Stephen A. Goldman Consulting Services, L.L.C.
Stephen A. Goldman, M.D., LFACLP, DLFAPA

Cost-effective medical product safety services provided to industry, government, academia and associations worldwide 

Risk Communication and Risk Management

  • Preparation/evaluation of risk management programs (NDA; postmarketing)

  • Assessment/recommendations for optimal risk communication 

  • Preparation/evaluation of health professional education strategies 

  • Generation/revision of product labeling 

Clinical Safety and Postmarket Surveillance/Pharmacovigilance (CSP)

Auditing  

  • Review policies/procedures for regulatory compliance, use of latest 

    • CSP methods and efficient coordination with other departments

  • Examine quality of case evaluation and output 

  • Assess local and global requirements for consistency 

  • Evaluate departmental structure

Training

  • In-house course covering all aspects of medical product CSP, including

  • Pre- and postmarketing regulations (national, international, ICH)

  • Clinical case evaluation and causality assessment

  • Labeling

  • Pharmacoepidemiology

  • Communication and management of medical product risk

Medical Review of Cases/Signals of Concern

  • Utilizing training in

  • Clinical pharmacology

  • Neuropsychiatry

  • General internal medicine

  • Experienced use of postmarketing databases (e.g., FAERS)

Regulatory Intelligence/Regulatory Affairs  

  • Interpretation of applicable regulatory requirements 

  • Effective communication with regulatory authorities

Contact

Call
Phone: (301) 983-1808
Cell: (973) 462-6593

Email
sagcs@aol.com

BACKGROUND

  • Managing Member, Stephen A. Goldman Consulting Services, L.L.C. 

    • Chair for North America, Clinical Safety/Pharmacovigilance Special Interest Area Community, Drug Information Association (DIA)

      • 2005 DIA Outstanding Service Award recipient

    • National Academy of Sciences Institute of Medicine Food and Nutrition Board Committee on Framework for Evaluating the Safety of Dietary Supplements

    • Life Fellow of the Academy of Consultation-Liaison Psychiatry (LFACLP)

    • Distinguished Life Fellow of the American Psychiatric Association (DLFAPA)

  • Director, Pharmacoepidemiology 

    • Knoll Pharmaceutical Company (Mount Olive, NJ)

  • Medical Director, MedWatch (Office of the Commissioner) 

U.S. Food and Drug Administration (FDA) (Rockville, MD) 

  • Office of the Commissioner's Commendable Service Award

    Individual: “For continual development and fostering of efficient mechanisms to ensure the flow of information of information on new medical product safety issues from the Centers to MedWatch”

MedWatch Group: “For recognition of exceptional service in the development of efficient mechanisms to rapidly communicate new medical product safety information to health professionals” 

  • ICH-related activities: E2B; MedDRA® 

  • FDA Task Force on Risk Management: Report to the FDA Commissioner

“Managing the Risks from Medical Product Use: Creating a Risk Management Framework”

  • FDA/Uniformed Services University of the Health Sciences (USUHS) Staff Fellow in Clinical Pharmacology and Regulatory Drug Evaluation Sciences  

FDA/USUHS (Rockville/Bethesda, MD)

  • FDA's Commissioner's Special Citation/Harvey W. Wiley Medal 

“For exceptional service in furthering the goals of MedWatch through the development of the June 10, 1994 CDER Conference on The Management of Drug-Induced Disease”

  • Director, Consultation-Liaison Division, Department of Psychiatry Clinical Assistant Professor of Psychiatry and Medicine

Indiana University School Of Medicine (Indianapolis, IN)

  • Fellow/Assistant Attending in Consultation-Liaison Psychiatry

Montefiore Medical Center (Bronx, NY)