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Beverly H. Lorell, MD Senior Medical & Policy Advisor King & Spalding LLP

Beverly H. Lorell, MD Senior Medical & Policy Advisor King & Spalding LLP

PHARMA CONGRESS October 28, 2008 Pharmacovigilance and Drug Safety: Assessing Future Regulatory and Compliance Developments. Beverly H. Lorell, MD Senior Medical & Policy Advisor King & Spalding LLP. Assessing Future Developments. Pharmacovigilance - A definition Four drivers of change

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441 views • 29 slides
Pharmacoepidemiologic Assessment

Pharmacoepidemiologic Assessment

Pharmacoepidemiologic Assessment. Judy A. Staffa, PhD, RPh Epidemiology Team Leader Division of Surveillance, Research & Communication Support Office of Drug Safety, CDER. When and why are pharmacoepidemiologic studies recommended?.

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293 views • 14 slides
ANSI Safety Colors

ANSI Safety Colors

ANSI Safety Colors. Engineering Concepts. ANSI. The American National Standards Institute has served as administrator of the US private sector standardization system for more than 90 years. Accredits standards that are developed by different organizations, private or government

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290 views • 9 slides
Concept Paper #3: Risk Assessment of Observational Data Session 1: Good Pharmacovigilance Practices

Concept Paper #3: Risk Assessment of Observational Data Session 1: Good Pharmacovigilance Practices

Concept Paper #3: Risk Assessment of Observational Data Session 1: Good Pharmacovigilance Practices. Linda S. Hostelley on behalf of PhRMA. PhRMA Supports FDA Efforts on Risk Management Risk Management is a Continuum Positive Benefit Risk is Key Benefits and Risks Drive RMP

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314 views • 7 slides
One Year Post-Exclusivity Adverse Event Review: Fluvastatin Pediatric Advisory Committee Meeting April 11, 2007

One Year Post-Exclusivity Adverse Event Review: Fluvastatin Pediatric Advisory Committee Meeting April 11, 2007

One Year Post-Exclusivity Adverse Event Review: Fluvastatin Pediatric Advisory Committee Meeting April 11, 2007. Amy M. Taylor, MD, MHS, FAAP Medical Officer Pediatric and Maternal Health Staff Office of New Drugs Food and Drug Administration. Background Drug Information.

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71 views • 6 slides
Pharmacovigilance - Controlling Data Overload and Minimizing Risk

Pharmacovigilance - Controlling Data Overload and Minimizing Risk

Today in this digital age, pharmacovigilance is doing everything possible to find the ways for controlling data overload and minimize risk. Read more to get more information about this.

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77 views • 3 slides

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