Pharmanovia’s Post

Coordinating operational excellence for fully enabled patient access https://lnkd.in/eX2mRP9R Join our presentation on March 13 at World EPA Congress. Regardless of the stage in the product lifecycle, the new reality of health technology assessment (HTA) processes in Europe means driving innovation through cross-functional operational excellence. Join our main-stage presentation on March 13 at World EPA Congress where you will learn about the increasing need for cross-collaboration and consideration of the immediate and downstream stakeholders (colleagues, healthcare professionals, payers, patients) on the path to access. The need for pre-emptive and continuous engagement with regulatory agencies, healthcare professionals, patients, and payers will be examined, and you will gain recommendations on how to optimize final access and ensure appropriate value is generated for all. https://lnkd.in/eX2mRP9R #WorldEPA #EPACongress #EPA2024 #MarketAccess #WeAreAvalereHealth

Biosimilars are the most immediate and available solution to high drugs prices - especially for popular and effective biologics. Competition works for other products in the US, so why not medicines? Let's fix the barriers and get affordable access for patients now #biologics #biosimilars #biotech #regulatoryreliance #accessmatters #accessforall #HealthForAll  #PassionForHealth

In June, our medicines optimisation team hosted a webinar with Health Service Journal on how medicines optimisation should be defined, measured, and valued.⚖️ HSJ's report highlights the importance of looking beyond costs and considering factors like patient impact and quality of life. In the evolving landscape of healthcare, ICSs provide fresh opportunities to measure medicine value. Collaboration among healthcare professionals is key, and patient input is crucial. 🔗 Read the report here: https://bit.ly/3ECCD9p

Today, the last interinstitutional Trilogue negotiations for the European Health Data Space (EHDS) take place, it will be a decisive day. Just recently MedTech Europe has, as part of a coalition of 35 health stakeholder organisations, expressed its shared concerns about the latest negotiations on the proposed #EHDS. Our recommendations: ▶ The EHDS must provide clearer and more coherent definitions (e.g. 'EHR system'). ▶ Clarification of the interaction with other applicable legal frameworks (GDPR, MDR, IVDR, etc). ▶ The EHDS must harmonise rules, reduce legal fragmentation and ensure that the regulation can be implemented consistently across the EU. ▶ Clear specification of the scope of electronic health data categories for secondary use. ▶ The EHDS should avoid any opt-in and only incorporate an opt-out mechanism as long as it does not lead to inconsistent implementation, increased health data disparities, and excessive administrative burdens. ▶ Safeguard and incentivise health research and innovation activities that are performed in line with the existing regulatory frameworks. ▶ The EHDS should leverage existing health data infrastructures, set up by health institutions and stakeholders, to allow continuity and build on existing expertise. ▶ Avoid excessive data localisation and international health data transfer restrictions that go beyond the requirements of the GDPR’s framework.

MedTech Europe, together with 35 health stakeholder organisations, shares its concerns about the proposed Regulation on the European Health Data Space #EHDS that is being negotiated by EU institutions. For this legislation to succeed, fundamental issues still need to be addressed in the final regulation to build an enabling health data ecosystem. With regard to these complex challenges, MedTech Europe calls on the EU institutions to leverage the expertise of the healthcare stakeholders and duly consider our recommendations to adopt a fit-for-purpose legislation. Read the stakeholder’s recommendations here ➡️ https://bit.ly/3OVtwGm

When #Patients, #HealthCare professionals #Industry, #Academia , #CivilSociety all come together and share the SAME position, politicians better be listening. #EHDS can help save lives in the short term, but it's biggest potential is in the LONG term - unlocking health research to come up with awesome innovative solutions. This is only possible IF: 💔 EHDS avoids fragmentation of implementation: ONE regulation & ONE interpretation for the whole of EU. ✔ EHDS avoids OPTING-IN, so not to create disparities and more red tape. It takes courage. It is the right thing to do.

The Sandoz integrated #ESG and annual report provides an overview of our positive #impact on patients, communities, and #healthcare systems worldwide. Check out our impact here: https://lnkd.in/duUBNmDk

Your trusted partner in international healthcare. #sarianhealthcare #pharmadistributor #pharmaexports #pharmadistributornetwork #globalpharma #internationalhealthcare #pharmaexportbusiness #pharmamanufacturing #nutramanufacturing #cosmeticmanufacturing #contractmanufacturing #harmonalproduct

What are the latest trends in patient clinical trials – and what do they mean for patient and health care providers? Listen to Teva expert Shoshi Friedman, Head of Global Clinical Operations, Innovative Medicines, talk about new directions in the sector, from greater accessibility to increased diversity. https://lnkd.in/dYjWrFTY #Tevapharm #ClinicalTrials #HealthcareTrends #Accessibility #DiversityinClinicalTrials

The #EuropeanCommission recently released two guidelines to support manufacturers in approaching direct and indirect treatment comparisons for their submission to the #EMA. Whilst the methodological guidelines offers recommendations for synthesising evidence from various sources to inform decision-making processes, the practical guideline provides actionable strategies to analyse diverse data sources, facilitating evidence-based practices and enhancing healthcare efficacy. The guidelines aim to enhance the robustness and validity of comparisons between healthcare interventions. The release of these guidelines, which emphasise what manufacturers have already been implementing highlights the potential inclusion of such criteria for the upcoming #JCA to help SME manufacturers better prepare for their launch. https://lnkd.in/gKCfGVPn https://lnkd.in/ey3pRTHt