PharmaLex’s Post

Announcing Season 2 of our Summer Shorts: TMF Excellence Edition! Why settle for boring summer reruns when you can join our fresh, informative webinars? Get the latest TMF best practices and guidelines from industry experts to ensure your TMF health with less time and effort. Upcoming Must-Watch Topics: 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗣𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴: 𝗔 𝗡𝗲𝘄 𝗛𝗼𝗽𝗲 | 𝗝𝘂𝗹𝘆 𝟯𝟬𝘁𝗵, 𝟮𝟬𝟮𝟰 Speed up document processing while improving quality. Learn from top-performing companies. 🔗 https://lnkd.in/dqTHKRmN 𝗥𝗶𝘀𝗸-𝗕𝗮𝘀𝗲𝗱 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗥𝗲𝘃𝗶𝗲𝘄: 𝗜𝗻𝘀𝗶𝗱𝗲 𝗢𝘂𝘁 | 𝗔𝘂𝗴𝘂𝘀𝘁 𝟲𝘁𝗵, 𝟮𝟬𝟮𝟰 Master the balance of risk vs. return in your TMF with expert guidance. 🔗 https://lnkd.in/dqTHKRmN 𝗛𝗼𝘂𝘀𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗜𝗻𝘀𝗽𝗲𝗰𝘁𝗼𝗿 | 𝗔𝘂𝗴𝘂𝘀𝘁 𝟭𝟯𝘁𝗵, 𝟮𝟬𝟮𝟰 Prepare for TMF inspections to avoid delays and additional costs. Take the TMF Throne! 🔗 https://lnkd.in/dHmEwnXc Don't miss out on these invaluable sessions! #PharmaLex #TMFExcellence #Webinar #SummerShorts

Unlock the secrets to flawless site inspection readiness with Louise Uí Fhatharta! In this episode of PharmaLex Talks, we dive deep into the essential steps for ensuring your site is inspection-ready. With over 20 years of experience in Microbiology, Quality Control, and Quality Assurance, Louise shares her invaluable insights from leading FDA, HPRA, and DEKRA Health Authority inspections. Don't miss out on this expert guide to operational readiness and compliance. Tune in now to gain the knowledge you need to excel in your industry! 🎧 Listen here: https://lnkd.in/dHSsM8Bh ⏱️ Duration: 18 minutes #PharmaLex #PharmaLexTalks #Podcast #PharmaceuticalIndustry #QualityAssurance #InspectionReadiness

Unlock the secrets to successful technology transfer in our latest article, published in BioProcess International! Dive into "Keys to Successful Technology Transfer" by PharmaLex QMC experts Olena Chervonenko and Gerardo Gomez, Ph.D. Discover the full article here: https://lnkd.in/dEGNf8-y #PharmaLex #TechnologyTransfer #BioProcessInternational #PharmaIndustry #QMCExperts #Biotech #Pharmaceuticals

🔔 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

🌞🎧 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

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

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

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

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