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PROTECT HomePharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium
http://www.imi-protect.eu/
Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium
http://www.imi-protect.eu/
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PROTECT Home | imi-protect.eu Reviews
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Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium
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PROTECT Home
http://www.imi-protect.eu/governance.shtml
The PROTECT governance structure is a multi-layer structure comprising three components:. Governance and scientific oversight. Project management and administration. Project Management Support Team. Managing Entity of the IMI JU fund. All Work Package members. The interactions between the involved structures are depicted in the following diagram:. Includes one representative from each PROTECT participant and meets, in principle, once a year. Main roles and responsibilities:. Adoption of the annual budget;.
PROTECT Home
http://www.imi-protect.eu/objectives.shtml
The overall objective of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe. In order to achieve this overall goal, PROTECT has been designed as a comprehensive and integrated project aiming to develop and validate a set of innovative tools and methods that will:. Enhance data collection directly from consumers of medicines in their natural language in several European Union countries, using modern tools of communication;. Test and validate various methods developed in PRO...
PROTECT Home
http://www.imi-protect.eu/adverseDrugReactions.shtml
Adverse Drug Reactions Database. The PROTECT ADR database. The current database has been updated up to 30 June 2015 based on latest available SPC which can be found on the European Commission website. The database includes for each product the date of the SPC which has been used to list ADRs. It is aimed to routinely update the database at least once a year based on amended SPCs. It can also be amended between routine updates to correct data entries. A data set of established ADRs also allows a compariso...
PROTECT Home
http://www.imi-protect.eu/workprogram.shtml
The total work programme has been divided among seven Work Packages (WPs), which may be described as follows:. One WP concerned with all aspects of the organisation and management of PROTECT:. WP1: Project management and administration. Four 'vertical' WPs targeting the specific scientific objectives and methodological developments:. WP2: Framework for pharmacoepidemiology (PE) studies. WP3: Methods for signal detection. WP4: New methods for data collection from consumers. WP7: Training and communication.
PROTECT Home
http://www.imi-protect.eu/pregnancyStudy.shtml
What is the study about? This study is being carried out to test new ways of collecting information on lifestyle factors, health and use of medicines throughout pregnancy in a large number of pregnant women. This information is needed to help find out more about the safety of medicines in pregnancy, so we can improve the advice given to pregnant women who need to take medicines. This study would like to answer to the following questions:. Bull; How are medicines used during pregnancy? Please click on the...
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drugis.org | Projects
http://www.drugis.org/about/projects
Our current work on ADDIS 2. Is part of the IMI GetReal. Project. The ADDIS 1. Project was funded by TI Pharmas Escher. Project. Additional funding for the further development of the MCDA user interface. Was received from the IMI PROTECT. GetReal (IMI, 2013 - 2016). Incorporating real-life clinical data into drug development. Project is part of work package 4,. Promoting best practice in evidence synthesis and predictive modelling of relative effectiveness. Escher Project (TI Pharma, 2008 - 2013). In wor...
Links
http://www.scopejointaction.eu/links
Work Package 1 â Coordination. Work Package 2 â Communication and Dissemination. Work Package 3 â Evaluation. Work Package 4 â ADR Collection. Work Package 5 â Signal Management. Work Package 6 â Risk Communications. Work Package 7 â Quality Management Systems. Work Package 8 â Lifecycle Pharmacovigilance. Skip to main Content. You are here: Home. Please click on a hyperlink to access the relevant page. Showing 1-10 of 11 links. 2010 European Pharmacovigilance Legislation. Showing 1-10 of 11 links.
ENCePP Home Page
http://www.encepp.eu/Training.shtml
PhEpi and PhV activities. Training in Pharmacoepidemiology and Pharmacovigilance. Offered by its partners and other centres. Like ENCePP, the. European Programme in Pharmacovigilance and Pharmacoepidemiology (Eu2P). Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT). Projects aim to strengthen the monitoring of the benefit-risk of medicines in Europe. The Eu2P training partnership. Eu2P is the first European online education and training programme in pharmacov...
ENCePP Home Page
http://www.encepp.eu/links.shtml
PhEpi and PhV activities. See also: ENCePP Linking Policy. 8226; EU Regulatory Bodies. European Commission - DG Health and Consumer Protection. European Commission - DG Research and Innovation/Health. 8226; Learned Societies. International Society for Pharmacoepidemiology (ISPE). International Society for Pharmacovigilance (ISoP). International Society for Pharmacoeconomics and Outcomes Research (ISPOR). European Association for Clinical Pharmacology and Therapeutics (EACPT). 8226; Training Opportunities.
ENCePP Home Page
http://www.encepp.eu/events/index.shtml
PhEpi and PhV activities. Upgrade of EU PAS Register. A new version of the EU PAS Register was released on 14 July 2016. This latest upgrade includes a number of performance enhancements and important improvements in terms of searching and data management. From now on it will be possible to search the database by the unique study identifier which will also be displayed with the study record on screen and included on printouts. A new mandatory data field titled ' RMP study category. Raquo; EU PAS Register.
BIFAP » Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria
http://bifap.aemps.es/proyectos.php
Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria. Solicitud de estudios a BIFAP. Multiple Imputation Strategies for multi-database drug Safety Studies: the MISS Collaboration. Eventos tromboembolicos venosos asociados al tratamiento con medicamentos anti-osteoporosis. Http:/ www.advance-vaccines.eu/. Http:/ www.safeguard-diabetes.org/. Desarrollar un conjunto de herramientas y métodos que mejoren la detección precoz de las reacciones adversas de los medicamentos, así como su...
Panacea News Archives » Pharmacovigilance.
http://www.panaceapharmaprojects.com/panacea-news
Tel: 44 1624 672777. Vision, Mission, & Values. Why Clients Choose Us. Panacea update on ISO IDMP implementation. Whilst ISO IDMP is still a few years away from its complete implementation, Panacea is using our current PV and XEVMPD knowledge to stay ahead of the curve. We can see that this project will improve the protection of public health in the EU and hope you will find this update useful for this important step in our industry. A new database will be created with the SPOR data, but the data current...
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PROTECT Home
Welcome to the PROTECT website! The latest version of the Adverse Drug Reaction database, updated up to 30 June 2016 in now available on the PROTECT website and can be accessed. The European Medicines Agency (EMA) evaluates regulatory impact of PROTECT. In the course of this evaluation, a survey tool to measure the public health impact and feasibility of research projects has been developed and piloted. The report is available here. PROTECT WP2 new publications added. Two new publications from WP2 are no...
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