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(J-4) #RNINews #ProductLifeGroup company | 🎧 We invite you to join us for our FREE Webinar on "Medical Device : Update 2024 - What's New?".  _________________ 📅Thursday, December 5th, 2024 🕐3:00 PM France/2:00 PM London   Topics to be covered : Stay informed with the latest regulatory updates for medical devices in the EU and UK. Join us to get answers to pressing questions and prepare for the year ahead. ✔ What new proposals from the European Commission could impact your regulatory strategy in the EU? ✔ How are evolving UK regulations affecting your compliance requirements? ✔ What essential updates in MDCG guidance will affect your device? 👨🎓 Speakers : ◾ Keval Bhoola - Business Development Manager & Senior Consultant Self-Care Products ◾ Rafailia Vakasiri - Scientific Affairs Officer Medical Devices   Link to register 👉 https://bit.ly/3Oemhsg

🚀 Navigating eCTD Baseline Submissions Made Simple Are you navigating the complexities of Baseline Submission for your Marketing Authorization Application (MAA)?  A well-executed baseline submission can improve lifecycle management, enable efficient regulatory reviews, and ensure compliance across regions. At ProductLife Group (PLG), we specialize in supporting your eCTD Baseline Submission with: ✅ Expert Guidance: Decades of experience in regulatory publishing and a proven track record of successful submissions. ✅ Advanced Tools: Industry-leading publishing systems and automated quality checks to ensure compliance and accuracy. ✅ Global Presence: Publishers across three time zones, offering seamless support and collaboration worldwide. Baseline submissions can be challenging, but with our expert team at PLG, you will benefit from improved dossier quality, efficient review processes, and a clear lifecycle audit trail. 🔗 Read the full article now and discover how PLG can help you achieve regulatory success: https://lnkd.in/dXpQwvQS ➡️ Visit our website for more information on our regulatory submission services: https://lnkd.in/dsRWmsS9 #regulatoryaffairs #ectd #baselinesubmission #PLG #regulatorysuccess s #pharma #ProductLifeGroup

(J-7) #RNINews #ProductLifeGroup company | 🎧 We invite you to join us for our FREE Webinar on "Medical Device : Update 2024 - What's New?". _________________ 📅Thursday, December 5th, 2024 🕐3:00 PM France/2:00 PM London Topics to be covered : Stay informed with the latest regulatory updates for medical devices in the EU and UK. Join us to get answers to pressing questions and prepare for the year ahead. ✔ What new proposals from the European Commission could impact your regulatory strategy in the EU? ✔ How are evolving UK regulations affecting your compliance requirements? ✔ What essential updates in MDCG guidance will affect your device? 👨🎓 Speakers : ◾ Keval Bhoola - Business Development Manager & Senior Consultant Self-Care Products ◾ Rafailia Vakasiri - Scientific Affairs Officer Medical Devices Link to register 👉 https://bit.ly/3Oemhsg

STRATEGIQUAL SAS - a ProductLife Group company, propose un nouveau programme d'audits mutualisés ! 𝗔 𝗾𝘂𝗶 𝘀’𝗮𝗱𝗿𝗲𝘀𝘀𝗲-𝘁-𝗶𝗹 ? ➡️ Aux exploitants et fabricants de médicaments 𝗣𝗼𝘂𝗿𝗾𝘂𝗼𝗶 𝗰𝗲 𝗻𝗼𝘂𝘃𝗲𝗮𝘂 𝗽𝗿𝗼𝗴𝗿𝗮𝗺𝗺𝗲 ? ➡️ Beaucoup d’entreprises pharmaceutiques collaborent avec les mêmes prestataires, c’est pourquoi Strategiqual a créé ce nouveau service pour permettre à ses clients d’optimiser les coûts en réalisant leurs audits de façon mutualisés. 𝗤𝘂𝗶 𝗿𝗲́𝗮𝗹𝗶𝘀𝗲 𝗹𝗲𝘀 𝗮𝘂𝗱𝗶𝘁𝘀 ? ➡️ Un auditeur consultant sénior qualifié de Strategiqual 𝗤𝘂𝗲𝗹𝘀 𝗮𝘃𝗮𝗻𝘁𝗮𝗴𝗲𝘀 ? ➡️ Mutualisation, Collaboration, Optimation, Conformité et Excellence ! 𝗤𝘂𝗶 𝗰𝗼𝗻𝘁𝗮𝗰𝘁𝗲𝗿 ? ➡️ François-Xavier ROUBIERE – Consultant Sénior et Angélique Houel – Consultant Sénior   📅 A vos agendas! Le 1er audit mutualisé sera consacré au prestataire HandiCaPZéro les 10 et 11 février 2025 à Paris et Jaunay-Marigny. Si vous avez des questions ou bien envie d’y participer, n’hésitez pas à les contacter ! #auditmutualisé #compliance #pharma #qualité #audit

Today is the International Day for the Elimination of Violence Against Women 💙 We'd like to take a moment to shine a light on this topic, which remains largely unreported due to the impunity, silence, stigma, and shame surrounding it.   From whistleblower protections to health & safety measures, ProductLife Group is committed to protecting all employees, including the hundreds of women we proudly call colleagues.    There is #NoExcuse for violence against women.    Join us, and the United Nations, in our call to prevent and end gender-based violence.   Click to learn more about UN's UNiTE Campaign, which lasts from now until International Human Rights Day on December 10 🔗 https://lnkd.in/g2Wh_82G #EndViolenceAgainstWomen

#RNINews #ProductLifeGroup | 🎧 RNI invites you to join us for our FREE Webinar on "Medical Device : Update 2024 - What's New?". _________________ 📅Thursday, December 5th, 2024 🕐3:00 PM France/2:00 PM London During this webinar, you will be an active participant. The idea is straightforward: you ask you questions prior to the session, and RNI answers them! Topics to be covered : Stay informed with the latest regulatory updates for medical devices in the EU and UK. Join us to get answers to pressing questions and prepare for the year ahead.  ✔ What new proposals from the European Commission could impact your regulatory strategy in the EU? ✔ How are evolving UK regulations affecting your compliance requirements? ✔ What essential updates in MDCG guidance will affect your device? 👨🎓 Speakers : ◾ Keval Bhoola - Business Development Manager & Senior Consultant Self-Care Products ◾ Rafailia Vakasiri - Scientific Affairs Officer Medical Devices Link to register 👉 https://bit.ly/3Oemhsg

📚 Discover the publication of our collaborator Véronique TRAYNARD, Senior Consultant Phd Nutrition at #ProductLifeGroup - #RNI Very good job Véronique! 👏

D-4 [Free Webinar in French 💻] 🆕 Gestion des pénuries de dispositifs médicaux : un enjeu de santé publique à relever pour les opérateurs économiques. La disponibilité des DM et DMDIV est cruciale pour garantir la continuité des soins auprès des patients. 👉 Inscription ici: https://lnkd.in/erdu83M7 Industriels, de nouvelles obligations réglementaires vous imposent désormais de mettre en place des mesures de prévention des risques de rupture. Fabricant, Importateur ou Distributeur de Dispositifs Médicaux, vous êtes concernés par ces évolutions réglementaires ! Ne manquez pas notre webinaire le mardi 19 novembre de 11h30 à 12h30 pour un décryptage complet (inscription gratuite)! 🔔 Pascale Cousin et Blandine Thébault seront là pour répondre à vos questions et vous offrir des conseils d’expert. 👉 Inscription ici: https://lnkd.in/erdu83M7 STRATEGIQUAL SAS ProductLife Group #DM #DMDIV #santé #gestionpénurie #ANSM #webinaire #pharma #dispositifsmedicaux #medtech

🚀 On-site update from MEDICA 2024! Good morning Dusseldorf. Are you excited for Day 2 of the biggest Medtech event of the year? ProductLife team is ready to welcome you at Booth C80, Hall 3, on the German Pavilion! Stop by to connect with our global team of experts and developers: Pascale Cousin, Lebon Aymeric, Fernando Mayoral Alonso, Keval Bhoola and Vincent L. 🗓️ Looking to enhance your knowledge on topics that are either fundamental or new and challenging? Join us at our 𝐭𝐰𝐨 𝐬𝐩𝐞𝐚𝐤𝐢𝐧𝐠 𝐬𝐞𝐬𝐬𝐢𝐨𝐧𝐬 𝐛𝐲 𝐌𝐞𝐝𝐭𝐞𝐜𝐡 𝐂𝐨𝐦𝐦𝐞𝐫𝐜𝐢𝐚𝐥 𝐃𝐢𝐫𝐞𝐜𝐭𝐨𝐫 - Lebon Aymeric: 📍 Location: Hall 3, German Pavilion Stage 📅 Date & Time and session highlights: ·     12 November | 15:15 – 15:45 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐟𝐨𝐫 𝐈𝐕𝐃𝐑 𝐓𝐫𝐚𝐧𝐬𝐢𝐭𝐢𝐨𝐧 Learn how to develop a robust regulatory strategy to ensure a smooth IVDR transition, aligning with your business objectives and preparing for successful market entry. ·      13 November | 15:30 – 16:30 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐕𝐚𝐥𝐢𝐝𝐚𝐭𝐢𝐨𝐧 𝐟𝐨𝐫 𝐀𝐈-𝐃𝐫𝐢𝐯𝐞𝐧 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 Discover how to tackle key challenges in AI software validation for diagnostics, including the impact of the European AI Act and techniques to reduce clinical investigation costs and timelines. Let’s connect and explore how ProductLife Group can support your MD/IVD lifecycle journey! #ProductLifeGroup #MEDICA #Dusseldorf #MedicalDevices #IVDR #ClinicalValidation #RegulatoryStrategy #MedicalSoftware #GlobalHealthcare #LifeSciences #GermanPavilion #MedTech #HealthcareInnovation

ProductLife Group is pleased to invite you to navigate the complexities of pharmacovigilance in multiple regions with our expert Beth Shaleesh, Head of North America Account Management, Safety & Vigilance. 🕑 This free webinar will take place on Tuesday, November 12, 2024, at 15:00 CET. 👉 Learn more about the key considerations when establishing a global PV program, focusing on the essential role of LSO and LPPV, and register here : https://lnkd.in/eezSb3f4 #webinar #pharmacovigilance #lifescience #halthcare #northamerica #safety