Month: July 2024

WELCOME to ESBiomech 2024: BIOMECHANICS FROM RESEARCH TO PRACTICE 30/06/2024

Dear colleagues, it is our great pleasure to invite you to attend the 29th Congress of the European Society of Biomechanics taking place in Edinburgh, Scotland from 30th June to 3rd July 2024. The main theme of the congress – Biomechanics from research to practice – brings the focus on the importance of the dialogue and collaboration between the biomechanics and the clinical communities.

The ESBiomech 2024 scientific programme will include keynote speakers, podium and posters contributions on the latest research developments on all branches of biomechanics.

All traditional ESB sessions and activities will be organized to their full extend – a rich scientific program, interactive and mentoring sessions, students activities, exhibition and networking events.

We are looking forward to welcome you in the beautiful city of Edinburgh!

Dear colleagues, it is our great pleasure to invite you to attend the 29th Congress of the European Society of Biomechanics taking place in Edinburgh, Scotland from 30th June to 3rd July 2024. The main theme of the congress – Biomechanics from research to practice – brings the focus on the importance of the dialogue and collaboration between the biomechanics and the clinical communities.
Future of the European Health Union, MedTech Europe advocates for innovation and competitiveness 21/06/2024

Today, the Council of the European Union adopted its conclusions on the Future of the European Health Union, emphasising critical areas such as availability of medical technologies, digitalisation of health, and building more resilient health systems. MedTech Europe calls on Member States to enact policies that support the competitiveness and innovation capacity of the industry to ensure continued and timely access to innovative medical technologies for patients across Europe.

MedTech Europe welcomes the Council’s acknowledgement of the significant challenges related to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (MDR, IVDR). To improve the security of supply for and access to medical devices and in vitro diagnostic medical devices for patients and health systems, it is essential that all the structural deficiencies in the MDR and IVDR are identified and tackled. The conclusions have highlighted several such areas, including governance, innovation, costs, resource and expertise requirements, the particular impact for small- and medium-sized enterprises (SMEs), as well as orphan and paediatric devices.

 

Member States now need to act swiftly to acknowledge the need for comprehensive and cohesive reform of the regulations, with a clear mandate to the European Commission to provide a proposal by end of 2025 upon the conclusion of their Targeted Evaluation.

The Council conclusions also recognise the pivotal role of digital technologies, AI and health data in enhancing patient care, advancing research, and shaping public health policy. Digital policy has been evolving rapidly in the last five years, necessitating a period of adjustment for companies to fully comply with new EU regulations. To ensure smooth implementation, harmonisation in application between Member States and clear guidance on overlapping requirements will be essential. As we move into the next phase when the new requirements start applying to medical technologies, we stress the importance of wide inclusion of all healthcare ecosystem
stakeholders in their implementation.

Building resilient health systems requires a robust, competitive, and innovation-driven industry. While EU regulations promote stability, trust and access to the world’s second-largest medical technology market, they have also raised barriers to entry and present risks of over-regulation. It is critical to adjust the regulatory environment so that it fosters innovation and supports manufacturers of any size, including SMEs, which are crucial for fostering a resilient and dynamic health sector. MedTech Europe hopes to work closely with Member States to find solutions that harmonise the current system and maintain Europe’s competitiveness and attractiveness for innovation to serve patients and health systems in Europe.

Setting the direction for EU health policy over the next five years, Member States now need to be ambitious in implementing their conclusions. Now is the time to make our health systems more patient-centric, digitally advanced, resilient and sustainable.

Today, the Council of the European Union adopted its conclusions on the Future of the European Health Union, emphasising critical areas such as availability of medical technologies, digitalisation of health, and building more resilient health systems. MedTech Europe calls on Member States to enact policies that support the competitiveness and innovation capacity of the industry to ensure continued and timely access to innovative medical technologies for patients across Europe.

MedTech Europe welcomes the Council’s acknowledgement of the significant challenges related to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (MDR, IVDR). To improve the security of supply for and access to medical devices and in vitro diagnostic medical devices for patients and health systems, it is essential that all the structural deficiencies in the MDR and IVDR are identified and tackled. The conclusions have highlighted several such areas, including governance, innovation, costs, resource and expertise requirements, the particular impact for small- and medium-sized enterprises (SMEs), as well as orphan and paediatric devices.

 

Member States now need to act swiftly to acknowledge the need for comprehensive and cohesive reform of the regulations, with a clear mandate to the European Commission to provide a proposal by end of 2025 upon the conclusion of their Targeted Evaluation.
Faster access to clinical trial information in Europe Revised rules for Clinical Trials Information System (CTIS) become applicable 18/06/2024

The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European Union (EU) for patients, healthcare professionals and other stakeholders. This is due to the revised transparency rules that become applicable today in Europe.

One of the key changes is earlier availability of information on authorised clinical trials. Importantly, the new rules eliminate the previously available deferral mechanism, which allowed clinical trial sponsors to delay publishing certain data and documents for up to seven years after a trial’s completion to protect commercially confidential information. Under the new rules, approximately 4,000 clinical trials with issued decisions are now publicly accessible through the CTIS search. The CTIS portal will add approximately 500 newly authorised clinical trials per month. This includes ongoing trials that have been transitioned to CTIS from the Clinical Trials Directive. Over the next few months, additional features will be added to the CTIS public portal to further enhance overall usability.

The updated rules strike a balance between transparency of information and protection of commercially confidential information. They benefit patients, because key clinical trial information, that patients flagged as being most relevant for them, is published early. They also benefit clinical trial sponsors because they introduce process simplifications. Finally, they benefit healthcare professionals because the resulting system is more user-friendly, facilitating access to information on clinical trials and enrolment in clinical trials, and also increasing awareness of possible treatment options.

Several resources have been created to help sponsors understand the revised transparency rules, including a user guide and an overview of which data and documents with key information will be published. Dedicated support activities are also being organised, starting with an event on 20 June open to all sponsors of clinical trials including pharmaceutical companies, contract research organisations, small and medium-sized enterprises and academic organisations.

The revised transparency rules were adopted by EMA’s Management Board in October 2023 following a public consultation held between May and June 2023.

The launch of a new version of the Clinical Trials Information System (CTIS) will allow earlier and more efficient access to information about clinical trials in the European Union (EU) for patients, healthcare professionals and other stakeholders. This is due to the revised transparency rules that become applicable today in Europe.

One of the key changes is earlier availability of information on authorised clinical trials. Importantly, the new rules eliminate the previously available deferral mechanism, which allowed clinical trial sponsors to delay publishing certain data and documents for up to seven years after a trial’s completion to protect commercially confidential information. Under the new rules, approximately 4,000 clinical trials with issued decisions are now publicly accessible through the CTIS search. The CTIS portal will add approximately 500 newly authorised clinical trials per month. This includes ongoing trials that have been transitioned to CTIS from the Clinical Trials Directive. Over the next few months, additional features will be added to the CTIS public portal to further enhance overall usability.