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URL:
https://www.uventia.com/event/4th-annual-extractables-leachables-summit-2024/
Submission: On February 15 via manual from US — Scanned from DE
Submission: On February 15 via manual from US — Scanned from DE
Form analysis
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<legend>Fill out the Request Form to receive the Event Brochure</legend>
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POST /event/4th-annual-extractables-leachables-summit-2024/#wpcf7-f5740-p6218-o3
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* Home * Events * Past Events * Sponsorship * About Us * Contact Us 0 * Home * Events * Past Events * Sponsorship * About Us * Contact Us 0 * Home * Events * Past Events * Sponsorship * About Us * Contact Us 0 4TH ANNUAL EXTRACTABLES & LEACHABLES SUMMIT 2024 1. uventia 2. Events 3. Pharma 4. 4th Annual Extractables & Leachables Summit 2024 DISCOUNT 10% REQUEST BROCHURE REQUEST BROCHURE Fill out the Request Form to receive the Event Brochure 1. Title * Mr.Ms.Mrs.Dr. First Name * Last Name * Job title * Company * Phone Number Email * 2. Where did you heard about this event? * Search EnginesEmail MarketingLinkedInFacebookColleague's RecommendationOther 1. I confirm that I have read and agreed to Terms & Conditions and Privacy policy. REGISTER NOW BECOME A SPONSOR Event Details * 21 Days 05 Hours 10 Min 29 Sec * Start Date March 7, 2024 10:00 am * End Date March 8, 2024 5:30 pm * Status Upcoming * Location * Online * Price €415 - €595 * Organizer * Uventia * Category * Pharma * Email register@uventia.com * Network * * * Time zone Central European Time * Language English * Zoom video platform Add to Calendar * OVERVIEW * SPEAKERS * AGENDA CONFERENCE OVERVIEW One of the most important phases of the biopharmaceutical development process is the evaluation of extractables and leachables. Regulatory bodies are particularly concerned about the interactions of pharmaceutical products with container closure systems, drug delivery devices, and bioprocess manufacturing systems. Therefore, it is crucial to carefully evaluate the migration of mobile molecules from the materials and components used in the production and storage of pharmaceuticals. We host a virtual conference where scientists, toxicologists, and E&L managers may exchange ideas about the most recent analytical approaches, regulatory updates, risk-based E&L programs, chemical characterization, and toxicological risk assessment. We also discuss analytical and safety thresholds, medical device materials, ISO 10993-18, and customized systems for various product kinds. Come to our event and discover the latest approaches for extractables and leachables analysis and testing. This should help you greatly reduce the risks connected with E&L while also ensuring patient safety and product integrity. WE WILL TALK ABOUT * Updated regulatory guidelines for E&L testing. * Implementation of a non-volatility test before quantitating E&L unknowns with a charged aerosol detector. * Toxicological assessments in E&L. * The current state and analytical challenges with the evaluation of E&L in pharmaceutical and medical device industries. * Approaches to the use of in silico methods in the toxicological assessment of extractables and leachables. * Sensitization safety assessment of extractables and leachables in pharmaceutical products. * Leachable risk assessment approaches: a comparison of USP <665>, biophorum, and other methods for assessing leachable risk in biopharmaceutical manufacturing systems. * Safety assessment of E&Ls: challenges with different administration routes. * E&L testing for medical devices. * Results of the elsie lab practices sub team’s surveys for understanding intra-lab method/procedure variations for the execution of extractable screening studies. * A novel simultaneous UHPLC-UV-CAD-HRMS multi-detector platform for comprehensive extractables and leachables analysis of pharmaceutical packaging and medical device materials. * Elastomer closures materials (TBC). * Leachable study of a parenteral vial products with complex and challenging formulations. WHO IS IT FOR? CxO, VPs, Directors, Heads, Managers of * Extractables and Leachables/ E&L * Analytical Chemistry/ Analytical Development/Analytical Science * Product Characterisation/ Risk Assessment * Drug Development/ Drug Substance * Drug Safety/ Compound Safety/ Toxicology * Device Development/ Device Engineering/Container Development * Good Laboratory Practice (GLP)/Good Manufacturing Practice (GMP) * Manufacturing Science & Technology/ Single Use Systems * Bioprocessing/ Bioproduction * Regulatory Affairs & Compliance * Materials Science/ Materials Selection/ Biocompatibility * Packaging & Labelling * LC-MS/ Mass Spectrometry [AGENDA] 4TH ANNUAL EXTRACTABLES & LEACHABLES SUMMIT 2024 Download the full summit program to find speaker biographies, case studies, key takeaways, the day's schedule, and details of each session. REQUEST BROCHURE REQUEST BROCHURE Fill out the Request Form to receive the Event Brochure 1. Title * Mr.Ms.Mrs.Dr. First Name * Last Name * Job title * Company * Phone Number Email * 2. Where did you heard about this event? * Search EnginesEmail MarketingLinkedInFacebookColleague's RecommendationOther 1. I confirm that I have read and agreed to Terms & Conditions and Privacy policy. Speaking Companies Our Sponsors BECOME A SPONSOR SPEAKER SPONSOR Previous Events Expired [•REC] - €395 3rd Annual Extractables & Leachables Summit 2023 * Pharma March 9, 2023 * Online Expired [•REC] - €375 2nd Annual Extractables & Leachables Summit 2022 * Pharma March 30, 2022 * Online * ATTENDEES IN 2023 * ATTENDEES IN 2022 ATTENDEES IN 2023 ● 3M ● Albhades ● ALK-Abelló S.A. ● Analytical Expertise Center, MoH of Azerbaijan Republic ● Antibiotice SA ● AstraZeneca ● B. Braun Medical Industries Sdn. Bhd ● B. Braun Medical SA ● Bausch Health ● Baxter Healthcare ● Bayer AG ● BD ● Bicycle Therapeutics ● BioConnection BV ● Biogen ● Brainfarma Industria Quimica e Farmacêutica S.A. ● Chorley Consulting Ltd ● CleanControlling Medical GmbH & Co. KG ● CSL Behring ● Datwyler ● Donaldson ● Donaldson BV ● Dr. Anika Schroeter e.U. ● DuPont ● E.L-Xpert Ltd ● Element Material Technology ● ELSIE Consortium ● EQUITOX ● Fastnet Biopharma ● Fischer PreclinTox Consulting ● Fresenius Kabi ● Gateway Analytical ● GBA Pharma GmbH ● GE HealthCare ● Gilead Sciences ● Gilead Sciences, Inc. ● Greg Erexson Toxicology Consulting ● GSK ● ICU Medical ● Incyte ● Instem ● Intertek Schweiz AG ● Johnson & Johnson ● Laboratorios Normon SA ● LACER, S.A.U ● Lhasa Limited ● Lonza ● Lonza Drug Product Services ● Made Consulting Ltd Oy ● Mallinckrodt Pharmaceuticals ● Merck Group ● Merck KGaA ● Neotron Spa ● Octapharma ● Padagis Israel Pharmaceuticals ● Pharmaceutical Firm Darnitsa ● PHOX Consulting e.U. ● Polpharma Biologics S.A. ● PolyCine GmbH ● Promega Corp ● Quinta-Analytica, s.r.o. ● Safetree Consulting e.U. ● Sartorius ● SCC Scientific Consulting GMBH ● SEPTODONT ● SGS Health Science ● Sun Pharmaceutical Industries Ltd. ● Terumo Blood and Cell Technologies ● Teva Pharmaceuticals ● Teva Pharmaceuticals Ireland ● Therapeutic Goods Administration ● Thermo Fisher Scientific ● Tofwerk AG ● U.S. Pharmacopeia ● United States Pharmacopeia ● Universidade de São Paulo ● US Food and Drug Administration ● Waldemar Link ● Westlake ● Wonderboom, Inc. ● WuXi AppTec ATTENDEES IN 2022 ● 3M ● Aché ● Adjutant Solutions Group LLC ● AGC Biologics ● Albhades Provence ● ALK-Abelló S.A. ● Aptar Pharma ● AstraZeneca ● Athens Analysis Laboratories ● B.Braun Melsungen AG ● Baxter Healthcare ● Bayer AG ● BBraun Avitum Italy SpA ● Becton Dickinson ● Biogen ● BioNTech ● Boston Scientific ● BSC International Medical Trading ● Carl Zeiss Meditec AG ● Charles River ● Cytiva ● Dalton Chemical Laboratories Inc. ● Deva Holding A.Ş. ● Eli Lilly ● Eli Lilly & Co. ● Gador ● Galapgos NV ● Galderma ● Gilead Sciences ● GlaxoSmithKline Biologicals ● GlaxoSmithKline Biologicals Kft. ● Greiner Bio-One GmbH ● GSK Vaccines ● Hall Analytical ● HORIBA Scientific ● Incyte ● Incyte Biosciences Tech Ops ● Intertek (Schweiz) AG ● L.Molteni & C. dei F.lli Alitti SpA ● LGC Standards ● Lhasa limited ● Lonza ● Medela AG ● Merck KGaA ● Nelson Laboratories ● Niutec AG ● Norbrook Laboratories Ltd ● Norner AS ● Novartis Pharma AG ● Octapharma AB ● Par Pharmaceutical ● Pharma Mar ● Pliva Croatia Ltd. ● PLIVA Hrvatska d.o.o. ● QUINTAANALYTICA s.r.o. ● Regeneron ● Safetree Consulting e.U. ● Sandoz ● Sanofi ● Sanofi-Aventis ● Sanofi-Aventis R&D ● Sartorius ● Sartorius Stedim Biotech GmbH ● Sumitomo Dainippon Pharma Co., Ltd. ● Takeda Pharmaceutical Co. Ltd. ● Teva Pharmaceutical Industries LTD ● Teva Pharmaceuticals Ireland ● TRIS Pharma ● UCB Biopharma SRL ● Waters Corporation ● Waters GmbH ● West Pharmaceutical Services ● Xellia d.o.o. REGISTER NOW Speaker Board BECOME A SPEAKER BECOME A SPEAKER Become a Speaker of the Event 1. Title * Mr.Ms.Mrs.Dr. First Name * Last Name * Job title * Company * Phone Number Email * 2. Your message here 3. Where did you heard about this event? * Search EnginesEmail MarketingLinkedInFacebookColleague´s RecommendationOther 1. I confirm that I have read and agreed to Terms & Conditions and Privacy policy. J. Susanne Becker Head of Extractables and Leachables Labs Intertek (Schweiz) AG * Will Parker E&L Technology Manager West Pharmaceutical Services * Ana Kuschel Principal Scientific Affairs West Pharmaceutical Services Armin Hauk Principal Scientist Sartorius Stedim Biotech GmbH Katherine Lovejoy Application Chemist Thermo Fisher Scientific * Jason Creasey Managing Director Maven E&L Ltd * Divya Regulagedda Manager (Global SME) Chemo Group * Jianwei Li Principal E&L Chemical Characterization Solutions LLC * Candice Johnson Senior Research Scientist Instem * Frank Liu Director, Safety and Toxicology Estee Lauder Companies * Erika Udovic Senior Principal Scientist Novartis Pharma AG * Mourad F. Rahi Senior Consultant Chemist Preclintox Services, LLC * Dujuan Lu E&L Manager/Global Leader SGS Health Science * Charlie Modlin Application Scientist Lhasa Limited * Douglas Kiehl Research Advisor Eli Lilly * Steve Zdravkovic Research Scientist II Baxter Healthcare * Etienne Michel Global QA for E&L GSK Vaccines * Marine Lepoutre E&L Global SME GSK Vaccines * Clemens Guenther Director, Senior Expert Nonclinical Safety Bayer AG * REGISTER NOW Summit Agenda REQUEST BROCHURE REQUEST BROCHURE Fill out the Request Form to receive the Event Brochure 1. Title * Mr.Ms.Mrs.Dr. First Name * Last Name * Job title * Company * Phone Number Email * 2. Where did you heard about this event? * Search EnginesEmail MarketingLinkedInFacebookColleague's RecommendationOther 1. I confirm that I have read and agreed to Terms & Conditions and Privacy policy. * March 7 * March 8 March 7, 2024 10:00 - 10:15 REGISTRATION March 7, 2024 10:30 Extractables and leachables from single-use systems and their assessment in advanced therapy medicinal product (ATMP) production ◆ E&L safety assessment in cell and gene therapies (CGT) is challenging. ◆ While suitable extractables data are available, exposure estimations to patients and the ex vivo manipulated biological material need to be improved by exposure modelling. ◆ Additionally, data for toxicological relevant end points for the ex vivo manipulated cells are required. ◆ It will be shown that morphological profiling with a cell painting assays (CPA) using human cells allows to identify potential detrimental effects relevant for E&L safety assessments. Sartorius-Stedim-Biotech-GmbH SARTORIUS STEDIM BIOTECH GMBH, DE Speakers: * Armin Hauk Principal Scientist Sartorius Stedim Biotech GmbH March 7, 2024 11:10 Implementation of a non-volatility test before quantitating E&L unknowns with a charged aerosol detector ◆ HPLC with 3 orthogonal detectors allows quantitation of unknowns by charged aerosol detectorand identification by easy-to-use low resolution MS ◆ Classification of unknowns as non-volatile or semi-volatile in the CAD reduces the uncertainty factor and improves quantification by surrogate standard. ◆ When using an inverse gradient, improved mixing with an inline capillary mixer after the merge point of the analytical and inverse gradients reduces inter-compound %RSD Thermo-Fisher-Scientific THERMO FISHER SCIENTIFIC, DE Speakers: * Katherine Lovejoy Application Chemist Thermo Fisher Scientific March 7, 2024 11:50 Toxicological assessments in E&L ◆ PQRI's recommendations for analytical and safety thresholds. ◆ The QSAR application and qualification standards. ◆ Analyzing toxicological risk and toxicity data. Bayer BAYER AG, DE Speakers: * Clemens Guenther Director, Senior Expert Nonclinical Safety Bayer AG March 7, 2024 12:20 - 13:20 Lunch Break March 7, 2024 13:20 [Speaker Sponsor] From Extractables Study to Leachables Study – from screening methods to validated target methods for Stability Testing in E&L ◆ Set of Extractables Study under realistic worst-case conditions. ◆ Leachables Simulation Study using drug substance/product solution. ◆ Selections of target compounds, method development and validation according to ICH. ◆ Case studies showing problems and possible solutions. Intertek INTERTEK, CH Speakers: * J. Susanne Becker Head of Extractables and Leachables Labs Intertek (Schweiz) AG March 7, 2024 14:00 The current state and analytical challenges with the evaluation of E&L in pharmaceutical and medical device industries ◆ The safety and analytical science expectations of E&L from the perspective of a quantitative “global” space of extractables and leachables in volatility, hydrophobicity, and molecular weight. ◆ A critical review of the current state of analytical testing strategies, including uncertainty on E&L testing. ◆ A critical overview of the major analytical challenges in solvent choice, sample treatment, mass balance, method sensitivity, response factor, accuracy of quantitation and identification, etc, with specific examples. ◆ Tips for choosing an analytical partner. CHEMICAL CHARACTERIZATION SOLUTIONS, LLC, USA Speakers: * Jianwei Li Principal E&L Chemical Characterization Solutions LLC March 7, 2024 14:40 Approaches to the use of in silico methods in the toxicological assessment of extractables and leachables ◆ Discusses various contexts in which in silico methods are applied in E&L assessments. ◆ Defines the fitness-for-purpose of in silico models in these contexts. ◆ Demonstrates how in silico profiling could be used to support read-across assessments. Instem INSTEM, USA Speakers: * Candice Johnson Senior Research Scientist Instem March 7, 2024 15:20 Sensitization safety assessment of extractables and leachables in pharmaceutical products ◆ Sensitization potential of extractables and leachables: a challenge. ◆ Sensitization safety assessment proposal for extractables and leachables. ◆ A hypothetical case study: the application of the proposal. Estee-Lauder-Companies ESTEE LAUDER COMPANIES, USA Speakers: * Frank Liu Director, Safety and Toxicology Estee Lauder Companies March 7, 2024 16:00 TBA ◆ Lhasa-Limited LHASA LIMITED, UK Speakers: * Charlie Modlin Application Scientist Lhasa Limited March 7, 2024 16:50 System suitability and incubation effects on extractables following exhaustive extraction ◆ The shortfalls of system suitability for determination of limit of detection as routinely performed for chemical characterization of solvent extracts of medical devices. ◆ The results and impact of a limited laboratory investigation on the effect of incubation on spiking selected standards commonly used for identification and quantification of extractables. ◆ Biocompatibility testing failure and identification of root cause. ◆ Recommendations to improve extraction and identification of reactive/toxic substances. Preclintox-Services,-LLC PRECLINTOX SERVICES, LLC, USA Speakers: * Mourad F. Rahi Senior Consultant Chemist Preclintox Services, LLC March 7, 2024 16:30 - 16:40 Chairman’s closing remarks and end of day one March 8, 2024 10:00 - 10:15 REGISTRATION March 8, 2024 10:30 Cumulative effect vs lego mode: how to simplify extractable approach The goal will be to present how to manage the cumulative effect and to explain which simplifications can be implemented for extractable studies and patient exposure scenario: ◆ Why extractable studies are not always representatives? ◆ How to deal with cumulative effect described in regulations? ◆ The concept of Lego approach to simplify cumulative evaluation? ◆ How to use of digital tool to support approach and simplify patient exposure scenario and toxicological evaluation? GSK GSK VACCINES, BE Speakers: * Etienne Michel Global QA for E&L GSK Vaccines * Marine Lepoutre E&L Global SME GSK Vaccines March 8, 2024 11:10 Leachable risk assessment approaches: a comparison of USP , biophorum, and other methods for assessing leachable risk in biopharmaceutical manufacturing systems ◆ There is no agreed format for leachable risk assessment. ◆ Both USP and Biophorum have published guidance. ◆ Presented is an alternative approach that might be considered, covering both severity and probability of leachable risk. Maven-E&L-Ltd MAVEN E&L LTD, UK Speakers: * Jason Creasey Managing Director Maven E&L Ltd March 8, 2024 11:50 Safety assessment of E&Ls: challenges with different administration routes ◆ Introduction to general safety and regulatory considerations for extractables/ leachables (E&Ls) in pharmaceutical products. ◆ Considerations for ocular administration routes. ◆ Assessment strategies for intrathecal (IT) route of administration. Novartis NOVARTIS PHARMA AG, CH Speakers: * Erika Udovic Senior Principal Scientist Novartis Pharma AG March 8, 2024 12:30 E&L testing for medical devices ◆ Chemical characterisation of medical device materials and ISO 10993-18. ◆ Evaluation of biocompatibility and toxicological risk. ◆ The verification of analytical methods. Chemo CHEMO GROUP, ES Speakers: * Divya Regulagedda Manager (Global SME) Chemo Group March 8, 2024 13:00 - 14:00 Lunch Break March 8, 2024 14:00 Results of the elsie lab practices sub team’s surveys for understanding intra-lab method/procedure variations for the execution of extractable screening studies ◆ Annecdotely, it’s been stated that extractable screening data obtained between laboratories will be unaligned to at least some extent in the qualitative and/or quantitative profiles reported, which has been hypothesized to be attributable to differences in the methods and procedures used. ◆ To that end, ELSIE has surveyed a large number of CRO and pharmaceutical (sponsor) companies with the goal of better understanding variations in methods and lab practices used between labs with the goal of understanding the extent of such variation that currently exists in the E/L field. ◆ This presentation will discuss the data obtained from these surveys, highlighting areas of alignment, or lack thereof, for key method/procedural aspects including surrogate standard selection, uncertainty factor determination and usage, system suitability parameters, and relevant methodology variables. Baxter-Healthcare ELSIE BAXTER HEALTHCARE, USA Speakers: * Steve Zdravkovic Research Scientist II Baxter Healthcare March 8, 2024 14:40 A novel simultaneous uhplc-uv-cad-hrms multi-detector platform for comprehensive extractables and leachables analysis of pharmaceutical packaging and medical device materials ◆ We will demonstrate the combination of the three detection techniques in one system to allow the concurrent measurement of UV absorption, Charged Aerosol Detection (CAD) signal and high resolution-accurate mass (HRAM) mass spectra from one injection. ◆ The inclusion of CAD detection provides complementary information to UV and HRMS, enabling more reliable semi-quantitation of non-chromophoric and non-volatile compounds. ◆ Several case studies will be shown with the application of this multi-detector approach in extractable studies of pharmaceutical packaging and medical device components. SGS-Health-Science SGS HEALTH SCIENCE, USA Speakers: * Dujuan Lu E&L Manager/Global Leader SGS Health Science March 8, 2024 15:20 Elastomer closures materials (TBC) ◆ Composition of elastomers used for pharmaceutical applications. ◆ Material composition and extractables. ◆ How to minimize extractables/leachables from elastomeric closures. WestPharma WEST PHARMACEUTICAL SERVICES, USA, DE Speakers: * Will Parker E&L Technology Manager West Pharmaceutical Services * Ana Kuschel Principal Scientific Affairs West Pharmaceutical Services March 8, 2024 16:10 [Available for Sponsors] ◆ Sponsoring the event is a great way to introduce your brand to an interested audience. ◆ You can find sponsorship options on the Sponsorship page. ◆ To book and secure a package - please send back a scan copy (or electronic version with electronic signature) of the registration form with your details (last page of the agenda). It is also possible to register directly via the Website. ◆ The moment you book a package your info will be added to the brochure which is being distributed within our network and through our marketing channels. ◆ To learn more, contact us info@uventia.com March 8, 2024 16:50 Pharma 4.0/5.0, FDA/FRAME and digital twins: Enabling advanced manufacturing and digital transformation in pharma through cross-collaborative partnerships ◆ What are the current drivers for Digital Transformation in Pharma? ◆ How is Pharma 4.0/5.0 defining the disruptive and transformative roadmap for more expedient operations, product development, advanced manufacturing, supply chain and lifecycle management? ◆ How are digital twins and cross-collaborative partnerships primary enablers for advanced manufacturing and digital transformation in pharma? EliLilly ELI LILLY, USA Speakers: * Douglas Kiehl Research Advisor Eli Lilly March 8, 2024 17:20 - 17:30 Chairman’s closing remarks and end of day two REGISTER NOW Event Details * 21 Days 05 Hours 10 Min 29 Sec * Start Date March 7, 2024 10:00 am * End Date March 8, 2024 5:30 pm * Status Upcoming * Location * Online * Price €415 - €595 * Organizer * Uventia * Category * Pharma * Email register@uventia.com * Network * * * Time zone Central European Time * Language English * Zoom video platform Add to Calendar Sponsors Event Tags * Conference * Events * Pharma Share This Event * Facebook * Twitter * LinkedIn * WhatsApp * Email Related Events You might also love these events. Combination Products Integrated Development Summit 2024 * Pharma April 25, 2024 10:00 am What are critical considerations on drug-device integrated development and how to choose the right regulatory and clinical strategy? 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