Michel Croes

Why 𝘌𝘶𝘳𝘰𝘧𝘪𝘯𝘴 𝘗𝘙𝘖𝘟𝘠 𝘓𝘢𝘣𝘰𝘳𝘢𝘵𝘰𝘳𝘪𝘦𝘴 is delighted to use the 𝗝𝗥𝗜-𝗠𝘆𝗦𝗶𝗿𝗶𝘂𝘀 𝗱𝗮𝘁𝗮 𝗿𝗲𝗴𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 𝘀𝘆𝘀𝘁𝗲𝗺? Based in the Netherlands, Eurofins PROXY Laboratories is part of Eurofins BioPharma Product Testing and perform testing for their customers. To provide reliable service to customers, Eurofins PROXY Laboratories uses a monitoring system from JRI in its production areas, cleanrooms and also for storage and performing tests, especially in the stability rooms where #humidity and #temperature are under control. The Nano SPY data loggers linked to the JRI-MySirius cloud software allow an efficient experience for Eurofins users in: ✔ Measurement data monitoring ✔ System setting ✔ Alarm management ✔ Traceability reports Watch this video to find out how an international pharma player like Eurofins manages to control sensitive parameters and measurement data. #JRI #NanoSPY #dataloggers #wirelesstemperaturemonitoringsystems #itssciencemedical https://lnkd.in/gHNqP_S4

5

Scientific advice – ensuring successful interactions with regulatory authorities | A webinar hosted by Karin Ruijtenbeek, PhD, Regulatory consultant at Zwiers Regulatory Consultancy BV 📅 May 30, 3PM CET 🔗 Register: https://lnkd.in/dJCWHnfW The considerations of developing a new medicinal product can be a minefield. Implementing new manufacturing technologies, innovative mechanisms of action, and more stringent safety regulations can significantly impact the choices and the cost of developing the product. Luckily, the medical industry has always provided solutions for developing and guiding medicinal products. Herein lies the Scientific Advice Meeting. This resource is a well-known avenue for drug developers to seek counsel from healthcare authorities. These authorities have an arsenal of seasoned industry professionals who can provide expert feedback on the forward processes of your drug development. In a strange twist of fate and for those unfamiliar with the process, you may need some guidance to access this guidance. ProductLife Group steps up to the plate to offer a free webinar on the scientific advice process. We will cover the WHY, WHO, WHAT, WHEN, and HOWs of the Scientific Advice Meeting and provide you with the basics of this unique resource. We will focus on the EU and the US authorities, providing details in these key regulated markets.   Click the registration link and join our webinar to learn the “ins and outs” of Scientific Advice, and of course, if you have any additional questions, you can freely contact us at: marketing@productlife-group.com #scientificadvice #scientificadvicemeeting #regulatoryaffairs #healthcare #pharma #webinar

54

Exciting Update! Thrilled to share insights from the latest edition of the GMP Update 2023-2024! This comprehensive update is a must-read for professionals in the pharmaceutical and healthcare industries. Dive into the latest trends, regulations, and advancements shaping our field in the article below! #Pharmaceuticals | #Healthcare | #Innovation | #GMPUpdate

10

Dive into the world of "Extractables & Leachables Studies for Orally Inhaled and Nasal Drug Products (OINDP)" with our E&L expert Nick Morley in this informative webinar. https://lnkd.in/eTM-QuRr Discover how to ensure patient safety, navigate stringent regulatory requirements, and understand the impact of materials on product quality. The webinar covers key topics, including definitions, risk assessment, regulatory insights, and solutions to testing complexities. Tailored for professionals in pharmaceuticals, medical devices, regulatory affairs, and quality control, this webinar offers valuable insights for those seeking a deeper understanding of extractable and leachable testing's impact on safety and compliance. Watch now and stay ahead in the landscape of OINDP development. #OINDP #MedicalDeviceTesting #ChemicalCharacterization #ISO10993 #ElementLifeSciences #Biocompatibility #HealthcareTech #BiopharmaManufacturing #EandLStudies #MaterialChanges #ExtractablesAndLeachables #AnalyticalEvaluationThreshold #MedicalDeviceTesting #RegulatoryCompliance

6

#biocides - 🎧Listen to our latest episode of #SaferChemicalsPodcast with the Biocidal Products Committee Chair Joost van Galen. In addition to the meeting highlights, Joost raises concern about the increasing number of incomplete applications and reminds companies of their responsibility to make sure their dossiers contain all required information. 🔗https://lnkd.in/gz7GH6AS #ChemicalSafetyEU

94

3 commentaren

Struggeling with your dossiers? Vali is here to support you. If you are finding the process of preparing biocidal dossiers a bit overwhelming, don’t worry. Our experienced team is specialized in navigating the complexities of biocides. Contact us today. We will connect you with your personal expert.   #Biocides #RegulatoryCompliance #DossierAssistance #ExpertSupport #Vali

7

FDA Draft Guidance on Bioresearch Monitoring Inspections The FDA has released a draft guidance document outlining processes and practices for Bioresearch Monitoring (BIMO) inspections. This guidance aims to ensure compliance with the Food and Drug Omnibus Reform Act of 2022 and enhance communication between the FDA and industry during inspections. 🔷Scope of Guidance: Details inspection requirements for establishments under the FDA’s BIMO program, focusing on data integrity and participant safety in FDA-regulated research. 🔷Inspection Types: Describes various inspections, including those supporting marketing applications and periodic reviews of ongoing activities. 🔷International Inspections: Addresses global inspections for clinical trials critical to FDA regulatory decisions. 🔷Communication Best Practices: Emphasizes the importance of clear communication before, during, and after inspections to facilitate compliance and address findings. 🗣This draft is open for comments, reflecting the FDA’s commitment to transparency and industry collaboration. #ClinicalTrials #FDAUpdate

1

The European Medicines Agency (#EMA) is transitioning from the eXtended EudraVigilance Medicinal Product Dictionary (#XEVMPD) to the International Organization for Standardization (#ISO) identification of medicinal products (#IDMP) #standards to better standardise the #global exchange of #medicinalproduct information. This article from Ratnam Tammineedi, Navaneetha G, Prabu Selvaraj, Anil Kumar M, Anamika Goel, Manju Joon, Kirti Yadav, Jacci Squire, Dr. Vivek Tomar and Allison Gillespie in the #April 2024 issue of #RegulatoryRapporteur discusses the current #XEVMPD #standards and the benefits offered by the transition to #IDMP #standards. Read it online now 👉 https://lnkd.in/eucbeRK8 #RegulatoryRapporteur is our peer-reviewed journal, published online 11 times a year and available free to #TOPRA members. This edition focuses on #data and explores how #industry is increasingly harnessing its capabilities across the #medicinesdevelopment #lifecycle to keep pace with #innovation and #digitisation.

17

Register now for Read-Across as an Alternative Approach for Assuring the Safety of Excipients webinar! #Excipients #excipientExperts https://conta.cc/3zGy5zA

6

Join Dr. Ulrich Herber, Senior Director of Scientific Portfolio Management at Charles River Laboratories, as he presents "A Case Study on Microbiological Contamination Incidents" at the Lounges Cleanroom Processes event on April 23, at 1:30 p.m. CEST. Gain valuable insights into identifying and addressing recurring microbiological contamination in the manufacturing process of a sterile drug and learn how to implement effective QC measures to minimize production disruptions and ensure product safety. https://okt.to/xh7Cs4

33

Learn more about EU GMP Annex 1 Air Speed Strategies for Unidirectional Flows and get answers to frequently asked questions in our latest presentation by PMS Senior GMP Scientist, Mark Hallworth. Click here: https://bit.ly/4aGpxXs #Annex1 #GMP #FAQs #UnidirectionalAirFlow

1

𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗗𝗿𝘂𝗴 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗢𝘂𝘁𝗽𝘂𝘁𝘀 𝗳𝗼𝗿 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝗧𝗮𝗹𝗸 𝘄𝗶𝘁𝗵 𝗮𝗻 𝗲𝘅𝗽𝗲𝗿𝘁 👉https://lnkd.in/e52sdG3P In this guidance, key aspects of drug delivery performance information are addressed for devices and combination products that include device constituent parts, intended to deliver human drugs, including biological products. FDA’s guidance describes the outputs of device design that are crucial to establishing and assessing drug delivery performance Also this guidance includes recommendations for the information and data to submit in investigational, marketing, and post-market change applications. This guidance focuses on the information and data submitted to the FDA regarding EDDOs for devices and device components of CDER-led and CBER-led combination products intended for administering human drugs, including biological products. Examples of such products include syringes, injectors (like autoinjectors and on-body injectors), infusion devices (such as infusion pumps), nasal sprays, inhalers, nebulizers, and vaginal systems. FDA Guidance: https://lnkd.in/eE_GW3Fz Contact BIOBOSTON CONSULTING today or visit our website at https://lnkd.in/dfarwCK2 to learn more about how we can support your organization. #compliance #quality #regulatory #clinical #pharmaceutical #biotechnology #consulting #fda

1

🌟Computerised Systems and Electronic Data in Clinical Trials🌟 Our CEO, Jelle ten Hoeve, will attend a workshop to learn the requirements of software suitable for clinical trials. We are steadily advancing the TIDE (https://tide.nki.nl/) technology for clinical utility, developing TIDE GxP and participating in events like this. Event details: ISPE Event - https://lnkd.in/erDhBivH #ClinicalTrials #CRISPR #Bioinformatics #TIDEGxP #GeneEditing

4

EDQM: New General Chapter on Extractable Elements in Plastic Materials Adopted While the European Pharmacopoeia (Ph. Eur.) already includes parts of the ICH Q3D guideline on elemental impurities in the general chapter on Elemental impurities (5.20), the requirements for extractable elements from plastic containers for pharmaceutical use and closures are legally binding. >>> read more: https://lnkd.in/eGj4z2KE #gmp #gmpnews #ichq3d #extractables

2

🚀 Transforming Drug Substance Development and Manufacture with ICH Guideline Q11 The pharmaceutical landscape is evolving rapidly, and at the heart of this evolution lies ICH Guideline Q11, shaping the development and manufacture of drug substances. Let's delve into the insights this guideline offers for optimizing processes and ensuring regulatory compliance. Embracing the principles outlined in ICH Guideline Q11 is crucial as the industry progresses, fostering innovation, maintaining quality standards, and ultimately enhancing patient outcomes. Examples of Implementation in ICH Guideline Q11: 🔍 Chemical Entities: Development and manufacture of chemical entities, including synthetic drugs, with a focus on optimizing synthetic routes and controlling impurities. 🔍 Biotechnological/Biological Entities: Guidelines for the development and manufacture of biotechnological and biological entities, including recombinant proteins and monoclonal antibodies, emphasizing process control and characterization. #DrugSubstanceDevelopment #ICHQ11 #PharmaInnovation #RegulatoryCompliance #ProcessOptimization #QualityManagement #AmaliaTech ✅ Like ✅ Repost ✅ Comment ☑ Follow us for more! Engaged in drug substance development? 💬Share your experiences and insights in the comments below! Seeking expert advice? 🤝Reach out to Niki Sorogas, PhD and Dimitra Kourtidou for tailored solutions!

6

What's FDA 21 CFR Part 11? How do you get ALCOA+ in place? What best practice should your document set-up follow? Answer these questions and more with our full guide to GxP electronic records and signatures! https://bit.ly/3wPnhhF

3

The European Commission has published an updated version, Version 21, of the Questions and Answers document on the Safety Features for Medicinal Products for Human Use. The new version contains updated responses to Questions 1.1, 1.20, 1.21, and 2.21. https://lnkd.in/eSn3vQDi

11