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Pharmacovigilance

Dr. Muiris Dowling, CRRO UCC

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Clinical Research Reporting Officer

Report to Vice President of Research and InnovationIndependent of the Cork CRFAct as Sponsor RepresentativeAssist UCC to meet statutory Sponsor responsibilities including:

- Approvals (Protocol & ICF review, signatures etc.)- GCP compliance- Monitoring / Auditing oversight- Pharmacovigilance- Training

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Pharmacovigilance

Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

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Pharmacovigilance

Adverse Event: Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Adverse Reaction: A response to a medicinal product which is noxious and unintended.

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Pharmacovigilance

Serious Adverse Event: Any Adverse Event that results in:• Death• Is life-threatening• Requires in-patient hospitalisation or prolongation

of existing hospitalisation• Results in persistent or significant disability or

incapacity• A congenital anomaly/birth defect• Important Medical Event / other

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Pharmacovigilance

Other safety data:

Any issue in a clinical trial that impacts on either the risk or the benefit to subjects (or the study).

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Pharmacovigilance

Other safety data:

• Patients cannot tolerate IMP• Obvious there is no benefit• Clear that the alternative (including

placebo or nothing) is better• New report of a study which highlights

efficacy or safety issues for IMP

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Pharmacovigilance

Other safety data; Quality issues:

• Tablets crumbling• Capsules fall apart in the hand• IMP discoloured• Labels fall off• Obvious one batch is accounting for all Adverse

Events• Temperature excursions not reported• Expired IMP dispensed

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Other safety data;

• Misuse of IMP (e.g. suppository swallowed)• Patient giving some to friend, relative or

daughter• Patients child taking IMP (accidentally)• Overdose (accidental or intentional)

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Other safety data;

• IMP taken while pregnant• IMP taken while breastfeeding

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Investigator:

• Report SAEs to the Sponsor within 24 hours• Send any follow-up within the same timeframe• Pregnancy reports must be handled in the same

way and must be followed up

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Sponsor:

• Report SUSARs• Fatal or life threatening within 7 days• All others within 15 days

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MedDRA (Medical Dictionary for Regulatory Activities)

• Standardised medical terminology coding dictionary

• Academic institutions have free access• Helps to harmonise terminology

Pharmacovigilance

Eudravigilance

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EVWeb

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Sponsor:

Must maintain oversight of safety profile of the study (and maintain oversight of Investigator)

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Pharmacovigilance

If any change to risk or benefit – must notify HPRA and Ethics Committee even if it is felt that no change is necessary (HPRA or EC may not agree).

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Questions?

Thank you

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