Reminder: Free Web Seminar Next Week

REMS, EU-RMP and FDAAA: Navigating the Clinical Trial Safety, Postmarketing Pharmacovigilance and Risk Management Alphabet Soup

Wednesday, September 9
2-3PM EST
Register: https://www1.gotomeeting.com/register/729981465
Priority Code: G1P1500W1TwitterBlog

This seminar will examine current national, regional and international perspectives and approaches to clinical trial safety, pharmacovigilance planning and risk management. Current EMEA and FDA regulatory requirements and standards, in combination with the vital ICH E2E guideline, will be discussed and also examined via case examples of risk assessment, communication and minimization methods.

What you will learn:
• ICH “Pharmacovigilance Planning” E2E guideline’s critical importance in today’s pharmaceutical safety environment

• Similarities and differences among FDA’s “Development and Use of Risk Minimization Action Plans” (RiskMAP) guidance, EMEA’s “Guideline on Risk Management Systems for Medicinal Products for Human Use” (EU-RMPs) and FDAAA-mandated Risk Evaluation and Mitigation Strategies (REMS)

• Relationship between pharmacovigilance planning and postmarketing risk management

• FDA’s new paradigm for pharmaceutical risk communication

About the presenter:

Stephen A. Goldman, MD, FAPM, DFAPA
Dr. Goldman is an independent consultant with extensive experience in academic/clinical medicine, public health, federal medical product safety regulation, and pharmaceutical industry. As Managing Member of Stephen A. Goldman Consulting Services, L.L.C., he internationally provides services that include risk communication/risk management program preparation, clinical trial safety and pharmacovigilance auditing, in-house training courses (clinical trial safety and pharmacovigilance; clinical trial safety for medical monitors/other development personnel; crafting quality medical case narratives) and medical signal review.

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