FDA Speakers Just Confirmed| | | | | | Jeff Shuren, MD, Director, Center for Devices and Radiological Health at the FDA | Marcia Gelber, Pharmacist, Division of Compliance Risk Management and Surveillance, Surveillance and Data Analysis Branch, Office of Compliance, CDER, FDA | | | |
Program Committee| | | | | | | | Stephen A. Goldman, MD, FAPM, DFAPA, Managing Member, Stephen A. Goldman Consulting Services, LLC, Former Medical Director, Medwatch FDA | L. Paul Starkey, MD, FAAFP, Executive Director, Medical Affairs – Americas, PRA International | Brian Edwards, MB MD, MRCP, Scientific Advisor, Pharmacovigilance and Drug Safety, NDA Regulatory Science Limited, UK | | | | |
How will you achieve optimal medical product safety in the US and abroad?During this three-day conference, experts offer strategies to overcome critical drug safety challenges faced through-out a product’s life cycle from premarketing clinical trials all the way to postmarketing safety surveillance/vigilance, and risk management. Participants learn about current regulatory national and international standards, state-of-the art methods and techniques in premarketing testing and evaluation, quality safety-related compliance and procedures, effective signal detection and assessment, adverse event reporting, and the latest risk management approaches in the US and abroad. - Review current pre- and postmarketing pharmaceutical safety reporting requirements in the United States and European Union
- Understand the latest pharmacovigilance standards in Japan and Asia/Pacific Rim
- Describe the FDA medical device 510(k) approval process and implications for patient safety
- Explain the integration of preclinical animal and human clinical pharmacology data into premarketing development, safety assessment and risk management
- Compare regulatory agency approaches to clinical trial safety and postmarketing pharmacovigilance inspections in the US, Europe and Japan
- Recognize the relative contributions of data quality, data mining and periodic safety update reports to signal detection and evaluation
- Discuss optimal Quality Assurance in medical product safety across the pre- and postmarketing continuum
- Summarize assessment of a medical product’s benefit/risk profile throughout its life cycle
- Define current risk management approaches in a global medical product safety environment
| | Download Brochure | | | Join the Conversation | | | Archived Webinar | REMS, EU-RMP and FDAAA: Navigating the Clinical Trial Safety, Postmarketing Pharmacovigilance and Risk Management Alphabet Soup Stephen A. Goldman, MD, FAPM, DFAPA | | Biopharma Blog | | | | Online Documentation | Optimally Leveraging Epidemiologic and Observational Studies in the Development of an Appropriate RiskMAP or REMS
Jeffrey J. Stoddard, MD, FAAP ,Vice President, Medical & Scientific Affairs, Covance Periapproval Services, Inc.
Public Perception on Industry and Drug Safety: Implications on the Culture of Safety
Matthew Whalen, National Harbor, Maryland |
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