Pharmacovigilance Dr. Muiris Dowling,

Slides:

Advertisements

Similar presentations

Managing Compliance Related to Human Subjects Research Review Joseph Sherwin, Ph.D. Office of Regulatory Affairs University of Pennsylvania Fourth Annual.

Advertisements

Susan Burner Bankowski, M.S., J.D. Chair, OHSU IRB

Safety Reporting IN Clinical Trials

ADVERSE EVENT REPORTING

Reporting Unanticipated Problems Involving Risk to Subjects or Others and Adverse Events WFUHS Policy/Procedure Effective Date 6/1/07 Wendy Murray Monitoring.

Monitoring and Auditing

Elements of a clinical trial research protocol

Update: 21 CFR PART 312 FDA Safety Reporting Requirements for INDs

Capturing and Reporting Adverse Events in Clinical Research

Pharmacovigilance Lindsey Connery Pharmacovigilance Manager, Cancer Research UK Clinical Trials Unit, Glasgow.

John Naim, PhD Director Clinical Trials Research Unit

Pharmacovigilance and Risk Management Chapter 17.

Managing Sponsorship Research Services University of Oxford.

Fulfilling the Promise of Medicine Together New FDA Safety Reporting Requirements 2010 John McLane, Ph.D. COO & Vice President Clinical and Regulatory.

The Language of Clinical Trials. Objectives Objectives: At the conclusion of this discussion, participants will be able to: –Define clinical research.

Field Investigators: ADE Detectives. Section One Introduction to the Team and Their Roles.

Basic Pharmacovigilance Training

Paula Nicholson Research Facilitator

SAE Report CTT21 V To:Quality Assurance Research & Development 34 Hyde Terrace LS2 9LN Date:…………………………….. Fax To:+44(0) From (name):………………………..

Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial Adverse Event Reporting Catherine Dillon.

Requirements of EU pharmacovigilance legislation for distributors Julia Sipos Quality Management Director Pharmacovigilance coordinator Version 03.

M ODULE H I NTERIM M ONITORING V ISIT Denise Thwing 21 Apr Version: Final 21-Apr-2010.

Adverse Events, Unanticipated Problems, Protocol Deviations & other Safety Information Which Form 4 to Use?

SERIOUS ADVERSE EVENTS REPORTING Elizabeth Dayag IRB Administrator Naval Medical Center Portsmouth.

Template for study specific training for Intrapartum Research Studies [ Please see guide before using this]

Adverse Events and Unanticipated Problems Presented by: Karen Jeans, PhD, CCRN, CIP COACH Program Analyst.

A S Nanivadekar Introduction to GCP. A S Nanivadekar Outline Definition and scope Definition and scope Purpose of clinical research Purpose of clinical.

1 Nuts and Bolts of Safety Reporting The Role of the CRO Dr. Noa Lowenton Spier Pharma-Clinical S.A.G.

Adverse Event Reporting.

Development and Approval of Drugs and Devices EPI260 Lecture 9 May 23, 2012 Richard Chin, M.D.

H. Lundbeck A/S21-Sep-151 Pharmacovigilance during clinical development SAE reporting, ASUR and PSUR IFF Seminar, 21. February 2007.

1 MRC SUPREMO (BIG 2-04) Selective Use of Postoperative Radiotherapy aftEr MastectOmy Phase III randomised trial of chest wall RT in intermediate- risk.

Collecting data in clinic.  Aim of BADBIR  Definition of Adverse Events  Adverse events in BADBIR  Adverse event recording in hospital case notes.

ADVERSE EFFECTS OF DRUGS Phase II May Adverse Drug Reaction An adverse reaction to a drug is a harmful or unintended response. ADRs are claimed.

Safety assessment. Safety and efficacy What is the most important? You can’t have one without the other! Equally important but with very different characteristics.

AE/SAE/EAE Identification and Reporting AE/SAE/EAE Identification and Reporting.

Adverse Event Reporting & SAE Reporting for Investigators Trial Number: (POLO-AML-2) Date of training:23 February 2013 Trainer: Deepa Sachdev Venue:Investigator.

EAE Training EAE Reporting and Assessment Overview DAIDS Regional Training Event, Regulatory Compliance Center Kampala, Uganda, September 2009 DAIDS Regional.

Agenda Introduction Study Objectives Study Design Delegation

Office of Research Oversight 1 Office of Research and Development Local Accountability Meeting January 2009.

Serious Adverse Event Reporting Start-up Meeting March 25, 2010 Kingston, ON.

European Patients’ Academy on Therapeutic Innovation Introduction to pharmacovigilance Monitoring the safety of medicines.

Stress Ulcer Prophylaxis in the Intensive Care Unit (SUP-ICU) SAR/SUSAR Mette Krag Dept. of Intensive Care 4131 Copenhagen University Hospital Rigshospitalet,

Role of Site Investigator Ensure subject safety is protected & well-managed Full compliance with requirements of Good Clinical Practice (GCP) Conduct the.

Overcoming challenges in pediatric oncology product development: Regulatory oversight of multi-national clinical studies Ursula Kern, Advisory Committees.

GCP for Emergency Medicine.  This presentation is intended for emergency physicians involved in recruiting patients to clinical trials and/or caring.

D3 ) Not Recovered d5) Fatal Was a post-mortem undertaken?YesNo Was the SAE ongoing at time of death from other cause? Yes No d d m m y y y y d1) Recovered.

REPORTING ADVERSE EVENTS AND COMPLETING THE REPORT FORM

Safety of the Subject Cena Jones-Bitterman, MPP, CIP, CCRP

Reportable Events Emory IRB 9/11/2014.

Assessing expectedness of an adverse event

EudraVigilance.

Administering Informed Consent Issues for Discussion

Expedited Adverse Event Reporting Requirements

Remote Monitoring of Adverse Events

Copenhagen University Hospital Rigshospitalet, Denmark

3. Key definitions Multi-partner training package on active TB drug safety monitoring and management (aDSM) July 2016.

Pharmacovigilance in clinical trials

Safety of the Subject Cena Jones-Bitterman, MPP, CIP, CCRP

UK Legal Requirement for Notification of Serious Breaches of Good Clinical Practice or The Trial Protocol John Poland, PhD Senior Director, Regulatory.

Expedited Adverse Event Reporting Requirements

*Continue on SAE supplemental page CTT21 A if more space is required

Remote Monitoring of Adverse Events

Pharmacovigilance (PV)

SERIOUS ADVERSE EVENTS REPORTING

WHAT TO DO IF A PATIENT DEVELOPS AN UNEXPECTED PROBLEM?

Research, Experimentation, & Clinical Trials

Adverse Event Reporting _____________________________

Dr Tim England TICH-2 SAE adjudicator

Serious Adverse Event Reconciliation

Presentation transcript:

Pharmacovigilance Dr. Muiris Dowling, CRRO UCC version 1.0

Clinical Research Reporting Officer Report to Vice President of Research and Innovation Independent of the Cork CRF Act as Sponsor Representative Assist UCC to meet statutory Sponsor responsibilities including: - Approvals (Protocol & ICF review, signatures etc.) - GCP compliance - Monitoring / Auditing oversight - Pharmacovigilance - Training version 1.0

Pharmacovigilance Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. version 1.0

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. version 1.0

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 version 1.0

Pharmacovigilance Other safety data: Any issue in a clinical trial that impacts on either the risk or the benefit to subjects (or the study). version 1.0

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 version 1.0

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 version 1.0

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) version 1.0

Pharmacovigilance Other safety data; IMP taken while pregnant IMP taken while breastfeeding version 1.0

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 version 1.0

Pharmacovigilance Sponsor: Report SUSARs Fatal or life threatening within 7 days All others within 15 days version 1.0

Pharmacovigilance MedDRA (Medical Dictionary for Regulatory Activities) Standardised medical terminology coding dictionary Academic institutions have free access Helps to harmonise terminology version 1.0

Pharmacovigilance Eudravigilance version 1.0

Pharmacovigilance EVWeb version 1.0

Pharmacovigilance Sponsor: Must maintain oversight of safety profile of the study (and maintain oversight of Investigator) version 1.0

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). version 1.0

Thank you Questions? 18 version 1.0