Wissenswertes aus dem Bereich PHV
|
|
- Julie Miles
- 6 years ago
- Views:
Transcription
1 Wissenswertes aus dem Bereich PHV Dr. Susanne Wolf Dept. Assessment Pharmacovigilance AGES-Gespräche Vienna, Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH
2 Addendum to the Clinical Overview Requirements for PHV renewal documents: Irrespective of the CMDh BEST PRACTICE GUIDE ON THE PROCESSING OF RENEWALS IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES submission of the following data is required for a renewal procedure in Austria: AT=RMS: An Addendum to the clinical overview should be submitted AT=CMS: An Addendum to the clinical overview currently only required if requested by the RMS. Nationally approved: An ACO is required, irrespective of a generic, well-established use, traditional herbal or homeopathic application. The Addendum to the clinical overview should cover the period from the date of approval to the date of submission of the renewal. Apothekeneigene Zulassungen are exempted from PSUR submission. However, identification of safety relevant aspects requires the submission of pharmacovigilance data. Addendum to the Clinical Overview = ACO 2
3 ACO Focus on: current benefit/risk balance taking account of PSUR data suspected adverse reaction reports additional pharmacovigilance activities effectiveness of risk minimisation measures contained in the RMP any relevant new information e.g. literature, clinical experience, new treatments available 3
4 ACO - strucutre History of pharmacovigilance system inspections Worldwide marketing approval status Actions taken for safety reasons during the period Significant changes to the SmPC Estimated exposure: cumulative exposure of subjects in clinical trials and from marketing exposure pattern of use of the medicinal product Data in summary tabulations (serious AEs from clinical trials, adverse reactions from post-marketing, safety and efficacy findings from clinical trials and non-interventional studies 4
5 ACO - strucutre Literature Risk evaluation Benefit evaluation Benefit/risk balance: a discussion on the benefit/risk balance for the approved indication should be presented, based on the above information. MAHs are advised to consider GVP Module VII on PSURs as guidance for preparation of the ACO. 5
6 ACO The Clinical Expert should: Confirm that no new clinical data (or pre-clinical data in the absence of a non-clinical overview) are available Confirm that the product can be safely renewed after 5 years for an unlimited period, or any action recommended should be specified and justified. Confirm that the authorities have been kept informed of any additional data significant for the assessment of the benefit/risk balance Confirm that the product information is up to date with current scientific knowledge 6
7 Medication Error An adverse reaction is a response to a medicinal product which is noxious and unintended. This includes adverse reactions which arise from: use of a medicinal product within the terms of the marketing authorisation; use outside the terms of the marketing authorisation, including overdose, misuse, abuse and medication errors; occupational exposure. Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/
8 Medication Error A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to harm to the patient. A failure in the drug treatment process does not refer to lack of efficacy of the drug, rather to human or process mediated failures. Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/
9 Medication Error The term potential medication error refers to all possible mistakes in the prescribing, storing, dispensing, preparation for administration or administration of a medicinal product by all persons who are involved in the medication process and may lead to a) a medication error with harm, but without knowing the actual cause b) a medication error without harm and without knowing the actual cause c) a medication error without harm, but with the awareness of the actual cause. Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/
10 Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/
11 Medication Error Good practice guide on recording, coding, reporting and assessment of medication errors, EMA/762563/
12 Medication Error With kind permission of Dr. Kayser, BfArM 12
13 GVP Module V Risk management systems Update still ongoing, consultation closed (02/2016) Final expected??? s/regulation/document_listing/document_listing_ jsp 13
Pharmacovigilance. Training session for patients and consumers involved in EMA activities, 25 November Presented by: Priya Bahri
Pharmacovigilance Training session for patients and consumers involved in EMA activities, 25 November 2014 Presented by: Priya Bahri An agency of the European Union 2 Pharmacovigilance - the science concerned
More informationRecent developments in Pharmacovigilance from the Regulator s Perspective. In strategy, competence, quality and flexibility
Recent developments in Pharmacovigilance from the Regulator s Perspective In strategy, competence, quality and flexibility Pharmacovigilance Regulatory Affairs Operations Medical Writing & toxicology Recent
More informationCMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures
October 2017 CMDh/004/2005/Rev.15 CMDh Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Table of contents (optional) 1. Introduction... 2 2. Legal framework...
More informationWhat is an ideal PSUR? A new focus based on aligned expectations
What is an ideal PSUR? A new focus based on aligned expectations Margarida Guimarães PRAC Member INFARMED, I.P. Periodic Safety Update Report Information Day 28 October 2016 London, UK Disclaimer The views
More informationPeriodic Safety Update Reports. Andrea Lohée, Pharm-AD DCVMN training on PV, May 2017
Periodic Safety Update Reports Andrea Lohée, Pharm-AD DCVMN training on PV, May 2017 Periodic Safety Update Reports - Evolution - Definition - Objective - Frequency and timing - EU vs USA and other non
More informationFormat and content of electronic periodic safety update reports (Technical contribution to EC implementing measure)
Format and content of electronic periodic safety update reports (Technical contribution to EC implementing measure) First Stakeholders Forum on the implementation of the new Pharmacovigilance legislation,
More informationPharmacovigilance- Content of the New EU Legislation and Challenges for BfArM
Pharmacovigilance- Content of the New EU Legislation and Challenges for BfArM 12 th DGRA Annual Congress June 15 to 16, Bonn U. Hagemann Bundesinstitut für Arzneimittel und Medizinprodukte BfArM Visit
More informationEuropean Risk Management
European Risk Management Plans Issues and concerns from the generics sector John Barber QPPV & Director, Head of Pharmacovigilance European Operations, Dr. Reddy s Laboratories Europe Risk Management Plans
More informationImplementing the New Pharmacovigilance Legislation
Implementing the New Pharmacovigilance Legislation Irish Medicines Board, Pharmacovigilance Information Day, Dec 2011 Dr. Almath Spooner Vigilance Assessment Manager, Human Products Monitoring Department
More informationPHV-3 Version 4 - Non-Interventional Post-Authorisation Safety Studies of Medicinal Products for Human Use
PHV-3 Version 4 - Non-Interventional Post-Authorisation Safety Studies of Medicinal Products for Human Use This guideline replaces PHV-3 guideline version 3 effective from 11. 01. 2016 The guideline provides
More informationNew Pharmacovigilance legislation. Post-authorisation safety studies. ENCePP Plenary meeting. 3 May 2012
New Pharmacovigilance legislation Post-authorisation safety studies ENCePP Plenary meeting 3 May 2012 Presented by: Annalisa Rubino, PhV and Risk Management, EMA An agency of the European Union Why? Public
More informationSafety Measures in the new Pharmacovigilance System
Safety Measures in the new Pharmacovigilance System Dr. Harald Tietz Director Global Patient Safety & Regulatory Affairs, Germany Lilly Deutschland GmbH Documentation and reporting requirements: Centralisation
More informationMircea Ciuca, MD Global Head Medical & Clinical Drug Safety
Mircea Ciuca, MD Global Head Medical & Clinical Drug Safety Disclaimer The views and opinions expressed in this presentation are solely those of the presenter and do not necessarily reflect those of Vifor,
More informationUK Standards for Pharmacovigilance Departments 2015
UK Standards for Pharmacovigilance Departments 2015 03 UK Standards for Pharmacovigilance Departments 2015 Introduction 1 European legislation (Directive 2010/84/EU; Regulation (EU) No 1235/2010) requires
More informationStakeholder Meeting, 17 June 2011, EMA, London. Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency
New Pharmacovigilance Legislation and Implementing Measures Minimum Requirements for Quality Systems (MAH, EMA, NCA), minimum requirements for Pharmacovigilance System Master File Stakeholder Meeting,
More informationQ&A - Pharmacovigilance Legislation
CMDh/257/2012, Rev.18 July 2017 Regulation (EU) No 1235/2010 and Directive 2010/84/EU Table of contents 1. a. As of 21 July 2012, new requirements for marketing authorisation applications have been introduced
More informationFOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE
FOOD AND DRUGS AUTHORITY GUIDELINES FOR QUALIFIED PERSON FOR PHARMACOVIGILANCE Document No. : Date of First Adoption : 1st February, 2013 Date of Issue : 1 st March, 2013 Version No. : 02 Revision 1 :
More informationIndustry perspective: Non-prescription medicines
EMA 7 th Stakeholders forum on the implementation of the new pharmacovigilance legislation 27 September 2013 Industry perspective: Non-prescription medicines Introduction Perfect timing for a review Comprehensive
More informationDoc. No. DPS/GDL/034 Revision No.: 0 Effective Date: 26 April 2018 Review-Due Date: 26 April 2021
National Drug Authority Head Office Rumee Towers Plot 19, Lumumba Avenue P. O. Box 23096 Kampala, Uganda Tel: 256-0414 - 255665/347391/2 E-mail: ndaug@nda.or.ug Website: http://www.nda.or.ug Doc. No. DPS/GDL/034
More informationGuideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/816292/2011 (superseded version) Guideline on good pharmacovigilance practices (GVP) Module VII Periodic safety update report Draft finalised by the Agency in collaboration with Member
More informationQUESTIONS AND ANSWERS ON THE PAEDIATRIC REGULATION (REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (EC) No 1901/2006, AS AMENDED)
QUESTIONS AND ANSWERS ON THE PAEDIATRIC REGULATION (REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (EC) No 1901/2006, AS AMENDED) ARTICLE 45 & 46 October 2007 Revision 4, November 2008 Question
More informationEU Pharmacovigilance Legislation - One Year Later. Sarah Daniels; Senior Partner TranScrip Partners LLP
EU Pharmacovigilance Legislation - One Year Later Sarah Daniels; Senior Partner TranScrip Partners LLP Since July 2012 we have officially been operating under EU legislation Directive 2010/84/EU amending
More informationGuideline on the processing of renewals in the centralised procedure
22 June 2012 EMEA/CHMP/2990/00 Rev.4 Committee for Human Medicinal Products (CHMP) Guideline on the processing of renewals in the centralised procedure Transmission to CPMP November 2000 Release for consultation
More informationGuideline on the processing of renewals in the centralised procedure
22 June 2012 EMEA/CHMP/2990/00 Rev.4 Committee for Human Medicinal Products (CHMP) Guideline on the processing of renewals in the centralised procedure Transmission to CPMP November 2000 Release for consultation
More informationGuide for Marketing Authorisation Holders on Direct Healthcare Professional Communications
Guide for Marketing Authorisation Holders on Direct Healthcare Professional Communications 1 INTRODUCTION A Direct Healthcare Professional Communication (DHPC) aims to promote safe and effective use of
More informationGuideline on good pharmacovigilance practices (GVP)
9 October 2017 EMA/827661/2011 Rev 1* Guideline on good pharmacovigilance practices (GVP) Module IX Signal management (Rev 1) Date of coming into effect of first version 2 July 2012 Draft Revision 1* finalised
More informationHow are medicines evaluated at the EMA
How are medicines evaluated at the EMA Presented by: Nathalie Bere Patient interaction / Stakeholders and communication Division An agency of the European Union The European System Centralised Procedure
More informationEMA Comments on Implementing Measures for Pharmacovigilance (PCIM/11/01)
7 November 2011 EMA/863255/2011 EMA Comments on Implementing for Pharmacovigilance (PCIM/11/01) The Agency welcomes the public consultation on the Commission concept paper on the implementing measures
More informationGVP Module X - additional monitoring of medicines
GVP Module X - additional monitoring of medicines 6 th Stakeholders forum on the implementation of the new pharmacovigilance legislation Mick Foy, Group Manager - MHRA An agency of the European Union Contents
More informationPublic Assessment Report Scientific discussion. Brimonidin Bluefish (brimonidine tartrate) SE/H/1600/01/DC
Public Assessment Report Scientific discussion Brimonidin Bluefish (brimonidine tartrate) SE/H/1600/01/DC This module reflects the scientific discussion for the approval of Brimonidin Bluefish. The procedure
More informationQ & A on PSUSA: Guidance document for assessors
31 October 2017 EMA/518909/2016 Human Medicines Evaluation Division Q & A on PSUSA: Guidance document for assessors Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA),
More informationThe Pharmacovigilance Quality System. What is it?
The Pharmacovigilance Quality System What is it? by Andy Blackman 12 November 2018 Are you starting to plan your first Marketing Authorisation Application? If yes, now is the time to start developing your
More informationModule VIII- Post-authorisation safety studies
Good Vigilance Practice Module VIII- Post-authorisation safety studies 4th Stakeholder Forum Xavier Kurz An agency of the European Union Post-authorisation safety study Any study relating to an authorised
More informationPublic Assessment Report Scientific discussion. Prednisolon Unimedic (prednisolone sodium phosphate) Asp no:
Public Assessment Report Scientific discussion Prednisolon Unimedic (prednisolone sodium phosphate) Asp no: 2015-1341 This module reflects the scientific discussion for the approval of Prednisolon Unimedic
More informationImplementation and Impact of the PV Regulations - how are we doing? Sue Rees Eisai Europe Ltd. & John Barber, Dr Reddy's Laboratories
Implementation and Impact of the PV Regulations - how are we doing? Sue Rees Eisai Europe Ltd. & John Barber, Dr Reddy's Laboratories Agenda PSMF PSURs Solicited sources RMPs Inspections Signal detection
More informationGuidelines on good pharmacovigilance practices (GVP)
15 September 2014 EMA/475236/2014 Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with revision 1 of module III on pharmacovigilance inspections and of module
More informationExplanatory Note to GVP Module VII
31 October 2017 EMA/670256/2017 Human Medicines Evaluation Division Explanatory Note to GVP Module VII Since the start of the Periodic Safety Update Report (PSUR) single assessment (PSUSA), the procedure
More informationAdjusting to Effectively Meet the New European Union Pharmacovigilance Requirements
Adjusting to Effectively Meet the New European Union Pharmacovigilance Requirements Deirdre McCarthy Michelle Bulliard GRP Webinar 31 January 2013 Copyright 2013 Quintiles Your Presenters Deirdre McCarthy
More informationThe EU Risk Management Plan - a tool to address the uncertainties at the time of approval, and manage the risks of medicines
The EU Risk Management Plan - a tool to address the uncertainties at the time of approval, and manage the risks of medicines Health care uncertainty assessment workshop Session 3: The challenges of health
More informationNeed for collaboration in pharmacovigilance to ensure effective health protection and promotion
Need for collaboration in pharmacovigilance to ensure effective health protection and promotion Measuring the impact of pharmacovigilance decisions Presented by Jacoline Bouvy on 17 September 2015 Pharmacovigilance
More informationThe new Pharmacovigilance legislation and implementation planning
The new Pharmacovigilance legislation and implementation planning Second Stakeholders meeting 17 June 2011 European Medicines Agency, London, UK Presented by: Franck Diafouka Manager, Pharmacovigilance
More informationAsp no: Public Assessment Report Scientific discussion. Karbamid NET (urea)
Public Assessment Report Scientific discussion Karbamid NET (urea) Asp no: 2018-0510 This module reflects the scientific discussion for the approval of Karbamid NET. The procedure was finalised on 2018-10-09.
More informationINTRODUCTION OF FEES TO BE CHARGED BY THE EMA FOR PHARMACOVIGILANCE
Ref. Ares(2012)723154-18/06/2012 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products authorisations, EMA Brussels, D(2012) INTRODUCTION OF FEES TO
More informationCMD(h) GUIDANCE FOR MAHs ON THE PHARMACOVIGILANCE SYSTEM AND RISK MANAGEMENT PLAN IN THE MUTUAL RECOGNITION & DECENTRALISED PROCEDURES
CMD(h) GUIDANCE FOR MAHs ON THE PHARMACOVIGILANCE SYSTEM AND RISK MANAGEMENT PLAN IN THE MUTUAL RECOGNITION & DECENTRALISED PROCEDURES 1. INTRODUCTION (BACKGROUND) November 2007 According to Article 8
More informationAsp no: Public Assessment Report Scientific discussion. Karbamid Evolan (urea)
Public Assessment Report Scientific discussion Karbamid Evolan (urea) Asp no: 2017-1221 This module reflects the scientific discussion for the approval of Karbamid Evolan. The procedure was finalised on
More informationGuideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/813938/2011 Guideline on good pharmacovigilance practices (GVP) Module VIII Post-authorisation safety studies Draft finalised by the Agency in collaboration with Member States and submitted
More informationENCePP Plenary: New Pharmacovigilance legislation
ENCePP Plenary: New Pharmacovigilance legislation 18 November 2010 Peter Arlett Head of Pharmacovigilance and Risk Management EMA An agency of the European Union In this talk 1. New pharmacovigilance legislation:
More informationGood Pharmacovigilance Practice Tunisian guidelines
Good Pharmacovigilance Practice Tunisian guidelines Introduction Arab ministers of health came to a common decree (number 7) in their 37th regular meeting in March 2012. The Higher Technical Committee
More informationGuidance on format of the risk management plan (RMP) in the EU part VII: Annexes
7 November 2012 EMA/716217/2012 Patient Health Protection Guidance on format of the risk management plan (RMP) in the EU part VII: Annexes Active substance Product(s) concerned (brand name(s)): MAH/Applicant
More informationEphMRA Adverse Event Reporting Guidelines 2016
EphMRA Adverse Event Reporting Guidelines 2016 Based upon the Guideline on good pharmacovigilance practices (GVP) Module VI Management and reporting of adverse reactions to medicinal products European
More informationGuidelines on good pharmacovigilance practices (GVP)
7 June 2013 EMA/321625/2013 Patient Health Protection Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with launch of public consultation of module VI revision
More informationChapter 28 Pharmaceutical acquis (human and veterinary medicinal products)
Chapter 28 Pharmaceutical acquis (human and veterinary medicinal products) Screening meeting with Serbia 5 December 2014 DG SANTE D5: Medicinal products - authorisations, EMA; D6: Medicinal products -
More informationPublic Assessment Report Scientific discussion. Pregabalin Aliud Pharma (pregabalin) SE/H/1635/01-08/DC
Public Assessment Report Scientific discussion Pregabalin Aliud Pharma (pregabalin) SE/H/1635/01-08/DC This module reflects the scientific discussion for the approval of Pregabalin Aliud Pharma. The procedure
More informationGuideline on good pharmacovigilance practices (GVP)
1 2 9 October 2017 EMA/827661/2011 Rev 1* - Track-change version following public consultation 3 4 Guideline on good pharmacovigilance practices (GVP) Module IX Signal management (Rev 1) Date of coming
More informationGuideline on good pharmacovigilance practices (GVP)
15 April 2014 EMA/876333/2011 Rev 3* (superseded version) Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 3) Date for coming into effect of first version 2 July 2012 Date
More information2008 Pharmaceutical Package - Impact on Implementation by BfArM
2008 Pharmaceutical Package - Impact on Implementation by BfArM Dr. Karl Broich Head of Licensing Division 4, German Alternate at CHMP Federal Institute for Drugs and Medical Devices (BfArM) Kurt-Georg-Kiesinger-Allee
More informationPublic Assessment Report Scientific discussion. Paracetamol NET, 500 mg, film-coated tablet (paracetamol) Asp no:
Public Assessment Report Scientific discussion Paracetamol NET, 500 mg, film-coated tablet (paracetamol) Asp no: 2016-1693 This module reflects the scientific discussion for the approval of Paracetamol
More informationCMDh STANDARD OPERATING PROCEDURE ON THE PROCESSING OF PSUR SINGLE ASSESSMENT PROCEDURES FOR NATIONALLY AUTHORISED PRODUCTS
CMDh STANDARD OPERATING PROCEDURE ON THE PROCESSING OF PSUR SINGLE ASSESSMENT PROCEDURES FOR NATIONALLY AUTHORISED PRODUCTS 1. INTRODUCTION CMDh/322/2014/Rev.0 November 2014 This Standard Operating Procedure
More informationQuality aspects Overview. QP declaration
Quality aspects Overview QP declaration Standards for the quality part of the dossier with focus on: - Materials from animals, nosodes - Proof of microbiological quality, pesticides, heavy metals, organic
More informationGuideline on good pharmacovigilance practices (GVP)
9 October 2017 EMA/876333/2011 Rev 4* Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 4) Date for coming into effect of first version 2 July 2012 Date for coming into effect
More informationThe PRAC Roles and challenges Focus on RMPs and RMAs. Prof. Jean-Michel Dogné. Head of the Department of Pharmacy PRAC effective member
The PRAC Roles and challenges Focus on RMPs and RMAs Prof. Jean-Michel Dogné Head of the Department of Pharmacy PRAC effective member Rue de Bruxelles, 61 B-5000 Namur, Belgium Phone: 0032 (0)81 724289
More informationPharmacovigilance Inspection Metrics Report
Pharmacovigilance Inspection Metrics Report April 2016 - March 2017 1. Introduction During the period 01 April 2016 to 31 March 2017, the GPvP Inspectorate conducted 36 inspections of marketing authorisation
More informationPublic Assessment Report Scientific discussion. Parapo, 500 mg and 1 g, film-coated tablet (paracetamol) Asp no: ,
Public Assessment Report Scientific discussion Parapo, 500 mg and 1 g, film-coated tablet (paracetamol) Asp no: 2016-1686, 2016-1687 This module reflects the scientific discussion for the approval of Parapo.
More informationOverview of the new pharmacovigilance legislation
Overview of the new pharmacovigilance legislation SME workshop: 19 April 2012 Dr Peter Arlett Head, Pharmacovigilance and Risk Management EMA An agency of the European Union In this talk: New legislation
More informationVM-ID: MU101_20_001e_WL - Wegleitung_HD - Hilfsdokument / V3.0 / dst / er / / 6
Contents 1 Abbreviations... 1 2 Requirements for signal reports... 2 3 Introduction... 2 4 Objective... 2 5 Scope... 2 6 Company signals (signals evaluated by the MAH)... 2 6.1 Signals involving a serious
More informationRegulatory Aspects of Pharmacovigilance
Regulatory Aspects of Pharmacovigilance Deirdre Mc Carthy Pia Caduff-Janosa Training Course Uppsala 2012 Agenda Risk based approach to spontaneous reporting (incl clinical trials) -> Pia Caduff-Janosa
More informationConsultation item no. 1 Should additional processes and pharmacovigilance tasks be covered? No, to our mind the list is complete.
Association Européenne des Spécialités Pharmaceutiques Grand Public Association of the European Self-Medication Industry Europäischer Verband der Arzneimittel-Hersteller AESGP Position Paper on the European
More informationPharmacovigilance. An agency of the European Union
Pharmacovigilance An agency of the European Union Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions and other medicine-related
More informationGUIDANCE DOCUMENT FOR MARKETING AUTHORISATION HOLDERS ON SUBMISSIONS of PSURs UNDER THE EU PSUR WORK SHARING SCHEME. Version 10 November 2009
1 GUIDANCE DOCUMENT FOR MARKETING AUTHORISATION HOLDERS ON SUBMISSIONS of PSURs UNDER THE EU PSUR WORK SHARING SCHEME Version 10 November 2009 This document sets out the responsibilities of the Marketing
More informationEffective Auditing of PV Interfaces
Outline Effective Auditing of PV Interfaces SQA Meeting March 29, 2017 Larry Thomas, RQAP-GLP, CQA Bayer Pharmaceuticals Whippany, NJ Audit Process Planning/Preparation, Execution and Reporting Functions
More informationPublic Assessment Report Scientific discussion. Etoricoxib Orion (etoricoxib) SE/H/1554/01-04/DC
Public Assessment Report Scientific discussion Etoricoxib Orion (etoricoxib) SE/H/1554/01-04/DC This module reflects the scientific discussion for the approval of Etoricoxib Orion. The procedure was finalised
More informationPublic Assessment Report. Scientific discussion. Human Albumin CSL Behring 5% and 20% solution for infusion. Human albumin DK/H/1508/ /E/002
Public Assessment Report Scientific discussion Human Albumin CSL Behring 5% and 20% solution for infusion Human albumin DK/H/1508/001-002/E/002 This module reflects the scientific discussion for the approval
More informationFunctioning of the PRAC
Functioning of the PRAC Sixth Stakeholders forum on the implementation of the new Pharmacovigilance legislation, November 8 th 2012 Presented by: Almath Spooner Vice Chair, Pharmacovigilance Risk Assessment
More informationSignal Management in the EU and future extended access to EudraVigilance for industry
Signal Management in the EU and future extended access to EudraVigilance for industry 6 th Industry Stakeholder Platform Meeting, 18 th December 2015 Presented by Georgy Genov 7 December 2015 Head of Signal
More informationGood Vigilance Practice Module VI
Good Vigilance Practice Module VI Management and reporting of adverse reactions to medicinal products Stakeholders forum 27th February 2012 Gilles Touraille Signal Detection and Data Analysis Pharmacovigilance
More informationGuideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/827661/2011 (superseded version) Guideline on good pharmacovigilance practices (GVP) Module IX Signal management Draft finalised by the Agency in collaboration with Member States and submitted
More informationSCOPE Work Package 8 Lifecycle Pharmacovigilance. Practical Guide on PSUR / PSUSA Assessment
Practical Guide on PSUR / PSUSA Assessment 2016 Contents Acknowledgments 3 1. Introduction 4 1.1 Purpose of the document 4 1.2 Relevant guidelines 4 1.3 Definitions and abbreviations 5 2. Background 7
More informationGuidelines for Pharmacovigilance Inspections
PHARMACY BOARD OF SIERRA LEONE Guidelines for Pharmacovigilance Inspections Guideline No. : PBSL/PVGCT/GDL/QPPV/04-2017 Effective Date. :27 th March, 2017 Version No. : 01 1 TABLE OF CONTENT TABLE OF CONTENT
More informationPharmacovigilance System Master file
IMPLEMENTING MEASURES IN ORDER TO HARMONISE THE PERFORMANCE OF THE PHARMACOVIGILANCE ACTIVITIES PROVIDED FOR IN DIRECTIVE 2001/83/EC AND REGULATION (EC) NO 726/2004 Pharmacovigilance System Master file
More informationSafety reporting requirements in the post marketing phase. Pharmacovigilance Specialty Committee SQA Conference March 2017 Washington
Safety reporting requirements in the post marketing phase Pharmacovigilance Specialty Committee SQA Conference March 2017 Washington DISCLAIMER These materials have been prepared solely for educational
More informationZonal Authorisation Projects in Austria
Zonal Authorisation Projects in Austria Dipl.Ing. Robert Womastek www.ages.at Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Introduction Legally binding zonal authorisation: For
More informationPublic Assessment Report Scientific discussion. Naproxen ABECE (naproxen) Asp no:
Public Assessment Report Scientific discussion Naproxen ABECE (naproxen) Asp no: 2016-1607-08 This module reflects the scientific discussion for the approval of Naproxen ABECE. The procedure was finalised
More informationGuideline on good pharmacovigilance practices (GVP)
1 2 3 19 June 2012 EMA/119871/2012 4 5 Guideline on good pharmacovigilance practices (GVP) Module III Pharmacovigilance inspections Draft finalised by the Agency in collaboration with Member States and
More informationQuality Management in PV. Andrea Lohée, Pharm-AD DCVMN training on PV, May 2017
Andrea Lohée, Pharm-AD DCVMN training on PV, May 2017 - Pharmacovigilance System - Overall Quality objectives in PV - Quality Management System overview - Quality Management System requirements - Quality
More informationPharmacovigilance - Regulatory perspective -
Pharmacovigilance - Regulatory perspective - Junko Sato Director for Risk Management, Office of Safety Pharmaceuticals and Medical Devices Agency (PMDA) Agenda Concept of Phamacovigilance Current Regulation
More informationNIS Considerations - Bulgaria
NIS Considerations - Bulgaria An overview of the considerations when conducting Noninterventional Studies in Bulgaria Stuart McCully CHCUK Ltd NIS-C-BG-2014 1 Table of Contents Disclaimer 5 Copyright 5
More informationIntroduction to the European Medicines Agency
Introduction to the European Medicines Agency EFA training for patient experts on allergy, asthma and COPD on getting involved with the EMA, 18 February 2014 Presented by: Isabelle Moulon Head of patients
More informationInterdependencies of Pharmacovigilance and Regulatory Affairs
Lorenz userbridge 2013 Budapest, September 17th Interdependencies of Pharmacovigilance and Regulatory Affairs Dr. rer. nat. Markus Dehnhardt Deputy QPPV Biologist Toxicologist Medical advisor Agenda 1.
More informationPublic Assessment Report. Scientific discussion. Natriumfusidat LEO 30 mg/100 cm 2 impregnated dressing. (Sodium fusidate) DK/H/2431/001/DC
Public Assessment Report Scientific discussion Natriumfusidat LEO 30 mg/100 cm 2 impregnated dressing (Sodium fusidate) DK/H/2431/001/DC 23 November 2015 This module reflects the scientific discussion
More informationMarketing Authorisation Routes in the EU
Marketing Authorisation Routes in the EU The EU medicines regulatory system and the European Medicines Agency: an introduction for international regulators and non-governmental organisations 18 September
More informationPharmacovigilance System in Russia and the EAEU
Pharmacovigilance System in Russia and the EAEU Authors: Sergey Simeniv CEO X7 Research, CRO; Olga Latysheva Head of Pharmacovigilance Department X7 Research, CRO; Dmitry Kryuchkov Executive Director X7
More informationPublication of Risk Management Plan (RMP) summaries:
Publication of Risk Management Plan (RMP) summaries: Analysis of the experience of the 1-year pilot phase Presented by Juan Garcia Burgos and Caroline Voltz An agency of the European Union Outline Background
More informationImportance of Pharmacovigilance for Pharmaceutical Industry
Importance of Pharmacovigilance for Pharmaceutical Industry JARIR AT THOBARI, MD, DPHARM, PHD FACULTY OF MEDICINE GADJAH MADA UNIVERSITY YOGYAKARTA, INDONESIA Role of Pharma Company Globally Investment
More informationPublic Assessment Report. Scientific discussion. Furosemid Orifarm 40 mg tablets. (Furosemide) DK/H/2430/001/DC. 1 December 2015
Public Assessment Report Scientific discussion Furosemid Orifarm 40 mg tablets (Furosemide) DK/H/2430/001/DC 1 December 2015 This module reflects the scientific discussion for the approval of Furosemid
More informationCOMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION PAPER ON COMPLIANCE WITH PHARMACOVIGILANCE REGULATORY OBLIGATIONS
The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 15 November 2001 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) POSITION PAPER ON COMPLIANCE
More informationReminder (VICH charter)
Dr. Marie Hendrickx Head of EU Pharmacovigilance Pfizer Animal Health IFAH Europe Representative VICH Electronic Standards Implementation Expert Working Group VICH Workshop Presentation of 2 Pharmacovigilance
More informationGuideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/816573/2011 Guideline on good pharmacovigilance practices (GVP) Module II Pharmacovigilance system master file Draft finalised by the Agency in collaboration with Member States and submitted
More informationEMA pharmacovigilance system manual
13 October 2016 EMA/623550/2013 Inspections, Human Medicines Pharmacovigilance & Committees Division Version 1.2 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000
More informationharmacovigilance A wake up for
harmacovigilance A wake up for lthcare professionals and the publ repared By: Mr. Sagar D. Kadam Asst.Professor & Admin. Officer HSBPVT s GOI College of Pharmacy, Kashti. Tal. Shrigonda, Dist. Ahmednagar.
More informationVOLUME 9 - PHARMACOVIGILANCE. Medicinal Products for Human and Veterinary Use
VOLUME 9 - PHARMACOVIGILANCE Medicinal Products for Human and Veterinary Use FOREWORD Directive 75/319/EEC as amended by Commission Directive 2000/38/EC of 5 th June 2000 and Directive 81/851/EEC as amended
More information