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Just in: New draft guidance from the FDA sets out how pharma and medical devices companies can legitimately respond to misinformation. This is big news - #misinformation is recognised by HCPs and health policymakers as a threat to health. But addressing misinformation has been complicated, especially in the public domain of social media and for regulated #pharma companies. The FDA draft guidance is out for consultation for the next 60 days. If you're in pharma and would like advice on responding, I'd be happy to talk and share some of our research findings to support your response. I'll be posting more about this so watch this space and follow for updates. Meanwhile, here's a handy first overview by @fiercepharma of the draft guidance.

A recent study discussed on News-Medical.net identifies various online tools, such as price comparison websites and discount programs, that help lower prescription drug costs. These tools enable patients to find the best prices, making medications more affordable. The study highlights the importance of competition from generic drugs, which significantly reduces prices, as confirmed by FDA reports. Additionally, broader policy changes are recommended to tackle high drug prices by ending anti-competitive practices and enhancing supply chain transparency. https://lnkd.in/griEmCjt #DrugPrices #Healthcare #AffordableMeds #HealthcareAccess

🚀 Calling all our members working in digital health! Final opportunity to join us for a special Coffee and Conversation session, delving into the US regulatory framework tailored just for you! 📝 🔍 Eva F. Yin, PhD, MPH, JD, FDA Regulatory Expert at Wilson Sonsini Goodrich & Rosati, will be your guide through critical topics including: 👉 Understanding the digital health services model versus the FDA-regulated product model. 👉 Navigating the unique regulations for digital health companies involving licensed healthcare professionals or healthcare services. 👉 Exploring the diverse business models within the industry and their unique regulatory requirements in the U.S. 💡 Eva's superpower lies in leveraging her extensive scientific background to tackle go-to-market and regulatory challenges head-on. Don't miss this golden opportunity to gain invaluable insights that will empower your company's journey in the digital health landscape! Secure your spot now 👇 With the regulatory landscape changing, we are here to keep you updated with the latest updates, insights and events. Members - Join our newsletter: https://bit.ly/3FX69EY #DigitalHealth #FDARegulations #CoffeeAndConversation #RegulatoryInsights

🔍 Prioritizing Patient Safety in Medication Information As part of MLPS, we're concerned about proposed changes to medication information delivery. While electronic product information (ePI) offers convenience, it could exclude millions of vulnerable Europeans from crucial medical details, increasing the risk of errors. Key Points: 1. Access for All: Many lack consistent digital access. Guaranteeing access requires 100% digital literacy, which is currently unattainable. 2. Print on Demand Issues: POD as an alternative poses practical challenges and risks inaccuracies. 3. Linguistic Needs: Abolishing paper leaflets isn't the answer. Collaboration can address language diversity. 4. Privacy Concerns: Online health data is vulnerable. Patients should have offline options for privacy. 5. Transition Period: The proposed five-year transition to ePI is insufficient. Prioritizing patient safety demands a balanced approach. Let's ensure access to vital medical information while addressing digital challenges effectively. #PatientSafety #Healthcare #Digitalization #PolicyChange Read more on our website https://lnkd.in/e2vy7uZw

Want to stay ahead of the competition? Incorporating social listening at your next medical congresses can help optimize your strategic decisions and make your strategies soar. Here are the top 9 tips for success from Within3: https://lnkd.in/d_bSZKVU #medical affairs #pharma #medicalcongresses #insightToImpact #AI

Check out our whitepaper to evaluate your medical affairs capabilities in patient-centricity. It was a pleasure working with Sunil John on this, download here: https://lnkd.in/gy6QMJV5

Make sure to join our Webinar next week on how Medical Affairs can help to overcome key launch challenges to drive launch success by taking the lead in collaboration with cross-functional teams. Don’t miss out and register with the link below. https://bit.ly/48J7i1D #LaunchExcellence #IQVIASwitzerland #MedicalAffairs

Navigating the complexities of clinical submissions can be daunting, but what if you had insider knowledge from a former Notified Body expert? 🤩💡 That's what we're offering, October 15 @ 9 am EST/ 3pm CEST. We're thrilled to have Dr. Yvonne Ndefo, former Chief Clinical Evaluator at NSAI, share her expert advice on what it takes to get your clinical submissions right the first time. Join this free webinar and learn directly from an industry insider how to ensure completeness and compliance in your clinical documentation. Register here: https://bit.ly/3XPb7yH #regulatorycompliance #submissions #eumdr #clinicalevaluation #medtech #medicaldevices #webinars #greenlightguru

Medical Affairs teams face mounting pressure to showcase value, both internally and externally. However, traditional metrics often fall short by focusing solely on quantity rather than quality and lacking outcomes-based measures. Discover IQVIA's strategic approach to establishing impactful metrics aligned with the medical plan. Find out more: https://lnkd.in/eEh6E4p5 #medicalaffairs #facts #value #outcomes #plan #strategy #map #metrics #Iqvia #effective

Missed Our Webinar? Watch It On-Demand Now! If you were unable to attend our August 15th webinar, "Medical Information: What Do They Do?", you can now view the entire session on-demand. In this informative session, Susan Wnorowski PharmD, BCMAS, Sr. Director of US Medical Information at Ipsen US Medical Affairs Division, shared her extensive expertise, drawing from over 24 years in Medical Information and Drug Safety. Key Takeaways: - Core responsibilities and daily activities of Medical Information professionals - Navigating complex compliance issues - The significant impact on patient care - Challenges and rewards in the field - Career opportunities and essential skills for success Whether you are currently in the industry or exploring a career in Medical Information, this webinar offers valuable insights that can enhance your understanding and career trajectory. Watch the full webinar here: https://lnkd.in/evmjjCfc Share, and subscribe for more expert-led content. #MedicalInformation #Pharmaceuticals #Healthcare #Webinar #CareerGrowth #PatientCare #ProfessionalDevelopment #ACMA #BCMAS #MedicalAffairs