Home
overview

For the latest COVID-19 Travel restrictions and recommendations please click here

 

SMi’s 4th Annual Conference
Injectable Drug Delivery
11 - 12 May, 2022 | London, UK
Workshops: 10 May 2022 | London, UK
-------------------------------------------------------------------------
As Part of Europe’s leading Injectable conference series, we will assess innovations in drug product formulation and biologics, new technologies in device design and the use of long-release injectable compounds.


There is a rising demand for vaccines, insulin, and many modern medicines used to treat cancer and other chronic diseases. As biologics are mainly administered through the injectable route, the significant growth in the biologics market is expected to drive the injectable drug delivery and prefilled syringe market in the coming years. The injectable drug delivery market is expected to rise at a compound annual growth rate of 12.9% reaching £915 billion by 2027.

 

The workshop will examine major implementation workstreams for MDR with an emphasis on effective implementation methods. The presenter will explain how early analysis of the text, though difficult is crucial to dealing with change. How to plan in absence of guidance. How identification of significant changes is crucial to planning and prioritization and ultimately how partitioning Article 117 provisions from those implemented for MDR may be beneficial. A discussion of the impact of new economic operator obligations on industry partners with no previous role in the regulated framework. Ambiguities created for distributors of non-integral drug device combinations. The presenter will discuss how to manage multiple implementation projects through to the accreditation process and CE marking.

Any organization with an interest in CE Marking or struggling with implementation for MDR or even IVDR may benefit from the approach described for implementation. The discussion of Article 117 would be of particular interest to any organization which has not yet been in a position to obtain a Notified Body Opinion.

  • 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:

 

Advanz Pharma; Amgen; AstraZeneca; BD - Becton Dickinson; Bd Medical-Pharmaceutical Systems; BD Technologies and Innovation; Becton Dickinson; Boehringer Ingelheim GmbH & Co. KG; Boehringer Ingelheim Pharma GmbH & Co. KG; BSI Group; Chugai Pharmaceutical CO. LTD.; Congenius; Core Human Factors; F Hoffmann -La Roche Inc; GlaxoSmithKline; Glenmark Pharmaceuticals Inc.; GSK; Haselmeierá; Haughton Design Ltd; Ipsen Biopharm Limited; Janssen Pharmaceutica; Janssen Pharmaceutica NV; Legacy Allergan/AbbVie; LEO Pharma A/S; MedinCell; Merck; Merck Connected Health & Devices; MHRA; Micropore Technologies Ltd; Novartis / DD&C; Novartis International AG; Novo Nordisk Pharma; Owen Mumford; Pfizer UK Limited; Raumedic AG; Roche; SABIC; Sabic SHPP; Sandoz – A Novartis Company; Sanofi; Sanofi SWI; Team Consulting; Teva Pharamceuticals; UCB; Vetter Pharma-Fertigung GmbH & Co. KG; Zealand Pharma A/S;
 

Workshop programme

13:00 Registration & Afternoon Coffee

13:30 Opening remarks and instructions

Blake  Green

Blake Green, Senior Manager Regulatory Affairs, Amgen Ltd
View Bio

13:40 Overview of key changes in the EU MDR

Blake  Green

Blake Green, Senior Manager Regulatory Affairs, Amgen Ltd
View Bio

  • Insight into key updates
  • Practical considerations for implementing changes
  • What is the impact of Article 117?
  • Unique device identification (UDI) mechanisms
  • 14:20 Overview of surprisingly difficult implementation challenges

    Blake  Green

    Blake Green, Senior Manager Regulatory Affairs, Amgen Ltd
    View Bio

  • Working ahead of the guidance ?
  • New Economic Operator roles ?
  • EUDAMED registration ?
  • Notified Body intervention for software medical devices
  • 15:00 Afternoon Coffee

    15:30 Afternoon Tea

    Blake  Green

    Blake Green, Senior Manager Regulatory Affairs, Amgen Ltd
    View Bio

  • Classification of devices: analysing the product scope expansion
  • What are the hurdles for manufacturers?
  • Sufficient clinical evidence for EU MDR compliance
  • Reflecting on the 2021 EU MDR update: lessons learnt
  • Roadmap of remaining deadlines and implementation activities
  • 16:10 How can we help each other

    Blake  Green

    Blake Green, Senior Manager Regulatory Affairs, Amgen Ltd
    View Bio

  • What is left to do?
  • What questions remain?
  • What worked and what didn’t?
  • 16:50 Closing Remarks

    Blake  Green

    Blake Green, Senior Manager Regulatory Affairs, Amgen Ltd
    View Bio

    17:00 End of Workshop

    +

    FEATURED SPEAKERS

    Blake  Green

    Blake Green

    Senior Manager Regulatory Affairs, Amgen Ltd

    Blake Green

    Senior Manager Regulatory Affairs, Amgen Ltd
    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.

     

    VENUE

    Venue To Be Confirmed

    London, United Kingdom

    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

    SAVE TO


    Outlook Calendar  OUTLOOK CALENDAR
    Google Calendar  GOOGLE CALENDAR
    ICal Calendar  ICAL CALENDAR
    Yahoo! Calendar  YAHOO! CALENDAR

    Venue To Be Confirmed

    London
    United Kingdom

    Venue To Be Confirmed

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 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.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SMi.
    Full details of our privacy policy can be found here https://www.smi-online.co.uk/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data@smi-online.co.uk.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smi-online.co.uk/opt-out