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Enforcement Update and Trends From a Global Perspective
Session Chair(s)
Barry Berger, JD, MBA
Retired
Former Professor of Regulatory Affairs, Temple University, United States
This forum will address from an industry, regulator and public interest perspective some of the key current enforcement actions and trends. How can each group better address and respond to issues that present challenges to public health?
Learning Objective : Explain key global enforcement trends; Describe what could be done by industry or regulators to better address regulatory concerns going forward; Discuss the patient/public citizen perspective on what additional steps are needed in the future.
Speaker(s)
FDA Point of View
Cynthia Schnedar, JD
Greenleaf Health Inc., United States
Principal, Regulatory Compliance
Viewpoint on FDA Enforcement
Douglas B. Farquhar, JD
Hyman, Phelps & McNamara, PC, United States
Partner
Clinical Trial Enforcement Trends
Mitchell Berger, JD, MPH, RAC
HHS, United States
Public Health Advisor
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Registration override should work.