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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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Pharmacovigilance
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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Pharmacovigilance
Other safety data;
• IMP taken while pregnant• IMP taken while breastfeeding
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Pharmacovigilance
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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Pharmacovigilance
Sponsor:
• Report SUSARs• Fatal or life threatening within 7 days• All others within 15 days
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Pharmacovigilance
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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Pharmacovigilance
EVWeb
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Pharmacovigilance
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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