A European Medicines Verification System
|
|
- Branden Norman
- 8 years ago
- Views:
Transcription
1 Ensuring patients have access to safe medicines A European Medicines Verification System Fighting counterfeit medicines to ensure patient safety in Europe Speaker: Ms. Monika Derecque-Pois Event: Scientific Support for Public Health: existing actions, new challenges and European added value Date: 14 th November 2013, Brussels
2 The European Stakeholder Model (ESM) for medicines verification The threat of falsified medicines penetrating the European supply chain is substantial and growing The European Stakeholders who will use it day-to-day have brought together their expertise in the development of the ESM GIRP is one of the initial 4 Stakeholders developing the ESM solution Talks ongoing with EGA, AESGP, EAHP and HOPE AESGP EAHP EGA GIRP HOPE PGEU Association of the European Self-Medication Industry European Association of Hospital Pharmacists European Generic Medicines Association European Association of Pharmaceutical Full-line Wholesalers European Hospital and Healthcare Federation European Association Representing Community Pharmacists 2
3 What is the ESM? A cost-effective solution for medicines verification Run on a non-profit basis An interoperable, pan- European system called the EMVS (European Medicines Verification System) enabling medicines to be verified at point of dispensing with risk based checks on wholesale distribution level Immediate verification of the pack (in milliseconds with one scan) Ensures safe access to medicines for patients Fully integrated in pharmacy workflow ESM A medicines verification system for Europe 3
4 ESM view on implementation of the FMD Safety Features Combine tamper-evident packaging and a unique randomised serial number Verify product authenticity by checking each pack against a central database at the point of dispensing System Design Harmonised standard coding system across the EU that allows national codes to be incorporated as necessary Sufficient flexibility to implement national or multi-country solutions within an overall EU technical framework Data Governance Manufacturers do not seek, and will not have access to, individual patient / prescribing profile information Transactional data belongs to stakeholder that created it e.g. pharmacists for dispensing data Systems should be established and managed by the stakeholders that will use them day-to-day Systems governed by independent non-profit organisations jointly managed by relevant stakeholders, Government involvement foreseen according to the terms of the Directive
5 Model and process European Hub Upload Data National System 1 - n Verification upon Dispense to Patient Product # Batch Expiry S/N Product Flow random/ risk-based verification by Wholesale distributors Pharmaceutical Manufacturer and Parallel Distributor Wholesaler Wholesaler Pharmacist Patient 5
6 Infrastructure overview Pharmaceutical Manufacturer European Hub Q1 14 Parallel Distributor National System 1 National System (Blueprint) National System 2 Q2-Q3 14 Pharmacy Wholesaler Pharmacy Wholesaler Pharmacy Wholesaler Parallel Distributor: mandatory verification + data upload Manufacturer: data upload + voluntary verification Periodic cross-region update Pharmacy: mandatory verification Wholesaler: voluntary verification System design for interoperability and efficiency 6
7 The Benefits of a European Hub The EU Hub is essential for interoperability between national systems in EU member states Secure platform for reconciliation of products traded across borders Effective handling of multi country packs A single interface for manufacturers European Hub infrastructure able to technically manage national data repositories (Blueprint systems) Avoiding 28 Interfaces with manufacturing authorisation holders 7
8 Phased Implementation First steps towards the implementation of the EMVS have been initiated in 2012 Timeline 04/2013: Contract awarded to Solidsoft and start of implementation project 08/2013: Completion of specification phase 11/2013: Standard for connected systems available 01/2014: User acceptance testing 03/2014: European Hub running July 2014: Connection to the SecurPharm system 8
9 Commitment to work with public authorities Ensure an effective and efficient system that responds to public needs Consistent with authorities rights under the FMD Reimbursement and Pharmacovigilance purposes (product recall) Dialogue with authorities during the development phase Provide consultation and access when the system is in use Authorities right to attend EMVO meetings Enable auditing activities as required Dialogue with end users including patients 9
10 Ensuring patients have access to safe medicines Thank you
European Medicines Verification System (EMVS) Status March 2015
European Medicines Verification (EMVS) Status March 2015 Introduction Grant Courtney Previously a member of the EFPIA Serialisaiton & Coding Steering Team Member of GS1 Healthcare Leadership Team 20 Years
More informationDelegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human use, and its Verification
Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human use, and its Verification Concept Paper submitted for Public Consultation Response from securpharm e.v. 26 April
More informationGuidance for Manufacturers What is required to be ready to connect to the EMVS?
European Medicines Verification System: Guidance for Manufacturers What is required to be ready to connect to the EMVS? Version V 1.0 Authors: Christoph Krähenbühl, Marian Omtzigt, Stefan Artlich, Peter
More informationLindsey Gilpin, Chair, English Board, On behalf of the Royal Pharmaceutical Society
Response by the Royal Pharmaceutical Society to the European Commission s Concept paper on the Delegated Act on the detailed rules for a unique identifier tor medicinal products for human use, and its
More informationThe Medicine Digital Network. Solution Report
The Medicine Digital Network Solution Report 2015 Contents 1. Introductions... 2 1.1 Aegate Operational Context and Opportunities to leverage Aegate s experience and live systems... 3 1.2 Critical success
More informationGIRP views on the proposal for a revision of the European Good Distribution Practice Guidelines (GDP)
GIRP views on the proposal for a revision of the European Good Distribution Practice Guidelines (GDP) The Good Distribution Practice (GDP) Guidelines aim to ensure that a harmonised level of quality is
More informationGS1 Healthcare Discussion paper on Mobile Applications and Services in Healthcare
Mobile Applications and Services In the last 20 years there has been a significant growth of mobile communication devices, such as mobile/cell phones, tablet computers and personal digital assistants (PDAs);
More informationmodel and building block for a European shield against counterfeit pharmaceuticals a system description
model and building block for a European shield against counterfeit pharmaceuticals a system description I. Introduction 4 II. Stakeholder Governance of the securpharm verification system 6 a Serialisation
More informationGlobal GS1 Healthcare Conference Lisbon, 23-25 October 2012
22 nd Global GS1 Healthcare Conference GS1 Standards - a globally harmonized way to improve patient safety Join a few hundred key stakeholders at the 22 nd Global GS1 Healthcare Conference in Lisbon from
More informationWhite Paper Healthcare Supply Chain Traceability
Executive Summary This white paper focuses on Healthcare supply chain Traceability, from manufacture to patient, going beyond, for example, what is currently regulated by the US 21 CFR Part 820 and ISO
More informationPharmaceutical Distribution Security Alliance (PDSA)
Pharmaceutical Distribution Security Alliance (PDSA) Our Mission The Pharmaceutical Distribution Security Alliance's (PDSA) mission is to develop and help enact a federal policy proposal that enhances
More informationSOUTH-WEST EUROPE 21
21 SOUTH-WEST EUROPE SOUTH-WEST EUROPE Croatia, Cyprus, Greece, Italy, Malta, Portugal, Slovenia, Spain Access to medicines and medical devices in Mediterranean EU Member States As members of the EU, all
More informationEuropean Medicines Verification System (EMVS) European Pack Coding Guidelines
European Medicines Verification System (EMVS) European Pack Coding Guidelines June 2013 Revision History V1.0 June 2008 Initial Release V1.1 June 2008 Amended some typographical errors, added extra detail
More informationA GLOBAL CURE FOR HEALTHCARE
A GLOBAL CURE FOR HEALTHCARE A new and independent report by McKinsey & Company has estimated the benefits - in lives and value - of implementing one single global standard in Healthcare To download the
More informationThe Business. for REDUCING DRUG ADMINISTRATION ERRORS USING 2D BARCODES
DnCirP+ A);. 1 39d~ - 71-\n- COMMERCIAL - IN - CONFIDENCE The Business Case for REDUCING DRUG ADMINISTRATION ERRORS Prepared by Mike Sim Chief Executive Officer Advias (Advanced Information Assurance Solutions
More informationSÉRIALISATION : UN CAS CONCRET DE CODIFICATION EN TURQUIE. Les Rencontres CIP/ACL 29 novembre 2012. Maison de l artisanat - Paris 8ème
SÉRIALISATION : UN CAS CONCRET DE CODIFICATION EN TURQUIE Maison de l artisanat - Paris 8ème LES RENCONTRES CIP/ACL 2012 14h00 14h30 Sérialisation : un cas concret de codification en Turquie o Doctor Saim
More information1083.4 SUPPLY CHAIN INTEGRITY AND SECURITY
BRIEFING 1083.4 Supply Chain Integrity and Security. A new series of general informational chapters describing various aspects of the pharmaceutical supply chain replaces Good Distribution Practices Supply
More informationNew Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)
Safeguarding public health New Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01) Tony Orme, Senior GDP Inspector Inspection, Enforcement and Standards Division
More informationHow companies leverage quality and quality certifications to achieve competitive advantage
How companies leverage quality and quality certifications to achieve competitive advantage Eize de Boer Systems & Services Certification International Business Development Manager Pharma Supply Chain for
More informationCompilation of Community Procedures on Inspections and Exchange of Information
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE- GENERAL Public Health and Risk Assessment Pharmaceuticals 3 October 2014 EMA/572454/2014 Rev 17 Compliance and Inspection Compilation of Community
More informationRx-360 White Paper on Traceability Data Exchange Architecture
Rx-360 White Paper on Traceability Data Exchange Architecture 14 March 2015 Introduction and Scope of Rx360 TDEA White Paper With the quickening pace of global pharmaceutical regulatory drug serialization
More informationCompilation of Community Procedures on Inspections and Exchange of Information
EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE- GENERAL Public Health and Risk Assessment Pharmaceuticals 27 June 2013 EMA/385898/2013 Rev 16 Compliance and Inspection Compilation of Community
More information11 MEDICATION MANAGEMENT
1 11 MEDICATION MANAGEMENT OVERVIEW OF MEDICATION MANAGEMENT Depending on the size, structure and functions of the health facility, there may be a pharmacy with qualified pharmacists to dispense medication,
More informationValue added services of pharmaceutical fullline wholesalers. Contact GIRP for discussing partnerships + 32 2 777 99 77 girp@girp.
Value added services of pharmaceutical fullline wholesalers Contact GIRP for discussing partnerships + 32 2 777 99 77 girp@girp.org Selected examples from GIRP s integrated member companies: Please note
More informationMass Serialization and Traceability Implementation in the Pharma Industry. Mathieu Aman, Global Program Lead F. Hoffmann-La Roche Ltd, Switzerland
Mass Serialization and Traceability Implementation in the Pharma Industry Mathieu Aman, Global Program Lead F. Hoffmann-La Roche Ltd, Switzerland What drives the industry towards more traceability Strategic
More informationThe ehealth platform as a support of high quality healthcare and administrative simplification
The ehealth platform as a support of high quality healthcare and administrative simplification Luc Maes Program Manager ehealth platform Sint-Pieterssteenweg 375 B-1040 Brussels E-mail: Luc.Maes@ehealth.fgov.be
More informationQUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 002-3 25 September 2007 RECOMMENDATION ON QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PIC/S September
More informationWorking Party on Control of Medicines and Inspections. Final Version of Annex 16 to the EU Guide to Good Manufacturing Practice
Version 8 (final) EUROPEAN COMMISSION ENTERPRISE DIRECTORATE-GENERAL Single market, regulatory environment, industries under vertical legislation Pharmaceuticals and cosmetics Brussels, July 2001 S\common\legal-legislation\75-319nd81-851\91-356\eudralexvol4\Annex
More informationEfficient Data Sharing in Healthcare
Efficient Data Sharing in Healthcare More and more efforts are underway in different countries on sharing data among doctors and hospitals in healthcare for achieving higher quality and efficiency of clinical
More informationIDIS CLINICAL TRIAL PROCUREMENT STRATEGIES. A trusted source for all of your global comparator needs
IDIS CLINICAL TRIAL PROCUREMENT STRATEGIES A trusted source for all of your global comparator needs WHAT YOU NEED, WHEN YOU NEED IT We typically source over 90% of comparators directly from the manufacturers
More informationDRUG REPOSITORY PROGRAM
OHIO STATE BOARD OF PHARMACY 77 S. High Street, Room 1702; Columbus, OH 43215-6126 Tel: 614-466-4143 Email: exec@bop.state.oh.us DRUG REPOSITORY PROGRAM ORC - Ohio Revised Code OAC - Ohio Administrative
More informationTrack/Trace Solutions. for the Manufacturing Industry
Track/Trace Solutions for the Manufacturing Industry Today s manufacturers, regardless of what they produce, have no choice but to follow private sector and government required mandates. As examples, two
More informationPROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 010-4 3 Appendices 1 January 2011 STANDARD OPERATING PROCEDURE PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING
More informationGuide to The Notification System for Exempt Medicinal Products
Guide to The Notification System for Exempt Medicinal Products AUT-G0090-1 10 JULY 2014 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only.
More informationImplementation strategy for ISO IDMP in EU
Implementation strategy for ISO IDMP in EU Paolo Alcini Head of Data Standardisation and Analytics Business Data & Analytics Information Management EMA An agency of the European Union The EU ISO IDMP Task
More informationDraft guidance for registered pharmacies preparing unlicensed medicines
Draft guidance for registered pharmacies preparing unlicensed medicines January 2014 1 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians and registered pharmacies
More informationEFPIA Principles for the Development of the EU Clinical Trials Portal and Database
Position Paper EFPIA Principles for the Development of the EU Clinical Trials Portal and Database Executive summary EFPIA sees the implementation of the Clinical Trials Regulation 1 as an opportunity to
More informationHow To Understand Your Role In A Pharmacy
Element 1 Element 2 Assist with the maintenance of pharmaceutical Issue pharmaceutical 277 278 Element 1 Element 2 Assist with the maintenance of pharmaceutical Issue pharmaceutical Background See background
More informationIBM Solution for Pharmaceutical Track & Trace
Secure and responsive supply chains IBM Solution for Pharmaceutical Track & Trace The underlying problem: Complexity in the pharmaceutical supply chain At its core, the pharmaceutical industry is about
More informationDrug Distribution Management Policy in Korea
Drug Distribution Management Policy in Korea Regarding introduction of Drug Serial Number System (Serialization) Ministry of Health and Welfare Drug Distribution Management Policy Overview Policy Objectives
More informationBOARD NOTICE 271 OF 2013 THE SOUTH AFRICAN PHARMACY COUNCIL RULES RELATING TO GOOD PHARMACY PRACTICE
STAATSKOERANT, 20 DESEMBER 2013 No. 37193 3 BOARD NOTICES BOARD NOTICE 271 OF 2013 THE SOUTH AFRICAN PHARMACY COUNCIL RULES RELATING TO GOOD PHARMACY PRACTICE The South African Pharmacy Council herewith
More informationTransport - track and trace with RFID and latest developments in barcoding
Transport - track and trace with RFID and latest developments in barcoding Thessaloniki, Dr. Knoth 21. April 2012 RFID- Technical data I RFID Radio-Frequency Identification I Uses non-contact identification
More informationEstate Planning and Patients' Rights in Cross-Border Healthcare
Directive 2011/24/EU on the application of patients rights in cross-border healthcare EPF for a patient-centred implementation Introduction These recommendations have been developed by the European Patients
More informationDraft guidance for registered pharmacies providing internet and distance sale, supply or service provision
Draft guidance for registered pharmacies providing internet and distance sale, supply or service provision September 2014 1 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy
More informationSafe medicine. linking healthcare providers, patients and health insurance companies
Safe medicine linking healthcare providers, patients and health insurance companies Radomir Veres, CFO & member of the board, Health Insurance Dôvera Marianna Ravallova, Senior consultant AIDC & deputy
More informationARRANGEMENTS FOR THE FUTURE SUPPLY AND REIMBURSEMENT OF GENERIC MEDICINES FOR NHS SCOTLAND. Consultation Document
ARRANGEMENTS FOR THE FUTURE SUPPLY AND REIMBURSEMENT OF GENERIC MEDICINES FOR NHS SCOTLAND Consultation Document Scottish Executive Health Department October 2003 Arrangements For The Future Supply And
More informationAmerican Academy of Physician Assistants
950 North Washington Street Alexandria, VA 22314-1552 703/836-2272 Fax 703/684-1924 TESTIMONY OF THE AMERICAN ACADEMY OF PHYSICIAN ASSISTANTS SUBMITTED TO THE DEPARTMENT OF HEALTH AND HUMAN SERVICES TASK
More informationASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PI 038-1 26 March 2012 AIDE-MEMOIRE ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION PIC/S March 2012 Reproduction
More informationEFPIA Good Practice Revision 1, October 2014
EFPIA Good Practice Revision 1, October 2014 Reducing Risk of Drug Products Shortages Introduction Authorities, industry and healthcare providers have a responsibility to ensure a modern and sustainable
More informationTrack & Trace. The Distribution Chain to the EU and within the EU
ECA ACADEMY The new GDP and Track & Trace Regulations in Europe Jersey City, NJ (New York City Metro Area), USA July 14-15, 2015 A conference organised by the ECA Academy and the European QP Association
More informationPosition Paper (II) Healthcare Provider Advisory Council Implementation in hospitals hindered by bar code symbol issues
I. Introduction Towards the end of 2011, GS1 Healthcare established the Healthcare Provider Advisory Council (HPAC) to be the forum for sharing and discussing the practical realities of implementation
More informationPharmaceutical Distribution in the US: Current and Future Perspectives
Pharmaceutical Distribution in the US: Current and Future Perspectives Publication date: July 2009 Number of pages: 83 Author: Dr Faiz Kermani Pricing: 1,495 (PDF) / 1,550 (print) "In the US, the pharmaceutical
More informationCOMMISSION RECOMMENDATION. of XXX
EUROPEAN COMMISSION Brussels, XXX [ ](2013) XXX draft COMMISSION RECOMMENDATION of XXX on the use of common methods to measure and communicate the life cycle environmental performance of products and organisations
More informationThe objectives of the Sri Lankan National Medicinal Drug Policy are
NATIONAL MEDICINAL DRUG POLICY FOR SRI LANKA Preamble Sri Lanka had a partly written Drug Policy from the 1960s. It was written as elements of a policy, beginning from selection of drugs for the government
More information20-21 May 2015, Lisbon, Portugal. Highlights. Speakers:
Speakers: Dr Afshin Hosseiny Chair of the ECA Expert Working Group on GDP, Tabriz Consulting Comply with the new EU GDP Guideline Dr Martin Egger Pharmaserv Dr Daniel Müller GMP/GDP Inspector All participants
More informationIBM Solution for Pharmaceutical Track & Trace: Supply chain visibility drives overall performance
Secure and responsive supply chains IBM Solution for Pharmaceutical Track & Trace: Supply chain visibility drives overall performance Lack of product visibility in pharmaceutical supply chains At its core,
More informationHow To Help The Global Healthcare User Group (Hug)
HUG Global Healthcare User Group - HUG GS1 s Brand Architecture 2 The global Healthcare User Group - HUG Mission: Lead the healthcare industry to the effective utilization and development of global standards
More informationPharmaceutical Distribution Supply Chain Pilot Projects; Request for Information Docket No. FDA-2016-N-1114
May 16, 2016 [Submitted electronically to http://www.regulations.gov] Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville MD, 20852 RE: Pharmaceutical
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Ref. Ares(2011)1044649-03/10/2011 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Pharmaceuticals SANCO/D3/RSR/iv(2011)ddg1.d3. 1137738 Update 1 October 2011 HANDLING
More informationCHAPTER 6 PROCUREMENT AND SUPPLY OF PHARMACEUTICAL PRODUCTS IN THE PUBLIC AND PRIVATE MEDICAL SECTORS
CHAPTER 6 PROCUREMENT AND SUPPLY OF PHARMACEUTICAL PRODUCTS IN THE PUBLIC AND PRIVATE MEDICAL SECTORS Overview 6.1 This chapter sets out the Review Committee s findings and recommendations on procurement
More informationMedicine price regulation the South African experience
Medicine price regulation the South African experience Dr Anban Pillay Chief Director: Health Financing and Economics National Department of Health PillaA@health.gov.za pillayanban@yahoo.com.au Tel: +27
More informationWhat Do We Really Mean By Security for RFID
What Do We Really Mean By Security for RFID And How Much Is Enough? March 26, 2008 SecureRF at a glance RFID tag and reader security development and consulting to protect Pharmaceutical Supply Chain and
More informationReflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
1 2 3 5 August 2011 EMA/INS/GCP/600788/2011 Compliance and Inspection 4 5 6 7 Reflection paper on the Use of Interactive Response Technologies (Interactive Voice/Web Response Systems) in Clinical Trials
More informationCompetentes en Medicamentos
VIII Encuentro de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (EAMI) 12-14 de Mayo 2010 Madrid MARTIN TERBERGER Jefe de la Unidad de Productos Farmacéuticos Nuevas iniciativas
More information116th Annual Convention
116th Annual Convention Date: Saturday, October 18, 2014 Time: 10:30 am 12:00 pm Location: Austin Convention Center, Room 19AB, Level 4 Title: Activity Type: Speaker: Understanding the Drug Quality and
More informationThe RFID Revolution: Your voice on the Challenges, Opportunities and Threats. Online Public Consultation Preliminary Overview of the Results
The RFID Revolution: Your voice on the Challenges, Opportunities and Threats Online Public Consultation Preliminary Overview of the Results 16 October 2006 Disclaimer: This document is a working document
More informationProposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
EUROPEAN COMMISSION Brussels, 1.3.2012 COM(2012) 84 final 2012/0035 (COD) Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relating to the transparency of measures regulating the
More informationSADC GUIDELINES ON IMPORT AND EXPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS
SADC GUIDELINES ON IMPORT AND EXPORT PROCEDURES FOR PHARMACEUTICAL PRODUCTS June 2006 1 INTRODUCTION Public health concerns demand that the manufacture of pharmaceutical products and their subsequent handling
More informationSuspect and Illegitimate Products. Francis B. Palumbo, PhD, Esq. University of MD School of Pharmacy Center on Drugs & Public policy
Suspect and Illegitimate Products Francis B. Palumbo, PhD, Esq. University of MD School of Pharmacy Center on Drugs & Public policy The Pharmacy Profession Pharmacists, have always enjoyed the comfort
More informationJOB DESCRIPTION. JOB TITLE: Lead Pharmacy Technician-Grade 4. The Portland Hospital for Women and Children
JOB DESCRIPTION JOB TITLE: Lead Pharmacy Technician-Grade 4 CLINICAL UNIT: BASE: MANAGED BY: ACCOUNTABLE TO: Pharmacy The Portland Hospital for Women and Children Pharmacy Manager Pharmacy Manager HOSPITAL
More informationIFA-Coding-System Transport Logistics Specification. Automatic identification of transport units in the pharmaceutical supply chain
IFA-Coding-System Transport Logistics Specification Automatic identification of transport units in the pharmaceutical supply chain Version: 1.00 Date of issue: December 2012 Table of Contents 1 Foreword
More informationThe European regulatory system for medicines and the European Medicines Agency
The European regulatory system for medicines and the European Medicines Agency A consistent approach to medicines regulation across the European Union An agency of the European Union This booklet is intended
More informationFramework for rapid assessment of the pharmaceutical sector in a given country
Framework for rapid assessment of the pharmaceutical sector in a given country Prepared for Flagship Course (Health) Glossary: EU GLP GMP HIF IMS INN MOH NGO OEBIG OECD OTC PER R&D Rx TRIPS VAT WHO European
More informationA CPhT Story: Past, Present, and Future Visions from
A CPhT Story: Past, Present, and Future Visions from a PTCB Certified Pharmacy Technician Sylvia Banzon, CPhT, CQiA, PMP Sutter Health Sacramento, CA Objectives Explain new or modified roles for pharmacy
More informationAdoption by GCP Inspectors Working Group for consultation 14 June 2011. End of consultation (deadline for comments) 15 February 2012
10 December 2013 EMA/INS/GCP/600788/2011 Compliance and Inspection Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular
More informationAchieving Better Value for Money in Supply of Medicines
Achieving Better Value for Money in Supply of Medicines 1. Introduction The Cabinet Committee on Health, in April 2005, considered a range of issues which was prepared to effect savings or at least ameliorate
More informationEURORDIS Position Paper on Centres of Expertise and European Reference Networks for Rare Diseases
EURORDIS Position Paper on Centres of Expertise and European Reference Networks for Rare Diseases EURORDIS - the European Organisation for Rare Diseases represents 310 rare disease organisations from 34
More informationA responsible approach to clinical trials. Bioethics in action
A responsible approach to clinical trials Bioethics in action What is bioethics? At Novo Nordisk bioethics is the expression used for all ethical issues related to the use of life science technologies
More informationHTA NETWORK MULTIANNUAL WORK PROGRAMME 2016-2020
EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Healthcare systems, medical products and innovation Medical products: quality, safety, innovation Brussels, 20 May 2016 HTA NETWORK MULTIANNUAL
More informationQUM and Continuity of Care A Prescribed Medicines Services and Programs
Community Pharmacy Roadmap Program Development Template Program/Service: Quadrant: 1. Program/Service Description QUM and Continuity of Care A Prescribed Medicines Services and Programs a) Background The
More informationThe Drug Supply Chain Security Act: Readiness and Implementation Update
The Drug Supply Chain Security Act: Readiness and Implementation Update Connie Jung, RPh, PhD U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Compliance Office of Drug
More informationRequirements set for account holders and representatives of emissions trading accounts
Record no. 954/302/2010 13 February 2015 Requirements set for account holders and representatives of emissions trading accounts These requirements are based on the Commission s Registry Regulation 1. The
More informationGuidance for registered pharmacies providing pharmacy services at a distance, including on the internet
Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet April 2015 The General Pharmaceutical Council is the regulator for pharmacists, pharmacy technicians
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL VERSION 4.1
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and products Medicinal products quality, safety and efficacy Brussels, SANCO/D/6/SF/mg/ddg1.d.6(2013) IMPORTATION OF ACTIVE SUBSTANCES
More informationProfessional Standards and Guidance for the Sale and Supply of Medicines
Professional Standards and Guidance for the Sale and Supply of Medicines About this document The Code of Ethics sets out seven principles of ethical practice that you must follow as a pharmacist or pharmacy
More informationProduct Serialisation to Advance Pharmaceutical Authentication and Patient Safety
Product Serialisation to Advance Pharmaceutical Authentication and Patient Safety The Pharmaceutical Industry Takes On a New Global Challenge By: Gaurav Banerjee, Director, Technical Services - US & EU,
More informationDelivering a Comprehensive Serialization Traceability Program Peggy Staver - Pfizer
Delivering a Comprehensive Serialization Traceability Program Peggy Staver - Pfizer Overview Pfizer History What it Takes Strategies Organization Solutions Business-as-Usual Summary April 21, 2015 2 Pfizer
More informationDo You Know Where the Drugs Are Going? Partners in Integrity
Do You Know Where the Drugs Are Going? Partners in Integrity Objectives At the conclusion of this presentation, participants will be able to: Identify common types of drug diversion activities. List at
More informationUse of barcodes to improve the medication process in the hospital
Use of barcodes to improve the medication process in the hospital Prof. Pascal BONNABRY Slovenian Pharmaceutical Society Ljubljana, October 26, 2009 To err is human USA Serious adverse events in 3% [2.9-3.7%]
More informationImpact of Serialization on Supply Chain
Impact of Serialization on Supply Chain Agenda Introduction What is serialization? Why required? Key developments international legislation and regulation Break Impact of serialization in supply chain
More informationStakeholder Meeting, 7 th June 2013 An inspector s perspective considerations for patient support and reimbursement programmes
Stakeholder Meeting, 7 th June 2013 An inspector s perspective considerations for patient support and reimbursement programmes Dr Anya Sookoo, Expert Inspector, Inspections, Enforcement & Standards Division,
More informationReal-time Pre and Post Claim Edits: Improve Reimbursement, Compliance and Safety
Real-time Pre and Post Claim Edits: Improve Reimbursement, Compliance and Safety An ESI Healthcare Business Solutions White Paper by Thomas Renshaw R.Ph. Introduction Outpatient pharmacies submitting claims
More informationWHITE PAPER The Impact of Rising Generic Drug Prices on the U.S. Drug Supply Chain
WHITE PAPER The Impact of Rising Generic Drug Prices on the U.S. Drug Supply Chain Over the past two years, the pharmacy industry has seen unprecedented increases in the prices of generic drugs, causing
More information1. JOB PURPOSE 2. KEY ACCOUNTABILITIES PRINCIPAL DUTIES:
Job Title: Location/Base: Dept.: Reporting to: Pharmacy Technician Claremont Hospital Pharmacy Pharmacy Manager 1. JOB PURPOSE The Pharmacy Technician, as part of a dedicated team, plays a key role in
More informationDonepezil hydrochloride 10 mg film-coated tablets PL 19156/0130
Donepezil hydrochloride 10 mg film-coated tablets PL 19156/0130 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific Discussion Page 4 Steps Taken for Assessment Page 12 Summary of Product Characteristics
More informationIntroduction 2. 1. The Role of Pharmacy Within a NHS Trust 3. 2. Pharmacy Staff 4. 3. Pharmacy Facilities 5. 4. Pharmacy and Resources 6
Index Index Section Page Introduction 2 1. The Role of Pharmacy Within a NHS Trust 3 2. Pharmacy Staff 4 3. Pharmacy Facilities 5 4. Pharmacy and Resources 6 5. Prescription Charges 7 6. Communication
More informationElectronic Prescription Service. Guidance for community pharmacy contractors on implementing Release 1
Electronic Prescription Service The Electronic Prescription Service Guidance for community pharmacy contractors on implementing Release 1 Contents With about 1.3 million prescriptions now being issued
More informationCMS & ehr - An Update
Health Informatics in Hong Kong CMS & ehr - An Update Dr NT Cheung HA Convention 2010 CMS / epr is essential in the HA Each Day... 12,000 users 90,000 patients 8M CMS transactions 700,000 epr views In
More informationHow To Understand The Paediatric Regulation
Paediatric Use Marketing Authorisation (PUMA) from a National Competent Authority Point of View DGRA Annual Congress 2006 Bonn, 10. May 2006 Dr. Susanne Keitel Content PUMA The Future Background Legislative
More information26/09/2013 Peter Ravnholt - www.itsmexcellence.com
Agenda 26/09/2013 Peter Ravnholt - www.itsmexcellence.com Purpose Ensure that valuable required to deliver and report on services are properly controlled, and that accurate and reliable information is
More information