Niromed’s Post

Excellent speakers at #ABPIconf24 highlighted the opportunities around clinical research, joined-up decision making, and manufacturing, ensuring the UK remains a globally competitive market. It's great to see the level of ambition and the direction of travel. The question now is, will it get the UK back near the top of the rankings for patient access and market launch? #UKhealthcare #clinicalresearch #earlystrategicplanning

🌐 Update from CoAImed! 🌐 We are thrilled to announce that CoAImed, an open caller in the ODIN project, recently participated in a consortium meeting at Azienda Ospedaliera Senese on June 25th. The meeting focused on the testing and evaluation of innovative Odin technologies. Stay tuned as we continue to collaborate closely within the ODIN consortium, contributing to the future of healthcare innovation. Together, we are shaping a brighter and healthier tomorrow through groundbreaking technologies. #CoAImed #ODINProject #HealthcareInnovation #MedicalTechnology #DataIntelligence #HealthcareRevolution #Collaboration #ResearchAndDevelopment #InnovativeHealthcare #PatientCare #MedicalDiagnostics #AIinHealthcare

The Foundation's CEO, Jayasree Iyer, delivered a keynote address at the World Evidence, Pricing and Access Congress 2024 yesterday, where she highlighted that industry plays a key role in reducing health disparities by implementing strategies that overcome barriers to access. "Only 1% of patients in low- and middle-income countries #LMICs have access to innovative medicines five years after the product has been launched. I encourage all industry players to consider whether your company's access strategies address unmet #healthcare needs and ensure lifesaving medicines reach patients in LMICs." Learn how the Foundation is mobilising essential healthcare companies to play their part and raise their game on access ➡ https://lnkd.in/e9U5Ukjq #EPAConf #AccesstoMedicine #EquitableAccess #AccesstoHealthcare #GlobalHealth #HealthcareEquity #pharma

A constant flow of clinical studies in our healthcare facilities is guaranteed by a commitment to competitive timelines. Know more about what makes Portugal a highly attractive country for conducting clinical studies at https://bit.ly/PCT-WHYPT #PortugalClinicalTrials #APIFARMA #AICIB #clinicaltrials #clinicalresearch #healthinnovation #healthawareness #investigation #innovation #health

I posted a comment on this article, but it appears to have been deleted by the owner of the article. I do not understand why. I merely posted a comment highlighting what I believe was not mentioned as to why there is a low availability of innovation in LMICs. This post (and others before it) have a remarkable pattern of throwing the emphasis on innovation asset holders to improve access in LMICs. As a former senior executive who worked across Sub-Saharan Africa for a global pharma company, I always try to 'balance' such posts by highlighting that LMIC governments also need to take action. In this example, I highlighted the high regulatory burden imposed by some of the markets in Sub Saharan Africa: 1. High regulatory fees - presumably to earn foreign exchange (USD). 2. Shorter renewal periods reduced from 5 years down to 3 years - generating more frequent revenue. 3. Manufacturing Site Inspection fees even when the sites are FDA compliant and approved as cGMP. In some cases, they collect the fee but do not inspect. What is the rationale for that, other than to generate revenue? 4. The requirement to carry out local in-market clinical trials that needs the company to appoint a local medically qualified practitioner because they will not deal directly with the corporate medical director. Do they not accept the data submitted to and accepted by FDA and MHRA? 5. Complex labelling requirements such as price, holograms and registration numbers on each pack. This makes for very high Cost of Goods (COGs) for such low volume 'market-specific' packs. This impacts to create low margins on selling prices. 6. Complete apathy towards securing product availability by allowing parallel imports and allowing excessive in-market margins for wholesalers and retailers. 7. Some markets stipulate local manufacturing after a period of time, such as a first or second regulatory renewal. This is extremely costly. Given all these Government factors is it any wonder there is reluctance to bring innovation to LMICs? The reality is that (likely) as much as 80% of global volume sales are in just North America, top 5 EU and Japan. Of the remaining 20%, 80% is likely to be in China and India along with selected North Africa and Latin American markets. From a commercial viewpoint, why would big pharma bother with LMICs to meet an ever-growing list of demands? A more balanced approach is needed when looking at 'access' instead of blaming asset holders.

💫 ABHI UK HealthTech Conference 2024: Global Perspectives & Key Takeaways We were fortunate to attend the #ABHI2024, where key topics like Post-Market Surveillance (PMS) and UK innovation were front and centre. One of the highlights was hearing updates from Dame June Raine, CEO of the Medicines and Healthcare products Regulatory Agency (MHRA), and Laura Squire OBE, Chief Healthcare Quality and Access Officer. 🗣️ Their key message was: 'The time is now' for #MedicalDevice Innovation and #HealthTech adoption in the UK - where they shared valuable insights on balancing #Patient access and safety in health technologies. 🌍 International #Collaboration was also a key theme, with contributions from Swiss Medtech and the US FDA, highlighting the importance of reliance on approvals and efforts to work together through the #IMDRF. Lastly, Adam Spinks LLB's session on 'Regulation as a Core Function of Business' reminded us that #Regulations should drive decision-making, promoting safer and more effective #Healthcare #Technologies. Curious about how regulation and international collaboration can enhance your business strategy? Get in touch with one of our experts today! https://lnkd.in/ejJJNcda #PMS #Innovation #GlobalCollaboration #MHRA #MedicalDevices #UKHealthTech #JoinThe8Fold

While the concept of PE is highly acknowledged and promoted, who can take part in the process is restricted via ‘𝗖𝗼𝗻𝗳𝗹𝗶𝗰𝘁 𝗼𝗳 𝗜𝗻𝘁𝗲𝗿𝗲𝘀𝘁’ 𝗽𝗼𝗹𝗶𝗰𝗶𝗲𝘀. 🚫 These policies vary between decision-makers, creating a range of potential barriers to patient participation in decision-making. Participants from different stakeholder groups will be invited to identify practical solutions to navigate the various types of conflict-of-interest policies. But we appreciate your opinion. Leave a comment and let us know what YOU think. ⤵️ 🗣️Valentina Strammiello (European Patients' Forum), Neil Bertelsen (HTAi Patient & Citizen Involvement in HTA Interest Group), Anke-Peggy Holtorf (Outcomes Strategies GmbH), and Finn McCartney (EUPATI). #PEOF

"Latest Issue Released! I'm thrilled to be part of the editorial team of MEDforum, a monthly newsletter dedicated to providing healthcare professionals with timely and trustworthy information on medicines and healthcare. Our newest issue, Volume 1, Issue 3, is now available! This issue features insightful articles on various topics, including [insert topics or article titles]. As a member of the editorial team, I'm proud to contribute to a publication that aims to support healthcare professionals in their pursuit of delivering quality care. #MEDforum #EditorialTeam #HealthcareNewsletter #PharmaceuticalInformation #ReliableResources"

It's less than one month to go until PMAANZ 2024 and it is shaping up to be another great conference! We are excited that Sound Business Systems will be an exhibitor at PMAANZ 2024! 🎉 Be sure to visit us at Stand 17! We're looking forward to catching up with practice managers in the wider health sector and forging new relationships that will contribute to faster, more complete clinical notes and better patient care. The last 2-3 years have been unprecedented as managers have navigated the pandemic and various weather events to get the team and the practice through difficult times. Now is actually a good time to take a step back and look at your current practices and tools as a whole. Do any of the bandaid processes implemented during the pandemic now need to be revisited? What are things that have changed, slipped, or been updated? What things are working and what aren't? See you in Auckland 12 -14 September ! 👋 #PMAANZ #practicemanager #healthtech #healthcare #operations #medicaloperations

Regulatory compliance is a robust foundation to build on. For #HealthTech developers, a culture of organisational compliance ensures that each product is also developed with regulations in mind. When #HealthTech starts replacing clinicians or bypassing human oversight, it will definitely become a #MedicalDevice and likely stray into a #CQCRegulatedActivity. So what? Well, registering with the CQC means the whole company has to satisfy regulations that don't just apply to a product (unlike Medical Device Regulations). The senior leadership team will need to adapt to new regulatory obligations. Departments previously not familiar with being audited may be in for a shock. Similarly, health and social care providers developing in-house tech solutions or deploying tech need to be aware that there are other legally mandated obligations that now apply. Whatever direction you take, having a clear regulatory road map and embedding a culture of compliance across the organisation will ensure you are building on solid foundations.