PREFILLED SYRINGES & INJECTIONS SUMMIT 2019

September 26–27th, 2019

 

The market of Prefilled syringes & Injections is growing at an incredible rate with no signs of slowing down. The value of the market is estimated to hit 7.9B USD by 2024. Prefilled syringes provide an easier way to perform drug delivery through injection as compared to traditional ways. In addition to this, it saves time and efforts of healthcare practitioners. It also reduces the wastage of active pharmaceutical ingredients (API). The demand for prefilled syringes is rising due to increase in patient safety and efforts of healthcare professionals to reduce the hospital errors. Pharma and Healthcare organizations have to meet this demand while dealing with the regulatory and manufacturing challenges. The Prefilled Syringes & Injections Summit 2019 will provide a comprehensive overview for market participants to overcome common industry hurdles and gain knowledge by fostering industry relationships, providing the opportunity for the development of innovative business solutions.

Key Practical Learning Points of the Summit:

•     Connected Device – The Next Big Thing in Injectables
•     The need for a reliable supply chain and how to create it strategically
•     Current market developments, trends, and needs for Pre-Filled Syringes (PFS) and injection devices
•     Patient centricity
•     Industry roadmap and value chain
•     Next generation design and materials for PFS
•     Latest technical, quality, and regulatory considerations for injection devices
•     Risk management background and the development
•     Combination products and auto-injectors: challenges and opportunities
•     Clinical case studies
•     Injection Devices: Critical Attributes and Risk Management
•     Patient centric design considerations for PFS
•     Interface between drug, device and patient
•     EU MDR considerations for developing the roadmap regulatory strategy

Who Should Attend:

CEOs, VPs, Drug developers, Academics and Researchers, Engineers, CROs, Scientists and Medical Doctors of:

•     Bioprocess Research and Development
•     Business Development
•     Combination Products
•     Container Development
•     Controls and Robotics
•     Device Development & Manufacturing
•     Device Engineering & Design
•     Drug Delivery & Devices
•     Research and Development
•     Risk Management
•     Sterile Products
•     Vaccines
•     Validation
•     Extractables & Leachables
•     Human Factors
•     Injectables
•     Materials Development
•     Medical & Connected Devices
•     Parenterals
•     QA/QC
•     Regulatory Affairs
•     Drug Packaging

Target Audience:

•     Pharmaceutical companies
•     Health-care companies
•     Biomedical companies
•     Biotech companies
•     Hospitals
•     Device Manufacturers

For any enquiry on regards to special offers & group discounts please contact us directly at:
info@globalbsg.com

Event Schedule
Event Speakers
Register
Day 1 :
08:50 Opening Address from the Chairperson
09:00 Speed Networking
09:10 Keynote Presentation | Polymer Prefilled Systems – The Past, The Present, The Future
09:50 Case Study | Particles and silicone – Critical aspects of prefilled syringes
10:30 Morning Coffee and Networking Break
11:00 Case Study | New Developments in VHP (Vaporized Hydrogen Peroxide) Low Temperature Terminal Sterilization for Heat
11:40 Case Study | The Rise of Integrated Safety Devices
12:20 Panel Discussion | Creating More Powerful Partnerships in Pharma Manufacturing
13:00 Business Lunch
14:00 Case Study | Regulatory Updates On Combination Products And Future Impact
14:40 Case Study | Risk Management model for Drug-Device Combination Products
15:20 Afternoon Coffee and Networking Break
15:50 Case Study | Selecting the right connectivity technology for your drug delivery device
16:30 Panel Discussion | Business Models of the Future: Establishing an outcome-based business model between pharma and device providers
17:10 Chairman’s Closing Remarks and End of Day One
17:20 Evening Drinks Reception
Day 2 :
  • Director, Global Product Management, Polymer Prefilled Systems and Vial Containment / West Pharma
    Nicolas Brandes has worked within the pharmaceutical packaging industry for almost ten years in areas of business development, research & development, technical services and marketing. Currently in his role as Director, Global Product Management, Polymer Prefilled Systems and Vial Containment, Nicolas is responsible for defining new market requirements, launching new products, supporting business development plans, and overall execution of global marketing strategies for West, all related to West’s portfolio of polymer container solutions. Dr. Brandes received his Ph.D. in Biology from the University of Wuerzburg, Germany, after performing his research studies at the University of Michigan, USA.
  • Senior Scientific Consultant / Intertek
    Tino Otte, Senior Scientific Consultant at Intertek, is an expert for analysis of impurities and contaminations in pharmaceutical products. He holds a degree in polymer-chemistry from the University of Halle/Saale and a Ph.D. from the Darmstadt Technical University, where he graduated in 2010. He joined Intertek (Schweiz AG) in 2016. Prior to joining Intertek, he worked with different research, development and manufacturing companies where he served in several functions in product management and development of analytical services. He has more than 7 years of experience in GMP regulated environment within multiple areas of product analysis including method development, validation and QC.
  • Application Project Manager, Team Lead / STERIS Corporation
    Amit Khanna is an Application Project Manager, Team Lead for STERIS Life Sciences. He has bachelor’s degree in Aerospace engineering. He joined STERIS in 2004 and has 15 years of experience with pharmaceutical and research process equipment in washing, sterilizing, WFI, PSG and VHP applications. He has worked on several customer projects in Europe, Middle East, South Africa and Asia.
  • Vice President Strategy, Pharma Segment / Aptar
    Patrick is an Industrial Pharmacist graduated from the Universities of Liège and Montpellier. Patrick started his career in 1993 at GSK Vaccines, holding successive Quality roles, culminating in leading the Quality activities for aseptic operations, packaging, warehousing and supplier management. He then started his own consulting practice (Pharma Jump Consulting) and joined the Board of Directors of Lasea as an Independent Director. As of September 2018, Patrick stopped his consulting practice to join Aptar as VP Strategy for the Pharma Segment while retaining his position in Lasea’s Board of Directors.
  • Associate Director Global Regulatory Affairs CMC Biologics / Sanofi
    Dr. Baerbel Grossmann did study Biology at the Ruprecht-Karls University in Heidelberg, Germany. She received her Diploma and PhD at the Institute for Human Genetics. After leading a group for basic research at the University Hospital in Mainz for four years, she started in 2006 to work at Sanofi, one of the leading Pharmaceutical Companies worldwide. Baerbel held different positions in Quality and Regulatory with increasing responsibilities. Currently, she is working as a project manager in Global Regulatory Affairs in Research and Development on different development and commercial products.
  • Production Section Head / GlaxoSmithKline
    Mohamed Ghalwash is a pharmacist with an experience in all sterile pharmaceutical industry and non-sterile with all pharmaceutical dosage form like Liquid, Suspension, Tablet, SG capsule ...etc. 

His Roles and responsibilities include changes between production and quality assurance.
His Production role includes experiences in manufacture (production) filed,
leading production operators in day to day activities ,
supervision of all critical activities in sterile manufacturing process,
comply with requirement and global standards and deal with audits and auditors, etc.
His experience has been distributed over multinational company and a local manufacturing company
  • Senior Director of Technology Management / Flex
    Lior Shtram is a Senior Director of Technology Management at Flex, which provides design, development, and manufacturing services for medical devices deploying the expertise of design teams and subject matter experts around the world. He has more than 15 years of experience designing and developing novel medical devices, helping to bring to market many diagnostic and therapeutic devices as well as drug delivery systems. Mr. Shtram has graduated from the Technion Institute of Technology Israel.
  • Vice-President, Research and Early Development / SCYNEXIS, Inc.
    Dr. Stephen A. Barat is currently the Vice-President of Preclinical Research and Early Development at Scynexis, a biopharmaceutical company focused on developing novel anti-infective agents for serious and life-threatening conditions. He is a recognized expert on the interface between safety assessment and CMC and frequently speaks in professional venues on subjects related to parenteral drug development. Dr. Barat is a member of the PQRI working group for leachables and extractables and the USP expert panel for biocompatibility of packaging materials.
  • Senior Manager Device Manufacturing Development / NovoNordisk
    Dr Peter Fairhurst, Senior Manager Device Manufacturing Development NovoNordisk NNAS.   15 years prefilled device experience with Novo Nordisk covering all aspects of their manufacture and design, including Moulding and moulding optimization, Component design modification, Assembly line manufacture and validation, Packaging line manufacture and validation, Production Management, Maintenance of marketed prefilled devices – i.e. meeting the ever changing market and regulatory authority needs.   Presently managing the implementation of two new prefilled device assembly production facilities in Asia (Tehran, Iran) and Africa (Boufarik, Algeria).
  • Director, Regulatory Sciences / Cardinal Health
    Phil Smith is a Director with Cardinal Health, overseeing all commercial activities in Europe, Middle East, Africa & Asia Pacific for the Regulatory Sciences division. He has over 25 years’ experience in pharmaceutical, biotechnology and medical device research and manufacturing projects. Originally trained in microbiology and biochemistry, he has worked across the entire drug development and manufacturing landscape as well as time in medical device and other highly regulated areas.
  • Global Head of Pharmaceutical Engineering / Sanofi
    Jean René Authelin has an Engineering degree in Chemical Engineering from ENSIC (Nancy France), and a PhD from The Institut National Polytechnique de Lorraine (France). He joined Rhone Poulenc in 1988 as a Chemical Engineer. In the 90’s, he founded the Physical Quality function, dedicated to the API crystallization, drying, polymorphism for which he was for 10 years Global Head in Rhone Poulenc Rorer, Aventis and finally Sanofi. Domains of interest of JRA include solid state, particle engineering and more recently biologics drug product process including freeze drying and medical devices. Jean René Authelin is the author or co-author of 20 publications or book chapters and the co-inventor of 9 patents.
  • Head Research and Development Drug Product Services / LONZA
    Thomas Schönknecht, Ph.D. is current Head R&D, Drug Product Services at Lonza. In this role, Thomas will provide ownership for the innovation strategy, overview and tracking for current and future DPS R&D activities, liaise with external collaborations for R&D related to parenteral drug delivery, and support the development of intellectual property and commercialization of DPS-related innovations. Prior to Lonza, Thomas held positions at SHL Group AB (Sweden), Schott Pharmaceutical Packaging (Mainz, Germany), Amgen Inc (Thousand Oaks, CA USA), Gerresheimer Bünde GmbH (Bünde, Germany) and Evotec Biosystems AG (Hamburg, Germany). He is a frequent speaker, moderator and chairperson on global events featuring science, technology, innovation and application in parenteral drug development and drug delivery.
  • Head of Prescription Business / Sandoz
    Frank hold a Master in Management and Marketing from IDRAC Lyon (France). He started his career by creating his start up in IT and after gain experience in international B2B in various industries. Frank joined Novartis group in 2009 as Global Head of Sales Ebewe and moved to Sandoz in 2011 as Head of ComOps Western Europe Oncology Injectables. In 2012 he became Head Hospital Specialty West Europe & MEA and also Head of Leading Africa Project before taking on the role of Head Prescription and Specialties Western Europe in 2015 and expend his role to Europe in 2018. Frank is an hospital expert and accomplished pharmaceutical executive in different diseases areas and various healthcare systems.He is also chairman of the Hospital Working Group of Medicines for Europe.
  • Director New Business Development CPS / Aperto - An IBM Company
    Christoph Derwort leads the Business Development in Healthcare and Lifesciences for the IBM iX Studio in Berlin. He orchestrates global digital ecosystems, strategies for hcp and customer facing communication and brings lean service creation to life.
  • Creative Director / IBM iX Studio Berlin (Aperto)
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