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13. Regulatory Reporting Pharmacovigilance

WEB13. Regulatory Reporting. When a healthy volunteer/patient suffers a negative reaction to a drug an adverse event is reported and filed containing various …

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27. Development safety update report (DSUR) Pharmacovigilance

WEBThe development safety update report (DSUR) is pre-marketing periodic report which covers safety information of drugs, biological, vaccines and combo …

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6. Spontaneous/voluntary Adverse event reporting:

WEB6. Spontaneous/voluntary Adverse event reporting: Although drugs are passed through a series of trials to establish their efficacy and safety in human beings …

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Risk benefit analysis Pharmacovigilance

WEBBenefit-risk assessment is the continuous examination (at all phases preclinical, clinical and post marketing) of the favourable and unfavourable results of a …

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31. Safety Signal – Introduction Pharmacovigilance

WEBSafety Signal – Introduction. What is Signal? A signal is essentially a hypothesis of a risk with a medicine with data and arguments that support it, derived …

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23. Aggregate reporting – Introduction Pharmacovigilance

WEB23. Aggregate reporting – Introduction. Aggregate reporting is the process that reviews the cumulative safety information from a wide range of sources, on a …

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PSUR Pharmacovigilance

WEBPeriodic safety update report (PSUR) provides a periodic and comprehensive assessment of the worldwide safety data of a marketed drug. Over time …

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Medsafety app Pharmacovigilance

WEBUMC – MED SAFETY APP: AN INTERNATIONAL MOBILE TOOL FOR DRUG SAFETY. Reporting of adverse events is a mainstay of pharmacovigilance, and an …

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Signal Pharmacovigilance

WEB36. Recommendation for Action and Exchange of Information. This step is performed by the pharmacovigilance physician: Based on the level of safety risk or …

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Turkish Pharmaceuticals and Medical Devices Authority (TITCK

WEBOn 20 Jun 2022, the TITCK published the guidelines to Good Pharmacovigilance (IFU) Module X and Module Xi – pre marketing Benefit/Risk assessment and Post marketing …

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Health Canada amendments to Labelling of natural health …

WEBHealth Canada has implemented amendments to labelling requirements under the Natural Health Products Regulations (NHPR) as a result of challenges …

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Medical Device Pharmacovigilance – Introduction

WEBMedical device vigilance, as known as materiovigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of …

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Adverse event of special interest (AESI) Pharmacovigilance

WEBAs per CIOMS VI, An adverse event of special interest (AESI) (serious or non-serious) is one of scientific and medical concern specific to the sponsor’s product or …

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PADER Pharmacovigilance

WEBA PADER is a type of aggregate safety report required to be submitted by a sponsor or marketing authorization holder (MAH) to the US Food and Drug …

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3. History and evolution of Pharmacovigilance

WEBHistory and evolution of Pharmacovigilance. Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. The historical …

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ICSR processing of Clinical trial cases Pharmacovigilance

WEB14. ICSR processing of Clinical trial cases: Clinical trials and pharmacovigilance are parallel processes, whenever any adverse event reported from …

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10. License partner and Regulatory authority reports

WEBPharmacovigilance Agreement means an agreement entered into by the Pharma companies to set forth the protocols and procedures for reporting adverse …

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16. Seriousness assessment of adverse event reports

WEBSeriousness assessment of adverse event reports | Pharmacovigilance. 16. Seriousness assessment of adverse event reports. Correct seriousness assessment is …

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Medical device reporting timelines Pharmacovigilance

WEBQuick reference on Medical Device Reporting Timelines. Once the company became aware of reportable incident the clock starts. If a death or serious injury has …

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