Evaluating a Structured Reporting Template to Increase Transparency and Reduce Review Time for Healthcare Database Studies

OMB Control No. 0910-0497 Expiration date: 10/31/2020

APPENDIX A: POTENTIAL STAKEHOLDERS TO CONTACT REGARDING PARTICIPATION FROM MEMBERS OF THEIR ORGANIZATIONS (LIST MAY BE MODIFIED)

Name		Title	Organization
Large Distributed Healthcare Data Networks
Jeffrey Brown, Ph.D.		Director of Scientific Operations, Associate Professor, Department of Population Medicine, Harvard Medical School	PCORnet, FDA’s Sentinel Program
Richard Platt, M.D., M.Sc.		Principal Investigator, Chair of Department of Population Medicine, Harvard Medical School	PCORnet, FDA’s Sentinel Program
Payers, Healthcare Delivery Systems
Sarah Priddy Alwardt, Ph.D.		Vice President Health Informatics and HEOR	McKesson Specialty Health
Troyen Brennan, M.D.		Executive Vice President and Chief Medical Officer	CVS Health
Páll Jónsson, Ph.D., M.Res.		Associate Director Research and Development	NICE
Will Shrank, M.D.		Chief Medical Officer	UPMC
Sarah Emond MPP		Executive Vice President and Chief Operating Officer	ICER
Wim Goettsch PhD		HTA-advisor	Dutch National Healthcare Institute
Regulators
Peter Arlett, B.Sc., M.B.B.S., M.R.C.P., F.F.P.M.		Head of Pharmacovigilance and Epidemiology Department	European Medicines Agency (EMA)
Hans-Georg Eichler, M.D., M.Sc.		Senior Medical Officer	European Medicines Agency (EMA)
Yoshiaki Uyama, Ph.D.		Director, Office of Medical Informatics and Epidemiology	Pharmaceuticals and Medical Devices Agency (PMDA), Japan
David Martin, M.D., M.P.H.		Liaison to the Reagan Udall Foundation IMEDS Program at U.S. FDA Center for Drug Evaluation and Research (CDER)	Food and Drug Administration (FDA)
Michael Nguyen, M.D.		FDA Sentinel Liaison, CDER	Food and Drug Administration (FDA)
Richard Swain, PhD		Acting Team Leader, Office of Surveillance and epidemiology, CDER	Food and Drug Administration (FDA)
Christian Hampp, PhD		Master Reviewer, Office of Surveillance and epidemiology, CDER	Food and Drug Administration (FDA)
Efe Eworuke, PhD		Team Leader, Office of Surveillance and epidemiology, CDER	Food and Drug Administration (FDA)
Clara Kim, PhD		Team Leader, Office of Translational Sciences, CDER	Food and Drug Administration (FDA)
Elande Baro, PhD		Statistical Reviewer, Office of Translational Science, CDER	Food and Drug Administration (FDA)
Stephanie Krauss, JD MPH		Regulatory Counsel, Office of Regulatory Policy, CDER	Food and Drug Administration (FDA)
Open Science
John Ioannidis, M.D., D.Sc.		Co-Director, Professor of Medicine and of Health Research and Policy at Stanford University School of Medicine	Meta-Research Innovation Center at Stanford
Brian Nosek, Ph.D.		Executive Director, Professor of Psychology, University of Virginia	Center for Open Science
Journal Editors
Sean Hennessy, Pharm.D., Ph.D.	Professor of Epidemiology and of Systems Pharmacology and Translational Therapeutics		University of Pennsylvania Perelman School of Medicine
Laura Happe	Editor in Chief of Journal of Managed Care and Specialty Pharmacy		Journal of Managed Care and Specialty Pharmacy
Christine Laine, M.D., M.P.H., F.A.C.P.	Editor in Chief, Associate Professor, Jefferson Medical College		Annals of Internal Medicine
Elizabeth Loder, M.D., M.P.H.	Head of Research, BMJ, Professor of Neurology, Harvard Medical School		BMJ
Henrik Toft Sørensen, M.D., Ph.D.	Editor in Chief		Clinical Epidemiology
Peter Tugwell, M.Sc., M.D., F.R.C.P.C.	North American Editor, Professor of Medicine and Epidemiology & Community Medicine at the University of Ottawa		Journal of Clinical Epidemiology
Wolfgang Winkelmayer, M.D., M.P.H., Sc.D., F.A.S.N.	Associate Editor, Professor of Medicine and Chief, Section of Nephrology, Baylor College of Medicine		Journal of the American Medical Association (JAMA)
Professional Society/Guidelines
Jesper Hallas, M.D., Ph.D.	President		ISPE
Sinead Langan PhD	Wellcome Senior Clinical Fellow and Professor		RECORD guidelines
Dick Willke, Ph.D.	Chief Scientific Officer		ISPOR
International Network of Academics
K. Arnold Chan, M.D., Sc.D.	Director, Health Data Research Center		National Taiwan University
Nam-Kyong Choi, B. Pharm., Ph.D.	Assistant Professor, Korea Institute of Drug Safety & Risk Management (KIDS) Advisor, Asian Pharmacoepidemiology Network (AsPEN) Chair-Elect		Ewha Womans University
Frank de Vries, Pharm.D., Ph.D.	Head of Research		Department of Clinical Pharmacy, Maastricht UMC+ The Netherlands
Contract Research Organization
Alison Bourke, M.Sc., F.R.Pharm.S.	Scientific Director, Real World Insights, QuintilesIMS		QuintilesIMS
John Seeger, Pharm.D., Dr.P.H.	Chief Scientific Officer		Optum Epidemiology

Name	Title	Organization
Pharmaceutical Industry
Dorothee Bartels, M.Sc., Ph.D.	Head of Global Epidemiology	Boehringer Ingelheim GmbH
Andrew Bate, Ph.D.	Senior Director, Analytics Team Lead in Epidemiology	Pfizer
Brian Bradbury, D.Sc.	Executive Director, Center for Observational Research	Amgen
Javier Jimenez, M.D., M.P.H.	VP, Global Head RWE and Clinical Outcomes	Sanofi
Kris Kahler, Ph.D.	Executive Director and the Global Head of Outcomes Evidence & Analytics	Novartis
Joanne Waldstreicher, M.D.	Chief Medical Officer	Johnson & Johnson

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