Global Drug Safety Updates from National Health Authorities

Global Drug Safety Updates from National Health Authorities

Recent Drug Safety Updates which included Signals, Product label updates, DHPC letters, etc.,

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Building Blocks [ICSR] in Drug Safety

Building Blocks [ICSR] in Drug Safety

Know the Basic fundamentals in Individual Case Safety Report (ICSR) - Case Processing in a Drug Safety Database

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PBRER Writing

PBRER Writing

Theoretical Guidance for writing a Periodic Benefit-Risk Evaluation Report (PBRER) - Know the fundamentals of presenting safety information in each section/subsections in PBRER

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DSUR writing

DSUR writing

Theoretical Guidance for writing a Development Update Safety Report [DSUR] - Know the fundamentals of presenting safety information in each section/subsections in DSUR

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Drug Safety: Aggregate reporting -An overview on types, regulatory timelines and requirements

The periodical reporting of aggregate safety reports to regulatory health authorities includes a comprehensive overview of the safety profile of medicinal product based on cumulative safety information accumulated by Marketing Authorization Holder (MAH). They also provide assurance that the MAH is continuously monitoring and critically assessing the benefit-risk profile of the product and taking appropriate

Voluntary reporting of medicine side effects from Public

Spontaneous reporting of adverse effects/reactions/experiences of medicinal products is quite essential for generating the safety information of a medicine (for both new & well established medicinal products). Voluntary side effects reporting is a significant source for real world drug safety experience. A transparent benefit risk profile for a pharmaceutical medicinal product can be achieved through

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