BEGIN:VCALENDAR PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN VERSION:2.0 BEGIN:VEVENT DESCRIPTION:SMi’s 9th Annual ConferencePre-Filled Syringes East CoastMain Conference: April \;25 - 26\, 2022 | Workshops: April 27\, 2022\n\nSh eraton Boston Hotel\, Boston\, MA\, USA\n\nwww.pfsamericas.com/\n\n \ ;\n\nSponsors are: SCHOTT\, ZEON\n\n \;\n\nExhibitors: Owen Mumford P harmaceutical Services\, PHC Corporation\, POLYPLASTICS- TOPAS\, Weiss-Au g Group\n \;\n\nDevice innovations\, connected delivery and regulator y guidance for advanced parenteral systems\n\n \;\n\nThe global pre-f illed syringes market was valued at $1139.6 million in 2020 and with the rapid growth of the industry\, is expected to grow at a CAGR of 8.95% up to 2027. With that in mind\, the 9th annual Pre-Filled Syringes East Coas t conference will bring together leading industry experts representing bi g pharma and device developers to discuss the key drivers accelerating th e expansion of the industry.\n\nThe past year has seen significant develo pments in the injectables landscape with the rapid introduction and devel opment of vaccines in response to the pandemic\, updates in regulations i ncluding the EU MDR and FDA guidance on bridging studies\, and increasing industry acceptance of connectivity to aid the user experience. As part of SMi’s leading injectable series\, the 2022 conference will provide an exclusive insight into the latest developing technologies for device desi gn\, advances in parenteral device platforms and development\, insights i nto growing integration of digital health and deep dives into recent case studies on novel delivery systems.\n\nThis two-day agenda offers you pee r-to-peer networking with Global Product Managers\, Senior PFS Engineers\ , Device Testing Managers\, Heads of Late-Stage PFS Development and many more.\n\n \;\n\nVisit the website at: www.pfsamericas.com/\n\n \; \n\nChair for 2022: \n\nGretchen Vandal\, Sr. Director\, Head of Global R egulatory Affairs – Devices and Combination Products\, Takeda\n\n \;\ n\nGuest FDA Speaker: \n\n\nJohn Barr Weiner\, Associate Director for Pol icy and Product Classification Office\, Office of Combination Products FD A\n\n \;\n\nFeatured 2022 Speakers Include: \n\n\nJoyce Zhao\, Associ ate Director\, Combination Product\, Takeda\nSuzette Roan\, Associate VP and Head of Global Device Regulatory Affairs\, Sanofi US\nChristine lynn lanning\, Distinguished Scientist\, Device Area Leader\, Merck\nHeather l . Guerin\, Associate Director\, Regulatory Affairs – CMC\, Janssen\nTiemi ng Ruan\, Senior Director of Device Development\, Alexion Pharmaceuticals \nJohn Schalago\, Executive Director\, Senior Global Program Director Reg ulatory Affairs\, Novartis\nGretchen Piwinski\, Manager\, Combination Pro duct Laboratories\, Regeneron\nMichael Song\, Associate Director\, Takeda \nDeep S Bhattacharya\, Senior Scientist\, Drug Product Development and D esign\, Pfizer\n\n \;\n\nBENEFITS OF ATTENDING:\n\n\nExplore the late st developments in innovative technologies for device design accelerating the path to self-administration \;\nAssess the evolving regulatory l andscape for pre-filled syringes and discuss approaches to work with regu lators as guidance is updated\nEngage in panel discussions with industry leaders to navigate the accelerating digital health landscape for combina tion products and drug delivery systems\nUnderstand the landscape of deli very for novel drug products and key considerations to overcome challenge s in CCI\n\nView the full agenda and speaker line-up online: www.pfsameri cas.com/\n\nWho should Attend: \n\n\nDrug-delivery developers\nMedical De vice Engineers\nPrimary Packaging material designers\nSecondary packagers \nSmart device developers\nTraining device developers\nDevice-safety solu tion providers\nDrug developers\n\nEARLY-BIRD RATES:\n\n\nBOOK BY 31st JA NUARY AND SAVE $200\nBOOK BY 28TH FEBRUARY AND SAVE $100\n\n \;\n\nRe gistrations can be made on the event website at: www.pfsamericas.com/\n\n  \;\n\nPOST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requir ements\n\nWorkshop Leader: Theresa Jeary\, Technical Specialist &\; Sc heme Manager\, BSi\n\n08.30 - 12.30\n\n \;\n\nOverview of the worksho p: \n\nThe workshop is aimed to provide an introduction to the key elemen ts of the Medical Device Regulation that Companies affected by article 11 7 need to consider.\n\n \;\n\nWhy you should attend: \n\n\nBe able to determine if Article 117 is applicable to your products\nUnderstand and be able to interpret the requirements of Article 117\nUnderstand the impa cts on your marketing authorization application or post-market variation\ nGain an appreciation and understanding of the MDR Annex I\, General Safe ty &\; Performance Requirements\nUnderstand requirements to facilitate the documentation preparation needed to obtain a NB Opinion\n\n \;\n \nPOST CONFERENCE WORKSHOP B: Developing User-Centric Next Generation Com bination Products\n\nWorkshop Leaders: Marty Coyne\, Principal &\; Co- Founder\, Matchstick and Chris Franzese\, Principal &\; Clinical Leade r\, Matchstick\n\n13.00 - 17.00\n\n \;\n\nOverview of the workshop: \ n\nThis interactive workshop will explore approaches for developing innov ative drug delivery device combination products offering tools for optima l device development with the user in mind. Workshop leaders will provide insights into effectives strategies for concept generation\, product tes ting and validation for the future of device design.\n\n \;\n\nWhy yo u should attend: \n\n\nDiscover innovative concept generation approaches for device development\nUnderstand how to utilise user feedback and exper iences in early stages of development\nWalk through unique examples asses sing effective testing to ensure an optimal product\nEngage in interactiv e discussions to assess opportunities for enhanced devices ensuring the p atient is kept at the forefront\n\n \;\n\nVisit the website here to f ind out more and to download the full agenda: www.pfsamericas.com/\n\n&nb sp\;\n\nAdditional Contact Info:\n\nT: +44 (0)20 7827 6088\n\nE: rjones@s mi-online.co.uk\n\nFollow us: \; @SMiPharm #SMiPFSUSA\n DTEND:20220426T180000 DTSTAMP:20260512T220023Z DTSTART:20220425T080000 LOCATION:SMi Group Ltd Registered & Head Office Ground Floor\, India H ouse\,\, 45 Curlew Street\, Boston\, MA\, SE1 2ND\, SEQUENCE:0 SUMMARY:SMi’s 9th Annual ConferencePre-Filled Syringes East CoastMain Conf erence: April \;25 - 26\, 2022 | Workshops: April 27\, 2022\nSheraton Boston Hot... 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