erstbewertende Kommission
English translation: leading ethics committee (LEC)
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| 22:52 Jan 22, 2019 |
| German to English translations [PRO] Medical - Medical: Pharmaceuticals / Regulatory document | |||||||
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|  Selected response from: andres-larsen Venezuela Local time: 13:15 | ||||||
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| Summary of answers provided | ||||
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| 1 | leading ethics committee (LEC) |
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| Summary of reference entries provided | |||
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| early benefit assessment (EBA) and ethical committees |
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| Discussion entries: 2 | |
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Answers
13 hrs confidence: 
leading ethics committee (LEC) Explanation: leading ethics committee (LEC) sources: ETHICS COMMITTEE INFORMATION - non grouped - NIH Collaboratory https://www.nihcollaboratory.org/.../ETHICS COMMITTEE%... As of 2012, Germany had a total of 53 research ethics committees ("ECs"), ...... This accredited EC plays the role of a Leading Ethics Committee (LEC) by ... interaction with ethics committees before, during and after a clinical trial. ctu.dk/media/12418/ECRIN_TWG_D2.pdf 6.2 Clinical Trial Submissions to ethics committees for approval. 14 ..... In Germany, the lead ethics committee is exclusively responsible for the ...... to the LECs. Planning Snapshot - Belgium - NIH Collaboratory https://www.nihcollaboratory.org/.../DispForm.aspx?ID... 7 mar. 2018 - This accredited EC plays the role of a Leading Ethics Committee (LEC) by coordinating the opinion of the local EC of each participating site. DRKS - Deutsches Register Klinischer Studien (German Clinical Trials ... https://www.drks.de/drks_web/navigate.do?navigationId=glossa... 22 nov. 2017 - Approved. Approval of the ethics committee. A trial must not be started before approval of the (leading) ethics committee. ETHICS COMMITTEE INFORMATION - Belgium - NIH Collaboratory https://www.nihcollaboratory.org/.../ETHICS COMMITTEE%... 23 ene. 2015 - This accredited EC plays the role of a Leading Ethics Committee (LEC) by coordinating the ... Only fully recognized ethics committees can give the single opinion required for multicenter trials. ... CIS Drug Or Medical Device. Agence Fédérale des Médicaments et des Produits de ... - Europa EU https://ec.europa.eu/health/sites/.../pc.../list_sa_be_eng_e... Describes general situations that lead to substantial amendments. → Annex 1 ... Competent Authority (CA) and the Leading Ethics Committee (LEC). The CA is ... Clinical Trials in Belgium: The Implementation of the European ... https://books.google.com/books?isbn=9050954200 - Caroline Trouet - 2004 - Law Single request for supplementary information by leading ethics committee: clock stop 161. During the review term of the application, the LEC may issue a single ... -------------------------------------------------- Note added at 16 hrs (2019-01-23 15:24:29 GMT) -------------------------------------------------- Glad to have been of help @Sarai Pahla (MD) MBChB, good luck with your endeavours! -------------------------------------------------- Note added at 945 days (2021-08-25 11:30:31 GMT) Post-grading -------------------------------------------------- Better late than never! Glad that this did help you when needed. |
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Reference comments
49 mins |
| Reference: early benefit assessment (EBA) and ethical committees Reference information: Early benefit assessment (EBA) in Germany: analysing decisions 18 ... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4059963/ J Ruof - 2014 - Since the introduction of the German health care reform in January 2011, an early benefit assessment (EBA) is required for all new medicines. Pharmaceutical manufacturers have to submit a benefit dossier for evaluation by the Institute for Quality and Efficiency in Health Care (IQWiG). A final decision is made by the Federal Joint Committee (G-BA). Patient relevant endpoints in oncology: current issues in the context of ... https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3901346/ I Dabisch - 2014 - 24 ene. 2014 - Ethical committees, caregivers and patients often demand ..... Outcomes of German HTA early benefit assessments in Oncology, 2011-2013 (all ... Early benefit assessment for pharmaceuticals in Germany ... https://www.researchgate.net/.../258201872_Early_benefit_ass... - early benefit assessment supports timely and transparent .... sier to the Federal Joint Committee providing evidence ..... We also examined the methodological and ethical challenges of comparative effectiveness research when determining. -------------------------------------------------- Note added at 56 mins (2019-01-22 23:48:49 GMT) -------------------------------------------------- Early Benefit Assessment for Pharmaceuticals in Germany: Lessons ... https://www.commonwealthfund.org/.../early-benefit-assessmen... 16 oct. 2013 - The German Pharmaceutical Market Restructuring Act experience provides lessons for the United States, where comparative effectiveness ... Four years of early benefit assessment of new drugs in Germany: a ... https://www.ncbi.nlm.nih.gov/pubmed/26837412 C Blome - 2017 - Eur J Health Econ. 2017 Mar;18(2):181-193. doi: 10.1007/s10198-016-0765-6. Epub 2016 Feb 2. Four years of early benefit assessment of new drugs in ... Early benefit assessment of new drugs in Germany - results from 2011 ... https://www.ncbi.nlm.nih.gov/pubmed/24472328 H Hörn - 2014 - Health Policy. 2014 Jun;116(2-3):147-53. doi: 10.1016/j.healthpol.2013.12.008. Epub 2014 Jan 8. Early benefit assessment of new drugs in Germany - results ... www.iqwig.de - Early benefit assessment increases transparency for ... https://www.iqwig.de/.../early-benefit-assessment-increases-... Their conclusion: Company dossiers and dossier assessments performed by IQWiG , which are published during the early benefit assessment of new drugs, ... AMNOG UPDATE – 17th of November 2017: G-BA publishes the ... https://skc-beratung.de/pharmaceutical/amnog-update1711?lang... 17 nov. 2017 - G-BA, etelcalcetid, pembrolizumab, rolapitant, early benefit assessment, ... With the KEYNOTE 087 a single-arm multicenter study was ... Inconsistent approaches of the G-BA regarding acceptance of primary ... https://bmchealthservres.biomedcentral.com/.../s12913-016-19... T Staab - 2016 - 14 nov. 2016 - Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent ... -------------------------------------------------- Note added at 1 hr (2019-01-22 23:52:34 GMT) -------------------------------------------------- www.iqwig.de - Dossier assessments https://www.iqwig.de/en/methods/.../dossier-assessments.3318... The G-BA then commissions IQWiG , which uses the dossier to assess whether such an ... G-BA: Information on early benefit assessment · Contributing expert ... -------------------------------------------------- Note added at 1 hr (2019-01-23 00:46:34 GMT) -------------------------------------------------- multicentre clinical trial leader ethics committee prior positive vote: Eurecnet - Information - Germany archive.eurecnet.org/information/germany.html According to AMG § 40 Sect. 1, 2nd sentence, clinical trials may only commence if there is a prior positive vote by an ethics committee. If no such vote is given, the trial may only commence if the competent authority the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, hereinafter referred to as BfArM) as indicated in § 77 Sect. 1 AMG) does not gain, within a period of 60 days. - As far as multi-centre trials are concerned a problem existed with the AMG because there were no legally binding guidelines of how to handle a situation where different regionally competent ethics committees involved in the same multi-centre study came to differing conclusions in terms of the ethical evaluation. According to § 20 Sect. 7, 2nd sentence, the vote of just one ethics committee is enough to fulfil the preconditions of the MPG in the case of multi-centre trials. § 92, 3rd sentence StrlSchV and § 28g, 3rd sentence RöV delineate, that in the case of multi-centre trials, the vote of one committee is sufficient. -------------------------------------------------- Note added at 12 hrs (2019-01-23 11:50:57 GMT) -------------------------------------------------- @Sarai Pahla (MD) MBChB Thank you so much for your asker / peer comment and am posting suggested translation expeditiously in reply! |
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