How To Create A Pediatric Health Care Database In The European Union
|
|
|
- Mary McDonald
- 5 years ago
- Views:
Transcription
1 GRiP Global Research in Paediatrics Pediatric Pharmacoepidemiology Platform Miriam Sturkenboom, Erasmus University Jan Bonhoeffer, Brighton Collaboration Foundation On behalf of the GRiP Network of Excellence
2 ENCePP DB sites with pediatric data Enpr-EMA The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
3 Objectives WP 2 To develop an integrated electronic infrastructure for pediatric (pharmaco)epidemiological research This infrastructure will exploit and link existing healthcare databases around the world to assess the occurrence of diseases in children, plus the use and effects of drugs (including vaccines) on a large scale. Methodologies for harmonization, data exchange across national boundaries (including ethical and governance issues), data mining and comparative safety and effectiveness studies will be developed and tested The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
4 What is the current status regarding evidence on effects of drugs in pediatrics? Many complaints about lack of data in pediatrics Many studies showing the off-label use of drugs in children Several pediatric regulations/initiatives to boost trials in children in the beginning of 2000 (FDA/EMA/WHO) Pediatric drug safety still often the cause for regulatory action (in for 28 medicines or drug classes safety warnings (Clavenna A et al. Archives of disease in childhood. Sep 2009;94(9): ) Postmarketing data need to be utilized, as many children are exposed very day and this information should be utilized. No single database has enough power to study serious safety issues in children. E.g. EU-ADR: 4.8 million children/adolescents across 7 databases in 4 countries, 25 Million PY Total 2,170 drugs prescribed / dispensed Anaphylactic shock (3/100,000): only for 8 drugs power to demonstrate RR>4 UGIB (10/100,000) only for 39 drugs power to demonstrate RR> 4 The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
5 WP 2 Vision relevant to ENCePP TO BUILD a SUSTAINABLE & TESTED GLOBAL PLATFORM TO IMPROVE INFORMATION ON THE USE & EFFECTS OF DRUGS IN CHILDREN
6 Key Products WP 2 1) A technical operational research infrastructure for collaborative data sharing / analysis accessible around the world 2) A catalogue of databases with contact and meta-data on pediatric patients that can be approached for collaborative pharmacoepidemiological studies 3) Description of ethical and governance issues related to secondary use of health care data across the world 4) Description of paediatric spontaneous reports in WHO- VIGIBASE, EUDRAVIGILANCE, AERS and VAERS 5) Catalogue of disease codes for different pediatric events to be extracted in SRS and EHR databases The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
7 Key Products WP 2 6) Reference set of positive and negative controls for signal detection to be used (vaccines/drugs) 7) Tested methods for Signal detection in pediatrics (SRS/EHR) and a comparison between databases and methods, together with EMA, PROTECT & OMOP 8) Templates and global proof of concept studies on drug/vaccine use, disease incidence, drug safety and effectiveness 9) Pediatric pharmacoepidemiology courses (e-learning) The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
8 Some outputs.. so far
9 Platform for data-sharing (Octopus) Functional platform in ARITMO, SAFEGUARD, GRIP Shared aggregated data within firewalls Remote access to work together and analyse and rotate coordinator ship The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
10 Description of available spontaneous reports (EUDRAVIGILANCE being analysed) Vigibase AERS VAERS Overall [1968-Feb2010] [ ] [ ] Age group N [%] N [%] N [%] N [%] 0-27 days 6,142 [2.3] 4,717 [4.4] - 10,859 [2.0] 28 days - 23 months 38,205 [14.2] 16,096 [15.2] 80,760 [46.2] 135,061 [24.6] 2-11 years 124,321 [46.4] 47,248 [44.5] 68,726 [39.3] 240,295 [43.8] years 99,477 [37.1] 38,061 [35.9] 25,463 [14.6] 163,001 [29.7] Total 268,145 [100.0] 106,122 [100.0] 174,949 [100.0] 549,216 [100.0] The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
11 Catalogue of databases to identify pediatric data globally Databases are contacted and requested to fill out an online survey The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
12 Results of the survey N. of responders= 46 (35% of 130 DB contacted) only 20 from EU Do you agree to be involved in the GRiP project? 11% 4% 22% yes (29) no (5) no answer (2) not completed or not displayed (10) 63% FDA will make SENTINEL available as well for studies The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
13 DBs in EU participating ENCEPP sites 1 GB 21 ES 17 IT 16 FR 15 DE 12 NL 9 PT 7 DK 6 CH 5 FI 4 BE 3 SE 3 GR 2 IE 2 AT 1 NO 1 RO 1 SK 1 The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
14 Invitation to ENCePP sites Participate in GRiP What to do? 1) Complete the survey if you have access to population-based data on drug/vaccine use / outcomes comprising children 2) Participate in proof of concept studies What do you get? 1) Get access to the OCTOPUS platform to initiate & perform studies 2) Publish together & boost the field of pediatrics 3) Find your partners for collaborative studies in pediatrics around the world The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
15 First proof of concept study proposal for collaboration Use & quality of prescribing of antibiotics in children globally ARPEC project (Mike Sharland): large differences in annual prevalence of use The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
16 How to participate? Indicate your interest Requirements: Access to prescription database & population database Creation of two standardized input files locally population: identifier, start follow-up, end follow-up, date of birth, sex Prescriptions: identifier, date, ATC code, duration Run JAVA or SAS script locally and share output table on RRE (in excel) Get token for RRE access Analyse/discuss /publish together with your colleagues The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
17 What is being shared on RRE? ATC7 AgeRange Year Month PersonDays PersonDays_ PersonDays_BExposedI ExposedInNewUsePrescript Prevalence (p Incidence (pe Mean duration J01CR02 age J01CR02 age J01CR02 age J01CR02 age J01CR02 age J01CR02 age J01CR02 age J01CR02 age J01CR02 age J01CR02 age G02CB03 age The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
18 Summary GRiP will provide a platform to work together ENCePP sites not yet well represented, whereas large USA sites will participate Opportunity to start working together (proof of concept) on a very relevant topic The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
19 Participants WP 2 Major contributors EMC (Miriam Sturkenboom) BF (Jan Bonhoeffer) AOPD (Carlo Giaquinto) CVBFTEDDY (A. Ceci) BIOEF (Adolf Valls-i-Soler) WHO (Krisanta Weereasuriya) FDA P-95 Minor contributors NICHD-NIH (S Hirschfeld) EMA (Agnes Saint Raymond) ULIV-MCRN (M. Turner) INSERM (E. Jacqz-Aigrain) NCCHD (Hidefumi Nakamura) SGUL (M. Sharland) AMC (M. Offringa) SoP (I Wong) HUS (K Hoppu) 19
20 Interested? The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7/ ) under grant agreement n
EU-ADR Healthcare Database Network vs. Spontaneous Reporting System Database: Preliminary Comparison of Signal Detection
Patient Safety Informatics V. Koutkias et al. (Eds.) IOS Press, 2011 2011 The authors and IOS Press. All rights reserved. doi:10.3233/978-1-60750-740-6-25 25 EU-ADR Healthcare Database Network vs. Spontaneous
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
The PROTECT project. Introduction. Xavier Kurz Pharmacovigilance and Risk management Patient Health Protection Unit European Medicines Agency
The PROTECT project Introduction Xavier Kurz Pharmacovigilance and Risk management Patient Health Protection Unit European Medicines Agency Brookings Active Surveillance Implementation Council Meeting
MedDRA in pharmacovigilance industry perspective
MedDRA in pharmacovigilance industry SFDA ICH MedDRA Workshop, Beijing, 13 14 May 2011 Christina Winter, MD, FFPM Medical director GlaxoSmithKline R&D / ICH MedDRA Management Board 2011 ICH International
FDA's Mini-Sentinel Program to Evaluate the Safety of Marketed Medical Products. Progress and Direction
FDA's Mini-Sentinel Program to Evaluate the Safety of Marketed Medical Products Progress and Direction Richard Platt Harvard Pilgrim Health Care Institute Harvard Medical School for the Mini-Sentinel Investigators
Overview of FDA s active surveillance programs and epidemiologic studies for vaccines
Overview of FDA s active surveillance programs and epidemiologic studies for vaccines David Martin, M.D., M.P.H. Director, Division of Epidemiology Center for Biologics Evaluation and Research Application
EphMRA Adverse Event Reporting Guidelines 2013
EphMRA Adverse Event Reporting Guidelines 2013 Based upon the Guideline on good pharmacovigilance practices (GVP) Module VI Management and reporting of adverse reactions to medicinal products European
Studying use and risks of medicines in children
Studying use and risks of medicines in children a European approach Sandra de Bie Studying use and risks of medicines in children: a European approach Sandra de Bie The work described in this thesis was
Introduction to Post marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER
Introduction to Post marketing Drug Safety Surveillance: Pharmacovigilance in FDA/CDER LT Andrew Fine, Pharm.D., BCPS Safety Evaluator Division of Pharmacovigilance Office of Pharmacovigilance and Epidemiology
Use of MedDRA in CTCAE and in the Biopharmaceutical Industry
Use of MedDRA in CTCAE and in the Biopharmaceutical Industry Ann Setser, BSN, MEd MedDRA MSSO MedDRA is a registered trademark of the International Federation of Pharmaceutical Manufacturers and Associations
ICD-9-CM to MedDRA Mapping How Well Do the. Disclaimer
ICD-9-CM to MedDRA Mapping How Well Do the Two Terminologies Correlate Anna Zhao-Wong, MD, PhD Deputy Director MedDRA MSSO Disclaimer The views and opinions expressed in the following PowerPoint slides
EphMRA Adverse Event Reporting Guidelines 2015
EphMRA Adverse Event Reporting Guidelines 2015 Based upon the Guideline on good pharmacovigilance practices (GVP) Module VI Management and reporting of adverse reactions to medicinal products European
Laboratory medicine as one of the pharmacists competencies
2014 EAFP Annual Conference Laboratory medicine as one of the pharmacists competencies Borut Božič Examinations of the body fluids in order to recognize the state of health of the individuals Greco-Roman
EMEA RM DRAFT GUIDANCE ISPE RESPONSE 1
EMEA RM DRAFT GUIDANCE ISPE RESPONSE 1 October 4, 2005 Guideline on Risk Management Systems for Medicinal Products for Human Use DRAFT London, 6 September 2005. This guideline will be included as chapter
The Product Review Life Cycle A Brief Overview
Stat & Quant Mthds Pharm Reg (Spring 2, 2014) Lecture 2,Week 1 1 The review process developed over a 40 year period and has been influenced by 5 Prescription User Fee Act renewals Time frames for review
Public Health and the Learning Health Care System Lessons from Two Distributed Networks for Public Health
Public Health and the Learning Health Care System Lessons from Two Distributed Networks for Public Health Jeffrey Brown, PhD Assistant Professor Department of Population Medicine Harvard Medical School
Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge
Exploring and Understanding Adverse Drug Reactions by Integrative Mining of Clinical Records and Biomedical Knowledge http://euadr-project.org PEDRO LOPES [email protected] University of Manchester October
Your first EURES job. Progress Summary 2014Q4. March 2015
Progress Summary 04Q4 March 05 This summary presents an overview of the implementation of Your first Eures job since the start date of activities in June 0 until the end of 04. It highlights in particular
OBSERVATIONAL MEDICAL OUTCOMES PARTNERSHIP
OBSERVATIONAL Opportunities for Signal Detection in an Active Surveillance System Andrew Bate Pfizer, Senior Director, Analytics Team Lead Epidemiology OMOP January 2011 Symposium Contents Background Signal
Export of unemployment benefits
Export of unemployment benefits PD U2 Questionnaire June 2014 Prof. dr. Jozef Pacolet & Frederic De Wispelaere HIVA KU Leuven Network Statistics FMSSFE This report has been prepared in the framework of
Doro PhoneEasy 331ph
Doro PhoneEasy 331ph 1 2 6 3 4 5 English 1 Ringer indicator 2 Hanging Hook for Handset 3 Redial function 4 Volume control 5 Flash button/programming 6 Speed dial memories This device is intended for the
EUROPEAN MEDICINES PRACTICES AND TOOLS AGENCY DRUG SAFETY
EUROPEAN MEDICINES AGENCY DRUG SAFETY PRACTICES AND TOOLS Henry Fitt, Kevin Blake, Xavier Kurz Pharmacovigilance & Risk Management European Medicines Agency, London Contents Eudravigilance & Signal Detection
Guideline on good pharmacovigilance practices (GVP)
1 2 20 February 2012 EMA/876333/2011 3 4 Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions Draft finalised by the Agency in collaboration with Member States 7 February 2012 Definitions
PRODUCT CLASSIFICATION FOR ACCOUNTING, BOOKKEEPING AND AUDITING SERVICES; TAX CONSULTANCY SERVICES AND BUSINESS AND MANAGEMENT CONSULTANCY SERVICES
PRODUCT CLASSIFICATION FOR ACCOUNTING, BOOKKEEPING AND AUDITING SERVICES; TAX CONSULTANCY SERVICES AND BUSINESS AND MANAGEMENT CONSULTANCY SERVICES RELEVANCE TEST BASED ON DATA COLLECTED IN THE EU AND
EXCHANGE STUDIES PRACTICAL INFORMATION. Kadri Toom International Relations Office, Tallinn University of Technology kadri.toom@ttu.
EXCHANGE STUDIES PRACTICAL INFORMATION Kadri Toom International Relations Office, Tallinn University of Technology [email protected]; Tel 620 3549 STEP 1: SELECTION By exchange committees in faculties
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
EMA Update Clinical Trials
EMA Update Clinical Trials Fergus Sweeney, Head, Compliance and Inspections, European Medicines Agency 16 October 2012 An agency of the European Union Disclaimer The views presented in this presentation/these
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
Strategy and pilot phase for patient registries
Strategy and pilot phase for patient registries Draft still under discussion Industry Stakeholder Platform - Operation of EU Pharmacovigilance Legislation 12 January 2015 Xavier Kurz, Head of Monitoring
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
EMA and Progressive Multifocal Leukoencephalopathy.
EMA and Progressive Multifocal Leukoencephalopathy. ENCePP Plenary, London 23 November 2011 Presented by: Henry Fitt Head of Coordination & Networking, Pharmacovigilance & Risk Management An agency of
TEPZZ 87_546A T EP 2 871 546 A2 (19) (11) EP 2 871 546 A2 (12) EUROPEAN PATENT APPLICATION. (51) Int Cl.: G05B 19/05 (2006.01)
(19) TEPZZ 87_46A T (11) EP 2 871 46 A2 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: 13.0.1 Bulletin 1/ (1) Int Cl.: G0B 19/0 (06.01) (21) Application number: 14188238.1 (22) Date of filing:
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
EUROPEAN CITIZENS DIGITAL HEALTH LITERACY
Flash Eurobarometer EUROPEAN CITIZENS DIGITAL HEALTH LITERACY REPORT Fieldwork: September 2014 Publication: November 2014 This survey has been requested by the European Commission, Directorate-General
Glossary of terms used in Pharmacovigilance
Glossary of terms used in Pharmacovigilance Absolute risk Risk in a population of exposed persons; the probability of an event affecting members of a particular population (e.g. 1 in 1,000). Absolute risk
Drug development for children: how adequate is the current European ethical guidance?
Chapter 7 Drug development for children: how adequate is the current European ethical guidance? ABSTRACT It is unacceptable that many drugs prescribed to children have not been proven safe and effective
Medicines and Healthcare products Regulatory Agency
Medicines and Healthcare products Regulatory Agency 11 April 2016 Update on progress with the Joint Patient Safety and Vigilance Strategy Purpose: This paper provides the Board with an update on the Joint
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
Guidance notes on collection of drug safety information by employees and agents of pharmaceutical companies
Guidance notes on collection of drug safety information by employees and agents of pharmaceutical companies March 2013 Guidance notes on collection of drug safety information by employees and agents of
SURVEY ON THE TRAINING OF GENERAL CARE NURSES IN THE EUROPEAN UNION. The current minimum training requirements for general care nurses
SURVEY ON THE TRAINING OF GENERAL CARE NURSES IN THE EUROPEAN UNION This survey serves as a background document for the discussion of the Commission's legislative proposal to modernize the minimum requirements
Guidance notes. for Patient Safety and Pharmacovigilance in Patient Support Programmes
Guidance notes for Patient Safety and Pharmacovigilance in Patient Support Programmes 9 May 2011 Approval Status Authors The ABPI Pharmacovigilance Expert Network Change History N/A Approval Date 9 May
Performance Management in Public Sector Organisations: The Contribution of the CAF
Seminar Performance Management in Public Sector Organisations: The Contribution of the CAF Maastricht (NL), 17-19 February 2016 European Institute of Public Administration Institut européen d administration
How to extract transform and load observational data?
How to extract transform and load observational data? Martijn Schuemie Janssen Research & Development Department of Pharmacology & Pharmacy, The University of Hong Kong Outline Observational data & research
Level crossing signs from the view of road users in Europe. Tamás Déri Hungarian NSA
Level crossing signs from the view of road users in Europe. Tamás Déri Hungarian NSA Due to the different approach on level crossing regulation in the European Union, we made a survey within the European
COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS GUIDELINE FOR THE CONDUCT OF POST-MARKETING SURVEILLANCE STUDIES OF VETERINARY MEDICINAL PRODUCTS
The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology EMEA/CVMP/044/99-FINAL COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS GUIDELINE FOR THE CONDUCT
Risk Management in the Pharmaceutical Industry. Elena Apetri, Global Medical Safety Surveillance Schering AG
Risk Management in the Pharmaceutical Industry Elena Apetri, Global Medical Safety Surveillance Schering AG Topics Environment Safety Risk Management Guidance Safety RM Systems Signal detection and evaluation
1. WEBAE - LEVERAGING EMERGING TECHNOLOGY FOR PHARMACOVIGILANCE
1. WEBAE - LEVERAGING EMERGING TECHNOLOGY FOR PHARMACOVIGILANCE SUMMARY The last 5 years have seen a number of highly disruptive and interrelated changes in the consumer technology market: Digital media
8. To ensure the accurate use of all pharmacy computer systems and to record all issues, receipts and returns of medicines.
JOB DESCRIPTION JOB TITLE PAY BAND DIRECTORATE / DIVISION DEPARTMENT BASE RESPONSIBLE TO ACCOUNTABLE TO RESPONSIBLE FOR Student Pharmacy Technician Band 4 (1st year 70% of top point on band 4, 2 nd year
European Alliance for Apprenticeships
European Alliance for Apprenticeships Dana BACHMANN Head of Unit DG DGVT Meeting, Dublin 21-22 May 2013 Context 26.5 million unemployed, out of which 5.7 million young people lowest rates DE and AU (both
The EMA current activities towards ISO IDMP implementation
The EMA current activities towards ISO IDMP implementation An overview Ginas meeting 11 June 2014 Presented by: Ilaria Del Seppia, B-BD-DCM EMA An agency of the European Union Outlines EMA Vision: Objectives
Current Status of Databases in Japan
Current Status of Databases in Japan 2012.03 Kiyoshi Kubota, MD, PhD, FISPE Department of Pharmacodpiemiology, Graduate School of Medicine, University of Tokyo [email protected] NPO Drug Safety Research
Czech Universities and the Environment for Innovation. Rudolf Hanka
Czech Universities and the Environment for Innovation Rudolf Hanka Czech Republic a cauldron of Central Europe? Geographical position Major motorways High speed backbone network Czech internet network
OHIM SEARCH TOOLS: TMVIEW, DSVIEW AND TMCLASS. Making trade mark and design information readily available for users
OHIM SEARCH TOOLS: TMVIEW, DSVIEW AND TMCLASS Making trade mark and design information readily available for users Mariano Riccheri Moscow, 24 September 2015 INTERNATIONAL COOPERATION AREA European Cooperation:
TEMPLATE DATA MANAGEMENT PLAN
TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager
European judicial training 2014. Justice
European judicial training 2014 Justice Europe Direct is a service to help you find answers to your questions about the European Union. Freephone number (*): 00 800 6 7 8 9 10 11 (*) Certain mobile telephone
S P E C I A L I S T A N D M A S T E R S T U D I E S
University Ss, Cyril and Methodius Skopje FACULTY OF PHARMACY S P E C I A L I S T A N D M A S T E R S T U D I E S Healthcare management and pharmacoeconomics Skopje, 2007 STUDY PLAN -Specialist Studies-
Singapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY
Singapore Clinical Trials Register Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY Clinical Trial Register Global Trend EMA: EU Clinical Trials
DHL Door-To-More UNLOCKING THE POTENTIAL OF DIRECT DISTRIBUTION
DHL Door-To-More UNLOCKING THE POTENTIAL OF DIRECT DISTRIBUTION 2 DHL Door-To-More TM DHL Door-To-More 3 DHL DOOR-TO-MORE The seamless intercontinental door-to-door distribution solution that delivers
the EU framework programme for research and innovation
the EU framework programme for research and innovation The Multiannual Financial Framework 2014-2020: Commission s proposals of 29 June 2011 1. Smart & inclusive growth ( 491bn) Education, Youth, Sport
Professor Heikki Ervasti University of Turku Department of Social Research [email protected] 02-333 5706 040-511 7146
Professor Heikki Ervasti University of Turku Department of Social Research [email protected] 02-333 5706 040-511 7146 Takis Venetoklis University of Turku Department of Social Research [email protected]
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
Risk Assessment in the Pharmaceutical Industry. Dorothea Köppe Liability Insurance: The Never-ending Story September 9th, 2009
Dorothea Köppe Liability Insurance: The Never-ending Story September 9th, 2009 - the 6 W WER WAS WANN WO WIE WARUM WHO WHAT WHEN WHERE HOW WHY 2009 Page 2 _10-Sep-09 Definitions 2009 Page 3 _10-Sep-09
Connecting Basic Research and Healthcare Big Data
Elsevier Health Analytics WHS 2015 Big Data in Health Connecting Basic Research and Healthcare Big Data Olaf Lodbrok Managing Director Elsevier Health Analytics [email protected] t +49 89 5383 600
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
Diagnostic Tests. Brad Spring Director, Regulatory Affairs
Regulatory Challenges in the Development of Diagnostic Tests Industry Perspective Brad Spring Director, Regulatory Affairs September 28, 2011 Balancing Evidence of Safety & Effectiveness and Time to Market
Permanent call for expression of interest
2 September 2015 EMA/471207/2015 Administration Division 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5565 Send a question via our
Stakeholder 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,
Post-authorisation safety studies and the EU PAS Register
Post-authorisation safety studies and the EU PAS Register Xavier Kurz European Medicines Agency EMA, 11 October 2012 An agency of the European Union Content of the presentation 1. PASS: definition and
Guideline on good pharmacovigilance practices (GVP)
22 June 2012 EMA/827661/2011 Guideline on good pharmacovigilance practices (GVP) Module IX Signal management Draft finalised by the Agency in collaboration with Member States and submitted to ERMS FG 19
MINING ELECTRONIC HEALTHCARE RECORD DATABASES TO AUGMENT DRUG SAFETY SURVEILLANCE
MINING ELECTRONIC HEALTHCARE RECORD DATABASES TO AUGMENT DRUG SAFETY SURVEILLANCE Preciosa Miguel Coloma ISBN: 978-94-6191-258-9 Cover design and layout by Catherine Coloma Layout by Legatron Electronic
EUROPEAN AREA OF SKILLS AND QUALIFICATIONS
EUROPEAN AREA OF SKILLS AND QUALIFICATIONS REPORT Fieldwork: April - May 2014 Publication: June 2014 This survey has been requested by the European Commission, Directorate-General for Education and Culture
Guideline on Detection and Management of Duplicate Individual Cases and Individual Case Safety Reports (ICSRs)
London, 21 April 2009 Doc. Ref. EMA/13432/2009 Committee for Medicinal Products for Human Use (CHMP) Guideline on Detection and Management of Duplicate Individual Cases and Individual Case Safety Reports
KNOWLEDGENT WHITE PAPER. Big Data Enabling Better Pharmacovigilance
Big Data Enabling Better Pharmacovigilance INTRODUCTION Biopharmaceutical companies are seeing a surge in the amount of data generated and made available to identify better targets, better design clinical
Clinical Trial Data Sharing
Clinical Trial Data Sharing NPA FDA Taskforce Meeting December 15, 2014 Joseph S. Ross, MD, MHS Section of General Internal Medicine, School of Medicine Center for Outcomes Research and Evaluation, Yale-New
Improving Teacher Quality the EU agenda
Improving Teacher Quality the EU agenda 1 Improving Teacher Quality the EU agenda Council Conclusions 2007: Improving the quality of teacher education 2008: Preparing young people for the 21st century:
The EU s 2030 Effort Sharing Agreement
The EU s 2030 Effort Sharing Agreement Brussels CEPS Workshop, 29.06.2015 Oliver Sartor, [email protected] Research Fellow, Climate & Energy Policy, IDDRI Celine MARCY, IDDRI Institute for Sustainable
Master program in paediatric clinical pharmacology: Scope, Organization, Training
Deliverable number D1.6 Master program in paediatric clinical pharmacology: Scope, Organization, Training GRiP Global Research in Paediatrics Network of Excellence HEALTH-F5-2010-261060 Lead Beneficiaries:
The Evidence Base on Lifelong Guidance
TRISTRAM HOOLEY The Evidence Base on Lifelong Guidance A GUIDE TO KEY FINDINGS FOR EFFECTIVE POLICY AND PRACTICE EXTENDED SUMMARY ELGPN Tools No. 3 The Evidence Base on Lifelong Guidance: a Guide to Key
TEPZZ 6_Z76 A_T EP 2 610 763 A1 (19) (11) EP 2 610 763 A1 (12) EUROPEAN PATENT APPLICATION. (51) Int Cl.:
(19) TEPZZ 6_Z76 A_T (11) EP 2 6 763 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: 03.07.2013 Bulletin 2013/27 (51) Int Cl.: G06F 17/30 (2006.01) (21) Application number: 12192220.7 (22)