Adverse event

Results: 2359



#Item
881Global Harmonization Task Force / Health / Medical device / Adverse event / Food and Drug Administration / Guidance document / Medicine / Medical equipment / Technology

Summary of SG2 Meeting SG2 met in Stuttgart, Germany from[removed]April[removed]Seventeen members from industry and regulatory agencies met under the leadership of Chair Larry Kessler. Dr. Kessler identified the following m

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:52:41
882Medicine / Global Harmonization Task Force / Medical device / XML Schema / XML / Adverse event / Medical equipment / Computing / Technology

Medical Devices: Post Market Surveillance: An XML schema for the electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (Based on GHTF SG2 N32v5.2)

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:52:53
883Pharmacology / Clinical research / Pharmaceutical industry / Drug safety / Pharmacovigilance / Pharmacy / European Medicines Agency / Adverse effect / Adverse event / Pharmaceutical sciences / Health / Medicine

Health Action International (HAI) is an independent, global network, working to increase access to essential medicines and improve their rational use through research excellence and evidence-based advocacy. Statement EU

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Source URL: 209.197.66.159

Language: English - Date: 2010-12-02 10:55:52
884Pharmacology / Medical terms / Nematodes / Dirofilaria immitis / Parasites / Zoonoses / Adverse effect / Pharmacovigilance / Serious adverse event / Medicine / Health / Veterinary medicine

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may

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Source URL: www.fda.gov

Language: English
885Clinical research / Pharmaceutical industry / Pharmacology / Food and Drug Administration / Juvéderm / Plastic surgery / Clinical trial / Premarket approval / Adverse event / Medicine / Pharmaceutical sciences / Research

FDA questions for Panel Consideration The analysis of the VOLUMA-002 Study, A multicenter, single-blind, randomized, “no treatment” control, study of the safety and effectiveness of Juvéderm Voluma XC Injectable Gel

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Source URL: www.fda.gov

Language: English
886Technology / Global Harmonization Task Force / Clinical research / Pharmaceutical industry / Medical technology / Medical device / GMDN / Clinical trial / Adverse event / Medicine / Medical equipment / Health

SUMMARY OF THE 10th GHTF STEERING COMMITTEE The 10th GHTF Steering Committee (SC) meeting was held in Lübeck, Germany from June 26 to 27, [removed]Welcome and apologies The Chair welcomed everyone to Lübeck. Mrs. Georg

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:53:19
887Research / Drug safety / Medical informatics / Clinical research / Clinical Data Management / Vaccine Adverse Event Reporting System / Structured Product Labeling / Electronic Common Technical Document / Adverse Event Reporting System / Medicine / Food and Drug Administration / Health

FDA Regional Technical Specifications for ICH E2B (R3) Implementation Postmarket Submission of Individual Case Safety Reports (ICSRs) for Vaccines Draft Technical Specifications Document This Document is incorporated by

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Source URL: www.fda.gov

Language: English
888Global Harmonization Task Force / Health / Medical device / Adverse event / Report / Food and Drug Administration / Medicine / Medical equipment / Technology

SG2 meeting highlights from Ottawa, Canada, Dates: 18-20 October 2000 Study Group 2 (SG2) along with the other Study Groups of the Global Harmonization Task Force (GHTF), met in Ottawa in conjunction with activities of

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Source URL: www.imdrf.org

Language: English - Date: 2012-11-13 17:52:41
889Pharmaceutical sciences / Pharmacology / Clinical trials / Food and Drug Administration / ClinicalTrials.gov / Adverse event / Trials / Approved drug / Pharmaceutical industry / Research / Clinical research

ClinicalTrials.gov Webinar Series, March 2011 Key FDAAA Issues Deborah A. Zarin, M.D., Director, ClinicalTrials.gov National Library of Medicine Hello. This presentation will cover key issues in the Food and Drug Admini

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Source URL: prsinfo.clinicaltrials.gov

Language: English - Date: 2014-11-17 12:05:43
890Pharmaceutical sciences / Science / Pharmacology / Design of experiments / Clinical trial / Safety monitoring / Institutional review board / Adverse event / Food and Drug Administration / Clinical research / Pharmaceutical industry / Research

Tip Sheet 25: Provisions in Contracts and Funding Agreements Related Accreditation Standard: I-8, Elements I.8.A., I.8.B., I.8.C., I.8.D., and I.8.E. AAHRPP Standard I-8 deals with five provisions for contracts and fundi

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Source URL: admin.share.aahrpp.org

Language: English - Date: 2014-08-06 15:58:36
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