We are halfway through 2024 already! Let's take a look at some of our key successes for the year so far... 🚀 Proudly launched our new Good Clinical Practice (GCP) compliance audits. 🔬 Expanding our Birsfelden, Switzerland laboratory to include stability studies, making it a one-stop-shop for GMP/non-GMP biopharmaceutical analytics. 🏆 We proudly accepted CRO Leadership awards across all 5 categories, thanks to the recognition from our customers! 🙌 One year after Clinical Trial Regulation (CTR) implementation, Belgium has successfully maintained its competitive edge in early-phase clinical trial timelines. 📜 Our laboratory in Fairfield, NJ, USA, has achieved the prestigious ISO/IEC 17025:2017 certification, this underscores our dedication to quality and excellence in laboratory services. 🌎 Our experts attended over 100 events across the globe! ⭐ and more... #healthscience
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Please join MTaPS on April 17 and 18 for the next two webinars in our Pharmaceutical Systems Strengthening (PSS) Learning Series Registration link: https://lnkd.in/dH7xtJ3B Webinar series page (with text on webinars and link to registration): https://lnkd.in/dxvUt86B Wednesday, April 17, 8:00–9:30 AM US ET/3:00-4:30 PM EAT: Sustainable Local Manufacturing and Resilient Health Supply Chains: The Critical Role of Strong Regulatory Systems This session will explore how regulatory systems impact local manufacturing and the relationship between regulatory systems and pharmaceutical supply chains. Thursday, April 18, 8:00–9:30 AM US ET/3:00-4:30 PM EAT: Identifying Key Enablers for Digitalization of Regulatory Information Management Systems (RIMS) This session will discuss the importance of digitalizing Regulatory Information Management Systems (RIMS) and how future investments in PSS can help streamline and harmonize efforts to address remaining gaps and challenges.
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The first webinar is tomorrow! Join the USAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program and several panelists representing USAID and other international organizations to discuss how creating a conducive regulatory environment can contribute to building sustainable and resilient #HealthSupplyChains and explore issues around local manufacturing of #medicines toward saving lives and achieving #HealthForAll ⬇
Have you registered for our two upcoming webinars on regulatory systems, which are part of our MTaPS Pharmaceutical Systems Strengthening Learning Series: https://lnkd.in/geP_yxh4 We will host two webinars on Wednesday, April 17, and Thursday, April 18, 2024, from 8 to 9:30 am. The webinars will feature various international professionals with multi-country perspectives and insights⬇️ • Sustainable local manufacturing and resilient health supply chains: the critical role of strong regulatory systems (Wednesday, April 17, 8:00 – 9:30 am US EDT/3:00 – 4:30 pm EAT) • Key enablers for digitalization of regulatory information management systems (Thursday, April 18, 8:00 – 9:30 am US EDT/3:00 – 4:30 pm EAT) Please register to join us➡️ https://lnkd.in/geP_yxh4
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In the critical sphere of #pharmaceutical #suppliermanagement, the roles and responsibilities of dedicated personnel are paramount in safeguarding the safety, efficacy, and quality of medications. Their responsibilities are broad and encompassing, ranging from meticulous oversight of supplier selection and evaluation to ensuring stringent compliance with regulatory standards. Together, they guarantee that the pharmaceutical supply chain operates with precision, efficiency, and adherence to all necessary regulations, a cornerstone in upholding patient health and securing trust in healthcare systems. 💡 Learn more about the key players within GMP supplier management in our detailed blog https://lnkd.in/dYKAqYKu 👉 Embark on your journey in Supplier Management by signing up for a Free Pharmuni Account and taking our new course : https://lnkd.in/ea7T22x7
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📅 On 27 June, IFPMA will be hosting a webinar on how the use of standards can transform product data management in the pharmaceutical industry. In the pharmaceutical industry, different departments—such as R&D, Supply Chain, and Finance—often have their unique ways of defining and describing products based on their specific needs and data principles. This can lead to challenges in reconciling product information across the organization, as each department may have implemented its own fragmented and non-interoperable systems. Consistent product information is crucial, especially for global pharmacovigilance. That’s where Identification of Medicinal Products standards (IDMP) come in, offering a consistent way to describe products. Join speakers from GSK, Novartis & Uppsala Monitoring Centre for this webinar to: - Understand how IDMP strengthens the R&D value chain and supports global pharmacovigilance. - Learn how a collaborative, standards-based approach to master data management improves business operations, with examples from pharma R&D and production. - Recognize the importance of IDMP in digital transformation and how aligning product master data can enhance compliance. - Appreciate the value of globally harmonized IDMP implementation and its support for WHO operations in improving global product safety. 💻 Register: https://ifpma.info/45g94Ht Tag: ISO - International Organization for Standardization, Jean-Gonzague FONTAINE, Malin Fladvad, Laurent Lefebvre
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Networking Professionals in Pharmacy & Healthcare: As the pharmaceutical field adapts, so must our knowledge of the regulatory frameworks governing our industry. The upcoming webinar, hosted by @FrierLevitt’s Dae Y. Lee and @Atrium24's Dr. Nicolette Mathey, is an unmissable event for those involved in #CompoundedMedications. 🔍 Topics covered will include: - Oversight of 503A Compounded Products - FDCA & FDA Guidance - Comparative Regulatory Landscape - Legalities in Central Fill and 503B Outsourcing 🗓️ March 19, 2024 | 🕐 1:00-2:00 PM EST Click the link below 👇 to register and ensure your practice remains compliant and at the forefront of the evolving pharmaceutical landscape. #HealthcareCompliance #RegulatoryAffairs #SemaglutideCompounding [Register Now] https://bit.ly/3TchaeB
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Regulatory Strategy & Market Access Expert | Driving Success in Medical Devices & Drugs | FDA & Health Canada
Attending the #RAPSConvergence2023 provided invaluable insights and networking opportunities, fostering a deeper understanding of industry trends and regulatory changes, ultimately enhancing our ability to navigate the ever-evolving regulatory landscape. Applied Pharmaceutical Innovation (API)
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When interacting with healthcare professionals, it is crucial for pharmaceutical companies to act with transparency and integrity by adhering to (often complex) local laws. Our newly-updated Global Compliance Guide for Engaging Healthcare Professionals is now live. It has been created to provide pharmaceutical companies with an overview and comparison of local requirements in 35 jurisdictions across the world to help ensure compliance. The guide now also features a new section to include regulatory requirements around medical devices. Click on the link below to access the full guide. #Pharmaceutical #Pharma #Compliance #Healthcare #MedicalDevices
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Have you booked your pass for Global Pharmaceutical Regulatory Affairs Summit? ⏳ It's you last chance to book with £900 off! 💸 🗓️ 23-25 October, 2023 📍 Double Tree By Hilton | Brussels 👉 BOOK NOW & SAVE £900 ENDING MIDNIGHT TONIGHT: https://bit.ly/3Nwov5F 👉DOWNLOAD THE 2023 AGENDA HERE: https://bit.ly/44qvNPx ✔ Align your regulatory operations and affairs teams ✔ Hear the latest on the EU Commission’s Pharmaceutical Strategy for Europe ✔ Dive into the revision of the EU General Pharmaceuticals Legislation ✔ Successfully implement the new Clinical Trials Regulation (CTR) ✔ Take a closer look at the EMA’s Agile Transformation ✔ Receive working group updates including UNICOM, CTADHL, & ICH MQ4 ✔ Discuss the latest Data Initiative Case Studies including DADI, PQ/CMC, CTIS, PLM, & G-SRS ✔ Get to grips with convergence and reliance across all emerging markets ✔ Understand eCTD implementation across Europe and industry’s current experiences ✔ Gain eCTD regional updates from Brazil, China and EAEU ✔ Unpick the the intersection of eCTD and IDMP #GPRAS2023 #GPRAS #GlobalRegs #IDMP #RIM #eCTD #eSubmissions #HybridEvent
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Act Now: CTIL/CTX Application Guideline 8th Edition Effective April 30, 2024 The CTIL/CTX application guideline 8th edition is now in effect as of April 30, 2024. New CRAs or CTIL/CTX holders, seize the opportunity for direct face-to-face training with regulators. Only one day left! For more information, click the link below. Time is ticking—don't miss out! #CRMtrialconnect2024
Mark your calendars on May 8, 2024, as the National Pharmaceutical Regulatory Agency (NPRA) and CRM Trial Connect 2024 will be hosting Pre-Conference Workshop 2: CTIL/CTX Good Submission Practice. This workshop is open to all Regulatory Affairs, Clinical Research Associates, and Clinical Trial Managers. Space is limited, register by clicking the link below to reserve your slot! Sign up at https://lnkd.in/gMnQVTtY #crmtrialconnect2024 #clinicalresearchmy #advancingclinicalresearch #askusaboutclinicalresearch #ctilctxgoodsubmissionpractice
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Product and Substance Master Data Process Lead at GSK and IDMP expert (ISO TC215/WG6 member, Contributor to IDMP implementation with regulatory authorities: EMA, FDA, WHO, etc.)
Please join this webinar from IFPMA. I will be discussing how IDMP* data model can be used as a core component of a strong MDM capability. *IDMP: Identification of Medicinal Product Pistoia Alliance IFPMA EFPIA - European Federation of Pharmaceutical Industries and Associations PhRMA #IDMP, #IDMP-O, #Pharma, #MDM, #DataGovernance,#MasterData
📅 On 27 June, IFPMA will be hosting a webinar on how the use of standards can transform product data management in the pharmaceutical industry. In the pharmaceutical industry, different departments—such as R&D, Supply Chain, and Finance—often have their unique ways of defining and describing products based on their specific needs and data principles. This can lead to challenges in reconciling product information across the organization, as each department may have implemented its own fragmented and non-interoperable systems. Consistent product information is crucial, especially for global pharmacovigilance. That’s where Identification of Medicinal Products standards (IDMP) come in, offering a consistent way to describe products. Join speakers from GSK, Novartis & Uppsala Monitoring Centre for this webinar to: - Understand how IDMP strengthens the R&D value chain and supports global pharmacovigilance. - Learn how a collaborative, standards-based approach to master data management improves business operations, with examples from pharma R&D and production. - Recognize the importance of IDMP in digital transformation and how aligning product master data can enhance compliance. - Appreciate the value of globally harmonized IDMP implementation and its support for WHO operations in improving global product safety. 💻 Register: https://ifpma.info/45g94Ht Tag: ISO - International Organization for Standardization, Jean-Gonzague FONTAINE, Malin Fladvad, Laurent Lefebvre
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