๐ Employee Spotlight! ๐ Today, we are excited to highlight our exceptional team member, Regina Dawkins! ๐๏ธ ๐ช๐ต๐ฎ๐ ๐ฎ๐ฟ๐ฒ ๐๐ผ๐บ๐ฒ ๐ธ๐ฒ๐ ๐ณ๐ฎ๐ฐ๐๐ผ๐ฟ๐ ๐๐ต๐ฎ๐ ๐ฝ๐ต๐ฎ๐ฟ๐บ๐ฎ๐ฐ๐ฒ๐๐๐ถ๐ฐ๐ฎ๐น ๐ฐ๐ผ๐บ๐ฝ๐ฎ๐ป๐ถ๐ฒ๐ ๐๐ต๐ผ๐๐น๐ฑ ๐ฐ๐ผ๐ป๐๐ถ๐ฑ๐ฒ๐ฟ ๐๐ต๐ฒ๐ป ๐ฎ๐๐๐ฒ๐๐๐ถ๐ป๐ด ๐๐ต๐ฒ๐ถ๐ฟ ๐ฐ๐ผ๐บ๐บ๐ฒ๐ฟ๐ฐ๐ถ๐ฎ๐น๐ถ๐๐ฎ๐๐ถ๐ผ๐ป ๐ฟ๐ฒ๐ฎ๐ฑ๐ถ๐ป๐ฒ๐๐ ๐ณ๐ผ๐ฟ ๐๐๐ฟ๐ผ๐ฝ๐ฒ? Understanding the complexity of the European market and local regulatory requirements is crucial, including identification of the necessary import and distribution licenses to successfully launch product within the EU market. Consideration of proposed fiscal supply chains to meet with regulatory expectations for market supply is key in establishing a compliant supply chain. Be aware that Switzerland and the UK whilst physically located in Europe are not EU countries. ๐๏ธ ๐ช๐ต๐ฎ๐ ๐ฎ๐ฟ๐ฒ ๐๐ผ๐บ๐ฒ ๐ฐ๐ผ๐บ๐บ๐ผ๐ป ๐ฐ๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ๐ ๐๐ต๐ฎ๐ ๐ฝ๐ต๐ฎ๐ฟ๐บ๐ฎ๐ฐ๐ฒ๐๐๐ถ๐ฐ๐ฎ๐น ๐ฐ๐ผ๐บ๐ฝ๐ฎ๐ป๐ถ๐ฒ๐ ๐ณ๐ฎ๐ฐ๐ฒ ๐๐ต๐ฒ๐ป ๐ฒ๐ ๐ฝ๐ฎ๐ป๐ฑ๐ถ๐ป๐ด ๐ถ๐ป๐๐ผ ๐๐๐ฟ๐ผ๐ฝ๐ฒ, ๐ฎ๐ป๐ฑ ๐ต๐ผ๐ ๐ฑ๐ผ ๐๐ผ๐ ๐ต๐ฒ๐น๐ฝ ๐๐ต๐ฒ๐บ ๐ผ๐๐ฒ๐ฟ๐ฐ๐ผ๐บ๐ฒ ๐๐ต๐ฒ๐๐ฒ ๐ฐ๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ๐? Understanding the complexity of supplying medicines within European market and the regulatory licences required. With global to local market expertise, PharmaLex can support clients in the navigating complexities of EU, Swiss and UK regulations effectively to enable compliance, minimise risks and support speed to market. We support mapping supply chains and providing local licence expertise and support to successfully obtain local licenses and launch medicinal products within the European market. ๐๏ธ ๐๐ฎ๐ป ๐๐ผ๐ ๐๐ฒ๐น๐น ๐๐ ๐ฎ๐ฏ๐ผ๐๐ ๐ฎ ๐ฝ๐ฟ๐ผ๐ท๐ฒ๐ฐ๐ ๐ผ๐ฟ ๐ถ๐ป๐ถ๐๐ถ๐ฎ๐๐ถ๐๐ฒ ๐๐ผ๐ ๐ต๐ฎ๐๐ฒ ๐ฟ๐ฒ๐ฐ๐ฒ๐ป๐๐น๐ ๐ฏ๐ฒ๐ฒ๐ป ๐ถ๐ป๐๐ผ๐น๐๐ฒ๐ฑ ๐ถ๐ป ๐๐ต๐ฎ๐ ๐๐ผ๐๐ฟ ๐ฝ๐ฎ๐ฟ๐๐ถ๐ฐ๐๐น๐ฎ๐ฟ๐น๐ ๐ฝ๐ฟ๐ผ๐๐ฑ ๐ผ๐ณ? Supporting a US company successfully gain MA approval and launch with the European market by navigating them through the process from MA application, European entity establishment, local licence support, QMS design and development, Qualification of Outsourced activities, staff augmentation, inspection support and successful supply of product to patient. ๐๏ธ ๐ช๐ต๐ฎ๐ ๐ฎ๐ฑ๐๐ถ๐ฐ๐ฒ ๐๐ผ๐๐น๐ฑ ๐๐ผ๐ ๐ด๐ถ๐๐ฒ ๐๐ผ ๐๐ผ๐บ๐ฒ๐ผ๐ป๐ฒ ๐๐ต๐ผ ๐ถ๐ ๐ฐ๐ผ๐ป๐๐ถ๐ฑ๐ฒ๐ฟ๐ถ๐ป๐ด ๐ฎ ๐ฐ๐ฎ๐ฟ๐ฒ๐ฒ๐ฟ ๐ถ๐ป ๐๐ต๐ฒ ๐ฝ๐ต๐ฎ๐ฟ๐บ๐ฎ๐ฐ๐ฒ๐๐๐ถ๐ฐ๐ฎ๐น ๐ถ๐ป๐ฑ๐๐๐๐ฟ๐? A career in the pharmaceutical industry is rewarding, offering development, growth, and job satisfaction while supporting patient safety. Start hands-on in a lab or manufacturing facility to understand processes and systems, enhancing problem-solving skills. Get involved in auditing early to expand your knowledge and expertise, as good auditing skills are invaluable and support an inquisitive mind. ๐ Learn more about our team's work: https://lnkd.in/e_2XZwqt #PharmaLex #TeamSpotlight #PharmaceuticalIndustry #QMC
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๐ Don't miss out on valuable insights! Watch our on-demand webinar with Louise Uรญ 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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๐๐ง 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: โข Understanding the intricate EU pharmacovigilance (PV) system โข Strategies for market entry - including the benefits of outsourcing PV activities โข Exploring different pathways for product authorization โข 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. Donโt miss this fantastic opportunity to network with fellow professionals in the pharmaceutical and medical device regulatory affairs industry. ๐ Date: Thursday, August 1, 2024 ๐ Time: 5:30 PM ๐ 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 โก๏ธ 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. ๐ Read the full article: https://lnkd.in/gfk4v8pj #PharmaLex #PatientSafety #RegulatoryCompliance
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๐ Meet the Experts! ๐ Weโre thrilled to introduce the brilliant minds who will be addressing your questions during our live webinar on managing Clinical Trial Regulation (CTR): ๐ฉโXandra Neuberger - Associate Director, Regulatory Affairs, International Service Lead for Clinical Trial Applications, PharmaLex ๐ฉโ๏ธ Dr. Carolin Gloger - Manager, Regulatory Affairs, PharmaLex ๐ฉโ๏ธ Dr. Berit Bachmann, M.D.R.A. - Senior Manager, Regulatory Affairs, PharmaLex ๐๏ธ July 24th, 2024 โฐ 5 pm CEST / 4 pm BST / 11 am EDT Donโt miss out! Secure your spot today: https://lnkd.in/dhHqXHmy #MeetTheExperts #RegulatoryCompliance #PharmaLex #Webinar
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The European Medicines Agency (EMA) has updated its guidelines on advanced therapy medicinal products (ATMPs), emphasizing a collaborative approach with stakeholders. Key takeaways include: ๐งฌ Separation of guidelines for Gene Therapy Medicinal Products (GTMPs) and Cell Based Medicinal Products (CBMPs) was suggested but not implemented; ๐งฌ Updates on stage-appropriate CMC expectations to alleviate high validation demands; ๐งฌ 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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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! ๐ 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. ๐ 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! ๐ #PharmaLex #Leadership #Iberia
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