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SMi Group is proud to present the Pre-Filled Syringes and Injectable Drug Devices Workshop Day...

Combination Product Development – a roadmap for success

As more and more drug products are being developed as combination products, device development plays a critical role. To successfully develop a combination product, it requires collaboration and consideration from multiple angles.

In this workshop we will dive into each of these factors from primary container and device selection to manufacturing considerations and ways to platform and streamline development activities without running into regulatory risks. Some of the areas we will explore include
- Drug product and primary container interaction and impact on device selection and development
- How to select the right device and utilizing design control and strategic approaches to minimize development risks and timeline.
- Design verification, biocompatibility, extractable and leachables
- Packaging and manufacturing consideration.
- Stability and controls strategy
 

 

Drug Delivery Device Testing Solutions

 In the drug delivery device, testing world, the regulatory requirements add complexity to the simplest of test. What occurs when the testing moves from the simple to multifaceted is an exponential amount of effort to meet industry demands. Finding the best partner starts with a full understanding of your internal and external requirements. Uncovering the unknowns is an arduous task but a crucial one to your success.

 

 

How to pass a Human Factors Validation study

 Hear expert opinions on how to structure a human factors program from product conceptualization and early design through risk analysis development and iterative usability testing in order to pass a human factors validation study on the first attempt.

 

Combination Product Development – a roadmap for success

  • Learn about interlinked relationship between drug product, primary container, device, and packaging.
  • Consideration and ways to minimize device development risks
  • Dive into design verification, biocompatibility, E&L, and control strategies
  • Role packaging play in successful combination product
  • Process development and consideration

 

Drug Delivery Device Testing Solutions

  • Understand the importance of User Requirements Specification and functional design specification
  • Discuss Prefilled Syringes testing and spring simulation
  • Explore auto injector and pen injector testing methods - wearable device testing
  • Learn about the regulatory  demands for device testing

 

How to pass a Human Factors Validation study

  • Learn how to build and optimize your company’s human factors and usability engineering process and how that can be applied to every development project in order to reduce development delays and improve the chances of first-time success
  • Discuss the regulatory imperative of HFE, and the focus on use-related harm, as well as other uses of HFE
  • Discuss how HFE as an R&D activity, not a documentation activity
  • Discuss development and testing of instructions for use (IFU)
  • Discuss how to scale HFE programs and how programs vary from product to product
     

 

 • Drug-delivery developers
• Medical Device Engineers
• Primary Packaging material designers
• Secondary packagers
• Smart device developers
• Training device developers
• Device-safety solution providers
• Drug developers
• Previous attendees include:


 

 

 3P Innovation Ltd; Accord Healthcare; Advio Associates; ANTEV Limited; Aspen Pharmacare; AstraZeneca; Barts Health NHS Trust; Barts Health Pharmaceutics; Bayer AG; BD; BD Medical - Pharmaceutical Systems; Biocompatibles Uk Ltd; Biogen Idec; Boehringer Ingelheim Pharma GmbH & Co. KG; Clexio Biosciences; Datwyler Pharma Packaging International NV; Eveon; FRUH VERPACKUNGSTECHNIK AG; GlaxoSmithKline; GSK; GSK R&D; Harro Hofliger Packaging Systems Ltd; Harro Hofliger Verpackungsmaschinen GmbH; Harrow Hofiger; Horizon Pharma; Industrias Farmaceuticas Almirall S.L; LGC; marketing; MedImmune; Merck; MHRA; Mikron S A Boudry; Mikron SA Boudry; MITSUBISHI GAS CHEMICAL COMPANY, INC; Mitsui Chemicals GmbH; Mitsui Chemicals, Inc.; Nelson Labs NV; Nemera; Nipro Europe NV; Novartis; Novartis A G; Novartis International AG; Novo Nordisk A/S; Owen Mumford; Owen Mumford Ltd; Panasonic Healthcare Co., Ltd.; ProQR Therapeutics; Richter Gedeon Plc; Roche; Roche Holding; Roechling; Safepoint; Sanofi; SCHOTT Pharmceutical Systems; SCHOTT Schweiz AG; Sio2 Medical Products; Swiss Fillow AU; Terumo Europe; Terumo Europe NV; Teva Pharmaceuticals; Teva Pharmaceuticals USA; Ultrapolymers; Vetter Pharma International GmbH; Vetter Pharma-Fertigung GmbH & Co. KG; W.L. Gore & Associates, Inc.; Zeon Europe GmbH; ZwickRoell Ltd;

 

Workshop programme

8:30 Registration & Coffee

8:55 Combination Product Development – a roadmap for success

9:00 Session 1

Michael Song

Michael Song, Sr. Manager, AstraZeneca
View Bio

• Primary Containers Components
• Drug Product and Primary Container interaction and considerations
• Extractable and Leachables
 

9:35 Session 2

Michael Song

Michael Song, Sr. Manager, AstraZeneca
View Bio

• Device selection and characterization
• Considerations from process, manufacturing, packaging, and usability standpoint
• Key drivers for success and novel devices
 

10:10 Morning Coffee

10:30 Session 3

Michael Song

Michael Song, Sr. Manager, AstraZeneca
View Bio

• Process and manufacturing overview considerations (clinical, commercial, and automation)
• Packaging considerations and risk reduction
• Risk Assessment, Controls strategy and DV testing
 

11:05 Session 4

Michael Song

Michael Song, Sr. Manager, AstraZeneca
View Bio

• Design Verification and Validation
• Stability approaches
• Future trends, digital health, wearables, and novel technology

11:45 Session Recap

Michael Song

Michael Song, Sr. Manager, AstraZeneca
View Bio

12:00 Networking Lunch

12:55 Drug Delivery Device Testing Solutions

13:00 Drug Delivery Device Testing Overview

Michael Goehring

Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell
View Bio

• Importance of a URS (User Requirements Specification
• Functional Design Specification
 

13:35 (Prefilled) Syringe Testing and Spring Simulation (power pack)

Michael Goehring

Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell
View Bio

• Glide Force New ISO 7886-1
• ISO 11040-4, -6, -8
• ISO 80369-7, -20
 

14:10 Auto Injector and Pen Injector Testing – Wearable Device Testing

Michael Goehring

Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell
View Bio

• ISO 11608-1 (Pen), ISO 11608-2 (Needle), ISO 11608-3 (Cartridge)
• ISO 11608-2 (Needle)
• ISO 11608-3 (Cartridge)
• ISO 11608-5 (Full Function test on Auto Injectors)
• ISO 11608-6 (Wearables)
 

14:45 Device Testing – Regulatory Demands

Michael Goehring

Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell
View Bio

• 21 CFR Part 11 – Traceability (When, Who, What, Why and Who is Responsible)
• DQ, IQ, OQ and why not PQ. MDR Europe
 

15:20 Session Recap

Michael Goehring

Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell
View Bio

15:55 How to pass a Human Factors Validation study

16:00 Scaling HFE - Doing More with Less

  • Regulatory imperative and focus on safety
  • Time and cost tradeoffs in iterative design
  • Can you be a biosimilar or generic?
  • Making changes after a Validation
  • Marc  Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    16:35 Human Factors Protocols that Work

  • Valid assessments of risks
  • Non-biasing study designs and interview techniques
  • Pivoting from a pilot
  • Pre-submission process
     
  • Marc  Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    17:10 Instructions for Use, a Human Factors Perspective

  • Why IFUs should be considered early and often
  • Initial design
  • Iterative development
  • The good, the bad, and the ugly
     
  • Marc  Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    17:45 Case Studies

  • Case study #1
  • Case study #2
  • Case study #3
  • Case study #4

     

  • Marc  Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    18:20 Session Recap

    Marc  Egeth

    Marc Egeth, Senior Director, Core Human Factors, Inc
    View Bio

    Patricia Anderson

    Patricia Anderson, Senior Associate, Core Human Factors, Inc
    View Bio

    +

    FEATURED SPEAKERS

    Marc  Egeth

    Marc Egeth

    Senior Director, Core Human Factors, Inc
    Michael Goehring

    Michael Goehring

    Medical & Pharmaceutical Industry Manager, ZwickRoell
    Michael Song

    Michael Song

    Sr. Manager, AstraZeneca
    Patricia Anderson

    Patricia Anderson

    Senior Associate, Core Human Factors, Inc

    Marc Egeth

    Senior Director, Core Human Factors, Inc
    Marc  Egeth

    Pati and Marc manage all aspects of human factors projects at Core Human Factors. Our experience includes hundreds of different types of medical devices and combination products. We have worked on every phase of HF work, run studies all around the world, and helped dozens of different companies manage their HF programs and navigate regulatory pathways. Part of our work includes IFU design, development and testing.

    Michael Goehring

    Medical & Pharmaceutical Industry Manager, ZwickRoell
    Michael Goehring

    BSEE – Instrumentation and Systems – University of Connecticut
    Field Systems Engineer for materials and component test systems
    Territory Manager for Laboratory Information Management Systems
    District and Regional Sales Manager for materials and component test system
    North America Sales Manager for material preparation and analysis
    Industry Manager – Medical & Pharmaceutical
     

    Michael Song

    Sr. Manager, AstraZeneca
    Michael Song

    Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

    Patricia Anderson

    Senior Associate, Core Human Factors, Inc
    Patricia Anderson

    Pati and Marc manage all aspects of human factors projects at Core Human Factors. Our experience includes hundreds of different types of medical devices and combination products. We have worked on every phase of HF work, run studies all around the world, and helped dozens of different companies manage their HF programs and navigate regulatory pathways. Part of our work includes IFU design, development and testing.

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

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    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    HOTEL BOOKING FORM

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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, SMI 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@smi-online.co.uk

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