Press release -Basel, 27 September 2023
Today, the MPP Annual Conference, themed “Therapeutic innovation with combined products – better healthcare to patients”, is taking place in Basel, Switzerland. Shayesteh Fürst-Ladani (SFL), MPP President, and Ruth Foster (MSD), Chair of the 2023 Annual Conference Program Committee, will open the conference and present the program. Michael Berntgen (EMA) will deliver a keynote address on the EMA’s perspective on combined products.
A panel discussion will provide forward-looking perspectives on the development of combined products on global level withrepresentatives from the US FDA, the EMA, Swissmedic, the European Aids Treatment Group, and Industry.
The sessions will include an overview of the digital health landscape, regulatory assessment of combined products, and companion diagnostics.
Shayesteh Fürst-Ladani said that “Many years ago the journey began with a conference in Zürich, and today we can be proud of the progress and achievements Association made over the last years”. She added that “recent advancements in the EU and various other areas emphasize the importance of collaboration among stakeholders in advancing safe and innovative integrated products, a central focus of the MPP’s mission. The engaging program curated by the Program Committee, along with the extensive discussions and networking prospects, undoubtedly will facilitate exchanges and synergies, promoting a well-rounded framework that better aligns with the requirements of patients”.
Publication of two papers
The MPP association is proud to announce the publication of two papers today. One paper focuses on the interface of the Medical Devices Regulation, In Vitro Diagnostics Regulation (IVDR) and the Clinical Trials Regulation (CTR), highlighting the challenges involved with conducting combined trials and inviting all stakeholders to find practical solutions. The second explores the challenges associated with regulatory pathways in the EU for a subset of connected combined products, i.e. those consisting of a medicinal product used with a delivery device with wireless connectivity to a standalone software. Their publication signals a strong commitment of the MPP Association to advance and advocate for informed regulatory policies with all relevant stakeholders and regulators.
Establishment of new in vitro diagnostic working group
The MPP Association is honored to announce the establishment of a new working group, which will be dedicated to in vitro diagnostics (IVDs). The evolving regulatory landscape in Europe, particularly the IVDR, comes with a multitude of complexities for IVD manufacturers, heath institutions, as well as pharmaceutical companies engaged in the development of combined products or utilization of IVDs in their clinical trials. To facilitate a smooth transition, all actors including the competent authorities, Notified Bodies, the European Commission and IVD manufacturers must work together to ensure the continued access to IVDs and clinical trials for patients in the European Union. The MPP Association ambitions to contribute to these efforts through the newly established working group.
About the Medtech & Pharma Platform Association (MPP)
The MPP Association is a cross-sectoral not-for-profit industry association focusing on combined products. The Association comprises medtech, pharma and tech companies dedicated to enhancing the synergies between these industries. The Association aims to achieve a balanced regulatory framework for combined products in Europe, reduce time to market and improve access to innovative and safe healthcare products.
Contact for the MPP
Shayesteh Fürst-Ladani, President
c/o SFL Regulatory Affairs & Scientific Communication GmbH
Aeschenvorstadt 52, CH-4051 Basel, Switzerland
+41 61 361 9443