ich e2a- priyanka

8/3/2019 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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