302 Internal Investigations & Research – Linda Robinson
• 303 Clinical Research Outside the Academic Medical Center, Compliance and Legal Pitfalls – Jennifer Geeter, Bernadette Broccolo
• 304 Waivers of Informed Consent for Emergency Research: What Can We Learn from PolyHeme®’s Experience? – John Mills

• 401 Privacy and Security Issues in Clinical Research – Marti Arvin
• 403 Clinical Research: The Intersection between Commercial Interests and Government Regulation – Michael Mustokoff