20. March 2023 : MDR extension deadline: it’s set in stone!

Press Release

Wien, 20.03.2023 – MDR extension deadline: it’s set in stone! The European Parliament has just published in the Official Journal of the European Union the extension of the transition period for full application of the Medical Device Regulation (MDR). The European Parliament adopted a proposal by the European Commission to delay the transition period due to concerns about […]

Diese Fachärztin verhilft Medikamenten zum Durchbruch

Interview in the Kurier with Ghazaleh Gouya-Lechner Medical breakthrough

von Uwe Mauch – 16.03.2023, 18:00 Diese Fachärztin verhilft Medikamenten zum Durchbruch Ghazaleh Gouya-Lechner unterstützt mit ihrem Team all jene, die neue Medikamente zur Zulassung bringen möchten. Corona-Pandemie, Mangel an Fachärzten, nicht lieferbare Medikamente: In der Flut an negativen Meldungen alleine aus dem Gesundheitsbereich ringen die guten Nachrichten oft mal um Aufmerksamkeit. Doch es gibt sie, […]

Von der Ärztin zur Forschungsexpertin

News article by Radio Niederösterreich about Ghazaleh Gouya-Lechner titled "Von der Ärztin zur Forschungsexpertin" (From doctor to research expert)

Von der Ärztin zur Forschungsexpertin Wenn Firmen Hilfe beim Zulassungsprozess von Medikamenten brauchen, steht Ghazaleh Gouya-Lechner beratend zur Seite. Derzeit hilft die gebürtige Iranerin mit Wohnsitz in Mauerbach (Bezirk St. Pölten) dabei, die klinische Forschung im Land besser zu vernetzen. „Niederösterreich ist ein großer Schatz“, sagt Gouya-Lechner, denn „27 Gesundheitseinrichtungen unter einem Dach“ (im Rahmen […]

01. March 2023 : Tips for Clinical Trial Sponsors: Regulation (EU) No 536/201420

Press Release

01. March 2023 : Tips for Clinical Trial Sponsors: Regulation (EU) No 536/2014 A quick guide on the rules and procedures of the updated Clinical Trials Regulation (CTR) EU No 536/2014 was just released. This guidance, drawn up by the Clinical Trials Coordination and Advisory Group (CTAG), is meant as a practical approach for clinical trial (CT) sponsors […]

20. February 2023 : Clinical trials 23 : results to look forward!

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20.02.2023 : The most interesting clinical trials coming to an end in 2023… Recently, Nature Medicine reporters C. Arnold and P. Webster asked leading researchers to name the most interesting clinical trials coming to an end in 2023.  Roger Albin, Professor of Neurology and co-director of the Movement Disorders Clinic at the University of Michigan Medical School, highlighted the Exenatide phase […]

31. January 2023 : CTIS : a single-entry point for EU clinical trials

Press Release

31.01.2023 : CTIS : a single-entry point for EU clinical trials Today, January 31st 2023, the Clinical Trial Information System (CTIS) becomes mandatory as the single-entry point for the submission and assessment of clinical trial data for sponsors and regulators in the European Union (EU).  The new Clinical Trial Regulation (CTR) (EU) No 536/2014 entered into application a year ago […]

Enriched stable 204Pb as tracer at ultra-low levels in clinical investigations

Enriched stable 204Pb as tracer at ultra-low levels in clinical investigations

Abstract The potential of enriched Pb (204Pb) was assessed to monitor pathways of trace levels of Pb in the pg range within the human body via isotope pattern variation in situations where natural lead cannot be used as a tracer due to regulatory limitations. Isotope ratio measurements were accomplished by means of (multi-collector) inductively coupled […]

04. April 2022 : The HEART Approach for Clinical Trial Leadership

IFAPP Today newsletter clipping, April 2022 Number 23 about the HEART approach for leading drug development

PRESS RELEASE Project management vs Project leadership New drug development remains highly risky and costly despite the fact that approval success rates increased to 62% in 2017 (Galson et al., Nature, 2021). Galson et al. name poor execution and inadequate project management as one of the factors causing every third study to fail in phase […]

1. April 2022 : Neuigkeiten am Corona Horizont

Press Release

💡Neuigkeiten am Corona Horizont: 🦠 Das Paul-Ehrlich-Institut hat in seinem aktuellen Newsletter 03/2022 von 1 April 2022 folgende Neuigkeiten zu Neuzulassungen in der Covid19 Prophylaxe und Impfstoffe bekanntgegeben: Antrag auf bedingte Zulassung für den proteinbasierten COVID-19-Impfstoffkandidaten Vidprevtyn gestellt👉https://lnkd.in/e3KQJqdE Rolling-Review für Booster-Impfstoff COVID-19 Vaccine HIPRA hat begonnen👉https://lnkd.in/eChgTDbd Zulassung der monoklonalen Antikörper-Kombination Evusheld (Tixagevimab und Cilgavimab) zur COVID-19-Prophylaxe erteilt👉https://lnkd.in/ef9aCnM2