Pharmacovigilance Office of Product Review
|
|
- Megan Austin
- 6 years ago
- Views:
Transcription
1 Pharmacovigilance Office of Product Review Dr Jane Cook Office Head Office of Product Review, Monitoring & Compliance Group, TGA 7/10/2011
2 Overview of talk Overview Post TGA 21 and OPR New Guidelines Key Points How does OPR manage adverse events Safety Signal Detection Investigation Response Questions? 2
3 Post TGA21 Separation into pre and post market areas - Market Authorisation Group (MAG) and Monitoring and Compliance Group (MCG) MCG includes: Office of Product Review Office of Manufacturing Quality Office of Laboratory Scientific Services Office of Product Review: Devices and medicines adverse event databases Devices and medicines signal detection and investigation RMP evaluation and monitoring Recalls Advertising
4 Current Reviews Internal: Transparency review Professor Pearce Advertising Review Review of recall procedures External: Horvath Review of Vaccine Safety
5 Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Medicines Result of consultation process with industry over several years. Aligns requirements of all sponsors of medicines Differentiates requirements between registered and listed medicines based on risk Comes into effect on 1 October 2011 Until then dual documentation will remain on TGA website and will be removed post 1 October 2011
6 Key Elements Requirement to submit all serious adverse events within 15 days of becoming aware. While guideline refers to serious expected and unexpected adverse events both must be reported. Need to follow up these reports to provide as much information as possible. A serious adverse event involves hospitalisation, is life threatening, results in death or ongoing impairment/disability. Results in a congenital abnormality or congenital defect, is a medically important event of reaction (usually results in a visit to a healthcare professional). Maintain a record of all adverse events and be able to supply these on request. Notify the TGA within 72 hours of any major safety issue (outlined in guideline).
7 Specific Issues Periodic Safety Update Reports Requirement for registered medicines as part of conditions of registration Sponsors of listed medicines are required to monitor the safety of their product, can be provided as a case line listing if requested by the TGA. Review of Literature This is encouraged for listed medicines and is not mandatory at this stage. Albeit this could be seen as an element of effective monitoring of the safety of a product. Use of MedDRA terminology Sponsors are requested to provide reports using MedDRA terminology. This facilitates efficient and timely entry into the database. Will allow automatic entry into database once E2B capability in place.
8 Qualified person responsible for Pharmacovigilance The Qualified Person for Pharmacovigilance should: 1. Have experience in all aspects of pharmacovigilance and if not medically qualified (do not have a medical degree) should report to, or have access to a medically qualified person. 2. Be resident within Australia. The Qualified Person for Pharmacovigilance is responsible for ensuring: 1. The establishment and maintenance of a system which ensures that information about all suspected adverse reactions which are reported to the sponsor are collected and collated and where serious reported to the TGA. 2. The preparation, where the medicinal product is registered, of Periodic Safety Update Reports (PSURs). 3. Monitoring the safety of the sponsor s products once they are on the market and for the duration of the products lifetime. 4.Responding to requests from the TGA for information relating to the effectiveness and safety of the the product 5. The name of the Qualified Person for Pharmacovigilance should be provided to the TGA. 6. The position of Qualified Person for Pharmacovigilance can be held either within the company or contracted out. If the position is contracted out it is important to ensure a clear contract outlining the roles and responsibilities held by that individual is implemented.
9 Why spontaneous Adverse Event monitoring is undertaken Differences between listed and registered medicines In the case of registered medicines: not all AEs, precautions and contra-indications will be identified in clinical trials undertaken in the pre market phase of a medicine due to relatively small numbers and exclusion criteria The content of the PI/CMI to a large degree largely relies on spontaneous adverse drug reporting to detect safety related events occurring in the post marketing period where the product is used in larger population groups Detects rare AE as population group larger and event therefore more likely to occur In the case of listed medicines Safety profile usually known through established use Can detect clusters that relate to manufacturing quality Long term population effects e.g. potential increased risk of cardiovascular disease (calcium and Vitamin E) 9
10 Goals of adverse event reporting Complement other sources of information Provide a sample of AEs occurring, not a registry of AEs Most interested in serious AEs hospitalisation or Dr visit/death/disability or sequelae/certain conditions Analysis indicates whether further investigation required
11 Problems with spontaneous adverse event reporting Occurrence of adverse events research has shown 10% of people presenting to GP have experienced an adverse event in the previous 6 months, of these 7% resulted in hospitalisation (Adverse drug events in general practice patients in Australia - Graeme C Miller et al, Medical Journal of Australia) Significant cause of morbidity Under-reporting international studies have shown maybe as great as 94% (Under-Reporting of Adverse Drug Reactions: A Systematic Review Lorna Hazell1 and Saad A.W. Shakir, Drug Safety 2006)
12 Volume TGA receives about 12,000 ADR reports a year, in received around 14,000 Less than a third of these would be considered potentially serious AEs Small percentage contain insufficient information to identify a unique event and are rejected
13 Who reports GPs Hospitals Companies Others
14 Reporting of Adverse Events Mandatory reporting of serious adverse events to the TGA by sponsors Requirement to monitor safety of a product by a sponsor Not mandatory for health professionals or consumers to report AEs to medicines Some states and territories (6 of 8) have legislation requiring mandatory reporting of Adverse Events Following Immunisation (AEFIs) to S&T Health Departments - these are then reported to the TGA
15 How reports are received Blue card (health professionals, consumers and sponsors) CIOMS form (international format) from sponsors Letters/ s (health professionals and consumers) Web reporting via TGA website sponsors, consumers & health professionals Telephone via Adverse Medicine Event Line (NPS) consumers
16 TGA s ADRS Database Scanned reports (Blue cards, faxes, s) Web reports and further information Lodgement Triage Coding MO Review Posting Acknowledgment Structured Database (Oracle) Interrogation may include case line listings, PRR summaries, crosstab reports, analysis
17 Assessment of Reports Triage Officer determines if serious, non-serious, CIOMS form and assigns to relevant draw on ebs All done electronically CIOMS contain MedDRA terms (coding terms) entered by clerical staff Reports of non-serious AEs entered by clerical staff e.g. nausea, injection site reaction Reports containing serious AEs are assessed and entered by medical officers
18 Entry onto database Reports containing AEs are assessed and the reactions coded according to an international coding convention (MedDRA) Most reports contain multiple AEs which are individually entered onto the database for each report OPR has guidelines on coding conventions and the way an AE will be entered e.g. liver injury requires specific information (range of LFT tests are 2xULN) before the coding term can be used
19 Causality Assessment Based on WHO classification: Certain Probable Possible Unclear Where the AE is assessed as being unclear it is unlikely or not associated with the drug & the report is General Listed, that is the report is accessible but not used in consideration of a safety signal
20 Follow up information Need sufficient detail to determine causality requires information on concomitant medication, medical history, concurrent illness, time to onset of AE Need to identify confounders and determine temporal association Process for repeat FI requests implemented where a serious unexpected AE or AE of Special interest. Request for information on these is requested on three occasions before no further follow up is undertaken
21 Signal Detection 3 components Signal identification ideally a mix of proactive and reactive activities to identify harmful effects of medicines, through review of spontaneous ADR reports from healthcare providers, industry and consumers, including the application of data mining tools review of international vigilance activities and reports review of published literature review of post approval studies
22 PRR Undertaken on a 4 weekly cycle Evaluation by professional staff Thresholds vary between new and older medicines Identifies potential signals further investigated by OPR Assessment and evaluation of a particular AE and medicine can be provided to the Advisory Committee on the Safety of Medicines (ACSOM) for advice
23 Calculating the PRR REACTION Reaction OF of INTEREST a interest Drug of interest DRUG OF INTEREST All other reactions c d ALL OTHER REACTIONS c d PRR = a/(a+c) b/(b+d) = a(b+d) / b(a+c) Need to have > 3 cases where PRR > 3 a ALL OTHER DRUGS All other drugs b b
24 Data Mining example AMITRIPTYLINE HYDROCHLORIDE All cases Sole suspected PRR Chest pain Heart rate increased Palpitations Pulmonary embolism Serotonin syndrome Tremor
25 Signal Detection 3 components continued Signal assessment elucidation of the nature, magnitude and health significance of safety signals and their impact on the overall benefit-risk of the product Application of appropriate analytical skills in pharmacovigilance, epidemiology, biostatistics, risk assessment and clinical practice Utilisation of international data, expert analysis and advice (ASCOM and/or ad hoc Expert Panels) Liaison with other regulators Informs the regulatory response
26 Risk-Benefit Assessment The TGA evaluates the risks of individual therapeutic goods and the ingredients used in them, for the population they are intended for; The healthcare provider (the medical practitioner) evaluates risks for the individual patient; and The consumer evaluates risks in terms of their personal values, based on information provided about the product.
27 Risk-Benefit Assessment Benefit evaluation: Epidemiology and natural history of the target disease(s) Purpose of treatment (cure, prophylaxis, etc.) Summary of efficacy and general toleration data compared with: other medical treatments surgical treatment or other intervention no treatment
28 Risk-Benefit Assessment Risk Evaluation Background Weight of evidence Analyses Consideration of explanation of problem Predictability, preventability, reversibility Issues related to alternate therapies Review of complete safety profile (other AEs)
29 Signal Detection 3 components continued Signal response (regulatory response) actions taken to mitigate the risks Alteration of product labelling Communication of important benefit-risk information MSU articles, other publications, interaction with NPS educational activities eg RADAR or Australian Prescriber Product removal suspension, cancellation, recall Decision maker will be in OPR
30 Pharmacy only medicine for nausea Long established medicine Early reports of hallucination, psychosis, blurred vision in the space of 6 working days On 6 th day (Friday) teleconference with sponsor held, samples obtained for analysis; expert advice was sought - recommended recall 2 further reports following Monday delirium in one passenger necessitating diversion of plane Monday afternoon consumer level recall initiated Presentations consistent with toxicity of active ingredient Assay subsequently showed 10 fold variation in hyoscine levels consequence of manufacturing deficiencies
31 Questions?
MEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL REPORTING ADVERSE DRUG REACTIONS IN SOUTH AFRICA IMPORTANT NOTE This guideline applies only to the reporting of SAEs during clinical trials. An update of the guideline for this
More informationIntroduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER
Introduction to Post-marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER Sara Camilli, PharmD, BCPS, Safety Evaluator Team Leader Selena Ready, PharmD, CGP, Safety Evaluator Division of Pharmacovigilance
More informationCorporate Induction: Part 2
Corporate Induction: Part 2 Identification of preventable Adverse Drug Reactions from a regulatory perspective March 1 st 2013, EMA Workshop on Medication Errors Presented by Almath Spooner, Pharmacovigilance
More informationOverview of Draft Pharmacovigilance Protocol
Overview of Draft Pharmacovigilance Protocol Identifying ADRs in Africa Special Challenges Malaria - pan-systemic clinical features Life-threatening condition Real-world trial AS/SP and co-artem safety
More informationPost Market Surveillance Requirements. SAMED Regulatory Conference 2 December 2015
Post Market Surveillance Requirements SAMED Regulatory Conference 2 December 2015 Topics Surveillance & Vigilance Adverse Events Reportable Adverse Events Reporting Adverse Events Time frames Exemptions
More informationICH Topic E 2 D Post Approval Safety Data Management. Step 5 NOTE FOR GUIDANCE ON DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (CPMP/ICH/3945/03)
European Medicines Agency May 2004 CPMP/ICH/3945/03 ICH Topic E 2 D Post Approval Safety Data Management Step 5 NOTE FOR GUIDANCE ON DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING (CPMP/ICH/3945/03)
More informationTable of Contents Service Information... 2
Protocol October 2015 Version 1.0 Table of Contents Service Information... 2 Service objective... 2 Clinical service overview... 2 Documentation... 3 Staff Roles... 3 Facilities to support the program...
More informationTITLE: Reporting Adverse Events SOP #: RCO-204 Page: 1 of 5 Effective Date: 01/31/18
SOP #: RCO-204 Page: 1 of 5 1. POLICY STATEMENT: The research team is responsible for recognizing changes in subject health that may qualify as adverse events, classifying those results as defined in the
More informationThis document provides information on conducting the Perindopril New To Therapy Program using GuildCare software.
Perindopril New To Therapy Program PROTOCOL This document provides information on conducting the Perindopril New To Therapy Program using GuildCare software. April 2015 Table of Contents Executive Summary...
More informationEvaluating adverse events from patient support and market research programs: proposed best practices and regulatory changes
Evaluating adverse events from patient support and market research programs: proposed best practices and regulatory changes 2 nd Adverse Event Reporting and Safety Strategies Summit December 8-9, 2015
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL REPORTING OF POST-MARKETING ADVERSE DRUG REACTIONS TO HUMAN MEDICINAL PRODUCTS IN SOUTH AFRICA Important Note: Guideline 2.11 Reporting ADRs in South Africa addresses the reporting
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL POST-MARKETING REPORTING OF ADVERSE DRUG REACTIONS TO HUMAN MEDICINES IN SOUTH AFRICA This document has been prepared to serve as a guideline to those reporting adverse drug reactions.
More informationIDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES
IDENTIFYING, RECORDING AND REPORTING ADVERSE EVENTS FOR CLINICAL INVESTIGATIONS OF MEDICAL DEVICES DOCUMENT NO.: CR012 v2.0 AUTHOR: Raymond French ISSUE DATE: 18 September 2017 EFFECTIVE DATE: 02 October
More informationVarious Views on Adverse Events: a collection of definitions.
Various Views on Adverse Events: a collection of definitions. April 20, 2008 Werner CEUSTERS a,1, Maria CAPOLUPO b, Georges DE MOOR c, Jos DEVLIES c a New York State Center of Excellence in Bioinformatics
More informationSubmission to the Therapeutic Goods Administration regarding
Submission to the Therapeutic Goods Administration regarding Changes to accessing unapproved therapeutic goods through the Authorised Prescriber (AP) and Special Access Schemes (SAS) This joint submission
More informationNew To Therapy GuildCare Program
Spiriva/Spiolto Respimat (Tiotropium/Tiotropium and Olodaterol) New To Therapy GuildCare Program PROTOCOL This document provides information on conducting the Spiriva/Spiolto Respimat New To Therapy Program
More informationMarie-Claire Rickard, RG and GCP Manager Jimena Lovos, Quality Assurance Manager Elizabeth Clough, R&D Governance Operations Manager
Standard Operating Procedures (SOP) for: Pharmacovigilance processing for the JRMO SOP Number: 26c Version Number: V1 Effective Date: 5/8/16 Review Date: 5/8/17 Author: Reviewer: Reviewer: Authorisation:
More informationStandard Operating Procedure
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-07-004 Recording, managing and reporting Adverse Events for Clinical Trials of Investigational Medicinal Products and trials of Advanced
More informationWHO Programme for International Drug Monitoring, Pharmacovigilance Centres & Patient Safety
WHO Programme for International Drug Monitoring, Pharmacovigilance Centres & Patient Safety Birth of WHO Drug Monitoring Programme Thalidomide Phocomelia 2 16th World Health Assembly 1963 Assembly Resolution
More informationGuide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices
Guide to Incident Reporting for General Medical Devices and Active Implantable Medical Devices SUR-G0003-4 09 JULY 2012 This guide does not purport to be an interpretation of law and/or regulations and
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Safety Reporting in CTIMPs and ATMPs SOP number: TM 003 SOP category: Trial Management Version number: 03 Version date:
More informationGuide to Incident Reporting for In-vitro Diagnostic Medical Devices
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices SUR-G0004-4 02 AUGUST 2012 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes
More informationBiomedical IRB MS #
Department for Human Research Protections Institutional Review Boards Biomedical IRB MS # 1035 419-383-6796 IRB.Biomed@utoledo.edu Social, Behavioral and Educational IRB MS # 944 419-530-6167 IRB.SBE@utoledo.edu
More information3 HEALTH, SAFETY AND ENVIRONMENTAL PROTECTION
1 PURPOSE The purpose of this procedure is to describe the method by which Adverse Events (AE)/relevant Safety Information and Product Quality Complaints (PQC) will be received, triaged, and documented
More informationRetrospective Chart Review Studies
Retrospective Chart Review Studies Designed to fulfill requirements for real-world evidence Retrospective chart review studies are often needed in the absence of suitable healthcare databases and/or other
More informationPOLICY ON RESEARCH RELATED ADVERSE EVENT REPORTING
POLICY ON RESEARCH RELATED ADVERSE EVENT REPORTING CLASSIFICATION TRUST POLICY NUMBER APPROVING COMMITTEE R & D Governance Committee RATIFYING COMMITTEE Quality & Risk Committee DATE RATIFIED October 2009
More informationSponsor Responsibilities. Roles and Responsibilities. EU Directives. UK Law
EU Directives Pharmacovigilance Legislation, SOPs and Reporting Louise Boldy, Governance & Safety Manager David Martin, Pharmacovigilance Monitor EU Legislation 2001/20/EC 2005/28/EC EudraLex Vol 10 UK
More informationSafeguarding public health. The New PV Legislation its Impact on PV & MI
Safeguarding public health The New PV Legislation its Impact on PV & MI Sarah Vaughan - MHRA PIPA 2013 Manager s Meeting 13 th February 2013 Content Scope of change Key areas - ADR reporting - DDPS to
More informationFOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE
FOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE Document No. : FDA/SMC/SMD/GL-QPP/2013/03 Date of First Adoption : 1st February, 2013 Date of Issue : 1 st March, 2013 Version
More informationGuideline on good pharmacovigilance practices (GVP)
1 2 26 July 2012 EMA/118465/2012 3 4 Guideline on good pharmacovigilance practices (GVP) Module XV Safety communication 5 Draft finalised by the Agency in collaboration with Member States and submitted
More informationMedDRA User Group. Paris, April 16, 2015 Victoria Newbould, European Medicines Agency. An agency of the European Union
MedDRA User Group Paris, April 16, 2015 Victoria Newbould, European Medicines Agency An agency of the European Union HMA meeting 28 November 2013 HMA agreed with the deliverables to be completed over the
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Safety Reporting in CTIMPs and ATMPs SOP number: TM-003 SOP category: Trial Management Version number: 04 Version date:
More informationWhat does governance look like in homecare?
What does governance look like in homecare? Dr David Cousins PhD FRPharmS Head of Pa)ent Safety, Healthcare at Home Ltd This Satellite is sponsored by Healthcare at Home Ltd Definitions Clinical governance
More informationTable of Contents Service Information... 2
Protocol October 2015 Version 1.1 Table of Contents Service Information... 2 Service objective... 2 Clinical service overview... 2 Screening... 2 Documentation... 3 Staff Roles... 3 Facilities to support
More informationCHAPTER 9 PERFORMANCE IMPROVEMENT HOSPITAL
CHAPTER 9 PERFORMANCE IMPROVEMENT HOSPITAL PERFORMANCE IMPROVEMENT Introduction to terminology and requirements Performance Improvement Required (Board of Pharmacy CQI program, The Joint Commission, CMS
More informationSOP Title: Reporting Adverse Events and New Safety Information
Page 1 of 14 General Control of medication use requires collecting field data about adverse events (AEs) resulting from medication therapy. Regulation 7(B)(2) of Pharmacists Regulations (Medical Products)
More informationDose Administration Aid Patient Detect Service
Dose Administration Aid Patient Detect Service Protocol October 2015 Version 1.3 Table of Contents Executive Summary... 1 Program objective... 1 Patient qualification... 2 Clinical Service... 2 Reporting/Claiming...
More informationStandard Approaches to Adverse Event Reporting. Jonathan Deutsch, M.D.
Standard Approaches to Adverse Event Reporting Jonathan Deutsch, M.D. 1 DISCLAIMER The opinions contained in this presentation are those of the presenter and do not necessarily reflect those of BMS 2 Scope
More informationDetermining and Reporting Adverse Events vs. Product Complaints
Determining and Reporting Adverse Events vs. Product Complaints Pharma Perspective: Jacqueline Grissinger Director, Office of Consumer Medical Safety Johnson & Johnson Medical Device Perspective: Lisa
More informationChapter 13. Documenting Clinical Activities
Chapter 13. Documenting Clinical Activities INTRODUCTION Documenting clinical activities is required for one or more of the following: clinical care of individual patients -sharing information with other
More informationUse of disease registries for benefitrisk evaluation of medicines: A regulatory perspective. DIA Europe April Basel, Switzerland
Use of disease registries for benefitrisk evaluation of medicines: A regulatory perspective DIA Europe 2018-17-19 April Basel, Switzerland Presented by Xavier Kurz Head of Service Surveillance and Epidemiology
More informationACRIN ADVERSE EVENT REPORTING MANUAL. 1 March 2006 v.3
AMERICAN COLLEGE OF RADIOLOGY IMAGING NETWORK ADVERSE EVENT REPORTING MANUAL 1 Prepared by the American College of Radiology Imaging Network Administrative Center September 2002 Revised March 2006 American
More informationPHARMACY SERVICES/MEDICATION USE
25.01. 10 Drug Reactions & Administration Errors & Incompatibilities. Drug administration errors, adverse drug reactions and incompatibilities must be immediately reported to the attending physician and
More informationInformation Brochure Professional Certificate in Pharmacovigilance
Information Brochure Professional Certificate in Pharmacovigilance Catalyst Clinical Services Pvt. Ltd. Unit No. 11, CSC-12, Block D1, Sector-16, Rohini, Delhi - 110089 (India) M: +91 9818356273 Email:
More informationAdopted by Pharmacovigilance Risk Assessment Committee 20 February Adopted by Pharmacovigilance Inspectors Working Group 21 March 2014
21 March 2014 EMA/INS/PhV/192231/2014 Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal Adopted
More informationGood Pharmacovigilance Practice. Overview of GVP Modules on ADR, PSURs, Signal Management and Additional Monitoring Mick Foy - MHRA
Good Pharmacovigilance Practice Overview of GVP Modules on ADR, PSURs, Signal Management and Additional Monitoring Mick Foy - MHRA Content ADR Reporting Definition & Increased scope Transition arrangements
More informationStudy Management SM STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting
Study Management SM 306.00 STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick M. Schnell, MD,
More informationHelping physicians care for patients Aider les médecins à prendre soin des patients
CMA s Response to Health Canada s Consultation Questions Regulatory Framework for the Mandatory Reporting of Adverse Drug Reactions and Medical Device Incidents by Provincial and Territorial Healthcare
More informationProfessional Student Outcomes (PSOs) - the academic knowledge, skills, and attitudes that a pharmacy graduate should possess.
Professional Student Outcomes (PSOs) - the academic knowledge, skills, and attitudes that a pharmacy graduate should possess. Number Outcome SBA SBA-1 SBA-1.1 SBA-1.2 SBA-1.3 SBA-1.4 SBA-1.5 SBA-1.6 SBA-1.7
More informationGUIDELINES FOR NATIONAL PHARMACOVIGILANCE SYSTEM MEDICINES CONTROL AGENCY THE GAMBIA
GUIDELINES FOR NATIONAL PHARMACOVIGILANCE SYSTEM MEDICINES CONTROL AGENCY THE GAMBIA 30TH MARCH 2017 1 Contents Preface/Forward... 5 ACKNOWLEDGEMENTS... 6 Abbreviations/Acronyms... 7 1. INTRODUCTION...
More informationVaccination Recording
Protocol January 2017 Version 1.6 Table of Contents Service Information... 2 Service objective... 2 Clinical service overview... 2 Documentation... 3 Staff Roles... 4 Facilities to support the program...
More informationFERCI MODEL SOPs. [The IEC members (author/s, reviewer/s) and Chairperson will sign and date the SOP on this first page]
Title: SOP Code: SOP 12/V1 [The IEC members (author/s, reviewer/s) and Chairperson will sign and date the SOP on this first page] Prepared by: Dr. Padmaja Marathe, FERCI Member (Signature with Date) Reviewed
More informationMedicine Reconciliation FREQUENTLY ASKED QUESTIONS NATIONAL MEDICATION SAFETY PROGRAMME
Medicine Reconciliation FREQUENTLY ASKED QUESTIONS NATIONAL MEDICATION SAFETY PROGRAMME The Process What is medicine reconciliation? Medicine reconciliation is an evidence-based process, which has been
More informationMeasures of impact of pharmacovigilance processes (3.3)
Measures of impact of pharmacovigilance processes (3.3) Session 4 - Reports from breakout sessions: gaps and observations Workshop: Measuring the Impact of Pharmacovigilance Activities London, 5-6 December
More informationChanging Requirements for Devices//Device Constituent Parts in Combination Products
Changing Requirements for Devices//Device Constituent Parts in Combination Products Dan Wozinski, RPH, MBA Sanofi Disclaimer The content and viewpoints of this presentation are mine alone and not those
More informationThe New EU PV Legislation: View from the European Commission
The New EU PV Legislation: View from the European Commission International seminar 26 May 2011 Lenita LINDSTRÖM Senior Policy Officer Pharmaceuticals Unit/DG SANCO Rationale for the revision Calls for
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Adverse Event Identification, Recording and Reporting in Clinical Trials of Investigational Medicinal SOP-RES-019 Version Number 2 Issue Date 08 th Dec
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL GUIDELINES FOR RECALL/ WITHDRAWAL OF MEDICINES This document has been prepared to serve as a recommendation to applicants regarding the recalls of medicines, and the Medicines
More informationTools for Pharmacovigilance and Cohort Event Monitoring
Tools for Pharmacovigilance and Cohort Event Monitoring Magnus Wallberg Senior Systems Architect M Sc Engineering Physics Dar Es Salaam November 26 th, 2009 magnus.wallberg@who-umc.org Agenda Where does
More informationGuideline on good pharmacovigilance practices (GVP)
9 October 2017 2017 EMA/118465/2012 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module XV Safety communication (Rev 1) Date for coming into effect of first version 24 January 2013 Draft
More informationWHO Pharmacovigilance Indicators. Dr. Nitin Gaikwad Co-coordinator, ADR Monitoring Center, PvPI Additional Professor, Pharmacology AIIMS Raipur
WHO Pharmacovigilance Indicators Dr. Nitin Gaikwad Co-coordinator, ADR Monitoring Center, PvPI Additional Professor, Pharmacology AIIMS Raipur Scope of presentation Sensitization of Coordinators, Co-coordinators,
More informationLessons from the EMA Patient Registries Initiative
Lessons from the EMA Patient Registries Initiative STAMP Commission Expert Group 8 th June 2018 Presented by Peter Arlett, with contributions from Patricia McGettigan and Jane Moseley Head of Pharmacovigilance
More informationUser Guide for Patients
User Guide for Patients December 2016 Contents Health365 Overview... 3 What can I do with Health365?... 3 How to get started... 4 Sign In... 4 Home Page - Patient options... 6 Appointments... 7 To make
More informationBETTER REGULATION OF MEDICINES INITIATIVE (BROMI): FIFTH REPORT ON PROGRESS
A2 BETTER REGULATION OF MEDICINES INITIATIVE (BROMI): FIFTH REPORT ON PROGRESS March 2012 A3 BETTER REGULATION OF MEDICINES INITIATIVE (BROMI) FIFTH REPORT ON PROGRESS Chief Executive s foreword In January
More informationPFF Patient Registry Protocol Version 1.0 date 21 Jan 2016
PFF Patient Registry Protocol Version 1.0 date 21 Jan 2016 Contents SYNOPSIS...3 Background...4 Significance...4 OBJECTIVES & SPECIFIC AIMS...5 Objective...5 Specific Aims... 5 RESEARCH DESIGN AND METHODS...6
More informationIIS Sponsor Reference Guide
IIS Sponsor Reference Guide The IIS Portal is the global, single point of access for all IIS submissions Table of Contents Logging in 2 Registration. 2 Study Submission 3 Submission Questionnaire Details.
More informationProcess and methods Published: 23 January 2017 nice.org.uk/process/pmg31
Evidence summaries: process guide Process and methods Published: 23 January 2017 nice.org.uk/process/pmg31 NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-ofrights).
More informationAdverse Event Reporting
Adverse Event Reporting The current version of all Hillingdon Hospital R&D Guidance Documents and Standard Operating Procedures are available from the R&D Intranet and Internet sites: www.thh.nhs.uk/departments/research/research.htm
More informationRITAZAREM CRF Completion Guidelines
RITAZAREM CRF Completion Guidelines 10 Sept 2013 Version 1.2 Author: Michelle Lewin RITAZAREM Trial Coordinator Michelle.lewin@addenbrookes.nhs.uk Tel: +44(0) 1223 349350 Fax: +44(0) 1223 586767 Version
More informationGuideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
1 2 31 January 2017 EMA/430909/2016 3 4 5 Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or Draft Adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2017 Adopted
More informationBariatric Surgery Registry Outlier Policy
Bariatric Surgery Registry Outlier Policy 1 Revision History Version Date Author Reason for version change 1.0 10/07/2014 Wendy Brown First release 1.1 01/09/2014 Wendy Brown Review after steering committee
More informationTHE BOARD OF THE EURASIAN ECONOMIC COMMISSION RESOLUTION. dated December 22, 2015 N 174
THE BOARD OF THE EURASIAN ECONOMIC COMMISSION RESOLUTION Dated December 22, 2015, N 174 ON APPROVAL OF REGULATIONS OF MEDICAL DEVICE SAFETY, QUALITY AND EFFECTIVENESS MONITORING In accordance with paragraph
More informationUniversity of South Carolina. Unanticipated Problems and Adverse Events Guidelines
University of South Carolina Unanticipated Problems and Adverse Events Guidelines These guidelines define the procedures of USC for addressing unanticipated problems involving risks to research participants
More informationFINAL DOCUMENT. Global Harmonization Task Force
GHTF/SG5/N5:2012 FINAL DOCUMENT Global Harmonization Task Force Title: Reportable Events During Pre-Market Clinical Investigations Authoring Group: Study Group 5 of the Global Harmonization Task Force
More informationNATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Interim Process and Methods of the Highly Specialised Technologies Programme
NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Principles Interim Process and Methods of the Highly Specialised Technologies Programme 1. Our guidance production processes are based on key principles,
More informationPatient Centricity In Pharmacovigilance:
Patient Centricity In Pharmacovigilance: New Directions, New Horizons Background The importance of Pharmacovigilance (PV) as a science and its role in effective patient care in clinical practice and public
More informationNHS GREATER GLASGOW AND CLYDE POLICIES RELATING TO THE MANAGEMENT OF MEDICINES SECTION 9.1: UNLICENSED MEDICINES POLICY (ACUTE DIVISION)
SECTION 9.1: UNLICENSED MEDICINES POLICY (ACUTE DIVISION) CONTENTS POLICY SUMMARY... 2 1. SCOPE... 4 2. AIM... 4 3. BACKGROUND... 4 4. POLICY STATEMENTS... 5 4.1. GENERAL STATEMENTS... 5 4.2 UNLICENSED
More informationED0028 Adverse event, critical incident, serious issue, and near miss procedure
ED0028 Adverse event, critical incident, serious issue, and near miss procedure 1. Full description Adverse event, critical incident, serious issue, 2. Preamble Doctors working in Australia have responsibilities
More informationGuidance notes for patient safety and pharmacovigilance in patient support programmes
Guidance notes for patient safety and pharmacovigilance in patient support programmes Authors: The ABPI Pharmacovigilance Expert Network Version: 2.14 Date: March 2018 Acknowledgements: We thank the many
More informationDCP Safety Committee. Update and Review. January 19, 2017
DCP Safety Committee Update and Review January 19, 2017 1 Overview: FDA s IND Safety Final Rule DCP s Response DCP Safety Committee Harmonizing Medical Monitors Process SAE Reporting SAE Flow Chart Process
More informationPG Certificate / PG Diploma / MSc in Clinical Pharmacy
PG Certificate / PG Diploma / MSc in Clinical Pharmacy 2008/09 Programme Course manager: Brian McCaw (b.mccaw@qub.ac.uk) Distance Learning Centre The School of Pharmacy Queen's University Belfast PG Certificate
More informationFrequently asked questions about active TB drug-safety monitoring and management (adsm)
Frequently asked questions about active TB drug-safety monitoring and management (adsm) Version: 3 November 2016 The Global TB Programme of World Health Organization (WHO/GTB) issued interim policy on
More informationBariatric Surgery Registry Outlier Policy
Bariatric Surgery Registry Outlier Policy 1 Revision History Version Date Author Reason for version change 1.0 10/07/2014 Wendy First release Brown 1.1 01/09/2014 Wendy Brown 1.2 02/03/2015 Monira Hussain,
More informationThe Role of the Agency for Healthcare Research and Quality (AHRQ) in the US Drug Safety System
The Role of the Agency for Healthcare Research and Quality (AHRQ) in the US Drug Safety System Scott R. Smith, MSPH, PhD Center for Outcomes & Evidence Agency for Healthcare Research & Quality July 20,
More informationDetails: Approval: Distribution & Storage: Pharmacovigilance for Researchers for UoL / LTHT Sponsored CTIMPs. Standard Operating Procedure
Details: Author: Razwan Mahroof - QA Clinical Trials Monitor SOP Pages: 10 Version No. of replaced SOP: 1.0 Effective date of replaced SOP: 04 December 2015 Approval: Version No: of the SOP being approved.
More informationDANNOAC-AF synopsis. [Version 7.9v: 5th of April 2017]
DANNOAC-AF synopsis. [Version 7.9v: 5th of April 2017] A quality of care assessment comparing safety and efficacy of edoxaban, apixaban, rivaroxaban and dabigatran for oral anticoagulation in patients
More informationTable 1. Big Data Sources of Interest for Pharmacovigilance (PV)
Health Sciences Authority, Singapore 1 National Electronic Health Electronic Health Record Interest Preliminary stage, exploring access to records Record 2 Electronic medical records Laboratory data, discharge
More informationApplication Guide Global Awards in Transthyretin (TTR) Amyloidosis Research Research. A Competitive Grants Program Supported by Pfizer
Application Guide 2017 Global Awards in Transthyretin (TTR) Amyloidosis Research Research A Competitive Grants Program Supported by Pfizer www.aspireresearch.org Table of Contents THE ASPIRE PROGRAM...
More informationNATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Single Technology Appraisal (STA)
Thank you for agreeing to give us a statement on your organisation s view of the technology and the way it should be used in the NHS. Healthcare professionals can provide a unique perspective on the technology
More informationHealth Technology Assessment and Optimal Use: Medical Devices; Diagnostic Tests; Medical, Surgical, and Dental Procedures
TOPIC IDENTIFICATION AND PRIORITIZATION PROCESS Health Technology Assessment and Optimal Use: Medical Devices; Diagnostic Tests; Medical, Surgical, and Dental Procedures NOVEMBER 2015 VERSION 1.0 1. Topic
More informationVersion Number: 003. On: September 2017 Review Date: September 2020 Distribution: Essential Reading for: Information for: Page 1 of 13
CONTROLLED DOCUMENT Reporting Research Incidents and Breaches Policy CATEGORY: CLASSIFICATION: PURPOSE Controlled Number: Document Policy Governance To set out the framework and principles for reporting
More informationEQuIPNational Survey Planning Tool NSQHSS and EQuIP Actions 4.
Standard 1: Governance for safety and Quality and Standard 2: Partnering with Consumers Section 1 Governance, Policies, Business decision making, Organisational / Strategic planning, Consumer involvement
More informationPOLICY AND PROCEDURE DEPARTMENT: Pharmacy Operations
PAGE: 1 of 6 SCOPE: Centene Corporate Pharmacy Department, Centene Corporate Pharmacy and Therapeutics Committee, Health Plan Pharmacy Departments, Health Plan Pharmacy and Therapeutics Committees, and
More informationM. Rickard, Research Governance and GCP Manager R. Fay Research Governance and GCP Manager Elizabeth Clough, Governance Operations Manager
Standard Operating Procedures (SOP) for: Pharmacovigilance and Safety Reporting for Sponsored non-ctimps SOP Number: 26b Version 2.0 Number: Effective Date: 29th November 2015 Review Date: 3 rd December
More informationAPPENDIX B. Physician Assistant Competencies: A Self-Evaluation Tool
APPENDIX B Physician Assistant Competencies: A Self-Evaluation Tool Rate your strength in each of the competencies using the following scale: 1 = Needs Improvement 2 = Adequate 3 = Strong 4 = Very Strong
More informationKeele Clinical Trials Unit
Keele Clinical Trials Unit Standard Operating Procedure (SOP) Summary Box Title Safety Reporting and Pharmacovigilance SOP Index Number SOP 20 Version 4.0 Approval Date 31-Jan-2017 Effective Date 14-Feb-2017
More informationImproving the reporting of medication-related safety incidents
Rationale Improving the reporting of medication-related safety incidents Research shows that organisations which regularly report more patient safety incidents usually have a stronger learning culture
More informationPROMPTLY REPORTABLE EVENTS
PROMPTLY REPORTABLE EVENTS PURPOSE AND SCOPE To define the structure and responsibility for reporting unanticipated problems that occurs during the conduct of research. APPLICABLE REGULATIONS Policy II.02
More informationUNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD REPORTING UNANTICIPATED PROBLEMS INCLUDING ADVERSE EVENTS
UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD REPORTING UNANTICIPATED PROBLEMS INCLUDING ADVERSE EVENTS I. PURPOSE To specify the procedures for reporting unanticipated problems,
More informationAsian Journal of Phytomedicine and Clinical Research Journal home page:
Research Article CODEN: AJPCFF ISSN: 2321 0915 Asian Journal of Phytomedicine and Clinical Research Journal home page: www.ajpcrjournal.com TOWARDS ACTUALIZATION OF PHARMACOVIGILANCE IN ERITREA Mussie
More information