Download - ICH E2a- priyanka
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ICH-E2A
Priyanka VijayvargiyaPGDCTM, Cliniminds
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Wh at does ICH stand for?
International Conference on Harmonization ofTech nical Requirements for Registration ofPh armaceuticals for Human Use
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ICH guidelines
th ose relating to c h emical andph armaceutical Quality AssuranceQuality
th ose relating to in vitro and invivo preclinical studiesSafety
those relating to clinical studiesin human subjectEfficacy
cross-cutting topics wh ich do not fituniquely into one of t h e aboveMultidisciplinary
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ICH E2A
CLINICAL SAFETY DATA MANAGEMENT:DEFINITIONS AND STANDARDS FOR
EXPEDITED REPORTING
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Expedited Reporting
Reporting of any unobserved or undocumentedevents on a fast track basis.
Purpose: to make regulators, investigators, andoth er appropriate people aware of new, important
information on serious reactions.
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2 Aspects
standard definition& terminology
mechanism forhandling
expeditedreporting
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STANDARD DEFINITIONS & TERMINOLOGY
AE & ADRUnexpected ADRSAE & its criteriaSeverity v/s seriousnessExpectedness
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Adverse Event(AE) & Adverse Drug Reaction (ADR)
AE-Any untoward medical occurrence in a patientor clinical investigation subject administered aph armaceutical product and w h ich does not
necessarily h ave to h ave a causal relations h ip with th is treatment.
ADR-All noxious and unintended responses to amedicinal product related to any dose t h at musth ave a reasonable causal relations h ip with th istreatment, i.e., t h e relations h ip cannot be ruled.
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U nexpected Adverse Drug Reaction
An adverse reaction, t h e nature or severity of w h ichis not consistent with th e applicable productinformation.
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SAE & its Criteria
A serious adverse event (experience) or reaction isany untoward medical occurrence t h at at any dose:results in deat h ,is life-th reatening,requires inpatient h ospitalization or prolongation ofexisting h ospitalization,results in persistent or significantdisability/incapacity, oris a congenital anomaly/birt h defect.
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Serious Adverse Event or AdverseDrug Reaction
Th ese need expedited reporting because:
Seriousness Unexpectedness
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Severity v/s Seriousness
Severity: describes t h e intensity of a specific eventsuch as mild, moderate, severe.
Seriousness: it is associated wit h th e outcome & isserves as a guide for regulatory reporting.
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Expectedness of an Adverse DrugReaction
Expected Unexpected
Until source documents are amended,expedited reporting is required for additionaloccurrences of t he reaction.
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W hat to report?
SERIOUS & UNEXPECTED ADRs
An increase in t h e frequency for an expectedserious ADR
A significant h azard to t h e patient population
A major safety finding from a newly completedanimal study (such as carcinogenicity)
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W hat not to report?16
Serious but expected reactions
Reactions unrelated to study product(exp/unexp)
Non-serious adverse reactions(exp/unexp)
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W hen to report?1
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Fatal or life-t h reatening unexpected ADRs:W ith in 7 calendar days
All oth er serious, unexpected ADRs:W ith in 15 calendar days
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Minimum criteria for reporting1
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Patients identitySuspected medicinal product
Reporting sourceEvent/ outcome
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How to report?1
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CIOMS Form
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Informing Investigators & ECs/ IRBs Of NewSafety Information
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Sponsor of a study s h ould amend t h e Investigator'sBroch ure to keep t h e description of safety
information updated.
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