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Significant disability incapacity - PowerPoint PPT Presentation

Safety Workshop: Part II Expedited Reporting & Assessment Training

Safety Workshop: Part II Expedited Reporting & Assessment Training

Safety Workshop: Part II Expedited Reporting & Assessment Training. August 19, 2010 Albert Yoyin , M.D. DAIDS Regulatory Support Center ( RSC ). Objectives. Definitions Assessment of Adverse Events Expedited Reporting Processes Moving from Manual v1.0 to v2.0.

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1.16k views • 69 slides
Basic Pharmacovigilance Training provided by BayerPharma AG

Basic Pharmacovigilance Training provided by BayerPharma AG

Basic Pharmacovigilance Training provided by BayerPharma AG Muellerstr . 178, D-13353 Berlin, Germany GPV.CaseProcessing@bayer.com. Consumer, patients and healthcare professionals play an important role in the reporting process of safety related information.

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730 views • 20 slides
Overview of Pediatric Safety Reporting and Role of the Committee Pediatric Advisory Committee Meeting March 22, 2006

Overview of Pediatric Safety Reporting and Role of the Committee Pediatric Advisory Committee Meeting March 22, 2006

Overview of Pediatric Safety Reporting and Role of the Committee Pediatric Advisory Committee Meeting March 22, 2006. Solomon Iyasu, M.D., M.P.H. Acting Deputy Director Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration.

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437 views • 17 slides
Unanticipated Problems

Unanticipated Problems

Unanticipated Problems. How to sort out the unexpected events that might have to be reported to the IRB. John A. Vanchiere, M.D., Ph.D. Associate Professor Department of Pediatrics. LSUHSC-S HRPP/IRB Standard Operating Procedures (p 222-234).

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285 views • 15 slides

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