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1 Medicinal Products Act (Arzneimittelgesetz – AMG)
https://www.gesetze-im-internet.de/englisch_amg/
Section 39dOther procedural provisions for traditional herbal medicinal products ; Division 6 ; Section 40General conditions for clinical trials.
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2 Publication of clinical trials results acc. Section 42b AMG - BfArM
http://www.bfarm.de/EN/Medicinal-products/Licensing/FollowUp-procedures/Publication-clinical-trials-results/_node.html
Section 42b AMG refers to the provision of result reports of clinical trials with licensed medicinal products for publication by the higher federal authorities.
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3 [Differences between clinical trials according to the ... - PubMed
https://pubmed.ncbi.nlm.nih.gov/12589461/
Results: Whereas AMG-based trials focus on the proof of efficacy of pharmaceutical agents, the MPG demands instead proof of functionality of the medical devices ...
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4 Clinical trial Protocol according to the German Medicinal ...
https://clinicaltrials.gov/ProvidedDocs/85/NCT03869385/Prot_000.pdf
Clinical trial Protocol according to the German. Medicinal Products Act (AMG). Title of the trial. Randomised controlled multicentre study ...
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5 Transmission Result Reports pursuant to 42b AMG ...
https://www.pei.de/EN/regulation/clinical-trials/result-reports-42b-amg/result-reports-42b-amg-node.html
This obligation applies regardless of whether one or more than one study centres were located in Germany, i.e. even if the entire clinical trial ...
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6 Medicinal Products Act (AMG) - MEDICRO |
https://en.medicro.de/encyclopedia/medicinal-products-act/
Germany and Austria both have laws regulating the trade of medicinal products. The primary objective of the legislators when enacting these laws is to ensure ...
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7 Medicinal Products Act (Arzneimittelgesetz – AMG) - LawEuro
https://laweuro.com/?p=14930
Laws / Regulations of Germany ... Section 42b Publication of the results of clinical trials. CHAPTER SEVEN Sale of medicinal products.
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8 Commercialisation of Healthcare in Germany: Overview
https://ca.practicallaw.thomsonreuters.com/2-617-6695?transitionType=Default&contextData=(sc.Default)
The German Drugs Act (Arzneimittelgesetz) (AMG) defines medicines as ... labelling) medicinal products intended for clinical trials, ...
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9 Medicinal Products Act (AMG) adapted to EU Regulation 536 ...
https://www.clipservices.de/en/aktuelles-2/aktuelles-uebersicht-2/116-amg-anpassung-an-eu-verordnung-536-2014-2
The Amendment of the German Medicinal Products Act [Arzneimittelgesetz – AMG] enters into force. The Clinical Trials Regulation, Regulation EU No 536/2014 ...
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10 According to Medicinal Products Act (Arzneimittelgesetz - AMG)
https://mediacc.de/en/mediacc/clinical-studies/according-to-medicinal-products-act-arzneimittelgesetz-amg/
Every Clinical Trial is Unique. Clinical trials are medical research procedures involving people. They are performed with human volunteers or patients in ...
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11 Best Practice Guide for Regulatory Affairs in a German CRO
https://www.dgra.de/media/pdf/studium/masterthesis/master_gurschke_e.pdf
Arzneimittelgesetz (German Drug Law / German Medicinal Products Act) ... Based on § 42a(4) AMG [22] the clinical trial has to be stopped immediately, if the.
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12 MEDICINAL PRODUCTS ACT (THE DRUG LAW)
https://www.gmp-compliance.org/guidelines/gmp-guideline/medicinal-products-act-the-drug-law-arzneimittelgesetz-amgof-the-federal-republic-of-germany
MEDICINAL PRODUCTS ACT (THE DRUG LAW) - (ARZNEIMITTELGESETZ – AMG)of the FEDERAL REPUBLIC OF GERMANY. Short Title: German Drug Law. Internet:.
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13 [Differences between clinical trials according ... - ResearchGate
https://www.researchgate.net/publication/8217197_Differences_between_clinical_trials_according_to_the_German_law_on_pharmaceuticals_Arzneimittelgesetz_and_trials_according_to_the_German_law_on_medical_products_Medizinproduktegesetz
The aim of MPG trials is thus CE marking instead of AMG-based registration. However, this focus on functionality implies that medical devices ...
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14 Clinical Trials with medicinal products on humans - Leopoldina
https://www.leopoldina.org/uploads/tx_leopublication/2014_02_Clinical_Trials_with_medicinal_products_on_humans.pdf
EC, clinical trials of medicinal products on human subjects in Germany are regulat- ed by the German Medicinal Products Act. (AMG) and the physicians' ...
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15 Clinical trials with medicinal products – AKEK
https://www.akek.de/en/arzneimittelgesetz-amg/
Here you will find information and assistance for the submission of a clinical study according to the German Medical Product Act (AMG) to one or more ethics ...
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16 II. Legal aspects - DRZE
https://www.drze.de/in-focus/medical-research-involving-minors/legal-aspects
Germany does not currently have any comprehensive special statutory regulations (see ... While § 40 AMG contains general preconditions for a clinical trial, ...
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17 Medicinal product regulation and product liability in Germany
https://content.next.westlaw.com/6-500-7507?__lrTS=20220725070802359
The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, ...
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18 GCP Refresher (AMG) - myGCP.world
https://www.mygcp.world/webshop/German-Refresher-Course.html
Refresher course for study nurses and members of an investigational team in clinical trials according to the German Medicines Act, the AMG (curricular ...
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19 Amgen | A Worldwide Pioneer in Biotechnology
https://www.amgen.com/

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20 Germany - BfArM's recommendations regarding clinical trials ...
https://www.ris.world/germany-bfarms-recommendations-regarding-clinical-trials-with-medicinal-products-where-sponsor-or-legal-representative-are-established-in-the-united-kingdom/
For clinical trials in which there is no sponsor or ... affected in accordance with Section 42a (3) of the German Medicines Act (AMG) prior ...
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21 Q&A: pharma & medical device regulation in Germany
https://www.lexology.com/library/detail.aspx?g=4e521a96-5e31-43f8-a45e-e4d080d32452
Sections 40 to 42b of the AMG provide the regulations and conditions for clinical trials. Reporting requirements. What requirements exist for ...
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22 Insurance for clinical trials - HDI Global
https://www.hdi.global/insurance/sector-specific-and-combined-cover/clinical-trials/
Patients taking part in clinical trials can be exposed to increased health ... with the German Pharmaceutical Products Act (AMG); clinical trials of medical ...
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23 Erenumab (AMG 334) Key Clinical Trials By The Numbers
https://www.novartis.com/news/media-library/erenumab-amg-334-key-clinical-trials-numbers
Erenumab (AMG 334) Key Clinical Trials By The Numbers ... Erenumab has been studied in several large, global, randomized, double-blind, placebo-controlled studies ...
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24 The New Clinical Trials Regulation EU No 536/2014
https://blog.profil.com/blog/new-clinical-trials-regulation-eu-no-536/2014-amendments-german-drug-law
Learn about the changes on the German Drug Law regarding clinical ... of the AMG (Arzneimittelgesetz), related to the new Clinical Trials ...
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25 Clinical Trial Application – EudraCT - Germany
https://www.acps-network.com/wp-content/uploads/2018/05/acps-library-ctm-eudract-application-de.pdf
of clinical trials on medicinal products for human use") ... Satz 2 Arzneimittelgesetz (AMG) sowie § 7 der Rechtsverordnung nach § 42 Abs. 3 AMG (GCP-V), ...
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26 Efficacy and Safety of AMG 570 in Subjects With Active ...
https://www.amgentrials.com/study/?id=20170588
Clinical Trial Summary: 20170588. Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE). Trial Status: Recruiting.
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27 Clinial trials with medicinal products - BASG
https://www.basg.gv.at/en/healthcare-professionals/clinical-trials/clinial-trials-with-medicinal-products
The tariffs for academic clinical trials of medicinal products are thus no ... Newsletter on clinical trial statistics according to AMG.
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28 Clinical trials - Cluster Medizin.NRW
https://www.medizin.nrw/en/topics/clinical-trials/
Clinical trials require approval and are subject to the German Medicines Act (AMG). A clinical trial in humans is “any investigation conducted in humans ...
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29 Life Sciences 2022 - Chambers Global Practice Guides
https://practiceguides.chambers.com/practice-guides/comparison/660/8625/13682-13686-13693-13703-13705-13708-13714-13720-13727-13735-13740
German law requires that clinical trial participants not only provide ... The German Drug Act (AMG), notably its Section 78, and the German ...
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30 AMG Archives - GCP Central
https://gcpcentral.com/product-tag/amg/
AMG · EU CTR Update Course for Clinical Drug Trials in Germany. € 199.00 · German Refresher Course_GCP Central_featured. Refresher ICH GCP Course for Clinical ...
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31 Regulatory and Start-up Guideline for Clinical Trials Germany
https://www.germannetpaet.de/fileadmin/Media/06_Material/Regulatory_and_Start-up_Guideline_Clinical_Trials_Germany_final_2019.pdf
AMG. Medicinal Products Act / German Pharmaceutical Act. AMGKostV. AMG Fee Regulation. BfArM. Federal Institute for Drugs and Medical ...
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32 Germany - Impact of Amendment of the German Drug Act on NIS
https://www.chcuk.co.uk/germany-impact-of-amendment-of-the-german-drug-act-on-nis/
Per Article 4 (23) AMG, non-interventional studies are not considered as clinical trials. Consequently the modifications described above and ...
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33 [Recording and reporting adverse reactions in clinical trials ...
https://czeek.com/ronbun/recording-and-reporting-adverse-reactions-in-clinical-trials-new-legal-provisions-according-to-the-12th-law-amending-the-german-drug-law-amg-and-the-ordinance-on-gcp-gcp-v/
New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)]. アブストラクト, With the 12th ...
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34 The new European clinical trials regulation
https://www.leukemia-net.org/international_trials/legislation/2001_20_ec___february_2013/e10092/infoboxContent10094/EU-Regulation.pdf
Frankfurt, Germany. The new European clinical ... “History” of the EU Drug Regulation. Germany. AMG Novelle 6.8.04 ... Clinical Trials Directive 2001/20/EG.
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35 Overview of the 14th Amendment of the German Drug Act
https://www.mondaq.com/germany/healthcare/38050/overview-of-the-14th-amendment-of-the-german-drug-act
18 AMG stipulated that a pharmaceutical entrepreneur was any person placing medicinal products under his own name onto the market. Sec. 4 para.
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36 Phase I study of AMG 211/MEDI-565 administered as ...
https://www.annalsofoncology.org/article/S0923-7534(19)48893-5/pdf
SPIRE: A phase Ib/ randomised IIa open label clinical trial combining ... Hamburg, Germany, 3Department of Medical Oncology and Comprehensive Cancer.
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37 Germany's Federal Institute for Drugs and Medical Devices
https://www.emergobyul.com/resources/europe/germany-federal-institute-drugs-medical-devices
European Authorized Representative for Clinical Trials · European Authorized Representative for Medical Device Companies · European MDR 2017/745 Gap Assessment ...
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38 Com pas sion ate Use Pro grammes - Pharmya
https://www.pharmya.com/wp-content/uploads/2022/11/Germany_Compassionate-Use-Programmes-PEI_28Oct2022.pdf
According to these regulations the use of unauthorized medicinal products is only possible in clinical trials but not.
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39 Study of AMG 673 in Subjects With Relapsed/Refractory Acute ...
https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2017-01941
Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid ... Trial Objectives and Outline ... Share this clinical trial with your doctor:.
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40 A. Clinical trials: Ethics Commission - Ethikkommission - Charité
https://ethikkommission.charite.de/en/application/antraege_extern/a_clinical_trials/
Clinical trials of medicines for human use falling under the revised German Medicinal Products Act (AMG). I. As of midnight, 30 September 2005, this is no ...
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41 AMG 853 - AdisInsight
https://adisinsight.springer.com/drugs/800027967
An open-label, phase I clinical trial was initiated in May 2010 to evaluate the pharmacokinetics of various tablet formulations of AMG 853 in 43 healthy ...
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42 EU Clinical Trials Register
https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-003461-35/HU
Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial ... D.3.9.2, Current sponsor code, AMG 552.
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43 KRasG12C inhibitors in clinical trials: a short historical ...
https://pubs.rsc.org/en/content/articlehtml/2020/md/d0md00096e
AMG 510 (10), developed by Amgen, was the first KRasG12C inhibitor that entered clinical trials in humans in August 2018 (NCT03600883).
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44 Download the IoT Clinical Trials Summit 2023 Agenda
https://www.amg-world.co.uk/iot-clinical-trials-us-2023-agenda/?utm_term
*By completing our forms, you understand and agree that the event organizer AMG World Ltd. may use your personal data in accordance with our privacy policy.
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45 Bettina Ziegele - AGAH
https://www.agah.eu/wp-content/uploads/Ziegele_InnovationOffice_PEI__RegulatoryOverview.pdf
clinical trials. Applications for ... AMG = German Medicinal Products Act. § = section ... Section 4 b (sub-section 3) of the German Medicinal. Products Act.
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46 AMG-900 | ≥99%(HPLC) | Selleck | Aurora Kinase inhibitor
https://www.selleckchem.com/products/amg-900.html
AMG 900 is a potent and highly selective pan-Aurora kinases inhibitor for ... including cell lines resistant to the antimitotic drug paclitaxel and to other ...
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47 Novartis' Phase II trial of AMG 334 demonstrates significant ...
https://www.clinicaltrialsarena.com/news/newsnovartis-phase-ii-trial-of-amg-334-demonstrates-significant-reduction-in-monthly-migraine-days-5007256/
Novartis' Phase II trial of AMG 334 demonstrates significant ... Chronic Heart Failure - Germany Drug Forecast and Market Analysis to 2022.
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48 amg International - The Future in Biodegradable GI Products
https://www.amggastro.com/
AMG International GmbH (AMG), is a Q3 Medical Limited Holding, a German ... UNITY-B is currently in clinical trials and not available for commercial sale.
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49 Clinical Trial on Advanced Solid Tumors: AMG 994, AMG 404
https://ichgcp.net/clinical-trials-registry/NCT04727554
› US Clinical Trials Registry
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50 Pharmaceutical Advertising Laws and Regulations Germany ...
https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/germany
Section 74a of the German Drug Act (Arzneimittelgesetz – AMG) stipulates that any ... “head to head” clinical trials before comparative claims may be made?
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51 Activation of Investigator-Initiated Clinical Trials with a ... - MDPI
https://www.mdpi.com/2072-6694/14/5/1308/htm
As examples, the number of clinical AMG-conform TOS performed by the German–Austrian–Swiss Society for Pediatric Oncology and Hematology (GPOH) dropped from 33 ...
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52 AMG 420 and AMG 701 in R/R myeloma - VJHemOnc
https://www.vjhemonc.com/video/yvuqywpgtki-amg-420-and-amg-701-in-rr-myeloma/
VJHemOnc – Video Journal of Hematological Oncology
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53 Clinical Trial Supply Service
https://www.phoenix-industrieportal.de/en/services/clinical-trial-supply-service
Your specialist for the procurement of comparators and drugs for clinical trials ... and secondary packaging in accordance with § 13 AMG (German Drug Law) ...
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54 Our Pipeline - BeiGene
https://www.beigene.com/our-science-and-medicines/pipeline/
For additional clinical trial information please visit clinicaltrials.gov. Tislelizumab (BGB-A317), an anti-PD-1 antibody. Pamiparib (BGB-290),
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55 Compassionate use in Europe - Osborne Clarke
https://www.osborneclarke.com/system/files/documents/22/03/30/Compassionate%20use%20product%20OCI%20-%20March%202022%28114177089.4%29.pdf
726/2004) or must be undergoing clinical trials for the ... The main statutory rule in Germany for compassionate use ... 6 AMG regulates the conditions.
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56 AMG 420 Continues to Show Efficacy in Relapsed/Refractory ...
https://www.ashclinicalnews.org/multiple-myeloma/amg-420-continues-show-efficacy-relapsed-refractory-myeloma/
Max S. Topp, MD, from the University Hospital of Würzburg in Germany, shared the findings at the 2019 American Society of Clinical Oncology ...
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57 National Information: Germany - Eurecnet
http://archive.eurecnet.org/information/germany.html
The AMG deals with pharmaceutical products and provides rules on the conduct of clinical trials in §§ 40-42 AMG. The following remarks apply to the AMG in ...
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58 Updated results from phase I dose-escalation study of AMG ...
https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.7508
Methods: AMG 330 was evaluated as a continuous IV (cIV) infusion using a 3+3 design. ... Clinical trial information: NCT02520427.
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59 Kyowa Kirin to Present Atopic Dermatitis Clinical Data from ...
https://kkna.kyowakirin.com/media-center/kyowa-kirin-to-present-atopic-dermatitis-clinical-data-from-khk4083-amg-451-phase-2-study-at-the-european-academy-of-dermatology-and-venereology-30th-congress/
KHK4083/AMG 451 is a potential first-in-class anti-OX40 fully ... and Germany to investigate the efficacy and safety of KHK4083/AMG 451.
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60 Clinical Trial Protocol (AMG) - German Cancer Research Center
https://www.dkfz.de/en/PaedOnko/download/Synopsis_Protokoll_Vorinostat_Final-2.3.pdf
According to § 4 German Drug Law (AMG). SPONSOR. Prof. Dr. med. Olaf Witt. University Hospital Heidelberg. Clinic for Pediatric Oncology, Hematology,.
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61 A Phase 1 First-in-Human Study of AMG 330, an Anti-CD33 ...
https://ashpublications.org/blood/article/132/Supplement%201/25/264250/A-Phase-1-First-in-Human-Study-of-AMG-330-an-Anti
Stein:Celgene: Speakers Bureau; Amgen: Speakers Bureau. Walter:Amphivena Therapeutics: Consultancy, Equity Ownership, Other: Clinical trial ...
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62 AMG 420 Shows Promise in Relapsed or Refractory Multiple ...
https://myelomaresearchnews.com/news/early-efficacy-data-shows-amg-420-potential-for-relapse-refractory-myeloma/
The first in-human clinical study of Amgen's immunotherapy AMG 420 ... The Phase 1 trial (NCT02514239), conducted in France and Germany, ...
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63 The BiTE (bispecific T‐cell engager) platform: Development ...
https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.32909
Only data from 2 single-arm studies (clinicaltrials.gov identifiers ... Several HLE BiTE molecules are in development, including AMG 160 ...
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64 Obesity - Amgen Congresses Hub
https://www.amgencongresses.com/-/media/Project/Amgen/AmgenConferenceHub/HUB/acc_downloads/i1-057_cv-clinical-trials-interactive_v11c_clean_hyperlinked.pdf
Clinical Trials Website. www.clinicaltrials.gov. ... To describe the safety and tolerability of 80 weeks of evolocumab (AMG 145) when added to standard of ...
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65 Comprehensive and effective system of standard operating ...
https://www.openaccessjournals.com/articles/comprehensive-and-effective-system-of-standard-operating-procedures-for-investigatorinitiated-trials.pdf
AE02-H: Serious adverse events handling in clinical trials with medical devices; AMG: German Drug Law; ET05-H: Procedures towards competent authority and ethics ...
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66 Research with Minors by Benedikt Buchner, Dieter Hart :: SSRN
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2152334
AMG (German pharmaceutical law). ... and clinical trials on ill minors without direct benefit for the individual participant, ...
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67 CLINICAL TRIAL PROTOCOL
https://www.uniklinik-ulm.de/fileadmin/default/Kliniken/Neurologie/Downloads/Studienzentrum/RAS-ALS-Protocol.pdf
Clinical Trial Director according to AMG (Leiter der Klinischen Prüfung) ... About 15 trial sites in Germany are planned to participate.
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68 What's changing in 2022: Life Sciences - Die Produktkanzlei
https://www.produktkanzlei.com/en/2022/01/17/whats-changing-in-2022-life-sciences/
... regulated under the German Medicinal Products Act (AMG) (B.). ... 536/2014 on clinical trials on medicinal products for human use.
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69 AMG 176, a Selective MCL1 Inhibitor, Is Effective in ...
https://aacrjournals.org/cancerdiscovery/article/8/12/1582/190903/AMG-176-a-Selective-MCL1-Inhibitor-Is-Effective-in
We report the discovery of AMG 176, a first-in-class orally bioavailable MCL1 inhibitor in clinical development for hematologic malignancies (ClinicalTrials.gov ...
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70 T-cell-based immunotherapy of acute myeloid leukemia - Nature
https://www.nature.com/articles/s41375-021-01253-x.pdf?origin=ppub
cific antibodies are in ongoing clinical trials. AMG 330, a BiTE molecule [24] was able to kill AML cells in primary human AML samples ...
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71 Pasotuxizumab, a BiTE® immune therapy for castration ...
https://www.futuremedicine.com/doi/10.2217/imt-2020-0256
Clinical trial registration: NCT01723475 (ClinicalTrials.gov) ... Pasotuxizumab (also known as AMG 212 or BAY 2010112), a 55 kDa BiTE immune ...
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72 (ECRIN) survey of ten European countries - Europe PMC
https://europepmc.org/articles/pmc2997627/bin/1745-6215-11-104-s1.pdf
European regulation, Off-label use, Randomised clinical trial ... with the 14th amendment of the German Medicines Act (AMG) and was updated ...
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73 Quality Assurance for Clinical Trials - Medizinische Fakultät
https://medfak.uni-koeln.de/en/faculty/core-facilities-kopie-2/quality-assurance-for-clinical-trials
For every clinical trial conducted in accordance with the German Medicines Act (AMG) or the Medical Devices Act (MPG), a sponsor within the ...
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74 Compliance with requirement to report results on the EU ...
https://www.bmj.com/content/362/bmj.k3218/rapid-responses
We are aware of no research assessing whether German trials do ... to be found in § 42b of the German Drug Law (Arzneimittelgesetz - AMG).
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75 Future Therapies | Celiac Disease Foundation
https://celiac.org/about-celiac-disease/future-therapies-for-celiac-disease/
In November 2021, Dr. Falk Pharma and Zedira announced the start of the phase 2b real-life clinical trial in several European countries including Germany, ...
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76 Ldl-C Lowering Efficacy of Evolocumab (Amg 145) Could ...
https://www.valueinhealthjournal.com/article/S1098-3015(14)03458-5/abstract
The current model aims to assess the ability of evolocumab (AMG 145), an investigational medication that is being evaluated in clinical trials, to reduce ...
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77 Licensing Guidelines and Regulations
https://www.gabionline.net/country-focus/germany/Licensing-Guidelines-and-Regulations
Drug products may be placed on the market in Germany after approval by the ... 1 of the German Medicines Act (Arzneimittelgesetz, AMG) or registered under ...
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78 Cell-based Medicinal Products: - Opportunities, Challenges ...
https://www.pmda.go.jp/files/000152059.pdf
Medicinal Products in Germany ... Aug 2004 Responsibility for Clinical Trial Authorisation ... National Implemetation in German Drug Law (AMG).
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79 Data privacy notes - German Breast Group
https://www.gbg.de/en/dataprivacy/
We process your data on the basis of your patient consent to the clinical trial and in accordance with the requirements of the Arzneimittelgesetz (AMG, ...
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80 Ethical Considerations for Clinical Trials conducted with Minors
https://ec.europa.eu/health/document/download/f0ee8371-b698-46af-8826-d98f0ecca506_en
In 2005, the German legislature introduced, through the 14th amendment to the German. Medicines Act (AMG), some innovations that follow ...
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81 The portal for rare diseases and orphan drugs - Orphanet
https://www.orpha.net/consor4.01/www/cgi-bin/ResearchTrials_Networks.php?lng=EN&data_id=126857&ClinicalTrialName=A-Phase-1-First-in-Human-Study-Evaluating-the-Safety--Tolerability--Pharmacokinetics--Pharmacodynamics-and-Efficacy-of-AMG-330-Administered-as-Continuous-Intravenous-Infusion-in-Subjects-With-Relapsed-Refractory-Acute-Myeloid-Leukemia&title=A%20Phase%201%20First-in-Human%20Study%20Evaluating%20the%20Safety,%20Tolerability,%20Pharmacokinetics,%20Pharmacodynamics%20and%20Efficacy%20of%20AMG%20330%20Administered%20as%20Continuous%20Intravenous%20Infusion%20in%20Subjects%20With%20RelapsedRefractory%20Acute%20Myeloid%20Leukemia&search=ResearchTrials_ClinicalTrials_Simple
Type of network : Multinational clinical trials; Geographic coverage : Global ... A Phase 1 Study of AMG 330 in Subjects With Relapsed/Refractory Acute ...
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82 Regulatory, Pricing, and Reimbursement: Germany
https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-germany/
The rules of the German AMG are essentially based on EU Directive ... completed clinical trials substantiating the efficacy and safety.
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83 Amgen Licenses AMG 634, An Investigational Treatment For ...
https://www.prnewswire.com/news-releases/amgen-licenses-amg-634-an-investigational-treatment-for-tuberculosis-and-leprosy-to-medicines-development-for-global-health-301197802.html
Amgen will continue to support the two Phase 2 clinical trials in ENL and TB set to begin in 2021 by providing study drug to both studies ...
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84 Updated results from a phase 1 study of AMG 757, a half-life ...
https://meetings.asco.org/abstracts-presentations/196548
... Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer Center Mainfranken, University Hospital Würzburg, Würzburg, Germany, ...
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85 Arzneimittelgesetz AMG - Translation into English
https://context.reverso.net/translation/german-english/Arzneimittelgesetz+AMG
Translations in context of "Arzneimittelgesetz AMG" in German-English from Reverso ... clinical trials in accordance with the Arzneimittelgesetz AMG (German ...
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86 German Pharmapool - Marsh - Yumpu
https://www.yumpu.com/en/document/view/52897790/german-pharmapool-marsh
An Explanation of the German Drug Law(AMG) and how the German ... Clinical trials insurance may not be required where thefollowing ...
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87 Safety, Tolerability, and Potential Clinical Activity of a ...
https://jamanetwork.com/journals/jamaoncology/fullarticle/2754745
Trial Registration ClinicalTrials.gov identifier: NCT02598960 ... Belgium, Canada, France, Germany, Italy, the Netherlands, Spain, ...
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88 Home | Phoenix Clinical Trial Landing Page
https://www.amylyxalstrial.com/

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89 AMG 211 (MEDI-565) - Immuno-Oncology News
https://immuno-oncologynews.com/amg-211-medi-565/
AMG 211 is a bi-specific antibody in early clinical testing to improve the ... A total of 51 participants have been enrolled at trial sites in Germany and ...
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90 The Stent Company - amg International
http://www.thestentcompany.com/profile.html
Clinical trials with experienced cardiologists are also important to collect ... the European Society of Cardiology Meeting and German Society of Cardiology ...
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91 Evaluation of clinical trials by Ethics Committees in Germany
https://www.egms.de/dynamic/en/journals/gms/2009-7/000066.shtml
The 12th Amendment of the German Medicines Act (AMG) [1] implemented Council Directive 2001/20/EC [2] in national law in Germany in August 2004.
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92 Ajmal A. - Freelance Senior Clinical Research Associate
https://uk.linkedin.com/in/ajmal-a-307727140
Senior Clinical Research Associate in phase I, II and III trials with a demonstrated history ... Grundlagenkurs nach dem AMG (German Drugs Regulatory Law).
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93 Customs online - Medicinal products and narcotics - Zoll
https://www.zoll.de/EN/Businesses/Movement-of-goods/Movement-of-goods-within-the-EU/Restrictions/Medicinal-products-and-narcotics/medicinal-products-and-narcotics_node.html
The legal basis for medicinal product legislation in Germany is the Medicinal Products Act (Arzneimittelgesetz - AMG). What are medicinal products? Medicinal ...
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94 AMG 595 – Drug Description - ADC Review
https://www.adcreview.com/amg-595-drug-description/
AMG 595 (being developed by Amgen) is an antibody-drug conjugate composed of ... In clinical trials, a single intravenous injection of AMG 595 at 17 mg/kg ...
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95 Research - Kartos Therapeutics
https://kartosthera.com/research
Kartos Therapeutics is a clinical stage biopharmaceutical company with an ... A Phase Ib Trial of Neoadjuvant AMG 232 (KRT-232) Concurrent With Preoperative ...
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