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

  Dossier Preparation

  • Provide safety expertise / leadership to teams crafting Integrated Summaries of Safety and Clinical Study Reports for NDA / BLA submission to FDA and equivalents for MAA in EU