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PROTECT Benefit-Risk | protectbenefitrisk.eu Reviews

https://protectbenefitrisk.eu

PROTECT Benefit-Risk

INTERNAL PAGES

protectbenefitrisk.eu protectbenefitrisk.eu
1

PROTECT Benefit-Risk

http://www.protectbenefitrisk.eu/index.html

Patient and Public Involvement. PROTECT Benefit-Risk Group is a collaboration amongst private and public sector partners. Read more. About our expert members. Our experience has been distilled into a clear set of practical recommendations for benefit-risk decision processes and supporting tools, organised around five generic stages. Read more. Methodologies related to benefit-risk assessment fall into four categories. To learn more about them, click here. Welcome to the PROTECT Benefit-Risk Website.

2

PROTECT Benefit-Risk

http://www.protectbenefitrisk.eu/lng.html

Patient and Public Involvement. Benefit- Risk integration and representation. Recommendations of the IMI-PROTECT Benefit-Risk. Hughes et al, Recommendations for the methodology and visualisation techniques to be used in the assessment of benefit and risk of medicines, Nov 2013. Review of methodologies for benefit-risk assessment of medicines. Mt-Isa et al, Review of methodologies for benefit and risk assessment of medication, May 2013. Wave 1 Case Studies. Visual representation review - Part one. Philips...

3

PROTECT Benefit-Risk

http://www.protectbenefitrisk.eu/recommendations.html

Patient and Public Involvement. Evidence Gathering And Data Preparation. Challenging scenarios for structured benefit-risk assessment. Introduction to the benefit-risk assessment roadmap. The experience of the case study teams has been distilled into a clear set of practical recommendations for benefit-risk decision processes and supporting tools, and these are organised around the five stages of a generic benefit-risk assessment roadmap (Figure 1). Figure 1 Benefit-risk assessment roadmap. Useful method...

4

PROTECT Benefit-Risk

http://www.protectbenefitrisk.eu/Natalizumab.html

Patient and Public Involvement. Which methodologies were tested? What are the lessons learned? What are the key messages? This report details a case study for assessing the benefit-risk of natalizumab for the treatment of relapsing remitting multiple sclerosis (RRMS) versus placebo or alternative RRMS drugs interferon 𝛽. 1a and glatiramer acetate. 1Should natalizumab be given marketing approval at the time of first registration given the evidence of PML in clinical trials? The following pages provide a ...

5

PROTECT Benefit-Risk

http://www.protectbenefitrisk.eu/Telithromycin.html

Patient and Public Involvement. Which methodologies were tested? What are the lessons learned? What are the key messages? Currently registered treatments by indication are:. 1CAP: Amoxicillin, Clarithromycin, Trovafloxacin,. 2AECB: Amoxicillin-clavulanic acid, Cefuroxime, Clarithromycin, Azithromycin. 3ABS: amoxicillin-clavulanic acid, and cefuroxime. 4TP: Penicillin, clarithromycin. The objective of this case study is to assess the feasibility and suitability of selected approaches for benefit-risk asse...

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LINKS TO THIS WEBSITE

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/credits.shtml

This website has been developed and is hosted by the European Medicines Agency (EMA), 30 Churchill Place, London, E14 5EU, UK. Content management: PROTECT Project Management Support Team. Contact: PROTECT Support@ema.europa.eu. ERoom - partners only. Adverse Drug Reactions Database. Drug Consumption Databases in Europe.

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/methodsRep.shtml

METHODS FOR SIGNAL DETECTION. Database of adverse drug reactions listed in the SPC of centrally authorised medicinal products. Database of adverse drug reactions listed in the SPC of centrally authorised medicinal products. WP 31 and WP3.8 Reference Dataset of adverse drug reactions (please note disclaimer). Reference dataset of ADRs WP 3.1 WP3.8. ERoom - partners only. Adverse Drug Reactions Database. Drug Consumption Databases in Europe.

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/copyright.shtml

Documents made available to the public may be reproduced and/or distributed, totally or in part, irrespective of the means and/or the formats used, for non-commercial and commercial purposes, provided that the PROTECT consortium is always acknowledged as the source of the material. Such acknowledgement must be included in each copy of the material. Citations may be made from such material without prior permission, provided the source is always acknowledged. ERoom - partners only.

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/news.shtml

PROTECT WP2 on PDS Special issue. The Pharmacoepidemiology and Drug Safety journal has published a Special Issue on the IMI-PROTECT WP2. The European Medicines Agency has announced it on its website with links to the main publications and a summary of the main results. You can find all the information here. ADR Database - Update now available. PROTECT at ICPE 2015. The report can be accessed through this link. PROTECT Symposium - materials available in the PROTECT website. Of the PROTECT website. PROTECT...

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/symposium.shtml

In this section you will find all presentations given at the PROTECT Symposium, which was held at the European Medicines Agency in London, on the 18-19-20 February 2015. Also, recordings from the event, which are available at the EMA YouTube Channel, can be accessed through the links below. Finally, a list of participants is available at the bottom of the page. PROTECT Symposium 18-20 Feb 2015 programme. PROTECT pre-Symposium Training Sessions - 18/02/2015 (20 videos). 31 Signal Detection in Practice-EMA.

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/disclaimer.shtml

This website is maintained to keep the public informed about the activities of the PROTECT consortium. Our goal is to keep this information and material timely and accurate. If errors are brought to our attention, we will try to correct them. In particular, the consortium is indemnified from and against all costs, proceedings, claims, expenses and liabilities whatsoever arising from any breach by any legal or natural person as a result of any representation or warranty providing to be a misrepresentation.

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/drugConsumption.shtml

Drug Consumption Databases in Europe. The inventory of Drug Consumption Databases in Europe. Is a comprehensive and structured source of information on drug consumption in Europe. It comprises two documents. The master document contains a detailed report of the available information, methods to retrieve this information, a description of the validity of national. Drug consumption data and a discussion. The country profile document summarizes the main results by country. Exploration of the availability of...

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/links.shtml

Innovative Medicines Initiative (IMI). European Commission Research Directorate-General. ERoom - partners only. Adverse Drug Reactions Database. Drug Consumption Databases in Europe.

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/index.shtml

Welcome to the PROTECT website! The latest version of the Adverse Drug Reaction database, updated up to 30 June 2015 in now available on the PROTECT website and can be accessed here. PROTECT WP2 on PDS Special Issue. The Pharmacoepidemiology and Drug Safety journal has published a Special Issue on the IMI-PROTECT WP2. The European Medicines Agency has announced it on its website with links to the main publications and a summary of the main results. You can find all the information here. Presentations fro...

imi-protect.eu imi-protect.eu

PROTECT Home

http://www.imi-protect.eu/results.shtml

Key achievements of PROTECT. Framework for pharmacoepidemiology studies. Methods for Signal Detection. New Methods for data collection from consumers. Benefit-Risk integration and representation. ERoom - partners only. Adverse Drug Reactions Database. Drug Consumption Databases in Europe.

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Patient and Public Involvement. PROTECT Benefit-Risk Group is a collaboration amongst private and public sector partners. Read more. About our expert members. Our experience has been distilled into a clear set of practical recommendations for benefit-risk decision processes and supporting tools, organised around five generic stages. Read more. Methodologies related to benefit-risk assessment fall into four categories. To learn more about them, click here. Welcome to the PROTECT Benefit-Risk Website.

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