Other Scientific Activities

 

Ad hoc Advisory and Consulting Positions

2015 Peer-reviewer for Clinical Pharmacology & Therapeutics

2012
- Peer-reviewer for Clinical Trials
- Peer-reviewer for American Journal of Public Health
 
2010 - Expert Peer-Reviewer for the AHRQ Report “Comparative Effectiveness and Safety of Oral Diabetes Medications for Adults with Type 2 Diabetes – Update Phase I” (EHC-2009-12-0043.R2).
 
2009 - Peer –reviewer for British Medical Journal (BMJ)
 
2008 - Peer –reviewer for Journal of the American Medial Association (JAMA)
 
2007
- Peer-reviewer for American Journal of Psychiatry.
 - Peer-reviewer for Journal of Clinical Psychopharmacology.
 - Editorial board member responsible for the statistical review at the Journal of Neonatal-Perinatal Medicine, which is an international peer-review journal that originated from GWU.
 
2006
- Peer-reviewer for Archives of General Psychiatry.
 - Peer-reviewer for Psychopharmacology.
 - Peer-reviewer for Medical Care.
 
2003 - Peer-reviewer for Journal of General Internal Medicine.
 
2000 - Peer-reviewer for Journal of the American Nutraceutical Association.
 
1995 - Peer-reviewer for Environmental Research.
 

Committee memberships

2016-2021
Member in the Innovative Medicine Initiative (IMI2) supporting the effort entitled “Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER)”

2016 
Chair of Merck’s Document Review Committee

2015 
Cardiac Organ Specific Safety Board, Merck Research Laboratory

2014-2016
Member in the ICH Expert Working Group (EWG) M4E (R2): ”Enhancing the Format and Structure of Benefit-Risk Information” updating section 2.5.6 in the Common Technical Document.

2015
Member in the DIA Benefit Risk Program Committee for the meeting entitled “Patient Engagement and Communication in Benefit-Risk Assessment Through the Life Cycle of Medical Products”.

2014
Collaborator in the Observational Health Data Sciences and Informatics (OHDSI, http://ohqdsi.org) program. OHDSI is a multi-stakeholder, interdisciplinary collaborative to create open-source solutions that bring out the value of observational health data through large-scale analytics. OHDSI is tasked with both developing large-scale analysis methods for observational research and applying them to observational health data network to answer real-world clinical questions.

2013
Member in the planning committee for the Institute of Medicine Forum on Drug Discovery, Development, and Translation’s workshop, “Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products.” FDA White Oak, Maryland, February 12-13, 2014.
 
2011
Council for International Organizations of Medical Sciences (CIOMS) Meta-analysis Working Group, WHO
 
2010
- Computational Science Center Change Management/Process Steering Group, CDER, FDA.
- AVANDIA Observational l Studies Analysis Team, Office of Surveillance and Epidemiology, CDER, FDA.
- Core committee of the International Society of Pharmacoepidemiology (ISPE)
- CDER Scientific Enclave Center Collaboration
 
2009-Present 
Course Director for “Epidemiology in Drug Safety” (formerly known as "Epidemiology for Non-epidemiologists") Course – offered once or twice per year
 
2009-Present
CDER Computational Science Center Board (CSC)
 
2008-2009
Chair of the Project Advisory Group (PAG) for the project entitled” Access to Longitudinal Patient-Level Electronic Medical Record Data”.
 
2008-2009
Project Advisory Group (PAG) for the project entitled “Scientific Program to Support Epidemiologic Investigations of Safety Related Issues of Marketed Drugs, and Evaluations of Risk Management Programs and Tools”.
 
2007-Present
Epidemiology Research Steering Committee (ERSC), Office of Surveillance and Epidemiology, CDER, FDA.
 
2007
- Weber Effect Working Group, Office of Surveillance and Epidemiology, CDER, FDA.
- AVANDIA Observational Studies Analysis Team, Office of Surveillance and Epidemiology, CDER, FDA.
- Quality Review Board (QRB) for hiring new epidemiologists, Office of Surveillance and Epidemiology, CDER, FDA.
- Planning committee between the Office OF Biostatistics (OB) and the Office of Surveillance Epidemiology (OSE) for collaboration on special scientific topics of mutual interest.
 
2006-2007
- Group leader of the Standardization of Data Manipulation and Analysis Process in the OSE (SDMAP) Working Group. Office of Surveillance and Epidemiology, CDER, FDA.
- Safety Reviewer Course Working Group. CDER, FDA.
 
2004-2007
The General Practitioner Research Database (GPRD) Working Group. CDER, FDA.
 
2004- 2006
- Meta-analysis for Safety Evaluation Working subgroup, which is a part of the “Research Synthesis Working Group (RSWG)”. CDER, FDA.
 
2004- 2005
- QT Statistical Discussion Group. CDER, FDA.
- CDISC-HL 7 Submission Data Standards Working Subgroup. CDER, FDA.
- Quantitative Assessment of Drug Safety Working Group. CDER, FDA.
- Health Related Quality of Life (Patient Reported Outcomes) Working Group. CDER, FDA.
- PhD Committee member, University of Maryland School of Nursing. Thesis entitled “Predictors of Nosocomial Bloodstream Infections in the Adult Trauma Population: A model testing approach”.  

Scientific Conferences Participation

  1. 2011 Chairperson of Postmarket Safety session. DIA/FDA CDER/CBER Computational Science 2nd Annual Meeting, Sheraton National Hotel, Arlington VA, USA, March 14-15, 2011.
  2. Invited speaker in a Public Meeting organized by DIA entitled “FDA Best Practices for Regulatory Information Synthesis of Randomized Trials for Product Safety Evaluation”. DoubleTree Hotel and Executive Meeting Center, Bethesda, MD, USA, March 10-11, 2011
  3. 2010 Chairperson of a session entitled “Role of Meta-Analysis in Drug Safety: Methodological Considerations and Regulatory Implications”. The 26th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Brighton, England, UK, August 19-22, 2010.
  4. Chairperson of a session entitled “Postmarket Safety”. DIA/FDA CDER/CBER Computational Science 1st Annual Meeting, Bethesda North Marriott, Bethesda, MD, USA, March 22-23, 2010.
  5. 2003 Chairperson of a session entitled “Application of an Existing Instrument to a New Drug Development Program?” in the Drug Information Association workshop for “Assessing Treatment Impact Using Patient Reported Outcomes: Challenges in Study Design, Conduct and Analysis”, Arlington, VA.

Scientific Conferences Attendance

  1. The 32nd International Conference on Pharmacoepidemiology and Therapeutic Risk Management. August 2016 Dublin, Ireland
  2. The 29th International Conference on Pharmacoepidemiology & Therapeutic Risk Management, Montreal, Canada, August 23-28, 2013.
  3. International Society for Pharmacoepidemiology 2012 Mid-Year Meeting, Miami Beach, FL, April 20-24, 2012.
  4. The 26th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Brighton, England, UK, August 19-22, 2010.
  5. The 25th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Rhode Island, August 16-19, 2009.
  6. Sentinel Methods Think Tank. Engelberg Center for Health Care Reform at Brookings, Carnegie Endowment for International Peace, Washington, May 7, 2009.
  7. The 24th International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Copenhagen, Denmark, August 17-20, 2008.
  8. NorthEast SAS Users Group 20th Annual Conference. Baltimore, Maryland, November 11-14, 2007.
  9. The 22nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management. “Pharmacoepidemiology for Public Health”. Lisboa Convention Centre, Lisbon, Portugal, August 24-27, 2006.
  10. GPRD User Group Meeting. London, England, August 21, 2006.
  11. The International Society for Pharmacoepidemiology (ISPE) Mid-Year Meeting: “Epidemiology and Management of Benefit & Risk”. Rockville, Maryland, USA, April 24, 2006.
  12. GPRD User Group Meeting, adjunct to the 21st International Conference on Pharmacoepidemiology and Therapeutic Risk. Nashville, TN, USA, August 20, 2005.
  13. The 21st International Conference on Pharmacoepidemiology and Therapeutic Risk Management. Nashville, TN, USA, August 21-24, 2005.
  14. The 51st Annual American Academy of Child and Adolescent Psychiatry Meeting. Research Forum “Issues in the Conduct and Interpretation of Studies of Adolescent Depression”, Washington, DC, USA, October 19–20, 2004.
  15. The integrity in Science conference: “Corporate and Political Influence on Science-Based Policymaking”. Sponsored by the Center for Science in the Public Interest, Washington, DC, USA, 2004.
  16. The Bi-Annual Conference of the Association of Egyptian-American Scholars, Washington, DC, USA, May 22-23, 2004.
  17. The 19th International Conference on Pharmacoepidemiology & 1st International Conference on Therapeutic Risk Management, Philadelphia, PA, USA, August 24, 2003.
  18. The 43rd Annual NCDEU (New Clinical Drug Evaluation Unit) Meeting sponsored by the National Institute of Mental Health, Baco Raton, Fl, USA, May 2003.
  19. The 1st workshop of Drug Information Association in cooperation with the FDA for “Assessing treatment impact using Patient Reported Outcomes: Challenges in study design, conduct and analysis”, Washington, DC, 2003
  20. The 1st workshop of Drug Information Association in cooperation with the FDA for “The clinical evaluation of QT interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs”, Washington, DC, USA, 2003
  21. The 38th Drug Information Association Annual Meeting, Chicago, IL, USA, June 16, 2002.
  22. The 9th Annual Drug Information Association Symposium for “Quality of Life Evaluation”, 2002.
  23. The American Academy of Orthopedic Surgeon, Orlando, FL, USA, 2000.
  24. The 2nd meeting of the American Nutraceutical Association, San Diego, CA, USA, 2000.
  25. The American College of Rheumatology 63rd annual scientific meeting, USA, 1999.
  26. The 1st meeting of the North America Nutraceuticals Council. San Antonio, Texas, USA, May 22, 1996.
  27. The 3rd Annual Women’s Health Research Symposium. “Women’s Health and Genetics Research: Panacea or Pandora’s Box.” Department of Epidemiology & Preventive Medicine, University of Maryland School of Medicine, 1996.
  28. The 44th Annual Meeting of the American Society of Tropical Medicine and Hygiene, Texas, USA, Nov. 17-21, 1995.
  29. The 43rd Annual Meeting of the American Society of Tropical Medicine and Hygiene, Ohio, USA, Nov. 13-17, 1994.
  30. The American College of Preventive Medicine and Association of Teachers of Preventive Medicine joint conference, Atlanta, Georgia, USA, March 19-22, 1994.
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