PharmaLex

New Month, New Opportunities! Our experts are heading to Northern Europe this week to explore exciting new opportunities. Don’t miss the chance to connect with them at these global events: 🔹BIO Europe Sweden | November 4th-6th, 2024 | Stockholm, Sweden 🎙️ Attendees: Kenneth Hollmén, Nina Andersson & Christine Mellborg 🔗 Register here: https://lnkd.in/dnuNZ2D 🔹Drug Safety Forum 2024 | November 4th, 2024 | Oslo, Norway 🎙️ Attendees: Hege Rønning 🔗 Register here: https://lnkd.in/di8ySzz9 🔹PDA Europe Annex 1 | November 5th-6th, 2024 | Dublin, Ireland 🎙️ Attendees: Elizabeth Hunt, Ann-Marie Purcell & Patrick Nieuwenhuizen 🔗 Register here: https://lnkd.in/eSuTh5cR #PharmaLexInTheField #Pharma #Networking #PharmaLex #Events #GlobalExpertise

How to successfully launch a pharmaceutical product in the highly regulated and complex Nordic Market? 💊 Navigate the challenges by learning the essential steps and getting practical knowledge of ✅ regulatory compliance ✅ quality management ✅ market and patient access strategies Update your knowledge by top experts Kirsi Nikkola, Heli Tenhola, Anne Soikkeli, and Annabelle Forsmark in an insightful webinar on the 27th of November! See the program and register now: https://buff.ly/3TC8aQP #productlaunch #pharmaindustry #PharmacaAcademy

🌐 Pharmaceutical companies are expanding globally, but with growth comes the challenge of diverse pharmacovigilance regulations. In our latest article, Alex Brenchat, Ph.D., delves into the complexities of meeting local pharmacovigilance obligations. Discover strategies to navigate these regulatory landscapes, ensure patient safety, and maintain compliance across different regions. Learn how adopting hub concepts and leveraging local expertise can streamline your pharmacovigilance processes. Read the full article: https://lnkd.in/diZ6pK9Y #Pharmacovigilance #GlobalHealth #PharmaLex #PatientSafety

Achieve quality and compliance excellence with our #QMC Solutions! 🌟 From navigating #compliance hurdles to mastering quality at every stage, we're here to guide you from innovation to #commercialization. Our expert team offers comprehensive support in key areas such as quality management system implementation, inspection readiness and remediation. Let's elevate your #qualitymanagement journey together! Discover our solutions now: https://lnkd.in/e_2XZwqt

Looking for insightful conversations, innovative concepts, and recent trends in international healthcare? Explore our #podcast episodes whether you're on your daily commute 🚗, hitting the gym 🏋️ or just relaxing at home 🏠, our podcast is the perfect companion. At Cencora PharmaLex we offer comprehensive product commercialization, encompassing global market access planning and implementation, all aimed at promoting healthier futures for patients worldwide. Happy Listening 🎙️ https://lnkd.in/eRBZ7NFa #CencoraPharmaLex

🚨 EU Parliament Proposes Major Revisions to MDR and IVDR! 🚨 On October 23, 2024, the European Parliament adopted a JOINT MOTION FOR A RESOLUTION addressing the urgent need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) (2024/2849(RSP)). The Parliament has called on the European Commission to publish acts that tackle the “most pressing challenges and bottlenecks” of the MDR and IVDR. They propose revising all relevant articles of these regulations, accompanied by an impact assessment. Key Points of the Resolution: • Support for SMEs: Specific measures to assist small and medium-sized enterprises. • Fast-Track Approvals: Accelerated approval processes for innovative technologies. • Transparent Fees and Timelines: Harmonized fee structures and timelines for notified bodies. • Elimination of Unnecessary Re-Certifications: Streamlining the certification process. • Approval of Innovative Devices: Focus on health emergencies and pediatric devices. • Inclusion of E-Health Applications: Certifying currently unregulated e-health applications. • Urgent Implementation of EUDAMED: Ensuring cancer and rare disease patients can participate in EU clinical trials. Next Steps: 1️⃣ European Commission to propose amendments to the MDR and IVDR by the end of Q1 2025. 2️⃣ Submission of the proposal to the Council and the European Parliament. 3️⃣ Legislative process. 4️⃣ Final adoption and implementation. Read the full resolution here: https://lnkd.in/gbteNB4R #MedicalDevices #InVitroDiagnostics #MDR #IVDR #PatientSafety #SME #NotifiedBodies

Yesterday I had a fascinating opportunity to moderate panel discussion in the annual RP day organized by Pharmaca Health Intelligence. Good insights and lively discussion about returns of medicinal products with Anna Ikonen Anni Svala Teemu Kivijärvi PharmaLex #GDP #QA #QMC

Explore the essential steps in designing a pharmaceutical manufacturing facility in our latest article by Tam Huynh, QMC Director at PharmaLex. This comprehensive guide covers everything from concept design reviews to compliance with FDA and EU standards. Learn how to balance immediate needs with future goals and avoid costly redesigns. Read full article here: https://lnkd.in/dsSAw6EA #PharmaManufacturing #FacilityDesign #GMP #PharmaLex #FDA

PharmaLex Newsletter: November Edition is Now Out! 📢 Stay ahead in the pharmaceutical industry with the November 2024 edition of the #PharmaLex newsletter. This edition covers: 📊 EMA’s Product Management Service (PMS) readiness: Strategic planning for both near- and long-term activities; 🔍 Local pharmacovigilance best practices: Ensuring compliance and patient safety at the affiliate level; 🌍 Commercialization steps in Europe: Navigating diverse national legislation and preparing for market entry; 🤝 Upcoming Nordic QAForum in Copenhagen: Discussing quality assurance and regulatory affairs with industry peers. Don’t miss out on the latest regulatory, #pharmacovigilance, and #commercialization updates. Read now and stay informed!

Explore the key takeaways from the Good Morning Meeting on Annex 1 compliance with PharmaLex and watch Patrick Nieuwenhuizen's interview recorded at the event. Key Highlights: 1. Quality Risk Management: Essential for ensuring compliance across all processes. 2. Contamination Control Strategy: Implementing robust measures to maintain sterility. 3. New Technologies: Leveraging isolators, robotics, and rapid monitoring systems. 4. Continuous Improvement: Adapting and evolving practices to meet regulatory expectations. Read the key takeaways: https://lnkd.in/db7Psi2A Stay ahead in pharmaceutical compliance with us. #PharmaCompliance #Annex1 #PharmaLex #QualityRiskManagement