Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations July 17, 2019 - 8:30 am to 4:00 pm Marriott Marquis Washington, DC 901 Massachusetts Ave NW Washington, DC 20001 As the time and costs associated with pharmaceutical research and development continue to rise,...
Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes July 11, 2019 - 8:30 am to July 12, 2019 - 1:00 pm The Westin Washington, D.C. City Center - National Ballroom 1400 M Street NW Washington, DC 20005 There are emerging opportunities to leverage real world data (RWD) and resultant real-world...
Advancing the Development and Implementation of Analysis Data Standards: Key Challenges and Opportunities June 12, 2019 - 9:00 am to 4:00 pm Tommy Douglas Conference Center - Building 9 Ballroom CD 10000 New Hampshire Avenue Silver Spring, MD, 20903 To support the efficient review of medical products, the U.S. Food and Drug Administration (FDA...
Public Meeting: Characterizing FDA’s Approach to Benefit-Risk Assessment throughout the Medical Product Life Cycle May 16, 2019 - 9:00 am Tommy Douglas Conference Center - Building 9 Ballroom CD 10000 New Hampshire Avenue Silver Spring, MD 20903 Following the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), the U.S....
Eleventh Annual Sentinel Initiative Public Workshop April 3, 2019 - 9:00 am to 4:30 pm Hyatt Regency Bethesda 1 Bethesda Metro Center Bethesda, MD 20814 The Sentinel Initiative was launched in response to the Food and Drug Administration Amendments...
Healthcare Costs Innovation Summit April 2, 2019 - 9:00 am to 3:00 pm AMPHITHEATER AT RONALD REAGAN BUILDING AND INTERNATIONAL TRADE CENTER 1300 PENNSYLVANIA AVENUE, NW WASHINGTON, DC 20004 West Health’s High Costs, Broken Promises: Healthcare in America Summit (HCI Summit) on April...
Prospect of Direct Benefit in Pediatric Clinical Trials March 29, 2019 - 9:00 am Grand Hyatt Washington 1000 H Street NW Washington, DC 20001 Children are a vulnerable population who cannot consent for themselves and therefore require...
Aligning Access with Outcomes for Early-Stage Alzheimer’s Disease Drugs February 25, 2019 - 9:00 am Duke-Margolis Center for Health Policy, Washington, DC A number of innovative “early stage” Alzheimer’s disease (AD) therapies are currently under...
Advancing Health Care Transformation in North Carolina February 8, 2019 - 9:00 am to 3:00 pm Washington Duke Inn 3001 Cameron Boulevard Durham, NC 27705 On February 8, 2019, the Duke-Margolis Center for Health Policy will bring together stakeholders...
Evaluating the Pressor Effects of Drugs & Ambulatory Blood Pressure Monitoring Studies February 4, 2019 - 9:00 am to 4:30 pm 1777 F Street NW Washington, DC 20006 The U.S. Food and Drug Administration (FDA) is announcing a public workshop entitled “Evaluating...
