The European Medicines Agency (EMA) has updated its guidelines on advanced therapy medicinal products (ATMPs), emphasizing a collaborative approach with stakeholders. Key takeaways include: 🧬 Separation of guidelines for Gene Therapy Medicinal Products (GTMPs) and Cell Based Medicinal Products (CBMPs) was suggested but not implemented; 🧬 Updates on stage-appropriate CMC expectations to alleviate high validation demands; 🧬 Clarification on potency assay validation and process evaluation/validation for clinical trials. Check out the full article by Pam Dhadda, Associate Director at PharmaLex, for an in-depth analysis of the changes and their impact on ATMP development in Europe. Read more: https://lnkd.in/dDcaNFVE #PharmaNews #ATMP #GeneTherapy #CellTherapy #PharmaLex #EMA
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🔔 Don't miss out on valuable insights! Watch our on-demand webinar with Louise Uí Fhatharta on "Preparing for Success: How to Ensure a Successful Health Authority Inspection." Learn how to take a proactive approach to inspections and identify key elements of regulatory noncompliance. Watch now: https://lnkd.in/dJyWTNkt #PharmaLex #OnDemandWebinar #HealthAuthorityInspection #RegulatoryCompliance
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🌞🎧 Summer Listening Alert! Tune in to our engaging #podcast featuring Quality Director Londa R. as she delves into how a robust quality culture shapes GMP activities. Discover the importance of prioritizing patient safety and implementing best practices in the biopharmaceutical industry. Listen now: https://lnkd.in/d9j4edN9 #PharmaLex #QMC #QualityCulture #PatientSafety #GMP
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Bringing a biopharmaceutical product to the European Union market involves navigating a complex regulatory landscape. Non-EU companies accustomed to single-agency frameworks like the FDA or PMDA may find EU requirements particularly challenging. Explore our latest article by experts Dr. Monica Buchberger and STEPHEN SUN to gain key insights on: • Understanding the intricate EU pharmacovigilance (PV) system • Strategies for market entry - including the benefits of outsourcing PV activities • Exploring different pathways for product authorization • Adhering to local PV requirements and the critical role of the Qualified Person for Pharmacovigilance (QPPV) Discover how to ensure compliance and successful market entry in the EU by reading the full article here: https://lnkd.in/dsCGw6V8 #PharmaLex #EUMarket #Pharmacovigilance #Biopharmaceuticals #RegulatoryCompliance #MarketEntry #PharmaIndustry
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Join us for a special Welcome Reception sponsored by PharmaLex on August 1, 2024, at 5:30 PM in beautiful Huntington Beach, CA! This exclusive event kicks off the Orange County Regulatory Affairs Discussion Group (OCRA) Annual Conference and is open to the first 50 registrants. Don’t miss this fantastic opportunity to network with fellow professionals in the pharmaceutical and medical device regulatory affairs industry. 📅 Date: Thursday, August 1, 2024 🕔 Time: 5:30 PM 📍 Venue: The Hilton Waterfront Beach Resort, 21100 Pacific Coast Highway, Huntington Beach, CA 92648 USA Don't miss the chance to hear from PharmaLex experts STEPHEN SUN and JOHN LOCKWOOD! Stephen will present on "Post-marketing Safety Reporting Regulatory Expectations and Operational Compliance" and John will be chairing a session. Secure your spot at the Welcome Reception by submitting the form by July 26, 2024: https://lnkd.in/d7ycVb-M Register here for the OCRA Conference on Aug 2 in Huntington Beach, CA: https://lnkd.in/dAtGeXuK We can't wait to see you there! #OCRA2024 #PharmaLex #Networking #RegulatoryAffairs #WelcomeReception
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Stay informed of all the latest news, events, and thought leadership in the pharmaceutical, biotech and medical device industry! Subscribe to our newsletter for exclusive industry insights about the rapidly-evolving #pharmaceutical industry ➡️ https://lnkd.in/ejiXKmbd #Pharmalex #Newsletter
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The new MDR and IVDR regulations in Europe emphasize the critical role of vigilance in the medical device industry. Manufacturers must rigorously report and assess adverse events related to their devices, aiming to enhance patient care and ensure product safety. Discover in-depth insights from our expert Belinda Dowsett on #vigilance with #medicaldevices under the #MDR and #IVDR frameworks. 🔍 Read the full article: https://lnkd.in/gfk4v8pj #PharmaLex #PatientSafety #RegulatoryCompliance
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🔍 Meet the Experts! 🔍 We’re thrilled to introduce the brilliant minds who will be addressing your questions during our live webinar on managing Clinical Trial Regulation (CTR): 👩⚕Xandra Neuberger - Associate Director, Regulatory Affairs, International Service Lead for Clinical Trial Applications, PharmaLex 👩⚕️ Dr. Carolin Gloger - Manager, Regulatory Affairs, PharmaLex 👩⚕️ Dr. Berit Bachmann, M.D.R.A. - Senior Manager, Regulatory Affairs, PharmaLex 🗓️ July 24th, 2024 ⏰ 5 pm CEST / 4 pm BST / 11 am EDT Don’t miss out! Secure your spot today: https://lnkd.in/dhHqXHmy #MeetTheExperts #RegulatoryCompliance #PharmaLex #Webinar
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We are thrilled to welcome our new Managing Directors for Iberia at PharmaLex, Gonzalo Casino as Regional Country Manager for Iberia region and Beatriz Caeiro for Portugal! 🌟 Gonzalo joins us with 24 years of experience in the healthcare sector, having held prominent roles at Deloitte Consulting and the health insurance company, DKV. His leadership, strategic planning, business development skills, and dedication to healthcare education and social causes will be instrumental in steering PharmaLex Spain towards continued growth and success. 🌟 Beatriz brings nearly 30 years of invaluable experience in the pharmaceutical industry, excelling in leadership roles, including as General Manager of Portuguese subsidiaries. Her expertise in sales and marketing, coupled with her multinational experience, makes her the perfect fit to navigate and lead PharmaLex Portugal through our current transformations and beyond. We are confident that their combined leadership will be pivotal in consolidating our strategy and affirming PharmaLex as a leading force in the market. Welcome to the team! 🚀 #PharmaLex #Leadership #Iberia
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