PPT-FDA: Challenges to Protecting Public Health – Pathology’s Perspective

Roger D Klein MD JD FCAP March 7 2013 Advocacy Shared Goals Ensure patient access to high quality testing Assure that tests being offered are analytically and clinically valid. Protecting Your Health What you should knowabout the safe and appropriate use of common AMERICAN COLLEGE OF GASTROENTEROLOGY www.acg.gi.org Printing supported by an educational grant from AstraZeneca  Perspective I N T R ODU C T I O N Today the public health professionals are in the midst of the epidemic of non-communicable diseases, which are known to have their risk factors in the way how peopl Three Perspectives on Community Health. Graves County. Three Perspectives. Data Perspective. Objective . Statistics from National, State and Local Sources. Organizational Perspective. Community Health Forums . Dr Shona Arora. Centre Director, Avon, Gloucestershire and Wiltshire . Public Health England. Key Issues. Demographic . pressures. Inequalities. Financial challenges for Local Authorities & the NHS. . Mike Wasko, Rich Buchanan, Fred Mura, and Laura Kaufman. PDS Life Sciences, Mt Arlington, New Jersey. T-69. t. Abstract. Based on our experience creating SEND datasets for FDA submission, we can group SEND mapping challenges for pathology into several patterns: 1) inconsistent or incomplete data entry for gross and microscopic pathology findings; 2) inconsistent use of units for clinical pathology findings; 3) inconsistent use of terminology for clinical pathology (use of the same term to mean different things in different parts of a dataset); and 4) uncertainty of which domain to map biomarkers. For all of these disciplines, it is critical that data capture be . JC Heunis. Centre for Health Systems Research & Development. General Practice &. . Hospital Management, Dubai, 8-9 Dec 2016. Outline. Background. Importance of public hospitals. Public hospitals – huge social investments. modelling. for public health decision-making. John Edmunds. , Jess Metcalf, Justin . Lessler. john.edmunds@lshtm.ac.uk. Why use models?. Observational studies of impact are retrospective, and difficult to interpret. Top 10 Public Health Achievements of the 20. th. Century. Routine use of . _____________. Improvements in . _____________ safety. Safer . _____________. Control of . _____________ diseases. _____________ in . Presenters:. Prevention Services. Tanisha Pettus. , DIS II. & . Linkage to Care. Julie Anderson, . DIS II. Understanding Public Health. Identifying & addressing public health threats. Enforcing laws that protect the public’s health. Addressing Gun Violence:. A Law and Public Health Approach. Dialogues for Public Discussion. Identifying a Crisis. A . crisis. is a serious situation that needs attention. A . public health crisis. is a situation that has (or potentially will have) a . JC Heunis. Centre for Health Systems Research & Development. General Practice &. . Hospital Management, Dubai, 8-9 Dec 2016. Outline. Background. 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