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Digital Connectivity between manufacturers and HCPs and patients has been facilitated by numerous advances, including recent regulatory requirements. This is true not just in the US, but globally. Unfortunately, it doesn’t appear that these incredible advances have been incorporated into pre-filled syringes and often, not even in secondary packaging. This is changing.

Even with existing digital connectivity solutions, there are are regulatory pitfalls. This includes compliance with 21 CFR Part 11 requirements (computer system validation), and ensuring data collected maintains its integrity. In this work shop, we will explore some of the solutions that are available for pre-filled syringes and other injectable products. We will also discuss compliance requirements under recent FDA guidance, and how manufacturers are incorporating additional information to support patient health. Finally, we will also have an open discussion on what it means to validate and qualify these solutions as they are integrated into fill and finish lines, as well as packaging lines.

Executives, Directors, VPs, Heads, Principals, Managers of:

Pre-Filled Syringes/ PFS
Autoinjectors
Device/ Device Engineering
Human Factor
Scientist
CMC
Product
Injectables
Sterile Manufacturing
Packaging
Regulatory Affairs
or anyone who works with Pre-Filled Syringes/ Autoinjectors within pharmaceutical, biotech and solution providers.
 

Abbott Laboratories; Alkermes; Allergan; Amgen; Anteris Medical GmbH; Baxalta; Baxter Healthcare; Bayer Healthcare; Bayer HealthCare AG; BCM Group LLC; Biogen Inc; Boehringer Ingelheim; Boehringer Ingelheim Pharmaceuticals Incorporated; Bosch Packaging Technology; Bristol-Myers Squibb Co; Cambridge Consultants Ltd; Centurion Medical Products; DDL; Eli Lilly ; Emergent BioSolutions Inc.; ENCO Pharmaceutical Development, Inc. (EPDI); Epione BioPharmaceuticals; FDA; Genentech; Genentech, Inc.; Getinge A B; Gilead Sciences; Gilead Sciences Inc; Insulet Corp; IntraCellular Therapies Inc; Ionis Pharmaceuticals, Inc.; KBI Biopharma; LoneStar Heart Inc; Maeda industry Co Ltd; Merck, Sharp & Dohme Corp.; MITSUBISHI GAS CHEMICAL COMPANY, INC; Mitsubishi Gas Chemical Singapore Pte Ltd; Noxilizer, Inc.; PAREXEL International; Pfizer; Pfizer CentreOne; Pharmacircle; Shire; Shire US Inc; Steris Corp; STERIS FINN-AQUA; Takeda Pharmaceuticals; Teleflex; Terumo Americas Holding, Inc; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; Teva Pharamceuticals; Teva Pharmaceuticals; UserWise; Versartis, Inc.; W.L. Gore & Associates, Inc.; Xcelthera; Xeris Pharmaceuticals; Xeris Pharmaceuticals, Inc.; ZebraSCI; zebrasci inc; Zeon Chemicals L.P.;

Workshop LEADER

keynote-img

Mark Paxton

Managing Director, AcceleratoRx

Mark S. Paxton is founder and Managing Director, AcceleratoRx, LLC. Prior to that, he served as CEO of RX-360, an international pharmaceutical supply chain consortium dedicated to patient safety. Mark’s role at Rx-360 followed his service as a Regulatory Counsel in the CDER Office of Compliance where he was responsible for developing supply chain security policies, both domestically and internationally, including serving as the overseer of a major global initiative under Asia-Pacific Economic Cooperation (APEC) to establish best practices for ensuring product quality moving in international commerce. Before joining FDA, Mark served as Associate Vice-President, International Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (“PhRMA”). In that capacity, Mark established a number of on-going dialogs and work programs with drug regulatory authorities throughout, Japan, China, East Asia, India, Europe and Latin America. These efforts were designed to assist regulators and constituent companies operating in these markets to better understand complex regulatory issues arising from the globalization of the pharmaceutical industry.

Mark is a regulatory attorney by education, experience, and training, and prior to joining PhRMA was in private practice in Lexington, Kentucky where he focused his practice on food and drug law. Mark received his B.S. (1991) and M.S. (1993) degrees in Economics from the University of Kentucky, and his J.D. from the University of Dayton School of Law in 1998.
 

AcceleratoRx

After leaving Rx-360, Mark Paxton founded AcceleratoRx to support synergistic relationships within and among the industry. AcceleratoRx focuses on regulatory support for implementation of digital connectivity strategies throughout the biopharmaceutical lifecycle, including clinical trials and commercial products.

Workshop programme

9:10 Topic Heading 1

13:30 Registration & Coffee

14:00 Workshop Leader Introduction

Mark Paxton

Mark Paxton, Managing Director, AcceleratoRx
View Bio

  •  

  • 14:15 Unintended Benefits Associated with DSCSA: Going beyond statutory requirements

    Michael Rush

    Michael Rush, Executive Director, Global Health Policy, Temptime Corporation

    14:45 Ensuring Quality with computer system validation, and cautious expectations regarding data integrity

    Harry Kochat

    Harry Kochat, Manager, Plough Center for Sterile Drug

    Mark Paxton

    Mark Paxton, Managing Director, AcceleratoRx
    View Bio

    15:30 Afternoon Tea and Networking Break

    16:00 Stress testing digital technologies in a Quality environment

    Michael Song

    Michael Song, Sr. Manager, Drug Delivery and Device Development, MedImmune Inc

    16:30 Open discussion with panel and workshop participants

    17:00 Closing Remarks from Workshop Leader and End of Workshop

    Mark Paxton

    Mark Paxton, Managing Director, AcceleratoRx
    View Bio

    +

    FEATURED SPEAKERS

    Harry Kochat

    Harry Kochat

    Manager, Plough Center for Sterile Drug
    Michael Rush

    Michael Rush

    Executive Director, Global Health Policy, Temptime Corporation
    Michael Song

    Michael Song

    Sr. Manager, Drug Delivery and Device Development, MedImmune Inc

    Harry Kochat

    Manager, Plough Center for Sterile Drug
    Harry Kochat

    Mark Paxton

    Managing Director, AcceleratoRx
    Mark Paxton

    Mark S. Paxton is founder and Managing Director, AcceleratoRx, LLC. Prior to that, he served as CEO of RX-360, an international pharmaceutical supply chain consortium dedicated to patient safety. Mark’s role at Rx-360 followed his service as a Regulatory Counsel in the CDER Office of Compliance where he was responsible for developing supply chain security policies, both domestically and internationally, including serving as the overseer of a major global initiative under Asia-Pacific Economic Cooperation (APEC) to establish best practices for ensuring product quality moving in international commerce. Before joining FDA, Mark served as Associate Vice-President, International Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (“PhRMA”). In that capacity, Mark established a number of on-going dialogs and work programs with drug regulatory authorities throughout, Japan, China, East Asia, India, Europe and Latin America. These efforts were designed to assist regulators and constituent companies operating in these markets to better understand complex regulatory issues arising from the globalization of the pharmaceutical industry.

    Mark is a regulatory attorney by education, experience, and training, and prior to joining PhRMA was in private practice in Lexington, Kentucky where he focused his practice on food and drug law. Mark received his B.S. (1991) and M.S. (1993) degrees in Economics from the University of Kentucky, and his J.D. from the University of Dayton School of Law in 1998.
     

    Michael Rush

    Executive Director, Global Health Policy, Temptime Corporation
    Michael Rush

    Michael Song

    Sr. Manager, Drug Delivery and Device Development, MedImmune Inc
    Michael Song

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