College ter Beoordeling van Geneesmiddelen
|
|
|
- Rose Turner
- 8 years ago
- Views:
Transcription
1
2 CESP Bijeenkomst RegNed Zoetermeer, 19 april 2012 Stan van Belkum
3 Agenda History and activities Conceptual model Practical use Metric of PoC and extended PoC Dutch experience Future steps
4 CESP history Industry / Agency meeting in 2010 on the next major version of the ectd. Multiple NCA portals available or planned No single delivery system for MR/DCP submissions Overhead of managing CDs/ DVDs needed to be reduced Incentive to move away from paper Agreed that an initial analysis be carried out and recommendations be presented to HMA. 4
5 Overview of Activities Jan Feb March April May June July August Sep Oct Nov Dec 2010 R Feasability study EXAMPLE TEXT R R 2011 Design and build of system Phase 1 Proof of concept 2012 Phase 2 Proof of Concept R Industry/Agency Workshop R HMA Project review 5
6 Participants Agencies DE (BfArM) UK (MHRA) UK (VMD) ES (AEMPS) AT (AGES) IE (IMB), NL (MEB) FI (Fimea) BE (FAGG) MT (MITTS) PT (infarmed) DK (DKMA) HR (HALMED) SI (JAZMP) IS (IMA) EE Se (MPA) Industry EGA EGGVP AESGP EFPIA IFAH-Europe >120 Industry Users Project Structure (Co) Chair: NL (MEB), UK (MHRA) Technical: IE (IMB), AT (Ages) Observer : EMA 6
7 Future model CESP Develop a single EU submission platform that can be used by both industry and agency for both Human and veterinary medicinal products using current and future standards such as ectd, NeeS, vnees, eaf and controlled terms. Converging with EU Telematics Systems in an appropriate time frame. Ideally the goal would be commitment of all NCA s to use CESP. 7
8 Single Integrated Process Pushed to NCA systems CESP, esubmission Gateway Validates submission Deliver to NCA s Uploads submission Submission Management System Builds Submission Creates Application form Based on harmonised criteria eaf, PDF, Word, XML Industry User 8
9 Technology User requirement PC with broadband access minimum 1mb Portal can be accessed by a user using two methods Using a secure file transfer client (preferred option) e.g. filezilla ( free download) or cuteftp professional Using a standard web browser with java enabled System Industry standard file transfer system Various levels of security available (sftp, HTTPS, PGP etc..) Ability to report of transfer and user access 9
10 How does CESP Work? User logs on to registration server and creates delivery file Registration Server Agency A User downloads delivery file to local PC Industry User Agency B User uploads submission and delivery file to FTP server File Transfer Server Files are moved to agency servers Agency C 10
11 Create delivery file 11
12 Delivery file step 1 12
13 Delivery file step 2 (MRP/ DCP) 13
14 Delivery file download 14
15 File delivery Two options sftp Client based File Transfer Web based File Transfer
16 File transfer (sftp) 16
17 Web based file transfer 17
18 PoC Phase 1: Original Aims Establish that the concept of CESP can: deliver a system capable of handling submissions of varying sizes manage one submission being received by various Agencies (human or vet) minimize the effort for handling CD/DVD applications High level requirements A simple and secure mechanism for exchange of submission information, covering MRP / DCP submissions for both human and veterinary products Platform would accept initial, variation submissions with mechanisms to handle resubmitting updated information One-way, from Industry to Regulator, with simple notification systems Is not dependent on submission standards, i.e. will accept eaf, ectd, NeeS, vnees but is not built around these Excludes dictionaries or validation Will use files of varying size (50, 100 and 500MB) establishing the potential for a working system Must be seen as a throw-away solution 18
19 PoC Phase 1 : Metrics Number of participating companies 22 Number of participating regulators 12 Number of packages submitted in two testing weeks 500+ Packages sizes 50, 100 and 500MB Performance Average size of a submission (new applications) Average size of a submission (variation) 50MB 100MB 500MB ca 650MB ca 100MB 2.5 Mins 7 Mins 11 Mins 19
20 PoC Phase 1: Results Feedback on the PoC was positive Industry liked its simplicity Generally found the speed good Was a good replacement to submitting CDs/DVDs Feedback from Agencies PoC worked effectively Early problems were rectified Broadly achieved aims Everyone keen to move forward 20
21 Conclusions HMA PoC The results of the PoC confirm that the primary goals are achieved. All stakeholders involved are unanimously positive and want to continue developing the CESP solution EMA agreed to continue to be involved with the group as an observer. Agreement for extended PoC Two subgroups: Technical specifications production system Governance 21
22 Extended PoC Minor modification to Delivery File Real life submissions Parallel submission of physical files (CD/DVD) Start from February 6 th, 2012 Industry can register on:
23 Dutch experience (1) Human Veterinary Number of packages received (February 6 -April 16 th, 2012) 43 New applications MRP/DCP RMS (6x suppl. Info) 8 New applications MRP/DCP CMS 2 1 New applications national 2 Variations MRP RMS 16 2 (PSUR) Variations MRP CMS 10 ASMF 1 Renewal
24 Dutch experience (2) No technical issues Parallel submission of CD/DVD not supported!! Investigation of additional use of delivery file (XML) 24
25 Next activities Project meeting 9-10 May, Utrecht Evaluation extended PoC: June 2012 Advice on governance to HMA Advice on technical specs production system to HMA Coordination with EMA initiatives
26
27 Information:
28
EMA SPOR master data management roadmap
EMA SPOR master data management roadmap EU ISO IDMP Task Force meeting For information March 2015 Presented by: Kepa Amutxastegi Business Data and Support Department An agency of the European Union Roadmap
Bundesinstitut für Arzneimittel und Medizinprodukte Step-by-step Guide on e-only Submission at BfArM
Step-by-step Guide on e-only Submission at BfArM Version 2.1 Date: December 30, 2014 Conditions for e-only submissions Electronic format only in ectd or NeeS regardless of whether submission concerns a
Harmonised Technical Guidance for ectd Submissions in the EU
Guidance for Industry on Providing Regulatory Information in Electronic Format Harmonised Technical Guidance for ectd Submissions in the EU Version 3.0 August 2013 Page 1 of 60 Table of Contents Table
esubmission Guidelines
esubmission Guidelines New ways of working at FAMHP Version 2.11 Publication date: 2/12/2011 Implementation date: 2/12/2011 DOCUMENT HISTORY Date Author Version Comments 14/05/07 André Lhoir 2.6 Updated
EU Change Control Process for Change Requests in the Entire Area of Electronic Submissions for Human Medicinal Products Version 2.
EU Change Control Process for Change Requests in the Entire Area of Electronic Submissions for Human Medicinal Products Version 2.1 May 2011 Document Control Change Record Version Date Author(s) Comments
A critical review of the current. marketing authorisation transfer procedure. in Europe
A critical review of the current marketing authorisation transfer procedure in Europe Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen
15 th EGA Regulatory and Scientific Affairs Conference Meeting the Future Challenges and Opportunities in the Regulatory Environment
15 th EGA Regulatory and Scientific Affairs Conference Meeting the Future Challenges and Opportunities in the Regulatory Environment 28 29 January 2016 Radisson Blu Portman Hotel 22 Portman Square, London
EMA esubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation
28 February 2014 EMA/609325/2011 EMA esubmission Gateway: Questions and answers relating to practical and technical aspects of the implementation This question and answer document aims to address the commonly-asked
INSPIRE Dashboard. Technical scenario
INSPIRE Dashboard Technical scenario Technical scenarios #1 : GeoNetwork catalogue (include CSW harvester) + custom dashboard #2 : SOLR + Banana dashboard + CSW harvester #3 : EU GeoPortal +? #4 :? + EEA
Milk Market Situation. Brussels, 27 August 2015
Milk Market Situation Brussels, 27 August EU Productions EU Productions (Jan-Jun compared to Jan-Jun 214) +,8% + 1,2% + 3,2% +,2% +,7% - 2,% - 3,1% -,1% - 11,1%!!! Data from some Member States are confidential
CMDv/BPG/001. BEST PRACTICE GUIDE for Veterinary Mutual Recognition Procedure (MRP) Edition 04. Edition date: 19 July 2013
EMA/CMDv/83618/2006 BEST PRACTICE GUIDE for Veterinary Mutual Recognition Procedure (MRP) Edition 04 Edition date: 19 July 2013 Implementation date: 23 November 2006 CMDv Secretariat: European Medicines
Use of CESP to submit electronic documents to EDQM
CFE/CB PUBLIC DOCUMENT (LEVEL 1) English only/anglais seulement PA/PH/CEP (13) 67, 1R Strasbourg, December 2013 Certification of suitability to Monographs of the European Pharmacopoeia Use of CESP to submit
CHAPTER 7 GENERAL INFORMATION
Chapter 7 General Information CHAPTER 7 GENERAL INFORMATION Revision July 2008 Table of Content Page 1. FORMAT FOR APPLICATION IN THE EU 2 2. LANGUAGES TO BE USED FOR DOSSIER, RESPONSES, VARIATIONS AND
The joint EU Telematics governance model
The joint EU Telematics governance model The joint EU Telematics governance model EU Telematics Management Board The EU Telematics Management Board provides the vision for, and strategic oversight of,
egovernment Digital Agenda Scoreboard 2014
egovernment Digital Agenda Scoreboard 2014 1 egovernment use in EU28 has been flat In 2013 egovernment services have been used by 41% of the EU28 population, down from 44% in 2012 and almost at the same
GUIDANCE for Administration of the Sunset Clause
GUIDANCE Edition number : 02 Edition date: 16/07/2010 Implementation date : 28/12/2007 CMDv Secretariat: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK CMDv/TEM/013-00 Tel. (44-20) 74 18 84 00 Fax.
Report from the CMDh meeting held on 21-23 September 2015. !!! 3 months to go until the mandatory use of the electronic application form!!!
Report from the meeting held on 21-23 September 2015!!! 3 months to go until the mandatory use of the electronic application form!!! Pharmacovigilance positions following PSUSA procedure for only nationally
CMD(v)/GUI/014. GUIDANCE for The Processing of Generic Applications Through MRP / DCP
EMEA/CMDv/262452/2008 GUIDANCE Edition number : 00 Edition date: 19 June 2008 Implementation date : 04 July 2008 CMD(v) Secretariat: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74
9th DGRA Annual Congress
Bundesinstitut für Arzneimittel und Medizinprodukte 9th DGRA Annual Congress Electronic Regulatory Submission from the Point of View of the National Drug Agencies - Germany Dr. Klaus Menges, BfArM 13.06.2007,
Accessing the FTP Server - User Manual
CENTRAL BANK OF CYPRUS Accessing the FTP Server - User Manual IT Department, CENTRAL BANK OF CYPRUS TABLE OF CONTENTS 1 EXECUTIVE SUMMARY... 1 1.1 AUDIENCE... 1 1.2 SCOPE... 1 2 CHANGES FROM THE OLD FTP
Questions & answers on signal management
23 October 2015 EMA/261758/2013 Inspections and Human Medicines Pharmacovigilance Division This document addresses a number of questions which stakeholders, in particular marketing authorisation holders
eaf becomes mandatory for all procedures what to consider by applicants
eaf becomes mandatory for all procedures what to consider by applicants Webinar for the usage of an eaf at applicants level Presented by: Georg Neuwirther, Klaus Menges and Kristiina Puusaari An agency
Ad Hoc (Temporary) Accounts Instructions
DLG/PDV SFTP Server Instructions 1. Ad Hoc (Temporary) Accounts. 2. LeadsGen (Permanent) Accounts. 3. Manually configuring SFTP Clients (WinSCP & FileZilla). 4. Uploading files into SFTP server. 5. Frequently
Foreign Account Tax Compliance Act (FATCA) IDES Implementation Update. April 2015
Foreign Account Tax Compliance Act (FATCA) IDES Implementation Update April 2015 IDES Implementation Developments 2 The IRS has made significant progress in developing and deploying technology capabilities
Elektronische Einreichung Wo steht die AGES PharmMed?
Elektronische Einreichung Wo steht die AGES PharmMed? AGES-Gespräch 27. November 2008, Vienna Dr. Christa Wirthumer-Hoche AGES PharmMed 2 Electronic submission - aims Reduction of (internal) paper-flow
HU CZ FI PL SI PT IT ES NO NL FR DK SE IE GB AT DE CH LU 0 10 20 30 40 Foreigners' share Source: Eurostat More trust 3 4 5 6 7 PL HU CZ SI PT GR ES DK FI SE
Supervisor Instructions for Approving Web Time Entry
Supervisor Instructions for Approving Web Time Entry Time Approval Deadlines by Category Local 2110 Members members submit time by NOON on Monday of the pay week. Time should be approved no later than
AT&T Global Network Client for Windows Product Support Matrix January 29, 2015
AT&T Global Network Client for Windows Product Support Matrix January 29, 2015 Product Support Matrix Following is the Product Support Matrix for the AT&T Global Network Client. See the AT&T Global Network
Going Green with BCBSNE
Going Green with BCBSNE Health Network Services March 25, 2014 Blue Cross and Blue Shield of Nebraska is an Independent Licensee of the Blue Cross and Blue Shield Association. Agenda Why electronic submission?
Our name ASPHALION derives from the Greek word asphaléia, alluding to values such as firmness, stability, certainty and reliability.
Company Profile Our History ASPHALION is an International Drug Development and Regulatory Affairs consultancy firm founded in 2000, with an international team of over 40 people. Our Values Our name ASPHALION
Analysis One Code Desc. Transaction Amount. Fiscal Period
Analysis One Code Desc Transaction Amount Fiscal Period 57.63 Oct-12 12.13 Oct-12-38.90 Oct-12-773.00 Oct-12-800.00 Oct-12-187.00 Oct-12-82.00 Oct-12-82.00 Oct-12-110.00 Oct-12-1115.25 Oct-12-71.00 Oct-12-41.00
Best Archiving Practice Guidance
Best Archiving Practice Guidance This document has been published under the auspices of the EU Telematics Implementation Group - electronic submissions (TIGes) Please note that this document has been published
The EU s 2030 Effort Sharing Agreement
The EU s 2030 Effort Sharing Agreement Brussels CEPS Workshop, 29.06.2015 Oliver Sartor, oliver.sartor@iddri.org Research Fellow, Climate & Energy Policy, IDDRI Celine MARCY, IDDRI Institute for Sustainable
ehealth in support of safety, quality and continuity of care within and across borders
ehealth in support of safety, quality and continuity of care within and across borders Gerard Comyn Acting Director Information Society & Media DG European Commission http://europa.eu.int/information_society/activities/health/index_en.htm
REQUIREMENTS FOR NATIONAL AND MUTUAL RECOGNITIONS VMP APPLICATIONS
1/13 REQUIREMENTS FOR NATIONAL AND MUTUAL RECOGNITIONS VMP APPLICATIONS 2/13 INDEX PAGE Applicable National Legislation and Community texts 3 Content of the application 3 Marketing authorisations 4 Language
Network Code Interoperability and Data Exchange Rules. Data Exchange Workshop
Network Code Interoperability and Data Exchange Rules Data Exchange Workshop Brussels 23 April 2013 Agenda 2 Data Exchange - Agenda Part 1: 1. Introduction Cost-Benefit Assessment 2. CBA Process 3. CBA
The EU Energy Tax Directive: overview about the proposed reform, impacts on national measures and state of play
Environmentally Related Taxes and Fiscal Reform Rome, Thursday, 15 December 2011 The EU Energy Tax Directive: overview about the proposed reform, impacts on national measures and state of play A short
The Clinical Trials Regulation EU No 536/2014: and Phase I trials
The Clinical Trials Regulation EU No 536/2014: and Phase I trials EUFEMED, Brussels, 20 May 2015 Presented by Fergus Sweeney Head, Inspections and Human Medicines Pharmacovigilance An agency of the European
Agenda The emdr Challenge
The emdr Challenge Agenda The emdr Challenge Terminology High-Volume Basic Requirements Low volume Requirements Decision tree high volume vs. low volume Lessons Learned & Tips for Successful emdr Implementation
COMPARISON OF FIXED & VARIABLE RATES (25 YEARS) CHARTERED BANK ADMINISTERED INTEREST RATES - PRIME BUSINESS*
COMPARISON OF FIXED & VARIABLE RATES (25 YEARS) 2 Fixed Rates Variable Rates FIXED RATES OF THE PAST 25 YEARS AVERAGE RESIDENTIAL MORTGAGE LENDING RATE - 5 YEAR* (Per cent) Year Jan Feb Mar Apr May Jun
COMPARISON OF FIXED & VARIABLE RATES (25 YEARS) CHARTERED BANK ADMINISTERED INTEREST RATES - PRIME BUSINESS*
COMPARISON OF FIXED & VARIABLE RATES (25 YEARS) 2 Fixed Rates Variable Rates FIXED RATES OF THE PAST 25 YEARS AVERAGE RESIDENTIAL MORTGAGE LENDING RATE - 5 YEAR* (Per cent) Year Jan Feb Mar Apr May Jun
OVERVIEW OF PURCHASE AND TAX INCENTIVES FOR ELECTRIC VEHICLES IN THE EU
01.04.2014 OVERVIEW OF PURCHASE AND TAX INCENTIVES FOR ELECTRIC VEHICLES IN THE EU This table provides an overview of the incentives that are granted in the Member States of the European Union for the
Quickstream Connectivity Options
A division of Westpac Banking Corporation ABN 33 007 457 141 Quickstream Connectivity Options Document History Date 25-Jun-2003 1-Jul-2003 3-July-2003 18-July-2003 18-Aug-2003 8-Sep-2003 19-Sep-2003 31-Oct-2003
BEST PRACTICE GUIDE for Handling of Periodic Safety Update Reports
EMEA/CMDv/408477/2007 12 March 2009 BEST PRACTICE GUIDE for Handling of Periodic Safety Update Reports Edition number : 00 Edition date: 12 March 2009 Implementation date : 27 March 2009 CMD(v) Secretariat:
FirstClass Division Product Bulletin
FirstClass Division Product Bulletin Title: FirstClass Client 9.022 Danish, Dutch, German and Spanish Release Announcement Bulletin Number: 199 Version: 1.0 Date: December 17, 2007 Audience This Product
Change Management Advisory Council. September, 2010
Change Management Advisory Council September, 2010 Agenda 8:00-8:20: 8:20-8:40: 8:40-9:00: 9:00-9:30: Introduce team; share role of Advisory Council and discussion questions Discuss program overview and
Text. Registry Onboarding and TLD Startup
Registry Onboarding and TLD Startup Background From Registry Onboarding to TLD Launch Registry Agreement Executed Delegation General Registration What is Onboarding? From Registry Onboarding to TLD Launch
Implementation 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
WWA FTP/SFTP CONNECTION GUIDE KNOW HOW TO CONNECT TO WWA USING FTP/SFTP
WWA FTP/SFTP CONNECTION GUIDE KNOW HOW TO CONNECT TO WWA USING FTP/SFTP Table OF Contents WWA FTP AND SFTP CONNECTION GUIDE... 3 What is FTP:... 3 What is SFTP:... 3 Connection to WWA VIA FTP:... 4 FTP
MEDICAL RECORDS ELECTRONIC SUBMISSION GUIDE
MEDICAL RECORDS ELECTRONIC SUBMISSION GUIDE The enhanced Care Improvement Plus Provider Portal allows CIP providers to support claims by uploading electronic health records without leaving the portal.
Data Transmission Method Selection Monday, October 5, 2015
Slide 1 - of 17 Welcome to the Data Transmission Method Selection course. Note: This module only applies to Responsible Reporting Entities (RREs) that will be submitting Section 111 claim information via
Baltic Marine Environment Protection Commission
Baltic Marine Environment Protection Commission Project on Development of a HELCOM Pollution Load User System Helsinki, Finland, 26-27 February 2014 PLUS 5-2014, 2-2 Document title Hosting and Application
GENERAL FILE TRANSFER GUIDELINES
GENERAL FILE TRANSFER GUIDELINES EMSTARS extracts (the XML files containing patient care records) will be transferred to the FDOH Secure Server at intervals defined in the EMSTARS Business Rules (available
PROFESSIONAL CERTIFICATE IN MARKETING
PROFESSIONAL CERTIFICATE IN The practical skills and knowledge required to devise and execute tactical marketing activities ONLINE LONDON BERKSHIRE The direct study centre of PROFESSIONAL CERTIFICATE IN
ERMInE Database. Presentation by Nils Flatabø SINTEF Energy Research. ERMInE Workshop 2 - Northern Europe Oslo, 1. November 2006
ERMInE Database Presentation by Nils Flatabø SINTEF Energy Research ERMInE Workshop 2 - Northern Europe Oslo, 1. November 26 Overview Content of the Ermine Database Electronic Questionnaire RTD&D Data
1 February 2016 EMA/13015/2014 Rev. 3
1 February 2016 Dossier requirements for referral, ASMF and NAP submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device Submission of applications
Section I Transmission Modes
Transmission Modes Transmission Options Available...2 Value Added Networks (VAN)...2 File Transfer Protocol (FTP)...2 HTTPS File Upload (WEB)...3 Storing and Receiving Data with File Transfer Protocol...3
Changes to 2015-16 reporting requirements. Teleconference December 2015
Changes to 2015-16 reporting requirements Teleconference December 2015 Resources Click to download 2015-16 Indicative format: workplace profile and reporting questionnaire 2015-2016 workplace profile worksheets
Enhancing Cyber Security in Europe Dr. Cédric LÉVY-BENCHETON NIS Expert Cyber Security Summit 2015 Milan 16 April 2015
Enhancing Cyber Security in Europe Dr. Cédric LÉVY-BENCHETON NIS Expert Cyber Security Summit 2015 Milan 16 April 2015 European Union Agency for Network and Information Security Summary 1 Presentation
Looking for the future model for roaming
BoR (14) 155 Looking for the future model for roaming J. Scott Marcus 0 Roaming Regulation in Europe Past, present, and future? Regulation of IMR since 2007 can be viewed as comprising three phases 2007
CEI Document Management in S/4 Initial Call
CEI Document Management in S/4 Initial Call, SAP Labs India Dec 2015 Disclaimer The information in this document is confidential and proprietary to SAP and may not be disclosed without the permission of
Helpdesk Ticketing User Guide
Helpdesk Ticketing User Guide University College of the North 1/5/2012 Table of Contents UCN Helpdesk Ticketing System Requirements... 1 Logging into Helpdesk Ticketing System... 1 Support Center Options...
GlobalSCAPE Mail Express
Reducing the Costs and Risks of Email Attachments Email is the main collaboration and communications tool in most businesses today. When users want to share files internally or with customers, partners,
Clinical Trial Data Transparency Environment & Expectations EMA Policy - Clinical Trials Regulation
Clinical Trial Data Transparency Environment & Expectations EMA Policy - Clinical Trials Regulation Joint BBS-EFSPI Seminar, Basel, 13 Nov 2014 Sabine Atzor, Head of EU Regulatory Policies PDR Overview
European Research Council. FP7 IDEAS Programme The European Research Council. Funding possibilities from The Europen Research Council.
FP7 IDEAS Programme The Funding possibilities from The Europen Research Council Gabor Nagy Achievements of the ERC - so far more than 2.600 funded proposals, 58% of them StG in more than 480 different
OCS Virtual image. User guide. Version: 1.3.1 Viking Edition
OCS Virtual image User guide Version: 1.3.1 Viking Edition Publication date: 30/12/2012 Table of Contents 1. Introduction... 2 2. The OCS virtualized environment composition... 2 3. What do you need?...
Guidance to applicants Submission of Marketing Authorisation Applications
Guidance to applicants Submission of Marketing Authorisation Applications The purpose of this notice to applicants is to clarify aspects related with the submission to Infarmed Autoridade Nacional do Medicamento
MRP & DCP step by steb instructions how to apply and how the procedures are conducted
MRP & DCP step by steb instructions how to apply and how the procedures are conducted 06 May 2013 Dubrovnik, Croatia Dr. Peter Bachmann Head of Unit Coordination Group European and International Affairs
Digital Agenda Targets Progress report. Digital Agenda Scoreboard 2014
Digital Agenda Targets Progress report Digital Agenda Scoreboard 2014 1 NGA coverage: Fast broadband technologies capable of providing at least 30 Mbps are available to 64%, up from 54% a year ago Among
BEMA Benchmarking European Medicines Agencies. linking competence to achieve excellence
BEMA Benchmarking European Medicines Agencies linking competence to achieve excellence EU/EEA Medicines Network linking loose pearls to a chain EU/EEA Medicines Network linking loose pearls to a chain
NCEPTION REPORT. Short Introduction to use of MESA Training Distance Education LMS
NCEPTION REPORT Short Introduction to use of MESA Training Distance Education LMS Implementation of the training strategy of the Monitoring for Environment and Security in Africa (MESA) programme EuropeAid/134534/D/SER/MULTI
COMPANIES REGISTRY. Third Party Software Interface Specification. (Part 1 Overview)
COMPANIES REGISTRY Third Party Software Interface Specification () of Integrated Companies Registry Information System Version 1.3 March 2014 The Government of the Hong Kong Special Administrative Region
Online Timesheets Guide for Contractors
Online Timesheets Guide for Contractors Table Of Contents 1. Welcome To Online Timesheets Page 2 2. Email Activation Page 2 3. Logging Onto The Online Timesheet Portal Page 2 4. Online Timesheet Portal
The EU Clinical Trial Regulation A regulator s perspective
5 The EU Clinical Trial A regulator s perspective Author Martyn Ward, Group Manager, Licensing, Medicines and Healthcare products Regulatory Agency (MHRA), UK. Keywords Clinical Trial Directive (the Directive);
Oracle Managed File Getting Started - Transfer FTP Server to File Table of Contents
Oracle Managed File Getting Started - Transfer FTP Server to File Table of Contents Goals... 3 High- Level Steps... 4 Basic FTP to File with Compression... 4 Steps in Detail... 4 MFT Console: Login and
THE FUTURE OF TELEVISION IN EUROPE
Information Analytics Expertise SEPTEMBER 2014 THE FUTURE OF TELEVISION IN EUROPE An assessment of the changing nature of television in Europe, and what is shaping the transformation Ben Keen: IHS Technology
The EU portal and database
The EU portal and database ECPC General Assembly - 20 June 2015 Presented by Laura Pioppo Clinical and Non-clinical Compliance Service An agency of the European Union Table of contents Legal basis CT programme
SEPA Update. 13 November 2007 Harry Leinonen
FACT Autumn meeting SEPA Update 13 November 2007 Harry Leinonen The views expressed are those of the author and do not necessarily reflect the views of the Bank of Finland. 1 SEPA is a process towards
SME Instrument statistics
SME Instrument statistics 0 beneficiaries Phase (June Sep 0), Phase (Oct 0) status January 0 SME Instrument (Horizon 00) DCC MANAGEMENT 0 SME Instrument Phase (Jun 0) beneficiaries Country breakdown Out
MasterPass Service Provider Onboarding & Integration Guide Fileand API-Based Merchant Onboarding Version 6.10
MasterPass Service Provider Onboarding & Integration Guide Fileand API-Based Merchant Onboarding Version 6.10 7 January 2016 SPBM Summary of Changes, 7 January 2016 Summary of Changes, 7 January 2016 This
Case 2:08-cv-02463-ABC-E Document 1-4 Filed 04/15/2008 Page 1 of 138. Exhibit 8
Case 2:08-cv-02463-ABC-E Document 1-4 Filed 04/15/2008 Page 1 of 138 Exhibit 8 Case 2:08-cv-02463-ABC-E Document 1-4 Filed 04/15/2008 Page 2 of 138 Domain Name: CELLULARVERISON.COM Updated Date: 12-dec-2007
Federal Aviation Administration FAA William (Bill) O Brien Aviation Maintenance Technician Awards Program AMT Individual Program
Federal Aviation Administration FAA William (Bill) O Brien Aviation Maintenance Technician Awards Program AMT Individual Program Tutorial Release 2.0 Revision History Summary Version Number Date Document
Tuition Reimbursement Program. Handbook
EMPLOY EE Tuition Reimbursement Program Handbook For Employees... Ed u c a t i o n m a d e a f f o r d a b l e! A t t h e E r n e s t O r l a n d o L a w r e n c e B e r k e l e y N a t i o n a l L a b
Leveraging Email, Social & Web. Budget Friendly & Effective Marketing
Leveraging Email, Social & Web Budget Friendly & Effective Marketing Agenda Why Leverage the Web? Web Metrics & Results Web Tactics Social & Email Marketing How to Get Started Today Feel free to ask questions
Quick Response (QR) codes in the labelling and package leaflet of centrally authorised 1 medicinal products
22 July 2015 EMA/493897/2015 Human Medicines Evaluation Division Quick Response (QR) codes in the labelling and package leaflet of centrally authorised 1 medicinal General principles of acceptability and
CENTERPOINT ENERGY TEXARKANA SERVICE AREA GAS SUPPLY RATE (GSR) JULY 2015. Small Commercial Service (SCS-1) GSR
JULY 2015 Area (RS-1) GSR GSR (LCS-1) Texarkana Incorporated July-15 $0.50690/Ccf $0.45450/Ccf $0.00000/Ccf $2.85090/MMBtu $17.52070/MMBtu Texarkana Unincorporated July-15 $0.56370/Ccf $0.26110/Ccf $1.66900/Ccf
Frequently Asked Questions. Third Party Software Interface
Frequently Asked Questions Third Party Software Interface A General Q1. What is Third Party Software Interface? Third Party Software Interface ( TPSI ) is a service provided by the Registrar of Companies
Retail Market IT Services Service Level Agreement
Electric Reliability Council of Texas Retail Market IT Services Service Level Agreement Summary: Availability targets and related service information for the IT services provided by ERCOT that facilitate
Using Open Source Software to Manage Policies and Clinical Guidelines. Library & Knowledge Service Derby Teaching Hospitals NHS Foundation Trust
Using Open Source Software to Manage Policies and Clinical Guidelines Library & Knowledge Service Derby Teaching Hospitals NHS Foundation Trust Overview Background Existing System. Requirements. Implementation
Pharmacovigilance System Master File (PSMF), QPPV and audits
Federal Agency for Medicines and Health Products (FAMHP) Pharmacovigilance System Master File (PSMF), QPPV and audits Matthijs Nele, PhV Inspector, DG Inspection BRAS - FAMHP/NM/ 1 Content Introduction
Annex A to the MPEG Audio Patent License Agreement Essential Philips, France Telecom and IRT Patents relevant to DVD-Video Player - MPEG Audio
Annex A to the MPEG Audio Patent License Agreement Essential Philips, France Telecom and IRT Patents relevant to DVD-Video Player - MPEG Audio PUBLICATION AR N 015678 - P970100444 05-Feb-97 17-Oct-05 AR006969
Service Central Your gateway to support
Service Central Your gateway to support Training deck November 2015 Topics Why using Service Central? How to login to Service Central - Option 1 - Option 2 How to submit a ticket How to modify a ticket/check
European developments in VET Quality Assurance
Sophie Weisswange DGVT meeting European developments in VET Quality Assurance Dublin 22-23 May 2013 EQAVET EQAVET list of indicators Underlying objectives: Better employability Better match between training
CO2 BASED MOTOR VEHICLE TAXES IN THE EU IN 2015
CO2 BASED MOTOR VEHICLE TAXES IN THE EU IN 2015 COUNTRY AT (AUSTRIA) BE (BELGIUM) BG (BULGARIA) CO2/FUEL CONSUMPTION TAXES A fuel consumption tax (Normverbrauchsabgabe or NoVA) is levied upon the first
VICTORIAN CARDIAC OUTCOMES REGISTRY. Data Management Policy
VICTORIAN CARDIAC OUTCOMES REGISTRY Data Management Policy Version 1.0 26 February 2014 Table of Contents 1. Document Version Control... 1 1. Preface... 2 2. Project Information... 2 2.1 Purpose of VCOR...
This symbol represents a handy tip or further information.
This symbol represents a handy tip or further information. 1. Logging In Open Internet Explorer or Firefox and log in to the system through the Business Systems front door page - https://frontdoor.spa.gla.ac.uk/login/
SUMMARY PROFESSIONAL EXPERIENCE. IBM Canada, Senior Business Transformation Consultant
Doreen Funk, MA 191 Discovery Ridge Blvd SW, Calgary Cell: 587-434- 0811 E- mail: dorfunk@hotmail.com SUMMARY Senior management consultant with 20 years of experience in applying strategies and implementing
The ICT workforce and e-leadership demand and supply (2014-2020)
The ICT workforce and e-leadership demand and supply (2014-2020) Tobias Hüsing, Senior Research Consultant, empirica GmbH Marianne Kolding, Vice President IDC European e-skills 2014 Conference e-leadership
Empowering users in the converged media-internet-telecom value web
Empowering users in the converged media-internet-telecom value web Impact of tools for the protection of minors from harmful content Pieter Nooren OBS-EPRA workshop on Empowering Users, Strasbourg, 15
Supercomputing for Everyone. Egis L4 Switch. PDF created with pdffactory Pro trial version www.pdffactory.com
Supercomputing for Everyone Egis L4 Switch Contents 1 Company 2 Egis L4 Switch 3 CLUNIX Egis L4 Switch 4 Reference Sites 1. Company Present Status General Information Main Businesses and Markets Core Capability