Medtech & Pharma Platform Association’s Post

✨ Exciting news for developers of innovative therapies! Member State authorities have endorsed the COMBINE programme, a cross-sector initiative designed to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme spans seven cross-sector projects to be rolled out over the coming years, focusing on: ✅ Piloting a single assessment process for multi-country combined studies under device and medicinal product regulations. ✅ Harmonizing serious adverse event reporting processes. ✅ Clarifying the interface between clinical trials and medical device regulations. ✅ Exploring ways to advise sponsors and foster knowledge exchange among national authorities. By fostering collaboration in an inclusive framework, the COMBINE programme brings together competent authorities for clinical trials and medical devices, the European Commission, the European Medicines Agency, ethics committees and key stakeholders like sponsors, clinicians, and patient representatives. 🔗 Learn more about the strategy here: https://lnkd.in/gV8Kya8m #HealthUnion

✨ Exciting news for developers of innovative therapies! Member State authorities have endorsed the COMBINE programme, a cross-sector initiative designed to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme spans seven cross-sector projects to be rolled out over the coming years, focusing on: ✅ Piloting a single assessment process for multi-country combined studies under device and medicinal product regulations. ✅ Harmonizing serious adverse event reporting processes. ✅ Clarifying the interface between clinical trials and medical device regulations. ✅ Exploring ways to advise sponsors and foster knowledge exchange among national authorities. By fostering collaboration in an inclusive framework, the COMBINE programme brings together competent authorities for clinical trials and medical devices, the European Commission, the European Medicines Agency, ethics committees and key stakeholders like sponsors, clinicians, and patient representatives. 🔗 Learn more about the strategy here: https://lnkd.in/gV8Kya8m #HealthUnion

✨ Exciting news for developers of innovative therapies! Member State authorities have endorsed the COMBINE programme, a cross-sector initiative designed to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme spans seven cross-sector projects to be rolled out over the coming years, focusing on: ✅ Piloting a single assessment process for multi-country combined studies under device and medicinal product regulations. ✅ Harmonizing serious adverse event reporting processes. ✅ Clarifying the interface between clinical trials and medical device regulations. ✅ Exploring ways to advise sponsors and foster knowledge exchange among national authorities. By fostering collaboration in an inclusive framework, the COMBINE programme brings together competent authorities for clinical trials and medical devices, the European Commission, the European Medicines Agency, ethics committees and key stakeholders like sponsors, clinicians, and patient representatives. 🔗 Learn more about the strategy here: https://lnkd.in/gV8Kya8m #HealthUnion

✨ Exciting news for developers of innovative therapies! Member State authorities have endorsed the COMBINE programme, a cross-sector initiative designed to streamline combined studies of medicines and medical devices, including diagnostics. The COMBINE programme spans seven cross-sector projects to be rolled out over the coming years, focusing on: ✅ Piloting a single assessment process for multi-country combined studies under device and medicinal product regulations. ✅ Harmonizing serious adverse event reporting processes. ✅ Clarifying the interface between clinical trials and medical device regulations. ✅ Exploring ways to advise sponsors and foster knowledge exchange among national authorities. By fostering collaboration in an inclusive framework, the COMBINE programme brings together competent authorities for clinical trials and medical devices, the European Commission, the European Medicines Agency, ethics committees and key stakeholders like sponsors, clinicians, and patient representatives. 🔗 Learn more about the strategy here: https://lnkd.in/gV8Kya8m #HealthUnion

Have you heard about our COMBINE project? 🔬   It's another example of how the EU is acting to make itself an attractive place for clinical research! 🚀   With patients as the ultimate beneficiaries, COMBINE project is an EU initiative addressing #combinedstudies.   💡 What are combined studies?   In these studies, medicinal products are assessed together with medical devices or diagnostics to develop innovative and personalised treatments.   The purpose of COMBINE is simple: to streamline processes and cut the time needed to get these treatments to patients.   The COMBINE project looked at the interface between three EU regulations: 🔹 Clinical trials regulation (CTR) 🔹 Medical devices regulation (MDR) 🔹 In vitro diagnostic medical devices regulation (IVDR).   Thanks to the collaboration between national authorities, ethics committees, European Medicines Agency, European Commission and stakeholders, we are today delivering the first output of the COMBINE project - an analysis of the current situation and possible ways forward to streamline the regulatory landscape.   Next steps of this project will look into developing some of the solutions. Sponsors will benefit from a reduction in the administrative burden, making Europe more attractive for investment and research. 🚀 Patients will always be at the heart of this project, as they will have access to more innovative and personalized treatments.   Read about the COMBINE analysis report here 👉 https://lnkd.in/eyCQHXMU #HealthUnion

Have you heard about our COMBINE project? 🔬   It's another example of how the EU is acting to make itself an attractive place for clinical research! 🚀   With patients as the ultimate beneficiaries, COMBINE project is an EU initiative addressing #combinedstudies.   💡 What are combined studies?   In these studies, medicinal products are assessed together with medical devices or diagnostics to develop innovative and personalised treatments.   The purpose of COMBINE is simple: to streamline processes and cut the time needed to get these treatments to patients.   The COMBINE project looked at the interface between three EU regulations: 🔹 Clinical trials regulation (CTR) 🔹 Medical devices regulation (MDR) 🔹 In vitro diagnostic medical devices regulation (IVDR).   Thanks to the collaboration between national authorities, ethics committees, European Medicines Agency, European Commission and stakeholders, we are today delivering the first output of the COMBINE project - an analysis of the current situation and possible ways forward to streamline the regulatory landscape.   Next steps of this project will look into developing some of the solutions. Sponsors will benefit from a reduction in the administrative burden, making Europe more attractive for investment and research. 🚀 Patients will always be at the heart of this project, as they will have access to more innovative and personalized treatments.   Read about the COMBINE analysis report here 👉 https://lnkd.in/eyCQHXMU #HealthUnion

Have you heard about our COMBINE project? 🔬   It's another example of how the EU is acting to make itself an attractive place for clinical research! 🚀   With patients as the ultimate beneficiaries, COMBINE project is an EU initiative addressing #combinedstudies.   💡 What are combined studies?   In these studies, medicinal products are assessed together with medical devices or diagnostics to develop innovative and personalised treatments.   The purpose of COMBINE is simple: to streamline processes and cut the time needed to get these treatments to patients.   The COMBINE project looked at the interface between three EU regulations: 🔹 Clinical trials regulation (CTR) 🔹 Medical devices regulation (MDR) 🔹 In vitro diagnostic medical devices regulation (IVDR).   Thanks to the collaboration between national authorities, ethics committees, European Medicines Agency, European Commission and stakeholders, we are today delivering the first output of the COMBINE project - an analysis of the current situation and possible ways forward to streamline the regulatory landscape.   Next steps of this project will look into developing some of the solutions. Sponsors will benefit from a reduction in the administrative burden, making Europe more attractive for investment and research. 🚀 Patients will always be at the heart of this project, as they will have access to more innovative and personalized treatments.   Read about the COMBINE analysis report here 👉 https://lnkd.in/eyCQHXMU #HealthUnion