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Injectable Drug Delivery (Virtual Conference)
12 May - 13 May 2021

Post event on demand access to recorded presentations will be available to all attendees 5 working days from the end date of the event.

Injectable Drug Delivery (Virtual Conference)

SAE Media Group is proud to present the 3rd Annual Injectable Drug Delivery Virtual Conference on 12th and 13th May 2021.


Part of Europe’s leading Injectable conference series, we will assess innovations in drug product formulation and biologics, innovations in device design, quality management and connectivity for enhanced subcutaneous delivery.

With rapid developments in the parenteral space the injectable drug delivery market is set to reach USD 39.8 billion by 2027, with an increased focus on patient centricity during DDC development, innovations in device development, including and new therapeutic applications including the delivery of siRNA - this year’s event will focus on advances in drug product formulation and innovations of device design and development to aid delivery. 

Furthermore, this year’s event will assess the evolving regulatory environment of injectable drug delivery with industry and regulatory representatives presenting updates on current guidelines.

This two-day agenda offers you peer-to-peer networking with Global Product Managers, Device Testing Managers, Senior Device Engineers, Heads of Device Development, Heads of Formulation and Drug Process Development, and many more.
 


 

FEATURED SPEAKERS

Alexander Zuern

Alexander Zuern

Device Testing Manager, Novartis
Bjorg K Hunter

Bjorg K Hunter

RA NextGen Drug-Device Department Manager, Novo Nordisk
Blake Green

Blake Green

Senior Manager Regulatory Affairs, Amgen
Christian Dechant

Christian Dechant

Director Primary Packaging & Process Development, Boehringer Ingelheim GmbH & Co. KG
Cinzia Rotella

Cinzia Rotella

Senior Materials Scientist, Sanofi
Erik Schwartz

Erik Schwartz

Product Developer, Sabic SHPP
Joel Richard

Joel Richard

Chief Development Officer, MedinCell
Jonathan Sutch

Jonathan Sutch

Medicinal Specialist, BSI Group
Kimberley Alexander

Kimberley Alexander

Principal Associate , Core Human Factors
Mark Palmer

Mark Palmer

Scientific Leader, Biopharm Device Engineering, GSK
Paul Greenhalgh

Paul Greenhalgh

Director of Design, Team Consulting
Rupal Nguyen

Rupal Nguyen

Consultant, R&D - Device and Combination Products, Allergan
Stefano Martini

Stefano Martini

Responsible for Special Programs, Medical Devices Development, Sanofi
Steve Beighley

Steve Beighley

Senior Associate, Core Human Factors
Tina Arien

Tina Arien

Principal Scientist, Janssen Pharmaceutica
Vikas Jaitely

Vikas Jaitely

Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck

Alexander Zuern

Device Testing Manager, Novartis
Alexander Zuern

Alexander Zürn is a pharmacist by training. He got a PhD in Pharmacology from the University of Würzburg, Germany and did a postdoc at the University of California Berkeley at the department of bioengineering. From there he joined Novartis in 2012 as a process expert. From the production he join the QC Department of Novartis Stein and was until 2017 a QC team leader and SPOC for the injectable device testing at the release site.
Since 2017 he has been in the Device Development and Commercialization (DD&C) department at Novartis Basel as a device testing manager and is the Analytics and Testing Network leader.
 

Amanda Matthews

Senior Director, Pfizer UK Limited
Amanda Matthews

Bjorg K Hunter

RA NextGen Drug-Device Department Manager, Novo Nordisk
Bjorg K Hunter

Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark. Bjorg started her career at GSK in 2010 and has held different roles within the Device development field primarily in the late stage parenteral area. She has held positions with increased resistibility stating as device lead for key GSK parenteral devices and progressing into leading a device management team, where she has had the accountability of project management and regulatory compliance for parenteral devices. Later Bjorg moved into a key management role in CMC regulatory where she was responsible for the global regulatory and advocacy strategy for GSK’s portfolio of devices across modalities and lifecycle. In May 2020 Bjorg took up a new position in NovoNordisk where she lead the NexGen Drug-Device RA department within RA CMC and Devices where she has RA accountability for both early and late stage drug-device combination products.

Blake Green

Senior Manager Regulatory Affairs, Amgen
Blake Green

Blake Green is a Regulatory Affairs Senior Manager with Amgen’s Global Medical Devices Regulatory team. Based in Cambridge UK. Blake is a Devices Regulatory lead for medicinal product/medical device combination products and co-packaged medical devices in the biopharmaceutical sector. Prior to joining Amgen, Blake had significant international experience securing multi-national market clearance for manufacturers of medical devices, medical device/medicinal product combinations, medical software, personal protective equipment, and biocides, located throughout the United States of America, European Union, North Africa, Middle East, Far East, Turkey, Israel, Australia, Canada, and Peoples Republic of China.

Christian Dechant

Director Primary Packaging & Process Development, Boehringer Ingelheim GmbH & Co. KG
Christian Dechant

Christian Dechant
Director Primary Packaging Development Biologicals
Pharmaceutical Development Biologicals
Boehringer Ingelheim Pharma GmbH&Co. KG


Christian Dechant brings more than 19 years experience in various roles to the primary packaging development at Boehringer Ingelheim.
At BI microParts GmbH he started working in research & development of microfluidic systems and was later responsible for the implementation and running of clinical trial manufacturing for Devices (e.g. Respimat)
In 2010 he starts working at Boehringer Ingelheim as a primary packaging engineer with focus on liquid formulations for parenteral and oral solutions. Since 2014 he is responsible for the primary packaging development group for parenteral solution within Pharmaceutical Development Biologicals. He established the primary packaging development group with focus on NCE and NBE development. In this role he is responsible for the selection of suitable container closure systems to ensure the stability of the formulation and the functionality within a combination product like an autoinjector.
Christian Dechant holds a Diploma degree in industrial engineering from the University of Applied Sciences of Bochum, Germany.
 

Cinzia Rotella

Senior Materials Scientist, Sanofi
Cinzia Rotella

I am in charge of the Material Lab. and of developing new methods to characterize materials. I am also responsible of projects related to rubber tribology and to the mechanical properties of glass primary containers.

I joined Sanofi in 2016

Before then
2012-2015 – Postdoctoral fellow at ESPCI Paris –Rheology of innovative polymer materials

2007-2011 – PhD in Physics at KULeuven – Glass transition of confined polymers probed by spectroscopy

2006 – Master in Materials Science, UNIPI – Polymer science
 

Erik Schwartz

Product Developer, Sabic SHPP
Erik Schwartz

Erik Schwartz is Lead Scientist at SABIC. He obtained his PhD in Polymer Science from the University of Nijmegen in 2010 working on the synthesis and characterization of helical polymers. Before taking up a position in SABIC he spent two years at the Scripps Research Institute in La Jolla, California and two years at Eindhoven University of Technology as a postdoctoral fellow. He has co-authored >30 peer-reviewed research papers; >15 patent applications and a book chapter. Erik joined SABIC as a product developer in 2014, leading projects focused on divers subjects throughout the years including delivering more sustainable solutions.

Joel Richard

Chief Development Officer, MedinCell
Joel Richard

Dr Joël Richard is currently Executive Committee Member and Head of Technical & Pharmaceutical Operations at MedinCell (Montpellier, France). He is leading all the development activities of the company, based on the proprietary technology BEPO® for Long-Acting Injectables. (LAIs). These activities comprise formulation and process development, device development, analytical development, process transfer and scale-up, manufacturing and supply of clinical batches, regulatory affairs and clinical development operations, quality and regulatory compliance. Dr Richard has more than 30 years of experience in chemistry and (bio)pharmaceutical R&D, including several global senior leadership positions in various Biotech and Pharma companies, such as Ipsen (France), Serono (Italy), MerckSerono (Germany), Ethypharm (France). Dr Richard has focused his research activity on new formulation technologies and innovative drug delivery systems (microspheres, nanosystems, self-assembling gels), especially for injectable peptide and protein formulations. He has graduated from Ecole Normale Supérieure (Cachan, France), and got a PhD in Materials Science (Paris VI, France), and the “Habilitation à Diriger les Recherches” in Chemistry (Bordeaux I, France). He has published 69 peer-reviewed scientific papers, 8 book chapters and 2 review editorials in various fields. He is the author of 140 international communications and 55 patent families. He has also been serving as an APGI Board Member for 3 years and is a Member of the Controlled Release Society (CRS).

Jonathan Sutch

Medicinal Specialist, BSI Group
Jonathan Sutch

Dr Jonathan Sutch is a medicinal specialist at the Notified Body BSI Group, working with medical devices containing medicinal substances and drug/device combinations. Jon trained as a Pharmacist at the London School of Pharmacy prior to completing a PhD in Pharmaceutical Sciences at Nottingham University. He has 15 years of experience in the pharmaceutical industry as a formulation scientist and manager before moving to BSI 2 years ago.

Kimberley Alexander

Principal Associate , Core Human Factors
Kimberley Alexander

Mark Palmer

Scientific Leader, Biopharm Device Engineering, GSK
Mark Palmer

Dr. Mark Palmer is currently a member of the Device Engineering group at GlaxoSmithKline and has worked on a variety of inhaled, intranasal, ophthalmic and parenteral drug delivery devices. Dr Palmer holds PhD from Cranfield University, an MSc in Engineering Design and a BSc in Physics.

Paul Greenhalgh

Director of Design, Team Consulting
Paul Greenhalgh

Paul leads Design and Innovation at Team, (based in Cambridge UK). Working closely with clients and colleagues to improve the user experience of medical devices, through carefully crafted industrial design, digital UI/UX, packaging and information design solutions.
With over 20 years’ experience helping companies bring innovative, user centred products into reality, Paul focuses on helping clients at the front end of development, to set the right direction and ensure user, commercial and technical needs are thoroughly understood.
His recent involvement in a number of early stage device programmes has reinforced Paul’s belief that the adoption of design thinking not only results in great products but helps to overcome many of the challenges that project teams face during the early stages of development.
 

Rupal Nguyen

Consultant, R&D - Device and Combination Products, Allergan
Rupal Nguyen

Rupal Nguyen is a Mechanical Engineer in the R&D Department of medical device & Pharma Industries. Currently, she works at Allergan as a consultant and responsible for developing medical devices and combination products. She holds Ph.D. and master’s degree in applied mathematics and mechanical engineering respectively. She also holds executive MBA certification from UCI, California. She has 17+ years of experience in Medical device industries. Her areas of expertise are advanced R&D - to convert concept into functional prototypes, in-vivo and in-vitro testing, Design Controls and Human Factors Engineering. For over 8 years, she has worked primarily in advanced R&D of neuro and peripheral implantable medical devices and combination products portfolio. She holds multiple patents related to implantable medical devices and delivery systems.

Stefano Martini

Responsible for Special Programs, Medical Devices Development, Sanofi
Stefano Martini

I joined Sanofi France, on June 2016 in Medical Devices Development – Primary Component (PCD) initially as Responsible of External Projects (June 2016-March 2018), then as Head of Operations of PC Early Stage and Platform Development (April 2018-June 2020) and since then as Responsible of Special Programs.

Over the last 30+ years I have gained a huge knowledge about PC development, working from 2013 to 2016 as Responsible of the Primary Component Forensic Characterisation laboratory at Amgen LTD in Ireland - Dublin and before then, for 20+ years, at Stevanato Group in several managerial position in both operations and process development for ampoules, vials and PFS.

I hold a BSc in Pharmaceutical Technologies from TU Dublin and a Lean Six Sigma Black Belt certification from Festo Italy.

Steve Beighley

Senior Associate, Core Human Factors
Steve Beighley

Tina Arien

Principal Scientist, Janssen Pharmaceutica
Tina Arien

Albertina Ariën, works since 1998 at Janssen Pharmaceutica in Belgium where she held various positions in the Pharmaceutical Sciences and Drug Product Development (DPD) organization. Currently she works as a principal scientist in the Parenterals and Liquids group of DPD and is expert in the development of complex injectable formulations and pediatric dosage forms. Dr Ariën holds a degree in biochemical engineering from Katholieke Hogeschool Limburg, Belgium and a PhD in Biomedical Sciences from the University of Bordeaux, France. She spent 2 years as a post-doc at the University of Nottingham, UK where she did research on polymeric nanotechnology.

Vikas Jaitely

Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck
Vikas Jaitely

Wendy Woodley

Staff Scientist, BD Technologies and Innovation
Wendy Woodley

Wendy Woodley is a Staff Scientist for the Translational and Clinical Sciences Center of Excellence at BD Technologies and Innovation (BDTI). She is a published author and inventor with 21 years of R&D and Product Development experience in the medical device industry with a focus on innovation in drug delivery devices and diagnostics. She received multiple degrees (BS microbiology, BS zoology, BA English, BA history) from North Carolina State University. Her current work at BDTI focuses on drug delivery innovations with a concentration in preclinical model development, clinical testing and translation of new ideas to product development.

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Conference agenda

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13:00

Registration & Coffee

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13:30

Apps for Humans – Part 1

  • Introduction: designing systems that mimic human relationships
  • An HF perspective on App development strategy and planning
     
  • Julian Dixon

    Julian Dixon, Director of Human Factors, Team Consulting

    Ben Cox

    Ben Cox, Head of Digital Design, Team Consulting Ltd

    Chris Davies

    Chris Davies, UX Designer, Team Consulting Limited

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    14:10

    App Prototyping

  • Getting real, real early in prototypes
  • Hands on session with App prototyping tools - first steps in designing and prototyping your App
     
  • Julian Dixon

    Julian Dixon, Director of Human Factors, Team Consulting

    Ben Cox

    Ben Cox, Head of Digital Design, Team Consulting Ltd

    Chris Davies

    Chris Davies, UX Designer, Team Consulting Limited

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    14:50

    Afternoon Tea

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    15:20

    App Testing

  • Getting real, real early in user research
  • The strength of the observational simulated-use study
  • Hands on session - first steps in testing your App with users
     
  • Julian Dixon

    Julian Dixon, Director of Human Factors, Team Consulting

    Ben Cox

    Ben Cox, Head of Digital Design, Team Consulting Ltd

    Chris Davies

    Chris Davies, UX Designer, Team Consulting Limited

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    16:00

    Apps for Humans - Part 2

  • Your App story: narrative and character
  • The importance of thinking like a writer
  • Julian Dixon

    Julian Dixon, Director of Human Factors, Team Consulting

    Ben Cox

    Ben Cox, Head of Digital Design, Team Consulting Ltd

    Chris Davies

    Chris Davies, UX Designer, Team Consulting Limited

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    16:40

    Chairs’ Closing Remarks and Close of Workshop

    Julian Dixon

    Julian Dixon, Director of Human Factors, Team Consulting

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Alexander Zuern, Device Testing Manager, Novartis

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    9:10

    Notified Bodies and Article 117

    Jonathan Sutch, Medicinal Specialist, BSI Group

  • Notified Bodies and Drug Device Combinations
  • BSI’s experience with Article 117 applications
  • Documentation from the manufacturer
  • Notified Body Opinion Report
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    9:50

    Beyond Article 117

    Blake Green, Senior Manager Regulatory Affairs, Amgen

  • Perspective: Annex I to Directive 2001/83/EC, point 12 of Section 3.2
  • Is the bar higher for Notified Body Opinions?
  • Co-packaging implications for Importers and Distributors
  • Co-packaging implications for the MAH
  • Clinical evaluation of prefilled devices
     
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    10:30

    Morning Coffee

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    11:00

    Advanced modalities and formulation in the injectable space

    Tina Arien, Principal Scientist, Janssen Pharmaceutica

  • An overview of the current requirements effecting injectable drug product formulation
  • Challenges in high viscosity and high concentration formulation for injectables
  • Advances for injectable delivery >2ml and industry considerations
  • Challenges in development of injectable oligonucleotide therapies
     
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    11:40

    Opportunities and challenges in delivering strategic platforms for injectable drug products

    Stefano Martini, Responsible for Special Programs, Medical Devices Development, Sanofi

  • Platform approach in designing and developing DDCS
  • Purchasing control and supplier relationship considerations for a successful platform approach 
  • Challenges and Opportunities in developing injectable platforms for novel drug products
  • Case studies leveraging platforms for parenteral drugs
  • What an enhanced supplier relationship and purchasing control can result in a win-win project
     

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    12:20

    Networking Lunch

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    13:20

    A study to investigate an acceptable flow rate for large volume subcutaneous injections in healthy volunteers

    Mark Palmer, Scientific Leader, Biopharm Device Engineering, GSK

  • Autoinjectors are commonly used for subcutaneous delivery of volumes of up to 1ml in around 10s while larger volumes may be delivered by wearable devices over tens of minutes
  • In this study we targeted subcutaneous delivery of up to 5ml of saline in 3 to 1.2 minutes
  • Acceptability was assessed by questionnaire and by Visual Analog Scale (VAS) pain scores
     
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    14:00

    MRI Clinical Imaging of Human Subcutaneous Injections up to 10ml in the Abdomen, Thigh and Arm

    Wendy Woodley, Staff Scientist, BD Technologies and Innovation

  • Discussion of a clinical pilot study exploring the application of Magnetic Resonance Imaging (MRI) to visualize and reconstruct 2, 5, and 10 mL subcutaneous (SC) depots
  • Visualize how MRI displays SC deposition and quantifies corresponding tissue expansion
  • Consider 3D reconstructions of in situ depot renderings and the insights gained on large volume SC depot shape and location
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    14:40

    Afternoon Tea

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    15:10

    Challenges for development of long acting injectables: focus on formulations of fragile molecules

    Joel Richard, Chief Development Officer, MedinCell

  • Successful technologies for long acting injectables and their limitations
  • Competitive advantages of injectable in situ forming implant technologies
  • Specific formulation challenges for fragile molecules (peptides and proteins)
  • Recent progress from BEPO® long acting injectable formulation development
     
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    15:50

    Designing Instructions for Use (IFU) guided by human factors

  • Human Factors principals of IFU design
  • FDA guidance on IFU design
  • Real-world IFU examples, including FDA feedback received on IFUs
  • Kimberley Alexander

    Kimberley Alexander, Principal Associate , Core Human Factors

    Steve Beighley

    Steve Beighley, Senior Associate, Core Human Factors

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    16:30

    Chair’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Alexander Zuern, Device Testing Manager, Novartis

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    9:10

    An industry Outlook: latest regulatory challenges in Pre-filled syringe innovation

    Bjorg K Hunter, RA NextGen Drug-Device Department Manager, Novo Nordisk

  • Submission of medicines including a device component in the EU post May 2020 are changing in accordance with EU MDR Art 117 and EU draft guidelines on quality aspects of a drug-device combination
  • Overview of what the changes means for pharma companies in ways of working
  • Areas of uncertainty which comes with these new ways of working
  • Examples of how the new requirements can be implemented
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    9:50

    Regulatory requirements for – Medicinal product incorporating a drug delivery device component in context with EU MDR

    Vikas Jaitely

    Vikas Jaitely , Director, Global Regulatory Affairs Transitional Medicine and Devices, Merck

  • Integral delivery systems for injectable drugs and what changes in context with EU MDR
  • Regulatory requirements to support registration of single integral medicinal product containing a drug delivery device component
  • How an end-to-end approach to drug product control, acceptable PQS and an appropriate risk profile can minimize the need for wholly on end product testing
  • Connected Health technologies in delivery of injectable drugs – future outlook
     
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    10:30

    Morning Coffee

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    11:00

    Regulatory updates regarding the EU MDR and the importance of life cycle management

    Amanda Matthews

    Amanda Matthews, Senior Director, Pfizer UK Limited

  • A review of current challenges in the regulatory landscape for medical devices and combination products
  • Adapting to the new EU requirements regarding Article 117 from an industry perspective
  • The relevance of post marketing changes – what sort of changes might trigger the need for a Notified Body Opinion?
  •  

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    11:40

    LNP™ material solutions addressing the needs for the circular economy in the medical industry

    Erik Schwartz, Product Developer, Sabic SHPP

  • Circular economy arguments and why should it matter to us
  • Sustainable solutions offer for the medical industry
  • PC copolymer to fulfil the need for improved chemical resistance
  • Improved lifetime, patient comfort and easy-to-use lubricated compounds 
  •  

     

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    12:20

    Networking Lunch

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    13:20

    Silicone Oil free pre-filled syringes (PFS) - Part of the future?

    Christian Dechant, Director Primary Packaging & Process Development, Boehringer Ingelheim GmbH & Co. KG

  • Advantages of silicone oil free prefilled syringes
  • Points that have to be considered in drug development from the beginning, e.g. compatibility of formulation and primary packaging materials
  • Overview of potential new technologies to select a silicone oil free prefilled syringe system 
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    14:00

    Click sound characterization of autoinjectors

    Alexander Zuern, Device Testing Manager, Novartis

  • Different devices were characterized on the frequencies and loudness of click sounds
  • A correlation between the click sounds and other parameters such as activation force were made
  • Homogeneity of click sounds were characterized
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    14:40

    Afternoon Tea

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    15:10

    Friction and Fracture: how science can improve patients' quality life

    Cinzia Rotella, Senior Materials Scientist, Sanofi

  • Identify areas where scientific gaps prevents sound design engineering of DDC
  • Case studies on using fundamental science to:
  • Rigorously define system requirements
  • Determine the appropriate control plans for robust manufacturing of DDC (PFS, Autoinjector, pen, …)
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    15:50

    To connect or not to connect: When should a parenteral device go connected?

    Paul Greenhalgh, Director of Design, Team Consulting

  • What is the problem you are trying to solve?
  • What does adding sensing really mean?
  • Don’t ignore the human factor!
     
  • clock

    16:30

    Chairman’s Closing Remarks and Close of Day Two


    Device Testing Manager
    Novartis
    Senior Director
    Pfizer UK Limited
    RA NextGen Drug-Device Department Manager
    Novo Nordisk
    Senior Manager Regulatory Affairs
    Amgen
    Director Primary Packaging & Process Development
    Boehringer Ingelheim GmbH & Co. KG
    Senior Materials Scientist
    Sanofi
    Product Developer
    Sabic SHPP
    Chief Development Officer
    MedinCell
    Medicinal Specialist
    BSI Group
    Principal Associate
    Core Human Factors
    Scientific Leader, Biopharm Device Engineering
    GSK
    Director of Design
    Team Consulting
    Consultant, R&D - Device and Combination Products
    Allergan
    Responsible for Special Programs, Medical Devices Development
    Sanofi
    Senior Associate
    Core Human Factors
    Principal Scientist
    Janssen Pharmaceutica
    Director, Global Regulatory Affairs Transitional Medicine and Devices
    Merck
    Staff Scientist
    BD Technologies and Innovation

    Sponsors

    Exhibitors

    Official Media Partner

    Key Media Partners

    Supporters

    Speaker interview with Wendy Woodley, BD Technologies and Innovation

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    Speaker interview with Christian Dechant, Boehringer Ingelheim

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    Preliminary Attendees List 2021

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    Speaker interview with Alexander Zuern, Novartis

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    Speaker Biographies 2021

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    Pre-Conference Interactive Workshop by Team Consulting

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    Brochure 2021

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    Full Programme 2021

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    Short Programme 2021

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    Speaker interview with Joel Richard, MedinCell

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    Paul Greenhalgh, Director of Design, Team Consulting

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    Speaker Interview - Julian Dixon, Team Consulting

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    Speaker Interview - Ben Cox, Team Consulting

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    Past Attendees

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    Presentation by Tom Fussey, Cambridge Design Partnership

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    Presentation by Stephen Paboojian, Novartis

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    Presentation by Sigrid Van Dyck, Janssen

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    Presentation by Quentin Le Masne, Merck

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    Presentation by Miranda Newberry and Louisa Harvey, MHFN

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    Presentation by Mark Hassett, Credence Medsystems

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    Presentation by Joel Richard, MedinCell

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    Presentation by Edward Sims, Crux Product Design

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    Presentation by Adeline Meilhoc, Eveon

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    Sponsors


    BD Medical - Pharmaceutical Systems

    Sponsors
    https://drugdeliverysystems.bd.com/

    As a partner of choice for the pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of ready-to-use drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems, self-injection systems and connected solutions that help ensure smooth delivery, regardless of drug complexity, viscosity and dosing volume.

    With an unbending emphasis on innovation and a high level of technical expertise, BD Medical - Pharmaceutical Systems provides pharmaceutical and biotechnology companies with support and resources to help them achieve their goals. We support their product launch and life cycle management through sophisticated consultative, analytical and clinical services to help ensure drug compatibility and seamless systems integration, while accelerating time-to-market and reducing risk.

    More information available @ drugdeliverysystems.bd.com


    Exhibitors


    Owen Mumford

    Exhibitors
    http://www.ompharmaservices.com

    Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.

    Media Partners


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.


    Pharma Journalist

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    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.

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    International Pharmaceutical Industry (IPI)

    Key Media Partners
    http://ipimediaworld.com/

    IPI – International Pharmaceutical Industry IPI – was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally. Edited by our carefully selected editorial advisory panel, and extensive research network, IPI provides a proven supportive means of communication to the pharmaceutical, bio pharmaceutical, nutraceutical and medical devices industry the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies which will enable them to be more efficient, bring products to market faster, reduce cost and make healthcare accessible to all.


    Pharmaceutical Technology

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    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


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    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    World Pharma News

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    pharmaphorum

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    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com

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    Farmavita

    Supporters
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    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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