As we approach the end of 2025, we recommend pharma include a focus on: - The UK market update - EU-FMD coming into force in Italy and Greece - Preparations for Switzerland switching to mandatory EU-FMD compliance While those already compliant with the EU-FMD can be confident that these new markets are not threat to existing operations, we’d urge pharma to check their serialization programmes in advance. Sign-up to our mailing list for the actionable insight we can provide: https://lnkd.in/eskd6Pjs
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Pharm-D 26' | Ambassador Med Sparkles SMC PVT | Volunteer at APSU | Customer Health Care & Management Professional | Pharmacy Professional
Attended an insightful webinar on "Drug Registration & Regulation in Leading Markets(US, EU, JAPAN). Nov, 20 2024 The session shed light on the complexities of drug development and clinical trials across the US, EU, and Japan. A remarkable opportunity to understand global regulatory frameworks and streamline drug approval processes. Grateful to the speaker Bhaskar Napte ~ Pharma Coach for simplifying intricate topics and sharing actionable knowledge. Let's innovate and accelerate impactful healthcare solutions. Key Learnings : 1. Streamlining Drug Development 2. Clinical Trial Phases 3. Compliance Challenges 4. Global Standards 5. Future Trends #DrugDevelopment #ClinicalTrials #PharmaRegulations #HealthcareInnovation #GlobalMarket
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In less than 2 months, experts in #pharma manufacturing will be coming to the Westin Copley Place in Boston to share their knowledge on various industry topics. One of these experts is Andrew Chang, VP, Quality and Regulatory Compliance, Regulatory Policy and Intelligence, Global Regulatory Affairs, Novo Nordisk. His session is titled "Empowering Quality Excellence: Revolutionizing Pharma Manufacturing and Outsourcing". During this session, he will be discussing multiple topics, some of which are highlighted below: 🔹Harmonizing policies for seamless manufacturing operations and outsourcing practices. 🔹Integrating innovative approaches to ensure product quality throughout the lifecycle. 🔹Leveraging collaborative efforts to shape regulatory landscapes and advocate patient interests. To listen to Andrew, and many other industry professionals, be sure to join us at the American Pharma Manufacturing & Outsourcing Summit from November 18-19. We have very few spots left, so we encourage you to register ASAP! Learn more here: https://hubs.ly/Q02RgGkC0 - #GenerisPMOS #USPharma24 #pharmaindustry #pharmainsights #pharmanews
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Director | TWO Communications | Senior healthcare communications leader passionate about making people's lives better
A timely reminder of how much there is to think about when planning geo-expansion across Europe. Some top tips here for anyone in 2025 planning right now 📈
Building on Part 1 of our European expansion series, we're delving into the critical role of patient-focused communication in healthcare launches across Europe. 🌍 🌟 While mature healthcare systems offer immense opportunity, regulatory landscapes, language diversity, and cultural nuances demand a fine-tuned approach to reach and support patients effectively... In Part 2, Hristo Deyanov emphasises how the EFPIA - European Federation of Pharmaceutical Industries and Associations Code and its local counterparts guide compliant communication. Yet, in many European countries, patients (especially in #RareDisease spaces) are exceptionally informed. 🗣 It’s more than just saying the right things, it's about making sure patients truly hear you! Read the full article here: https://lnkd.in/emK7yvVx #TWOCommunications #HealthcareComms #ThoughtLeadership
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We are delighted to announce that we are an #officialsupporter of the 13th Annual Global Pharma Regulatory Summit. Taking place between 19 and 21 June 2024 in #Mumbai this conference is the premier #pharma #regulatory event for the Indian #generics and #biosimilars industries. With the theme of ‘Harmonizing regulatory policies for ensuring safety, efficacy, and quality of drugs worldwide’, this 3-day conference will bring together regulatory operations and submission professionals to share best practice in the compilation, formatting, and submission of a variety of approval applications. Each day focuses on a specific geographical region, and we will be chairing the second day on the UK & EU Regulatory Landscape. Topics to be discussed include real world evidence (#RWE), #clinicaltrials, innovative therapies and #artificialintelligence (#AI). As an event supporter, our members can claim get a 5% discount on registration fees – find out more 👉 https://lnkd.in/gF58B799
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🌐 Join Anlitiks Inc. for an informative webinar on the European Union (EU) joint clinical assessment and its impact on the health technology landscape. The EU’s joint clinical assessment marks a paradigm shift in evaluating new health technologies, offering streamlined evaluations and faster market access. However, it also brings complex financial, regulatory, and operational considerations for pharmaceutical companies. Join us to: ➔ Explore financial implications and potential cost savings. ➔ Understand its influence on R&D strategies and clinical trial designs. ➔ Discuss accelerated market access and regulatory alignment. ➔ Address operational complexities and resource management. ➡️ REGISTER HERE: https://buff.ly/3LLNotT Featured speakers: Stephanie Butler Kitty Rajagopalan #ClinicalResearch #MarketAccess #ClinicalData #RegulatoryAffairs #RegulatoryCompliance #PharmaceuticalRegulation #Commercialization
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Are you planning to enter the EU or UK market and/or expand your market in the region? Join our upcoming EU and UK procedures for marketing Authorization online Masterclass by Norah Lightowler held on 25-26 June,2024. 🔍 Key Takeaways: • Overview of the current EU regulatory environment. • Knowledge of EU procedures for marketing authorization. • Proposed changes to EU pharmaceuticals legislation. • Knowledge of UK procedures for marketing authorization. • Post-authorization obligations; current & proposed. • Relevant factors to be considered. For more details - neetha.suresh@glceurope.com | DM Don't miss this opportunity to enhance your understanding of EU and UK regulatory environments and procedures. Register now to secure your spot! #glc #glceurope #onlinelearning #EURegulatory #UKPharma #MarketingAuthorisation #Biotherapeutics #MasterClass
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"Don't miss out on our upcoming MasterClass! Learn about current & proposed post-authorisation obligations in the EU & UK. #PostMarketingSurveillance #PharmaRegulations" Event - EU and UK procedures for marketing Authorization online Masterclass Date - 25-26 June,2024 Led by - Norah Lightowler For more details - neetha.suresh@glceurope.com | DM Limited seats Available!! #EURegulations #UKRegulations #PharmaRegulations #DrugDevelopment #MarketingAuthorization #ClinicalTrials #LifeSciences #PharmaCompliance #MasterClass #USPharma
Are you planning to enter the EU or UK market and/or expand your market in the region? Join our upcoming EU and UK procedures for marketing Authorization online Masterclass by Norah Lightowler held on 25-26 June,2024. 🔍 Key Takeaways: • Overview of the current EU regulatory environment. • Knowledge of EU procedures for marketing authorization. • Proposed changes to EU pharmaceuticals legislation. • Knowledge of UK procedures for marketing authorization. • Post-authorization obligations; current & proposed. • Relevant factors to be considered. For more details - neetha.suresh@glceurope.com | DM Don't miss this opportunity to enhance your understanding of EU and UK regulatory environments and procedures. Register now to secure your spot! #glc #glceurope #onlinelearning #EURegulatory #UKPharma #MarketingAuthorisation #Biotherapeutics #MasterClass
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🧭 Transformative waves of the new EU Health Technology Assessment Regulation! The EU Health Technology Assessment Regulation is set to reshape how we evaluate clinical data across Europe. This change brings a new level of collaboration and efficiency to health technology assessments. What does this means for EU Member States and the pharmaceutical industry? Check out our latest article to understand the upcoming changes. And more to come from us on creative solutions to help you navigate this landscape, stay tuned! The article 👉 https://lnkd.in/eaZqrrH4 #Healthcare #EUHTAR #HealthTechnology #Pharma #Regulation #FutureOfHealthcare #Innovation
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🚀📆 After intense negotiations, the European Parliament's ENVI committee has made significant strides in the revision of the EU pharmaceutical legislation. With an upcoming plenary session debate and vote scheduled for April 10-11, 2024, the amendments reflect a delicate balance between promoting innovation and ensuring equitable access to medicines across Europe. With European elections approaching in June, the implications for innovation and access to healthcare across the EU-27 are significant. Keep an eye on how this situation develops as it will determine the future of our industry. #PharmaFutureEU #PharmaReview #EU #MedicinalProducts
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🌍 𝐔𝐧𝐥𝐨𝐜𝐤𝐢𝐧𝐠 𝐭𝐡𝐞 𝐅𝐮𝐭𝐮𝐫𝐞 𝐨𝐟 𝐄𝐔 𝐏𝐡𝐚𝐫𝐦𝐚: 𝐀 𝐃𝐞𝐞𝐩 𝐃𝐢𝐯𝐞 𝐢𝐧𝐭𝐨 𝐭𝐡𝐞 𝐄𝐔 𝐋𝐞𝐠𝐢𝐬𝐥𝐚𝐭𝐢𝐯𝐞 𝐑𝐞𝐟𝐨𝐫𝐦𝐬 Join Marloes van Bruggen - van der Geer, Head of Regulatory Affairs at Celegence to explore the catalysts driving the transformative reform of EU pharmaceutical legislation. With insights born from the lessons of the recent pandemic and a keen eye on the future, she outlines the strategy's pivotal role in ensuring medicine quality, safety, affordability, and availability across the European Union. Beyond patient care, the strategy ambitiously aims to bolster the EU's global competitiveness, creating an environment where pharmaceutical innovation thrives. This comprehensive approach is not just about regulation—it's about setting a new standard for healthcare excellence worldwide. 💻 Access the full webinar for free, On-Demand. Sign up and enrich your understanding: https://lnkd.in/e3vr25zb At Celegence, we're committed to supporting pharmaceutical companies through this era of change. With our expertise and technology-enabled services, we stand ready to assist in navigating the nuances of the new regulations, ensuring your operations are not just compliant, but poised for success in the evolving healthcare market. Let's embrace the change, leveraging the opportunities of the Pharmaceutical Strategy for Europe to innovate, grow, and deliver on our promise of better healthcare for all. #PharmaceuticalIndustry #EURegulations #HealthcareInnovation #PharmaceuticalStrategy #RegulatoryAffairs #PatientCentricCare #GlobalCompetitiveness #Celegence #Webinar #ComplianceSolutions #LegislativeReform #EuropeanUnion
