[Free Webinar 💻] Computer Software Assurance: a Common-Sense Approach to Compliant Computerised Systems 📅 December 17th, 4PM CET 🔗 https://lnkd.in/dRn2jD3V Join Integrity's experts, Chris Reid and Thana Subramanian, as they explore how this practical approach can drive innovation and quality standards. Although the debate between CSA and CSV persists, transitioning to CSA becomes much more efficient by incorporating critical thinking, recognizing real risks, using modern tools and methods, creating value-driven records, and leveraging true subject matter experts. #csa #computersoftwareassurance #digital #compliance #computerisedsystems #CSAvsCSV #quality #innovation #webinar
ProductLife Group
Fabrication de produits pharmaceutiques
Courbevoie, Île-de-France 109 354 abonnés
À propos
ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions. Since almost 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 130 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics. With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.
- Site web
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http://www.productlifegroup.com/
Lien externe pour ProductLife Group
- Secteur
- Fabrication de produits pharmaceutiques
- Taille de l’entreprise
- 1 001-5 000 employés
- Siège social
- Courbevoie, Île-de-France
- Type
- Société civile/Société commerciale/Autres types de sociétés
- Fondée en
- 1993
- Domaines
- Data Management, Product Safety management, Pharmacovigilance, Artificial Intelligence, Regulatory Affairs, Market Access, Clinical Safety, Publishing, Labelling, e-CTD, CMC, Quality Assurance, Cosmetics, Medical Devices, CCDS, Scientific Advice, RIM: Regulatory Information Management, Full Dossier, IDMP, Guidance Interpretation, Strategic Consultancy, Gap analysis, Regulatory Intelligence, Due Diligence, Bibiliographic research, QPPV, Medical Writing, ERA, Medical Information, Promotional Material, RMP et Medical Device
Lieux
Employés chez ProductLife Group
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Candice Bosson
Chief People Officer & Certified Board Member
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Brigitte LOPEZ
Program Director chez ProductLife Group
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Jean-Christophe Massot
Chief Information Officer | Cybersecurity Leadership | Digital Transformation
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Felipe Leal da Costa
Senior Project Manager at MC Serviços | Financial Management | Performance Management | Team Leader | Global Finance Controller | Credit Management |
Nouvelles
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🎄 Let's begin to celebrate Christmas with this lunch in Milano, where two ProductLife Group Exco members, Charlène TRAVERS-CHEVALIER., Chief Commercial Officer, and Candice Bosson, Chief People Officer, joined our Italian leaders Mariangela Prada, Teresa Minero, Lino Fabrizi, and Marco Conti, along with representatives of their teams. It was a wonderful occasion to come together, reflect on our collective achievements in 2024, and celebrate the strong collaboration across our teams. Here’s to continued collaboration, shared vision, and many more successes in 2025! 🥂 #christmascelebration #teamwork #leadership #oneitaly #oneplg
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📣 Le 16 décembre 2024, la liste des médicaments critiques a été mise à jour avec l'ajout de 27 nouvelles substances actives. Retrouvez toutes les informations relatives à cette actualisation ici: https://lnkd.in/dEpScP7V 👉 ProductLife Group et STRATEGIQUAL SAS sont à votre disposition pour vous accompagner dans l'adaptation à ces nouvelles exigences. Contactez-nous ici ✉️ solutions@strategiqual.com #ema #unionlistcriticalmedicines #médicamentscritiques #regulatory #pharma
🚨 𝐋𝐢𝐬𝐭𝐞 𝐝𝐞𝐬 𝐦𝐞́𝐝𝐢𝐜𝐚𝐦𝐞𝐧𝐭𝐬 𝐜𝐫𝐢𝐭𝐢𝐪𝐮𝐞𝐬 𝐝𝐞 𝐥’𝐔𝐧𝐢𝐨𝐧 𝐞𝐮𝐫𝐨𝐩𝐞́𝐞𝐧𝐧𝐞 : 𝐍𝐨𝐮𝐯𝐞𝐚𝐮𝐱 𝐦𝐞́𝐝𝐢𝐜𝐚𝐦𝐞𝐧𝐭𝐬 𝐚𝐣𝐨𝐮𝐭𝐞́𝐬 ! Le 𝟏𝟔 𝐝𝐞́𝐜𝐞𝐦𝐛𝐫𝐞 𝟐𝟎𝟐𝟒, la liste européenne des médicaments critiques a été mise à jour avec 27 nouvelles DCI dans l'objectif d'assurer un approvisionnement stable en médicaments jugés critiques par l’EMA : 💊 𝐋𝐢𝐬𝐭𝐞 𝐝𝐞𝐬 𝐧𝐨𝐮𝐯𝐞𝐚𝐮𝐱 𝐦𝐞́𝐝𝐢𝐜𝐚𝐦𝐞𝐧𝐭𝐬 𝐚𝐣𝐨𝐮𝐭𝐞́𝐬 : - COMPLEXE PROTHROMBINE HUMAIN - FACTEUR VII DE COAGULATION HUMAIN - FACTEUR XIII DE COAGULATION HUMAIN - EPTACOG ALFA - ISAVUCONAZOLE - IMMUNOGLOBULINE ANTI-HÉPATITE B HUMAINE - VACCIN CONTRE LES HÉPATITES A ET B - VACCIN PENTAVALENT CONTRE LE ROTAVIRUS - VACCIN CONTRE LE PAPILLOMAVIRUS - THIOTEPA - FLUOROURACILE - MITOXANTRONE - DABRAFENIB - ENCORAFENIB - TRAMETINIB - IBRUTINIB - OBINUTUZUMAB - INOTUZUMAB OZOGAMICIN - DARATUMUMAB - DURVALUMAB - GEMTUZUMAB OZOGAMICIN - BRENTUXIMAB VEDOTIN - SACITUZUMAB GOVITECAN - VISMODEGIB - MITOTANE - IMMUNOGLOBULINE ANTI-THYMOCYTE (lapin) - CHLORURE DE RADIUM (223RA) 🔗 𝐂𝐨𝐧𝐬𝐮𝐥𝐭𝐞𝐳 𝐥𝐚 𝐯𝐞𝐫𝐬𝐢𝐨𝐧 𝐜𝐨𝐦𝐩𝐥𝐞̀𝐭𝐞 𝐝𝐞 𝐥𝐚 𝐧𝐨𝐮𝐯𝐞𝐥𝐥𝐞 𝐥𝐢𝐬𝐭𝐞 𝐬𝐮𝐫 𝐥𝐞 𝐬𝐢𝐭𝐞 𝐝𝐞 𝐥'𝐄𝐌𝐀 : 👉 https://lnkd.in/eKemr6xt 🔎 𝐂𝐞𝐭𝐭𝐞 𝐦𝐢𝐬𝐞 𝐚̀ 𝐣𝐨𝐮𝐫 𝐯𝐨𝐮𝐬 𝐢𝐦𝐩𝐚𝐜𝐭𝐞 ? 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐪𝐮𝐚𝐥 𝐯𝐨𝐮𝐬 𝐚𝐜𝐜𝐨𝐦𝐩𝐚𝐠𝐧𝐞 ! 📧 Contactez-nous : solutions@strategiqual.com 🌐 www.strategiqual.com #médicamentscritiques #pénurie #shortage #criticalmedicines #EMA
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Clinical leaders must be prepared to ensure inspection readiness and navigate the challenges of FDA drug or device approvals. Halloran Consulting Group, Inc. Group, part of ProductLife Group, shares seven actionable steps based on insights from nearly 100 industry leaders to help clinical professionals tackle FDA inspection readiness. 👉 For further insights, download their infographic or reach out to us here: https://lnkd.in/eHvTdd65 #pharma #inspectionreadiness #healthcare #fdainspection
Based on feedback from nearly 100 industry leaders, we’ve outlined the top inspection readiness fears and a seven step process for preparation. Download our infographic here. https://hubs.la/Q02-Pj7g0
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To follow up on our Market Access series, let's explore how collaborating with an expert to streamline and implement Managed Access Programs can enhance efficiency and ensure compliance. Outsourcing tasks such as patient enrollment, regulatory management, logistics, and ongoing support enables pharmaceutical companies to free up internal resources all while upholding the legal and ethical standards for MAPs. 👉 Learn how PLG can support your Patient Access needs here: https://lnkd.in/dnFRFcCa #healthcare #lifesciences #patientprograms #managedaccessprograms #marketaccess #pharma
In part 4 of our six-part series, we look at how partnering with an expert to streamline and execute Managed Access Programs can free up valuable medical team time and resources and deliver on the regulatory and logistics requirements more efficiently and effectively for the ultimate benefit of patients in need #CommercielEyes #ProductLifeGroup #healthcare #LifeScience #PatientPrograms
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📣 𝗟𝗲𝘁’𝘀 𝗰𝗼𝗻𝗻𝗲𝗰𝘁 𝗶𝗻 𝗽𝗲𝗿𝘀𝗼𝗻 𝐢𝐧 𝐒𝐚𝐧 𝐅𝐫𝐚𝐧𝐜𝐢𝐬𝐜𝐨! We’re excited to announce that ProductLife Group, alongside our specialized entities from the US (Halloran Consulting Group, Inc.) and Australia (Commercial Eyes Pty Ltd), will be exhibiting at 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝗦𝗵𝗼𝘄𝗰𝗮𝘀𝗲 at the 𝗛𝗶𝗹𝘁𝗼𝗻 𝗦𝗮𝗻 𝗙𝗿𝗮𝗻𝗰𝗶𝘀𝗰𝗼 𝗨𝗻𝗶𝗼𝗻 𝗦𝗾𝘂𝗮𝗿𝗲 from 13-15 January. 📍 𝗙𝗶𝗻𝗱 𝘂𝘀 𝗮𝘁 𝗕𝗼𝗼𝘁𝗵 𝟭𝟱 📲 Connect on event partnering to secure meetings with our team: Joanne Sullivan, Tanya van der Wall, Tania Zieja, Richard D., Eric Small, Sheila Gwizdak With global reach and a comprehensive range of services, we’re proud to be your ideal partner for business success. Let’s explore how we can support your goals from concept to commercialization! See you shortly after the New Year 🌟 #lifesciences #lifesciencespartner #concepttocommercialization #biotechshowcase2024 #innovation #biotech #biopharma
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✨ The Christmas spirit is high across the PLG Global Community! Last Friday, Maria Cristina Cadena Laso, Albert Ballester Vila-Pagès, Mariana Gomez-Ferreria Joan Tapias Terré, Virginia García Muñoz, and Maxim Bacher joined the Outcomes'10 team in Benicassim to celebrate the season. Take a look at their beaming smiles as we embrace the holiday cheer! Stay tuned for more festivities and heartwarming wishes from PLG communities around the world.🌍 #OnePLG #PeopleOfPLG #BestWishes #MerryChristmas #Global
🌟 Last Friday we celebrated our traditional Christmas lunch🎄. We joined the whole Outcomes'10 team in Benicàssim, to reconnect, enjoy the Mediterranean sun and beach views, and the best possible company 🌟 Of course, it was a pleasure to welcome part of the ProductLife Group team from Spain (🔝), and who already have a home in Castellón. Thank you all for coming and we are looking forward to seeing you again soon. #FelizNavidad #JoyeuxNoël #BuonNatale #MerryChristmas
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After learning about Patient Support and Access Programs, discover how we emphasize the importance of creating Patient Support Programs (PSPs) that empower individuals and enhance outcomes throughout their healthcare journey. Our comprehensive services are designed to put the patient experience first, improving health outcomes and quality of life at every step of their treatment journey. 🔗 Check out the full extent of our services here: https://lnkd.in/dnFRFcCa #patientprograms #lifescience #pharma #patientsupportprograms #marketaccess #healthcare
In part three of our six-part series, we focus on how the right design of Patient Support Programs empowers patients and improves outcomes in their treatment journey. At Commercial Eyes, our Patient Support Programs are designed to provide personalised, compassionate care that goes beyond medical treatment. By focusing on sustainability and collaboration with our clients, HCPs, patients and carers. We ensure that our programs remain effective and enduring, helping patients confidently navigate their treatment journey and ensure they continue to meet those changing needs over time. i.e. From telehealth services to in-home delivery, our end-to-end services are designed to prioritise the patient experience, enhancing both health outcomes and quality of life throughout their treatment journey. #CommercielEyes #ProductLifeGroup #LifeScience #PatientPrograms
Empowering Patients with Comprehensive Support: How Commercial Eyes' Patient Support Programs Make a Difference - Commercial Eyes
https://commercialeyes.com.au
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In this follow-up of our first insight, you will read about how Access Programs are crucial for providing innovative treatments to patients before they officially launch. While these programs can involve substantial product investment, they offer valuable returns by allowing healthcare professionals to gain experience with new treatments. Additionally, they ensure that patients in need of life-saving or transformative therapies can access them during the often lengthy period between product registration and reimbursement. ProductLife Group actively supports these programs, helping to bridge the gap between treatment development and patient access. 🔗 Learn more about our Patient Access Services here: https://lnkd.in/dqh3rmcP #lifescience #patientprograms #marketaccess #pharma #healthcare #patientaccess #accessprograms
In part two of our six-part series, we dive deeper into Access Programs, which, at their heart, play a pivotal role in bringing innovative treatments to patients prior to launch. While these programs can require significant investment in product, when designed correctly, access programs can provide valuable returns, ensuring that healthcare professionals (HCPs) gain hands-on experience with innovative treatments. Importantly, patients needing life-saving or life-changing treatment can access therapies in that often drawn-out period between registration and reimbursement. #CommercielEyes #ProductLifeGroup #LifeScience #PatientPrograms
Unlocking Patient Access and HCP experience - Commercial Eyes
https://commercialeyes.com.au
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Are you prepared to align your AI medical devices with the EU AI Act by 2026? 🚀 The EU AI Act, which entered into force in August 2024, marks a pivotal shift for the MedTech industry. By classifying AI systems as “high-risk,” even those considered lower-risk under MDR or IVDR, the regulation introduces strict requirements for transparency, data governance, human oversight, and conformity assessments. Imagine a wearable device that not only monitors vitals but also predicts health risks using machine learning. These innovations now demand comprehensive regulation to address risks to health, safety, and fundamental rights. While some provisions align with MDR/IVDR, others, like automatic log generation and data governance, demand new approaches. 🛡️ At ProductLife Group, we specialize in helping companies navigate these regulatory complexities, ensuring compliance while maintaining innovation. Read the full article now and discover how PLG can help you: https://lnkd.in/gc_DPZhc Learn how ProductLife Group can guide you through this evolving landscape and help secure compliance with your healthcare AI system. Visit our website for more information: https://lnkd.in/gX86hFKm #medtech #EUAIAct #compliance #innovation #AI #healthcare #medicaldevices #pharma
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