MediPhorum’s Post

MediPhorum's 'Post-Launch Change Requirements' workstream will be presenting the work and thought leadership developed across the last year in a #SAE conference next week, 8th May at 4pm in London, titled: Navigating the Complexities of Regulatory Compliance in Combination Product Lifecycle Management.    In the realm of combination products, the challenge is that substantial changes can affect product integrity and patient safety. The regulatory landscape demands strict adherence to the FDA’s risk-based framework to navigate these changes successfully.   Our objective in our MediPhorum workstream has been to delve into effective strategies that manage material changes without misinterpreting regulatory compliance. Victoria Ludlow, MediPhorum's Global Program Manager, will be excited to present insights developed across our membership participation, that will provide comprehensive guidance on FDA change categories and reporting requirements, ensuring compliance towards maintenance of product quality and efficacy.   To support this aim, the deliverable of our collaboration will be the publication of an interactive PDF designed to aid technical engineers alongside regulatory teams. Thanks to these collaborative efforts of our MediPhorum Membership, we now have a robust ‘decision tree’ tool at our disposal. This US-based resource amalgamates various guidance and frameworks, offering enhanced user-guidance and case studies. Spanning eight categories of design change, it includes comprehensive lists for evaluating the necessity of a design change and a library of justifications and evidence to support decision-making processes. The PDF tool will be published in June. Please contact any of the team to sign-up to receiving it, and more information on getting involved Victoria Ludlow Ed Birmingham Soroosh Bagheriasl , PhD Scott Ewan Alaster Stockwell-Jones   Stay tuned and subscribe to MediPhorum as we continue to empower professionals with the tools and knowledge to excel in the ever-evolving landscape of combination product management. #collaboration #combinationproducts #drugdelivery #medicaldevices #bipharmaceuticals BioPhorum

🌐 The rise of Integrated Delivery Networks (IDNs) has transformed pharmaceutical sales. Today's reps face a complex maze of stakeholders, far beyond the individual physician relationships of the past. Success in this new landscape demands a strategic approach. It begins with mapping intricate decision-making structures within IDNs and developing multi-level engagement strategies. Top performers are now adept at cultivating internal champions, leveraging data analytics, and mastering virtual engagement. Most crucially, sales effectiveness now hinges on navigating relationships and aligning with organizational goals across the IDN ecosystem. As this landscape evolves, continuous learning and adaptation have become essential. Is your sales team equipped to thrive in the world of IDNs? The right strategies and coaching can make all the difference in this new era. #PharmaSales #IDNStrategy #HealthcareEvolution #SalesEffectiveness

🌟 Leading Without Authority: A Hallmark of the MSL Role 🌟 MSLs are tasked to move a wide variety of stakeholders from one belief/behaviour to another, when they have no authority to do so and that my friends, is a big ask. The thing is, as an MSL, you have something more valuable than authority – you have the ability to build trust and relationships. You become a trusted advisor, using your scientific expertise and interpersonal skills to influence healthcare professionals and medical experts. It's all about collaboration and empowering others with your knowledge and expertise. MSLs don't just work within their own teams; they foster partnerships across departments and with external stakeholders. By breaking down silos and encouraging a culture of collaboration, MSLs ensure everyone is working towards a common goal. And the impact isn't limited to their immediate sphere. MSLs come alongside policy makers, patient advocacy groups, and industry thought leaders, shaping the future of healthcare. Leading without authority as an MSL requires continuous learning and staying on top of the latest scientific advancements and industry trends. It's not easy, but it's a crucial skill for success. I'd love to hear your experiences and insights on leading without authority in the MSL role. Let's collaborate, share knowledge, and shape the future of healthcare together! #MSL #Leadership #LeadingWithoutAuthority #Pharmaceuticals #HealthcareLeadership

As a critical function of #pharma companies large & small, #MedicalAffairs has exploded in recent years in size & strategic importance. With an increase like this, comes increased impact expectations. What may not yet have kept pace, are capabilities. The delivery, engagement & execution. If this is playing out for you, we can help your #MSL & Medical Advisor teams match their technical expertise, with communication excellence. #MAF The Echelon Effect

Mastering global drug launch strategies requires a holistic approach with Medical Affairs leadership at the forefront. 🎯 By integrating early scientific leadership, optimizing organizational performance, engaging stakeholders effectively, and planning for lifecycle management, Medical Affairs contributes significantly to the success of drug launches. Embracing a culture of continuous improvement and proactive decision-making, Medical Affairs navigates the complexities of global markets and drives the realization of clinical value for new drugs. Here are the 6 Key elements that make Global Drug Launch successful. ✨ Thank you Dr. Sakharam Garale, for guiding me to learn more about the topic #medicalaffairs #druglaunch #msl #medicaladvisor #outcomesresearch #heor Tanvi Sarode Vaishnavi Berad Varsha R Wadnere

I have just returned from a week of visit in the field and I would like to share some thoughts. In the dynamic and ever-evolving pharmaceutical industry, understanding our customers’ needs is paramount. It’s time for the executives to go beyond the boardroom and connect directly with those we serve. Here’s why field visits are essential for our success . By stepping into the field, we not only gain valuable insights but also strengthen our bonds with those who rely on our innovations. Together, we can drive meaningful change and make a lasting impact. When the executives step into the field, it sends a powerful message that we deeply value our customers. These personal interactions foster trust and loyalty, demonstrating that we are committed to their success and well-being. Direct conversations with healthcare providers and patients provide invaluable, unfiltered feedback. This real-time information helps us refine our products, address challenges, and innovate in ways that truly matter Experiencing the realities of the market firsthand enables us to make more informed and strategic decisions. This alignment with real-world conditions ensures that our strategies are practical and impactful. Our presence in the field showcases our commitment to a customer-centric approach. It reinforces that at every level, we are dedicated to improving patient outcomes and enhancing the quality of care When the associate see their leaders engaging directly with customers, it boosts morale and motivation. It shows that leadership is not only present but actively involved and supportive of their efforts. Comments and thoughts are welcome. # work at CSL #PharmaLeadership #CustomerEngagement #Innovation #PatientFirst #FieldVisits #ExecutiveCommitment #HealthcareExcellence

How is the MSL performance measured? Here is a report on MSL KPIs: This study is based on more than 15 years of research on MSL key performance indicators (KPIs). Exchanges with 100s of executives and MSLs over that time, and a constant refinement of measures produced this latest guide. It reviews current MSL performance metrics and offers model pathways that consider the specific needs within each phase to help executives establish best practices and refine the evaluation process.   Learn more here:    #pharmaceuticalindustry #medicalaffairs #healthcare #msl #medicalscienceliaison https://lnkd.in/esGppwnz

🌟 Regulatory Rockstar Spotlight! 🌟 Curious about how a pharmacy graduate’s unplanned career shift is transforming the MedTech industry? 🚀 Check out our latest blog, where we explore the inspiring journey of a Regulatory Affairs expert who went from clinical research to leading global submissions. 🌍 Discover how she navigates the complexities of MedTech regulations, advocates for modernizing frameworks, and shares valuable advice for anyone looking to excel in this ever-evolving field. Don’t miss this story of serendipity, innovation, and leadership! 🔗https://hubs.ly/Q02PDc890 #RegulatoryRockstar #MedTech #RegulatoryAffairs #CareerJourney #Innovation #Leadership #MedDevice Join the Movement today! https://hubs.ly/Q02PDk900

In anticipation of International Women's Day, I'm excited to share a beautifully-told story of early career achievement. This interview conducted by Jaishankar Kutty, Ph.D. with Anastassia Young, MS highlights three key ingredients to professional success: relationships, critical thinking, and expert knowledge. Expert knowledge could be in the field of medicine, as it is in Anastassia's case or computer technology as it is in mine, and any other industry that moves the world forward. Critical thinking and ability to build and foster relationships are the two anchor ingredients of any growth and, ultimately, success.  The second point made in this interview is the notion of the different paths to reaching our potential. Even with the most straight and pre-defined roads to professional growth, we often take detours. Kids, anyone? Or we choose to take a new path. Pursue a new act. Sheila Johnson, a business woman at a very different stage of her respective success, recently spoke at an event I attended. She spoke about the many acts we often have in our careers and how each act enriches us with skills, insights, and power to be more successful in yet our next endeavor. This International Women's Day, I wish all women in professional and business careers to reflect back on their own paths to success and the qualities they harnessed and fostered along the way to reach new horizons they haven't mapped out or even imagined. Well done you all! #success #career #expert #medicine #regulatorycompliance #internationalwomensday2024 #LiftAsWeRise #WomensHistoryMonth

Imagine transforming your Medical Excellence group from good to exceptional. Don’t let your strategy fall behind. Our benchmarking research, involving insights from 57 Medical leaders, reveals that success in Medical Excellence is relationship driven, staff must build trust and rapport with internal stakeholders. It is critical not to be perceived as “owning” or “dictating” excellence, but rather to listen to fellow teams, identify best practices, and pass credit along. Download our free summary to learn more about building effective Medical Excellence teams: https://lnkd.in/dnhAmUqE #MedicalAffairs #MedicalExcellence #MedAffairs #Pharma #MedicalDevices #BestPractices