AEQUO Law Firm’s Post

Exciting news from Ukraine! By embracing post-trial access programs, the nation is not only addressing therapeutic continuity but also fostering a culture of inclusivity in healthcare. Let's celebrate initiatives that prioritize patients' needs. #InclusiveHealthcare #PatientEmpowerment

Australia makes a significant contribution to the development of new medicines through research partnerships and clinical trials. But when it comes to accessing those medicines through the PBS, Australian patients have to wait for years after the medicine is available in other countries. A Stronger PBS will give Australians faster access to the new medicines we have helped to develop. Show your support for a Stronger PBS >> StrongerPBS.com.au

Wonder why access to medicines matters and is still a relevant topic in Europe?  In my latest op-ed shared with Euractiv, discover how Viatris is contributing to support patients’ needs, as I had the pleasure to represent my company at the Europe’s Critical Medicines Alliance launch in Brussels - with Medicines for Europe Read the op-ed here: https://bit.ly/44i1Ces Credentials for picture Belgian Presidency of the Council of European Union #CriticalMedicinesAlliance; #AccessAtScale; #ViatrisEurope 

The EU Clinical Trials Regulation, also known as Regulation (EU) No. 536/2014, went live by replacing the EU CTD (Directive 2001/20/EC)1 on 31 January 2022. This regulation streamlines the approaches for the initial application and maintenance of a clinical trial authorization and applies to both single and multiple member state trials in the EU countries, plus Iceland, Liechtenstein, and Norway. Ana Sengupta, MS, MBA, RAC outlines elements of the regulation, discusses strategic considerations for submission, and explores the impact at the industry sponsor level when transitioning clinical trials under the EU CTR in this latest article from RF Quarterly. RAPS members get exclusive access to this article: https://bit.ly/4905yRB

⚠ EU HTA UPDATE – Fresh Implementing Act open for consultation⚠ https://lnkd.in/eyYUaziK "The draft implementing act provides rules for cooperation with the European Medicines Agency to: 🔸share information 🔸plan and forecast joint clinical assessments and joint scientific consultations - for medicinal products and medical devices 🔸identify patients, clinical experts and other relevant experts to be involved in joint clinical assessments and joint scientific consultations. The draft implementing act also concerns the security and protection of confidential information exchanged between: 🔸the European Medicines Agency 🔸the HTA secretariat 🔸the Member State Coordination Group on HTA or its subgroups" More to come as we digest the text...

Please see our efforts to support patient needs through Europe Critical Medicines Alliance launch with our EU president Artur Cwiok representing Viatris in this very important alliance. At Viatris we are #1Billion patients proud and this partnership and alliance is another stepping stone on how we walk the talk on our commitment to patients. #CriticalMedicinesAlliance; #AccessAtScale; #ViatrisEurope

🌐🏥🔍📦 A great article on the challenges Europe faces from a #CriticalMedicines perspective #AfforableMedicines 🌡️🚑💊🌍🇪🇺

Elliott Rolfe and Harry Lancaster are attending the European Medicines Agency workshop on psychedelics today and tomorrow in Amsterdam! This event is set to bring together key stakeholders to discuss the therapeutic use of psychedelics and make progress towards a regulatory framework for the EU. Learn more: https://bit.ly/3Q1IOKv #PsychedelicsResearch #MedicalScience #PsychedelicTreatment

Will the European Clinical Trial Regulation attract more clinical trials to Europe? 🇪🇺 On January 31st, 2022, the Clinical Trial Regulation (CTR) entered into application. "It aims to ensure that the EU offers an attractive and favorable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants" - European Medicines Agency (EMA). The transition period is given until January 31st 2025 and by then, any ongoing trials approved under the previously Clinical Trials Directive will now fall under the Clinical Trials Regulation. The regulation is suppose to harmonise the processes for assessment and supervision of clinical trials throughout the EU. But is it really doing that, and will we really increase the number of clinical trials in Europe? 🧐 🤨 Read Natalia's latest blog post on our blog, about the CTR and her thoughts on the good, the bad, and the still existing needs and let us know what you think in the comment section below! 👇 You can find the post here: https://lnkd.in/dyXUZ553 If you need help with the transition period, please reach out to us and let us know how we can help you! 🤓 #ClinicalTrials #Regulatory #EMA #EU #Research #Medicine #CTR #EuropeanUnion

New day, new knowledge ✨️ So, I recently came across the EU clinical trials regulations systems which was news to me that only recently (exacly in January 2022), they unified a portal for all EU members to apply for multicountry clinical trials within their member states. These include all European Union countries + (Iceland, Liechtenstein, and Norway). 🌏 The exact statement on their website is "All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by 30 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU." 📅 Quite fascinating that this just happened only a couple of years ago, hoping for a similar unified vision for the MENA region which is definitely needed to produce local data and guidelines. 🙏 Sources: 📑 https://lnkd.in/d5AjhWyf https://lnkd.in/dmWkmvMb NIH IPPCR