6th November 2023: Reform of the European Union (EU) Pharmaceutical Legislation

Wien, 06.11.2023 – Text: Catarina Carrão Pharmaceutical Legislation Revision: objectives In April 2023, the European Commission (EC) has adopted a proposal for a new Directive and a new Regulation, which revises and replaces the existing general pharmaceutical legislation.1 The purpose is to create a future proof regulatory framework that supports the industry in promoting research and technologies to reach patient’s needs faster, while […]

01. Oktober 2023: Decentralized Clinical Trials and the use of Digital Health Technologies

Wien, 01.10.2023 – Text: Catarina Carrão With the impact of the COVID-19 pandemic, Decentralized clinical trials (DCTs) and digital health technologies (DHTs) gained a momentum in medical research, allowing for clinical study participants to remotely partake in trials using state-of-the-art DHTs.1-3 What are Decentralized Clinical Trials? According to Dr. Leonard Sacks, associate director for clinical […]

21. August 2023: Pragmatic Clinical Trials

Gouya Insights Clinical Development Logo

Wien, 21.08.2023 – Text: Catarina Carrão Schwartz and Lellouch pragmatic views The Merriam-Webster dictionary defines Pragmatism has a practical approach to problems and affairs.1 In relation to clinical trials, pragmatism surfaced in 1967 with an article from Schwartz & Lellouch, due to concerns that many trials did not adequately inform practice because they were optimized to determine efficacy.2 At the time, authors […]

10. Juli 2023: “Opt-In or Opt-out” The new European Health Data Space

ECG/EKG test result strip clinical biotechnology

Wien, 10.07.2023 – Text: Catarina Carrão “Opt-In or Opt-out” The new European Health Data Space One year ago, the European Commission proposed a new European Health Data Space (EHDS) legislative proposal to unleash a revolution in health data sharing and set-up a framework for data reuse, while ensuring the protection of this highly sensitive data.  The objective is […]

14. Juni 2023: Diversity in Clinical Trial Populations

gouya insights logo 2

Wien, 14.06.2023 – Text: Catarina Carrão Historically, there has been an underrepresentation of people from diverse groups in clinical trials, which has created gaps in the understanding of treatment safety and effectiveness across different populations. For example, certain demographic characteristics such as sex, age, race, and ethnicity, can have an impact on how a person […]

17. Mai 2023: Patient Engagement in Clinical Trials

gouya insights logo 2

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

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

Press Release

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!

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 […]

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 […]