Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges
Extractables & Leachables in Pharma: Navigating Evolving Regulations and Toxicological Challenges
This webinar on demand aims to provide a comprehensive overview of Extractables and Leachables (E&L) in pharmaceutical products, highlighting regulatory complexities, toxicological challenges, and practical approaches to study design and risk assessment across the product lifecycle.
Let's decode E&L risks and safeguard product safety and regulatory compliance!
On demand
1h
Pharma
English
Share
\
\
X (Twitter) 
\
\
LinkedIn 
\
\
WhatsApp 
\
\
Copy link 
\
\
Mail
About the webinar on demand
Extractables and Leachables (E&L) are critical impurities that can migrate from pharmaceutical packaging into the drug product, potentially compromising patient safety. This webinar offers a foundational understanding of what E&L are, why they matter, how E&L can impact drug safety and stability, and how they are assessed in pharmaceutical manufacturing.
Participants will gain insights into the current, often fragmented, regulatory landscape and learn about evolving global guidelines that influence E&L evaluations. A special focus will be placed on the toxicological assessment of E&L, including their classification, integration into risk assessment strategies, and their role across the product lifecycle. The session will also explore the practicalities of designing and executing E&L studies, supported by real-world examples.
Whether you're new to the topic or looking to deepen your expertise, this webinar provides the critical knowledge needed to navigate the complex regulatory and scientific terrain surrounding E&L.
What you'll learn
- The fundamentals of Extractables and Leachables (E&L), including definitions, sources, and their impact on drug safety.
- Current regulatory framework, including gaps, challenges, and relevant global guidelines.
- Insight on toxicological risk assessment strategies for E&L throughout the pharmaceutical product lifecycle.
- Best practices for designing and executing E&L studies, from planning to reporting.
- Review real-world study examples to understand practical applications and common pitfalls in E&L evaluations.
Speakers
Meet our expert speakers who will share valuable insights and practical knowledge drawn from extensive industry experience.
Natalia Herrera
Global Toxicology Liason
Natalia holds a PharmD and a Master's degree in Drug Research, Development and Innovation. With a strong background in business development, her career also...
Javier López
Consultant Toxicology
Javier holds a degree in Chemistry and a Master’s in Drug Discovery. He began his career in public research, focusing on the synthesis and structural characterization of cannabinoids, gaining valuable experience in organic chemistry and analytical techniques, moving later to the pharmaceutical industry focusing method validation and risk assessment of extractables and leachables (E&L) and elemental impurities in accordance with ICH Q3D guidelines.
Watch here
Submit your contact details to register to this webinar on demand. Don’t miss out on valuable insights and actionable strategies from our industry experts.
First name*
Last name*
Role*
Please SelectC-level / VPDirector(Sr.) ManagerSpecialist/AnalystIntern/ApprenticeIndividual contributorOther
Department*
Please SelectStrategy & ManagementRegulatory & VigilanceQuality Assurance & ControlIT & Digital InnovationManufacturing & ProductionProduct DevelopmentResearch & InnovationClinical Affairs & OperationsMedical AffairsMarket AccessSales & MarketingHRProcurementOther
Professional Email*
Company name*
Industry *
Please SelectMedical DevicesIn Vitro DiagnosticsPharmaBiotechAnimal HealthService providerConsumer HealthOther
Country*
Please SelectAfghanistanÅland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAsia/Pacific RegionAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCaribbean NetherlandsCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCook IslandsCosta RicaCote d'IvoireCroatiaCubaCuraçaoCyprusCzech RepublicDemocratic Republic of the CongoDenmarkDjiboutiDominicaDominican RepublicEast TimorEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaEuropeFalkland IslandsFaroe IslandsFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern and Antarctic LandsGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIranIraqIrelandIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLaosLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacauMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesiaMoldovaMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmar (Burma)NamibiaNauruNepalNetherlandsNetherlands AntillesNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorth KoreaNorthern Mariana IslandsNorwayOmanPakistanPalauPalestinePanamaPapua New GuineaParaguayPeruPhilippinesPitcairn IslandsPolandPortugalPuerto RicoQatarRéunionRomaniaRussiaRwandaSaint BarthélemySaint HelenaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint MaartenSlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth KoreaSouth SudanSpainSri LankaSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanTanzaniaThailandTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluU.S. Virgin IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited StatesUnited States Minor Outlying IslandsUruguayUzbekistanVanuatuVatican CityVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabwe
Would you like a one-on-one with our team?*
Please SelectYesNo
Content Title
Content Type
Content Division
Content Division (level 2)
Content Industry
QbD Group is committed to protecting and respecting your privacy, and we’ll use your personal information to administer your account and to provide the products and services you requested from us.
-
Yes, I agree to receive personalized newsletters with market insights, invitations for exclusive events and educational webinars from the QbD Group.
-
I consent to the privacy policy and understand that my personal data will be stored and processed. *
Upcoming webinars
.jpg)
From R&D to market IP and regulatory strategy across the product life cycle
Join this Biovia x Gevers x QbD Group webinar to explore product life cycle strategies, focusing on R&D, regulatory alignment, and Quality by Design insights for life sciences professionals.
Medical Devices
Read more
.jpg)
Nitrosamine Risk Assessment: Adapting to the Latest Regulatory Expectations
Manage the risk of nitrosamines in the pharmaceutical industry. Join our webinar and learn about regulation and risk analysis from experts.
Pharma & Biotech
Read more
From Strategy to First-in-Human: A Practical Roadmap for Biotech Development
Join our webinar to learn how to navigate nitrosamine risks and streamline your biotech development from early planning to first-in-human trials. Register now for expert insights.
Pharma & Biotech
Read more
-1.jpg)
AI in Life Sciences
Join our webinar with delaware on implementing compliant AI in life sciences. Learn best practices and avoid pitfalls in GxP environments from industry experts. Register now.
Software Solutions & Services
Read more
Discover all
We share the latest news
Staying on top of the latest in the life science industry can be a daunting task. This newsletter will keep you up-to-date with the latest news, blogs and webinars so you can keep ahead of the curve.
