17. Mai 2023: Patient Engagement in Clinical Trials
Wien, 17.05.2023 – Text: Catarina Carrão The patient’s voice is essential in the different regulatory activities throughout a medical product’s lifecycle. An individual’s real-life experience as a patient living with a condition offers a crucial complementary perspective to understand the value of the scientific evidence necessary for the evaluation and management of medical products. The […]
17. April 2023: Monitoring of Clinical Investigations: A Risk-Based Approach
Wien, 17.04.2023 – Text: Catarina Carrão The U.S. Food and Drug Administration (FDA) has just released an extension to the guidance “A Risk-Based Approach to Monitoring of Clinical Investigations”, previously published in 2013. The new guidelines are intended for clinical investigations regarding human drug and biological products, medical devices, and combination products; and it offers recommendations […]
22. March 2023: Mut ist die beste Medizin
Wien, 22.03.2023 – Text: Susanne Mayer Arzneimittel und Medizinprodukte herzustellen und zur Zulassung zu bringen, braucht viel Zeit und noch mehr Know-how. Die Medizinerin und klinische Forschungsexpertin Ghazaleh Gouya begleitet Start-ups aus dem Medtech- und Biotech-Bereich vom Anfang bis zur Marktreife, um nicht an den regulatorischen Hürden zu scheitern. 13 Jahre: So lange dauert es […]
20. March 2023 : MDR extension deadline: it’s set in stone!
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 […]
01. March 2023 : Tips for Clinical Trial Sponsors: Regulation (EU) No 536/201420
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!
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
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 […]
04. April 2022 : The HEART Approach for Clinical Trial Leadership
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
💡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
8. November 2021: Advancing Research : Gouya Insights holds Free Expert Consultation for clinical trials
PRESS RELEASE Advancing Research: Gouya Insights holds Free Expert Consultation for clinical trials Vienna, 08.11.2021 – Clinical trials are a central component of medical research. Without such trials, there would be no approved drugs and medical development would come to a standstill. PD Dr. Ghazaleh Gouya Lechner wants to further promote the development of clinical […]
