Northern California: 2017 Update: U.S. Healthcare Regulatory Changes

When:  May 18, 2017 from 6:00 PM to 8:45 PM (PT)

2017 Update: U.S. Healthcare Regulatory Changes and Their Impact on Clinical Research

Presented by: David Vulcano, AVP & Responsible Executive for Clinical Research, Hospital Corporation of America

Click here to view event flyer.

Description:
  • What Goes Away With A “Complete Repeal” of Obamacare?
  • What will the 21st Century Cures Act mean?
  • What’s the impact of OHRP’s Notice of Proposed Rule Making on informed consent, IRBs, definition of human subject and research?
  • What about the Office of Civil Rights Phase 2 HIPAA Audits that began 2016?
David brings his annual standing room only presentation at ACRP’s Meeting and Expo to the SF Bay Area. He distills and translates dry yet critical information with wit and perspective into how our daily clinical research work may be affected.

Join us for a stimulating presentation that analyzes the laws, regulations, policies and trends intended mostly for healthcare operations that are unintentionally (or intentionally) bleeding over into research operations.
While sites and sponsors have many opportunities to hear what the FDA, NIH and OHRP are doing, most of this presentation's sources often come as a surprise as they are not generally part of the clinical research ecosystem that they affect.

Learning Objectives:
  • Recall the relevant portions of the varying laws and regulations discussed.
  • Analyze the potential impact that the laws and regulations bring to the research industry.
  • Interpret how the laws and accompanying regulations affect them.
Agenda:
  • 6:00 – 6:45 PM Registration, Networking, & Dinner Buffet
  • 6:45 – 7:15 PM President’s Welcome, Volunteer and Sponsor Appreciation
  • 7:15 – 8:15 PM Educational Presentation
  • 8:15 – 8.45 PM Raffle, Open Mic, Networking 1:1 with speaker
Target Audience:
  • Clinical Research Professionals
  • Sponsors, Study Sites, Physicians, Nurses
  • Vendors/Service Providers/CROs, Consultants
  • Institutional Review Boards
  • Related–Clinical Quality Assurance, Project Management, Account Rep, HR, Recruiters/Staffing, Finance, Biometrics, Regulatory and Students
This event has been approved for 1.0 contact hours. Please click here to purchase contact hours.

#DataManagementandInformatics #StudyandSiteManagement #ClinicalTrialsOperationsandGCPs #CommunicationandTeamwork

Location

UC Berkley Extension (Golden Bear Center)
1995 University Avenue - Rooms 202 & 204
Berkley, CA 94704