Drug-Device Combination Products & Article 117

Are the regulatory complexities of Drug-Device Combination Products overwhelming you?

This webinar will explore the latest advancements and insights regarding integral Combination Products that must be registered as drugs under the current legislation.

Register here

On demand

1h

Pharma

English

Register here

Share

\ \ X (Twitter) \ \ LinkedIn \ \ WhatsApp \ \ Copy link \ \ Mail

Description

Did you know that MDR has amended the drug legislation regarding Combination Products?

Specifically, Article 117 requires manufacturers who are placing integral drug-device combination products on the market as “medicinal products” to seek a Notified Body Opinion (NBOp).

Additionally, an integral drug device without CE marking needs to be registered as a pharmaceutical drug under the drug legislation. The Notified Body must also assess the conformity of the device with the relevant general safety and performance requirements (GSPR) outlined in Annex I.

Watch the webinar on demand

What you'll learn

• Data requirements needed to demonstrate compliance with the relevant General Safety and Performance Requirements (GSPR).
• The process for selecting and working with a Notified Body to obtain a Notified Body Opinion (NBOp).
• Dossier and Common Technical Document (CTD) requirements for combination products.
• Key development considerations for combination products.
• Quality considerations specific to combination products.

Speaker

Join us as our expert speaker shares valuable insights and practical knowledge drawn from extensive industry experience.

Don’t miss the opportunity to learn and engage with professionals in the field.

Salma Michor, PhD

Division head Regulatory Affairs

Salma Michor is currently Division head Regulatory Affairs at the QbD Group. She served clients such as Johnson & Johnson, Novartis, Pfizer and CSL Behring. Previously, Michor worked for Chiesi-Torrex, Wyeth Whitehall Export Croma Pharma GmbH.

She teaches regulatory affairs and clinical strategies at the University of Krems, Austria, and is an independent expert to the European Commission.

Salma Michor is a member of the RAPS European Board. She holds a PhD in Bio engineering and an MSc in food and biotechnology from the University of Applied Life Sciences in Vienna, Austria; an MSc from King’s College, University of London in food technology; and an MBA from Open University and has earned the RAC (EU and Global). She is a Chartered Manager and a fellow of the Chartered Management Institute.

Watch here

Submit your contact details to access the full webinar anytime. Don’t miss out on valuable insights and actionable strategies from our industry experts.

First name*

Last name*

Professional Email*

Company 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

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

Industry*

Please SelectMedical DevicesIn Vitro DiagnosticsPharmaBiotechAnimal HealthService providerConsumer HealthOther

Would you like a one-on-one with our team?

Content Title

Content Type

Content Division

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

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

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

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.

Subscribe to newsletter