SFL is now Veristat

SFL followers - a reminder! SFL is now part of Veristat. To stay up to date with the latest news and updates, make sure to follow Veristat's LinkedIn 👇 https://hubs.li/Q02J9q6N0 #Regulations #MedicalDevice

The European Commission announced call for proposals for EU action grants in the area of crisis preparedness, under the EU4Health Annual Work Programme 2024, including calls for: 👉 The European Hub for vaccine development 👉 Next-generation respiratory protection 👉 Innovative manufacturing technologies/processes in the Union for medicines production 👉 The development of novel antivirals The deadline for applicants is 5 September 2024 > https://hubs.li/Q02HtMpg0 #EU4Health #Pharma

The German Parliament Bundestag adopted the revised Medical Research Act. The legislation among other aspects, will: ➡ Facilitate the implementation of decentralized clinical trials ➡ Create a legal basis for the publication of standard contractual clauses for trials ➡ Accelerate the conduct of mono-national clinical trials ➡ Task a specialized ethics committed in charge of special procedures at federal level ➡ Limit price confidentiality to pharmaceutical companies with research departments located in Germany ➡ Hold price negotiations first, then give manufacturers incentives to select whether the price should be confidential or public 🔗https://hubs.li/Q02HtRDN0 #EU #clinicalresearch #clinicaltrials

The Euresearch announced the launch of the European Research Council (ERC)'s Synergy Grants. The funding program is: 📌 Open to researchers based in Switzerland 📌 Endowed with a budget of €10 million 📌 Focused on any field of research 📌 Seeking public or private applicants A fact sheet detailing further conditions was made available. Swiss applications to the Synergy Grant can be submitted until 15 October 2024. Applicants located in the EU can apply until 6 November 2024. Euresearch fact sheet > https://hubs.li/Q02HtMd00 ECR Synergy Grant > https://hubs.li/Q02HtCfK0 #SynergyGrants

The European Commission released the report on critical medicines supply chains of the Health Emergency Preparedness and Response Authority (HERA). The EU Commission/HERA launched the Critical Medicines Alliance to address shortages of critical medicines earlier this year. The report investigated the supply chains of 11 medicines from the Union list of critical medicines. Recommendations include: ➡ Diversifying supply sources ➡ Enhancing production capacity ➡ Developing risk management frameworks 🔗 https://hubs.li/Q02HtCfJ0 #pharmaceutical #healthcare

The EMA published information material for accelerating the clinical trials in the EU initiative (ACT EU). This includes: 📍Map of national projects supporting non-commercial sponsors at the national level 📍Webpage with detailed information on the stakeholders and groups within the European Medicines Regulatory Network (EMRN) Read more > https://hubs.li/Q02FwbVx0 #clinicalresearch #clinicaltrials #CTIS

The FDA issued draft guidance on essential drug delivery outputs for devices intended to deliver drugs and biological products. The guidance: 👉 Targets combination products 👉 Aims to streamline device development 👉 Offers recommendations on design outputs 👉 Informs drug delivery performance Stakeholders may submit comments on the draft by 30 September 2024 > https://hubs.li/Q02Fw8RJ0 #IVDs #medtech #regulatoryaffairs

Innovative Health Initiative (IHI) launched a call for proposals on dealing with pressing challenges in health research and innovation. The funding round covers several topics: ➡ Combating cardiovascular disease in cities ➡ Using big data to make progress on osteoarthritis ➡ Regulatory sandboxes to support breakthrough innovation ➡ Understanding how best to capture patient-centered information Deadline: 10 October 2024 https://hubs.li/Q02FyVKv0 #pharma #lifesciences

The European Commission published a revised version of Medical Device Coordination Group (MDCG) guidance 2021-5 on standardization for medical devices. Revisions include: 📌 Additions on the references to EN ISO 15189 and ISO 14155:2011 📌 Updates on the Harmonized Standards 📌 A new section handling common specifications Read more > https://hubs.li/Q02Fwbrs0 #MDR #IVDR #MedicalDevices

The European Commission published the Science, Research and Innovation Performance Report. The report highlights: ➡ EU research & innovation ecosystem (R&I) remains underutilized ➡ Divide in R&I for activities/support ➡ Gap with the rest of the world raising private investments The report offers several recommendations: ➡ Improve the sector of research universities ➡ Allocate a fraction of R&I funds to government research labs and introduce accountability reforms ➡ Create an Advanced Research Projects Agency for Health (ARPA) modeled after the US ARPA-H Read more > https://hubs.li/Q02FwbZR0 #ResearchAndInnovation #pharmaceutical