STEPHEN A. GOLDMAN, M.D., FAPM, DFAPA   Managing Member, Stephen A. Goldman Consulting Services, LLC  Cost-effective medical product safety services to industry,    government, academia and associations worldwide:
Risk Communication and Risk Management Planning
Preparation/evaluation of risk management programs (REMS; EU-RMPs) Assessment/recommendations for optimal risk communication Preparation/evaluation of health professional education strategies Generation/revision of product labeling Establishment and governance of company-wide risk management committees
Clinical Safety and Pharmacovigilance (CSP)
Auditing
Review policies/procedures for national/international regulatory compliance and use of latest CSP methods Examine quality of case evaluation (individual and aggregate) including signaling and monitoring of benefit/risk profile Investigate database functionality through hands-on demonstrations Assess departmental structure and training of personnel Evaluate working relationships of safety group with relevant departments
In-House Training Courses*
Clinical Trial Safety and Postmarketing Pharmacovigilance (two or more days) Regulations (national, international) Case evaluation and causality assessment National and international initiatives Labeling Inspections and internal audits Clinical trials, including special issues Pharmacoepidemiological methods Risk Management (including REMS; EU-RMPs) Hands-on exercises illustrating good CSP practices   Clinical Trial Safety for Medical Monitors and Development Personnel (one-day) Regulations (national, international) Serious adverse events and risk assessment Aggregate data analysis Special issues in reporting and monitoring trials Pharmacovigilance planning and risk management   Crafting Quality Medical Case Narratives (one-day) Regulations (national, international) Clinical pharmacology of adverse drug events Evaluation of case reports (pre- and postmarketing) Fostering quality data via active query Hands-on exercises in generating medical narratives
	*Courses can be tailored for client-specific needs
Safety Database Evaluation
Assessment of database capability to facilitate: State-of-the-art pharmacovigilance, including signal detection End-user utility Compliance with safety-related regulatory requirements
Medical Review of Cases/Signals of Concern
Utilizing training in Clinical pharmacology Neuropsychiatry General internal medicine Experienced use of postmarketing databases  (e.g., AERS)
Regulatory Intelligence/Regulatory Affairs
Interpretation of applicable regulatory requirements Effective communication with regulatory authorities Participation in mock panels and meetings with regulators