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

A Roadmap to Regulation Quality Management Systems and Technical Standards:

The current regulatory environment for medical devices and combination products is sparking a significant shift in key device development processes in the industry. With the implementation of new regulatory requirements and standards such as the EU MDR, Article 117, post marketing safety reports, the ISO change management standard and the revision to ISO 14971, it is increasingly important for companies to prepare for this paradigm shift. Further challenges arise when developing products for international markets, requiring the need to align practices to the various local regulations. This workshop will aim to provide regulatory considerations to navigate and prepare for implementing the upcoming changes in the management systems and technical standards for the medical device and combination product development.

Testing requirements of Pre-Filled Syringes

The Workshop will describe the regulatory testing requirements of pre-filled syringes. It will give an overview of materials used for PFS as well as the need for testing throughout the different stages of a PFS.
 

Extractables and Leachables: Considerations for PFS Platforms

When developing a successful combination product, the examination of risk of extractable and leachable contamination and container interaction is key to ensuring correct and safe drug delivery. The topic of extractables and leachables is a key consideration in many fields of pharmaceuticals. This workshop will focus on the challenges and regulations within combination products and pre-filled syringes, discussing how we can improve as an industry to provide a comprehensive roadmap for successful and effective testing.

 

 

A Roadmap to Regulation Quality Management Systems and Technical Standards:

  • Staying on top of new requirements and understanding any impact to your company’s portfolio is key to ensuring efficient product approvals and compliance is maintained
  • Understand some of the key changes in regulatory requirements particularly for combinations products with the MDR/Article 117
  • Understand the relationship between some of those key changes and requirements and how to prepare to implement them
  • Hear how to utilize ISO 20069 effectively, for assessing your changes to a device that delivers a medicinal product

 

Testing requirements of Pre-Filled Syringes:

  • Understanding syringe components and technical requirements of material selections
  • Get a better understanding of syringe testing requirements related to ISO standards
  • Understand test methods and interpretation of test results

 

Extractables and Leachables: Considerations for PFS Platforms:

  • Learn from industry leaders about practices for extractables and leachables
  • Explore real world examples through PFS case studies
  • Discuss key considerations for drug compatibility and predictive tools
  • Assess the regulatory guidance for E&L documentation and safety assessments for leachables

 

• 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 A Roadmap to Regulation Quality Management Systems and Technical Standards

9:00 A review and discussion of the regulatory landscape challenges

Amanda Matthews

Amanda Matthews, Senior Director, Pfizer UK Limited
View Bio

  • Highlights of the key regulatory changes
  • New challenges for combination products and Article 117
  • What are the main questions or concerns from Industry
     
  • 9:35 Understanding how to align practices to new changes in regulations

    Amanda Matthews

    Amanda Matthews, Senior Director, Pfizer UK Limited
    View Bio

  • Look at one company approach to a new requirement / regulation and planning for change through a case-study
  • 10:10 Morning Coffee

    10:30 Assessing current practicse and exploring how to prepare for the unknown

    Amanda Matthews

    Amanda Matthews, Senior Director, Pfizer UK Limited
    View Bio

  • Gap analysis is ‘key’ to path forward
  • Understanding the changes in international markets
  • 11:05 Products currently on the market - what will need to be changed to align to new regulations?

    Amanda Matthews

    Amanda Matthews, Senior Director, Pfizer UK Limited
    View Bio

  • Considerations for medical devices
  • Considerations for combination products
     
  • 11:40 Session Recap

    12:00 Networking Lunch

    12:55 Testing requirements of Pre-Filled Syringes

    13:00 Syringe Systems & Materials

  • Glass / Plastic Materials
  • Glass / Plastic Syringe Manufacturing Processes
  • Advantages & Disadvantage of Syringe Materials
     
  • Horst Koller

    Horst Koller, CEO, HK Packaging Consulting GmbH
    View Bio

    13:35 Luer Compliance Requirements

  • ISO 80369-7 Dimensional Requirements
  • ISO 803697 - 20 Testing Requirements
  • Relation to ISO I 1040-4 /-6 (Glass / Plastic Syringes)
  • Horst Koller

    Horst Koller, CEO, HK Packaging Consulting GmbH
    View Bio

    14:10 Empty preassembled PFS

  • ISO I1040-4 / -6 Testing Requirements
  • Test Method Descriptions / Explanations
     
  • Horst Koller

    Horst Koller, CEO, HK Packaging Consulting GmbH
    View Bio

    14:45 Final filled PFS

  • ISO 11040-8 Testing Requirements
  • Device implementation
     
  • Horst Koller

    Horst Koller, CEO, HK Packaging Consulting GmbH
    View Bio

    15:20 Session Recap

    Horst Koller

    Horst Koller, CEO, HK Packaging Consulting GmbH
    View Bio

    15:30 Afternoon Tea

    15:55 Extractables and Leachables: Considerations for PFS Platforms

    16:00 Key considerations for material selection and overview of current testing practices

    Carsten Worsoe

    Carsten Worsoe, Principal Scientist, Novo Nordisk
    View Bio

  • Choice of critical components for drug compatibility in PFS
  • Predictive tools for interactions in PFS
  • Relationship between extractables, simulated leachables and leachables in PFS
  • Study designs for E&L documentation in PFS
     
  • 17:10 An interactive look at a PFS case study

    Carsten Worsoe

    Carsten Worsoe, Principal Scientist, Novo Nordisk
    View Bio

  • Case studies on extractables and leachables studies in PFS
  • Documentation level for leachables within registration applications containing combination of PFS and drug product
  • 17:45 How can we improve current processes to prevent unwanted container interactions

  • Safety risk assessments of extractables and leachables in PFS
  • The relationship between ICH Guidelines for impurities (Q3 & M7) and extractable & leachable thresholds
  • Raphael  Nudelman

    Raphael Nudelman, Director of Chemical and Computational Toxicology, Teva Pharmaceuticals Industries
    View Bio

    Carsten Worsoe

    Carsten Worsoe, Principal Scientist, Novo Nordisk
    View Bio

    18:20 Closing Remarks

    Carsten Worsoe

    Carsten Worsoe, Principal Scientist, Novo Nordisk
    View Bio

    Raphael  Nudelman

    Raphael Nudelman, Director of Chemical and Computational Toxicology, Teva Pharmaceuticals Industries
    View Bio

    +

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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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