Clinigen

Today, we celebrate 🌍 World Health Day, raising awareness of the importance of wellbeing across the globe. On this occasion, we invite you to listen to our regulatory experts as they delve into the critical aspects of paediatric plans in the EU and US. 👉 Watch a replay of our exclusive webinar, developed in partnership with TOPRA, ‘Navigating Paediatric Plans in the EU & US’ here: https://lnkd.in/eK8BUFMu #regulatoryaffairs #paediatricplans #Clinigenlifecycleservices Kinesys Consulting Ltd TOPRA - The Organisation for Professionals in Regulatory Affairs #worldhealthday

Meet two influential leaders who've dedicated over a decade to shaping Clinigen: SVP Suzanne Aitken (Managed Access) and SVP Julie Gosper (EU, US and International Markets Global Partnering). Beyond International Women's Day, we're celebrating their enduring commitment to our mission of accelerating access to innovative medicines for patients worldwide and to building a truly inclusive workplace where everyone can thrive, regardless of their background, creed, or connections - a commitment that translates into real-world impact. Swipe to read their insights on championing equitable access and cultivating a culture where everyone can flourish. When you empower women leaders in healthcare, you’re building a future of better patient outcomes. #BeyondIWD #WomenInLeadership #LeadWithPurpose #PatientAccess #InternationalWomensDay

Clinigen’s Ascenian Market Access group specialises in optimising pricing and reimbursement strategies while developing HEOR evidence to support payer and HTA submissions across the US, Europe, Brazil, and other key markets. By bridging disciplines and collaborating with both former and current decision-makers from pricing and reimbursement agencies, health plans, and policy bodies, we provide valuable insights into navigating market access. Visit https://lnkd.in/eY9eVm8b to learn more on how to effectively plan for optimal pricing and reimbursement in the context of EU HTA and national submission requirements. #HTA #MarketAccess #PriceandReimbursment #EUHTA #Payer #HEOR

🌟 Only two days left! Please join an exclusive webinar "Navigating Paediatric Plans in the EU & US" hosted in collaboration with TOPRA - The Organisation for Professionals in Regulatory Affairs. Join our speakers Karl-Heinz Huemer, Delphine Wagner, and Gerry McGettigan as they delve into:  ✅ Paediatric regulatory requirements in the EU   ✅ Key differences compared to the US   ✅ Implications for global programmes Don't miss this chance to gain valuable insights from our experts, including a former regulator, on the key aspects of paediatric plans, as well as the essential "do's and don'ts" when preparing these critical documents. 📅 When? 2 April 2025   ⏰ 11:00–12:00 EST / 16:00–17:00 GMT   👉 Sign up today: https://lnkd.in/e3y4vEXV #regulatoryaffairs #paediatricplans #Clinigenlifecycleservices Kinesys Consulting Ltd TOPRA - The Organisation for Professionals in Regulatory Affairs

At Clinigen, we’re invested in nurturing leadership. Our Future Shapers program empowers talented leaders like Jessica Boutefeu to drive strategic change. Beyond International Women's Day, we're excited to share her journey through this immersive 12-month development program, championed by our CEO Jerome Charton and Chief Supply Chain and Business Transformation Officer Alex Johnson. See what Jessica, Head of Quality for Clinigen Clinical Supplies Management has to say on how Future Shapers has influenced her leadership and strengthened her impact on accelerating patient access to innovative medicines worldwide. #LeadWithPurpose #BeyondIWD #WomenInLeadership #InternationalWomensDay #FutureShapers

As more states establish Prescription Drug Affordability Boards (PDABs) to address rising medication costs, pharmaceutical companies need comprehensive strategies to navigate this complex policy environment.   The latest white paper by Andréa L. Monteiro, Consultant and Head of the Centre of Excellence Market Access and HEOR at Ascenian a Clinigen company, explores: - PDAB powers and state-by-state differences - Legal challenges shaping implementation - Pricing and market access impacts - State initiatives' influence on national policy - Strategies to balance access and affordability - Future outlook as PDAB momentum grows Download now for key insights on how these policies may shape pharmaceutical pricing and market dynamics. https://lnkd.in/eUn8NHpY #PrescriptionDrugs #PharmaceuticalStrategy #MarketAccess #HealthcarePolicy #DrugPricing

Beyond International Women's Day, we're proud to spotlight the inspiring passion of two talented leaders at Clinigen who are making a real difference in patient access: Cristina Armendáriz (Regional Manager, Spain & Portugal, Access and Commercialisation) and Randa Atiyeh (VP Client Services, Clinical Supplies Management). For Cristina, ensuring women have equitable access to medicines isn't just a job, it's a "personal mission." For Randa, it's about creating a seamless experience for clients and, ultimately, the patients relying on clinical trials. This is leadership driven by purpose in action: real people dedicated to getting essential medicines to those who need them. Take a look below to see what fuels their impactful work. #LeadWithPurpose #BeyondIWD #WomenInLeadership #InternationalWomensDay #PatientAccess #PharmaServices

At this year’s 4th Clinigen Insights Conference, our experts Kieron Lewis and Natalie McGregor were joined by MHRA's Stephen Maddocks and engaged in impactful and important discussions on the UK’s Early Access to Medicines Scheme (EAMS). EAMS is a key part of our commitment to accelerate patient access to innovative, life-changing treatments and support the UK’s position as a global leader in life sciences. We’d like to thank everyone who attended our presentation and Insights conference. If you would like more information regarding EAMS, don’t hesitate to contact us at contactCLS@clinigengroup.com. Looking forward to the advancements we’ll make together in the year ahead!    #EarlyAccess #EAMS #RegulatoryAffairs #MHRA #MarketAccess #ClinigenInsights 

Dan Wasserstrom, Lauren Heiser and Toni Williams from our Managed Access team are at the Operationalize Expanded Access Programs (EAP) Conference 2025. Discussions have highlighted the evolving landscape of Expanded Access Programs, emphasising the importance of cross industry collaboration.    Key themes from this morning have included streamlining access for healthcare providers, with a focus on US-based digital solutions such as the eRequest App and Navigator platform. As well as developing sustainable solutions in low-to-middle-income countries and emerging markets, where a significant portion of the world’s population faces substantial unmet medical needs.   Clinigen is proud to be part of these vital conversations, working together to drive broader access to patients with unmet medical needs worldwide.   #ManagedAccess #ExpandedAccess #OperationalizeEAP

🌟 Clinigen would like to invite you to an exclusive webinar, hosted in collaboration with TOPRA - The Organisation for Professionals in Regulatory Affairs: "Navigating Paediatric Plans in the EU & US". Join our speakers Karl-Heinz Huemer, Delphine Wagner, and Gerry McGettigan as they delve into:  ✅ Paediatric regulatory requirements in the EU ✅ Key differences compared to the US   ✅ Implications for global programmes Don't miss this chance to gain valuable insights from our experts, including a former regulator, on the key aspects of paediatric plans, as well as the essential "do's and don'ts" when preparing these critical documents. 📅 When? 2 April 2025   ⏰ 11:00–12:00 EST / 16:00–17:00 GMT  👉 Sign up today: https://lnkd.in/e3y4vEXV #regulatoryaffairs #paediatricplans #Clinigenlifecycleservices Kinesys Consulting Ltd TOPRA - The Organisation for Professionals in Regulatory Affairs