'Adverse event reports' diaporamas de présentation

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PDUFA & FDA Legislation

PDUFA & FDA Legislation

PDUFA & FDA Legislation. FDA Regulatory & Compliance Symposium August 2006 Marc Wilenzick, Pfizer Dan Kracov, Arnold & Porter Dan Carpenter, Harvard Dept. of Government. Disclaimer.

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610 views • 36 slides
New Adverse Event Reporting Policy

New Adverse Event Reporting Policy

New Adverse Event Reporting Policy. Effective September 1, 2007. Local adverse event reporting. Local adverse events are those experienced by subjects enrolled by the investigator(s) at this institution or in the local community area

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617 views • 33 slides
POSTMARKETING ADVERSE DRUG EXPERIENCE INSPECTIONAL PROGRAM CDR Thomas R. Berry, RPh

POSTMARKETING ADVERSE DRUG EXPERIENCE INSPECTIONAL PROGRAM CDR Thomas R. Berry, RPh

POSTMARKETING ADVERSE DRUG EXPERIENCE INSPECTIONAL PROGRAM CDR Thomas R. Berry, RPh FDA, Investigator RAL-RP / ATL-DO. PADE Inspectional Program. Headquarters scientists use adverse event reports to evaluate the safety of marketed drugs

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421 views • 31 slides
Some Independent Software Verification Techniques Used within the FDA Regulatory Context

Some Independent Software Verification Techniques Used within the FDA Regulatory Context

Some Independent Software Verification Techniques Used within the FDA Regulatory Context. Brian Fitzgerald. Who am I?. Brian Fitzgerald Deputy Division Director, Division of Software and Electronic Engineering, Office of Science and Engineering Laboratories WO62-4218

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286 views • 28 slides
One Year Post Exclusivity Adverse Event Review: Topotecan Pediatric Subcommittee of the Anti-infective Drugs Advisory C

One Year Post Exclusivity Adverse Event Review: Topotecan Pediatric Subcommittee of the Anti-infective Drugs Advisory C

One Year Post Exclusivity Adverse Event Review: Topotecan Pediatric Subcommittee of the Anti-infective Drugs Advisory Committee Meeting June 9, 2004. Susan McCune, MD, MA Ed Medical Officer Division of Pediatric Drug Development Center for Drug Evaluation and Research

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391 views • 22 slides
One Year Post Exclusivity Adverse Event Review: Glyburide-Metformin Pediatric Advisory Committee Meeting February 14,

One Year Post Exclusivity Adverse Event Review: Glyburide-Metformin Pediatric Advisory Committee Meeting February 14,

One Year Post Exclusivity Adverse Event Review: Glyburide-Metformin Pediatric Advisory Committee Meeting February 14, 2005. Hari Cheryl Sachs, MD, FAAP Medical Officer Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration.

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288 views • 17 slides
Background and Objective

Background and Objective

Background and Objective. In the recently reported Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, the combination of ezetimibe/simvastatin (E/S) was associated with a significantly increased risk of cancer compared to placebo, causing widespread public concern.

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173 views • 9 slides
Drug Safety & Risk Management - Transforming Triage Process in Biotech Firm

Drug Safety & Risk Management - Transforming Triage Process in Biotech Firm

Pharmacovigilance companies handle triage documents manually which is not only very slow process & but also prone to human error & not readily auditable. Read more about biotech firms transforming their triage process to ensure compliance and reduce risk.

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78 views • 1 slides

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