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Inhalation APRIL2016 28 Previewing the Inhalation & Respiratory Drug Delivery Congress 2016 The 11th Informa Drug Device Combination Products Conference will be held December 6-7, 2016 in Berlin, Germany. The meeting will bring together competent authority, notified body and industry represen- tatives to discuss regulations for device/drug and drug/device combi- nation products. Conference topics This year's agenda will include a com- prehensive update on the European Medical Device Regulations and their impact on combination prod- ucts. In addition, a representative of the US Food and Drug Administra- tion (FDA) Office for Combination Products will discuss their latest updates and requirements. On Day 1, the main topics will be medical device regulations and com- bination products and successful clas- sification of borderline and compli- cated drug device combination prod- ucts. In the evening, an extended ses- sion will feature product-specific interactive round tables. On Day 2, a variety of topics in pre- sentations, interviews and panel dis- cussions will include: • Collaboration between pharma- c e u t i c a l a n d m e d i c a l d e v i c e manufacturers • Global outlook: Requirements for combination products • Human factors testing and usability • Mobile apps and software for com- bination products • Design considerations The conference will also include net- working lunches and receptions. Pre- and post-conference workshops On December 5, the in-depth pre- conference workshop, "Essential Key Updates on the European Medical Device Regulations" (MDR), will be held. Topics will include: • Current status of the MDR, up- dates on draft texts and timelines for publication and application • Key conclusions from draft texts and impacts on industry • Products that have not yet been addressed • Implications of the implementing and delegated acts • Impact of changes on Medicines Competent Authorities and data to be provided for device components of medicinal products • Understanding the impact of chan- ges on Notified Bodies and ensuring an effective working relationship • Post-market surveillance, vigilance and the MDR • Human factors consequences of upcoming MDR changes On December 8, a post-conference workshop will address the new Euro- pean Union IVD (in vitro diagnos- tics) Regulation and companion diagnostics. Additional information For more information, visit the con- ference website: https://lifesciences. knect365.com/drug-device-combi nation-products. Previewing Drug Device Combination Products What? Drug Device Combination Products Who? Competent authority, notified body and industry representatives Where? Sofitel Berlin Kurfurstendamm Hotel, Berlin, Germany When? December 6-7, 2016 Registration: Register online at https://life sciences.knect365.com/drug -device-combination- products For more information: Informa Life Sciences Tel: +44 2070 177481 registrations@informa-ls.com 28 OCTOBER 2016 Inhalation