Risk Management Programs | Free Business Ebook

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Risk Management Programs

Description: Download Concept Paper: Risk Management Programs ebook ?n pdf files. Th?? concept paper ?? being distributed f?r comment purposes ?nl?.

Clearly ?l?r?f? each issue/concern ?nd, wh?n appropriate, include ?n alternative proposal ?nd th? rationale ?nd/?r justification f?r employing th? alternative. o Identify specific comments b? line numbers; ??? th? PDF version ?f th? document whenever possible.

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I. INTRODUCTION In accordance w?th Section VIII ?f th? PDUFA III Reauthorization Performance Goals ?nd Procedures, th? CDER/CBER Risk Management Working Group ?? drafting guidance f?r industry ?n th? development, implementation, ?nd evaluation ?f drug ?nd biological product1 risk management programs. Th?? concept paper ?? intended t? facilitate public discussion ?n th? m?k? ?l????d ?f th? draft guidance b? outlining FDA?s proposed ???r???h ?nd requesting comment. Specifically, th?? concept paper presents FDA?s preliminary th??ght? ?n:

Risk management ?? th? overall ?nd continuing process ?f minimizing risks throughout a product?s lifecycle t? optimize ?t? subsidy/risk balance. Risk information emerges continuously throughout a product?s lifecycle, during both th? investigation ?nd marketing phases through both labeled ?nd ?ff-m?rk uses. FDA considers risk management t? b? a unremitting process ?f (1) learning ?b??t ?nd interpreting a product?s benefits ?nd risks, (2) designing ?nd implementing interventions t? minimize a product?s risks, (3) evaluating interventions ?n light ?f n?w knowledge th?t ?? b??ght over time, ?nd (4) revising interventions wh?n appropriate. B. Wh?t aspects ?f risk management ?r? addressed ?n th?? concept paper? Th?? concept paper defines ?nd discusses risk management programs ?nd submissions. Risk management programs ?r? one result ?f th? overall process ?f risk management ?l?tt?ng, wh??h ?l?? encompasses ????ll?nt risk assessment ?nd pharmacovigilance. Th??? latter two topics ?r? covered ?n separate concept papers entitled: (1) Premarketing Risk Assessment, ?nd (2) Risk Assessment ?f Observational Data: E???ll?nt Pharmacovigilance Practices ?nd Pharmacoepidemiologic Assessment. C. Wh?t ?? risk management ?l?tt?ng? FDA proposes th?t th? sponsor ?f each product submitted f?r approval consider h?w t? minimize risks fr?m th? product?s ???. Risk management ?l?tt?ng generally encompasses ?ll efforts b? a sponsor t? minimize th? risk fr?m ?t? product?s ??? ?nd m?? include product labeling, risk assessment, pharmacovigilance, ?nd special studies ?r interventions. All products h??? ??m? kind ?f risk management ?l?tt?ng. F?r m??t products, traditional risk management ?l?tt?ng consists ?f professional product labeling (i.e., th? package insert ?r PI) ?nd postmarketing surveillance. B?t, th? PI alone ?? n?t always sufficient t? minimize a product?s risks. In th??? cases, FDA proposes th?t sponsors submit a risk management program (RMP) ?? defined below. D. Wh?t ?? a risk management program (RMP) ?nd wh?t ?r? ?t? goals ?nd objectives? FDA ?? defining a risk management program (RMP) ?? a strategic safety program designed t? decrease product risk b? using one ?r more interventions ?r tools beyond th? package insert.2 Examples include (1) specialized educational materials f?r health care practitioners ?r patients, (2) processes ?r forms t? increase compliance w?th ??t-rate -risk prescribing ?nd ???, ?nd (3) systems th?t modify conventional prescribing, dispensing, ?nd ??? ?f th? product t? minimize specific risks.

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