A Day in Court: Critical Implications for Conducting Clinical Trials, presented by RAPS, with the support of AHLA
 24 July 2008
Washington, DC
The George Washington University Cloyd Heck Marvin Center
Program Description
Clinical trial programs are coming under increased government and patient scrutiny. More than ever, it is critical that regulatory professionals take every necessary precaution to adhere to the full spectrum of regulations governing clinical trials––even the smallest violation can land you in court. Ignorance of the law is not an excuse!
Discover how failure to adhere to Standard Operating Procedures (SOPs) and Quality Standards (QS) can lead to legal action through a fictional case based on a real-life situation. RAPS’ new full-day mock-trial program, A Day in Court: Critical Implications for Conducting Clinical Trials will address common violations throughout the increasingly complex and demanding clinical trials phases and will provide you with guidance on how to recognize and eliminate legal and regulatory liability.
This program also provides you with awareness of the legal trial process, what you should expect if you are summoned as a participant, and testimonial information from the patient, physician investigator, nurse coordinator, senior regulatory staff and corporate executive perspectives.
Developed in collaboration with the American Health Lawyers Association, the mock trial program will include direct and cross-examination testimonies, jury deliberation and verdict discussion and additional Q&A from expert regulatory professionals.
Learning Objectives
Upon completion of this session participants will learn:
- Most common deviations and violations of clinical investigators cited by FDA
- Implications for informed consent violations
- Protocol required for investigational plans
- Implications for ignoring adverse events
- Required clinical trial record retention
- Overview of the legal trial process
- Responsibilities of clinical trial participants (IRB, investigators, manufacturers, support staff…)
Trial Cast
Judge
Rhonda Fulton - Mother of clinical trial participant (Emily Fulton-11 yrs)–Plaintiff
Dr. Wilma Smith - Physician
Alex Crawford - Regulatory Affairs Associate
David Mitchum - Vice President, Regulatory Affairs, Onco-Shield – Defendant
Bill Williams - CEO, Onco-Shield – Defendant
Ankur Goel Plaintiff’s - Attorney
Jim Boswell Defense - Attorney
David Fox - Judge
Legal Participants
Legal roles will be cast by the following AHLA members:
James Boswell III, Partner, King & Spalding–Litigator
David Fox, JD, Partner, Hogan & Hartson LLP–Judge
Ankur Goel, JD, Partner, McDermott Will & Emery LLP–Litigator
Who Should Attend
Professionals working in the following areas:
- Legal
- Quality assurance and quality control
- Manufacturing
- Clinical
- Ethics
- Risk management
- Business/strategy/management
- DSMB (Data safety monitoring boards)
- CRO (Clinical Research Organizations)
Target Audience:
- CEO/President
- Vice President
- Director
- Manager
- Specialist
Levels: II, III, IV
Planning/Program Committee
Kevin Coker, JD, RAC, Director, COO, University of Arkansas For Medical Sciences, General Clinical Research Center
Jane Wright-Mitchell, JD, Director, Legal Affairs, Actelion Pharmaceuticals Ltd
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