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SMi is proud to present the 3rd Annual Injectable Drug Delivery Conference in London on 13th and 14th May 2020.


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 902.3 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.
 

We look forward to welcoming you to the conference in May.
 

  • DELVE into the latest work in complex formulation for subcutaneous delivery
  • BENCHMARK against leading pharma companies working to enhance device design and development
  • UNDERSTAND the regulatory environment of the injectables space from leading regulatory and industry advisors
  • ENGAGE in industry case studies on design controls, human factors and parenteral formulation
  • EXPLORE advances in connectivity and human factors key learnings in two pre-conference workshops
     

 

 Executives, Directors, VPs, Heads, Principals, Managers, Scientists, Researchers of:
• Autoinjectors
• Wearables
• Device Engineering
• Human Factors
• CMC
• Injectables
• Sterile Manufacturing
• Packaging
• Regulatory Affairs

Allergan; Almac Group; Bespak Europe Ltdá; Cambridge Design Partnership; Camurus AB; Covestro Deutschland AG; Credence MedSystems, Inc.; Crux Product Design, Ltd; Enable Injections; Eveon; Evonik Corporation; Full Spectrum Innovation Ltd; GlaxoSmithKline Biologicals S.A; GSK; Harvey Medical Consulting Ltd; Human Factors Centre Ltd; Inspired Usability; Janssen Supply Chain, Johnson & Johnson; Luto; MedinCell; Merck Serono S.A.; MHRA; Novartis Pharma AG; Owen Mumford; PA Consulting; Rebus Medical Ltd; SABIC; Sanofi; SMi Group Ltd; Team Medical Devices; TEN; UCB; UCL School of Pharmacy; Ypsomed; Zentiva, k.s.;

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Joel Richard

Joel Richard, Head of Technical & Pharmaceutical Operations, MedinCell
View Bio

9:10 A regulatory outlook of the Drug/Device Combinations (DDC) products space

Stefania  Ragone

Stefania Ragone , Pharmaceutical Assessor, Medicines & Healthcare products Regulatory Agency (MHRA)

  • An overview on the MHRA guidelines for Drug Device Combination products
  • An update on the EU MDR and guidance for industry
  • A future regulatory outlook for the injectable drug delivery space
     
  • 9:50 Beyond Article 117

    Blake Green

    Blake Green, Senior Manager Regulatory Affairs, Amgen
    View Bio

  • 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
     
  • 10:30 Morning Coffee

    11:00 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
     
  • 11:40 Challenges for development of long acting injectables: focus on formulations of fragile molecules

    Joel Richard

    Joel Richard, Head of Technical & Pharmaceutical Operations, MedinCell
    View Bio

  • 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
     
  • 12:20 Networking Lunch

    13:20 Advanced modalities and formulation in the injectable space

    Tina Arien

    Tina Arien, Principal Scientist, Janssen Pharmaceutica
    View Bio

  • 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
     
  • 14:00 A study to investigate an acceptable flow rate for large volume subcutaneous injections in healthy volunteers

    Mark Palmer

    Mark Palmer, Scientific Leader, Biopharm Device Engineering, GSK
    View Bio

  • 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
     
  • 14:40 Afternoon Tea

    15:10 CMC challenges of formulation and drug product development of biologics

    Camille Dagallier

    Camille Dagallier, Formulation and Drug Process Development Senior Scientist, Sanofi

  • Challenges with high concentration, high viscosity and large volume drug products
  • In-use studies for subcutaneous administration
  • Trends to overcome current challenges in injectable biologics space
     
  • 15:50 Evaluation of different pre-filled syringes for biologicals

    Benjamin Werner

    Benjamin Werner, Scientist, Boehringer Ingelheim Pharma GmbH & Co. KG
    View Bio

  • Essential performance requirements
  • Characterization of the siliconization
  • Particulate matters
  • 16:30 Chair’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Joel Richard

    Joel Richard, Head of Technical & Pharmaceutical Operations, MedinCell
    View Bio

    9:10 Getting ready for EMA post 2020 regulatory environment for drug-device combination products – A case study of EU MDR Art 117 implementation

    Bjorg K Hunter

    Bjorg K Hunter, Regulatory Manager, Devices, GSK
    View Bio

  • 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
  • 9:50 Notified Bodies and Article 117

    Jonathan Sutch

    Jonathan Sutch, Medicinal Specialist, BSI Group
    View Bio

  • Notified Bodies and Drug Device Combinations
  • BSI’s experience with Article 117 applications
  • Documentation from the manufacturer
  • Notified Body Opinion Report
  • 10:30 Morning Coffee

    11:00 Standardizing the design input process using system engineering tools

    Christopher Muenzer

    Christopher Muenzer, Senior Device Technology Manager, Novartis
    View Bio

  • Case study on the effort of Novartis to standardize our design input process
  • The challenges of setting design inputs
  • Why the boundary between design inputs and design outputs is so hard
  • What is a ‘good’ requirement
  • How system engineering tools can be applied to drug delivery devices
  • 11:40 Combination products design controls

    Rupal Nguyen

    Rupal Nguyen, Principal Engineer, Allergan
    View Bio

  • Early stage considerations
  • Combination Product Dos and Don’ts
  • Human factors examples
  • Case Studies
  • 12:20 Networking Lunch

    13:20 Building a human factors strategy for combination products

    Tiffany McIntire

    Tiffany McIntire, Senior Human Factors Engineer, Roche
    View Bio

  • Aligning your activities with planned clinical trials and submission(s)
  • Asking the right questions upfront to prevent some surprises happening late in the timeline
  • What information to pay close attention to
  • How to build your human factors timeline
  • 14:00 Click sound characterization of autoinjectors

    Alexander Zuern

    Alexander Zuern, Device testing manager, Novartis International AG

  • 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
  • 14:40 Afternoon Tea

    15:10 Designing instructions for use (IFU) guided by human factors

    Rebecca Moses

    Rebecca Moses, Director, Core Human Factors Inc.

  • Human Factors principles of IFU design
  • FDA guidance on IFU design
  • Real-world IFU examples, including FDA feedback received on IFUs
  • 15:50 To connect or not to connect: When should a parenteral device go connected?

    Paul Greenhalgh

    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!
     
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Alexander Zuern

    Alexander Zuern

    Device testing manager, Novartis International AG
    Andrew  Warrington

    Andrew Warrington

    Project Leader & Patient Advocate, Novartis
    Benjamin Werner

    Benjamin Werner

    Scientist, Boehringer Ingelheim Pharma GmbH & Co. KG
    Bjorg K Hunter

    Bjorg K Hunter

    Regulatory Manager, Devices, GSK
    Blake Green

    Blake Green

    Senior Manager Regulatory Affairs, Amgen
    Camille Dagallier

    Camille Dagallier

    Formulation and Drug Process Development Senior Scientist, Sanofi
    Christopher Muenzer

    Christopher Muenzer

    Senior Device Technology Manager, Novartis
    Joel Richard

    Joel Richard

    Head of Technical & Pharmaceutical Operations, MedinCell
    Jonathan Sutch

    Jonathan Sutch

    Medicinal Specialist, BSI Group
    Mark Palmer

    Mark Palmer

    Scientific Leader, Biopharm Device Engineering, GSK
    Paul Greenhalgh

    Paul Greenhalgh

    Director of Design, Team Consulting
    Rebecca Moses

    Rebecca Moses

    Director, Core Human Factors Inc.
    Rupal Nguyen

    Rupal Nguyen

    Principal Engineer, Allergan
    Stefania  Ragone

    Stefania Ragone

    Pharmaceutical Assessor, Medicines & Healthcare products Regulatory Agency (MHRA)
    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 International AG
    Alexander Zuern

    Andrew Warrington

    Project Leader & Patient Advocate, Novartis
    Andrew  Warrington

    Andrew is a health hacker and a member the #WeAreNotWaiting open source diabetes care movement. At his day job in the pharma industry, he works on finding ways to generate optimal medical outcomes by combining traditional medicines with digital therapeutics. He studied Creative Arts.

    Benjamin Werner

    Scientist, Boehringer Ingelheim Pharma GmbH & Co. KG
    Benjamin Werner

    Benjamin Werner obtained his Master degree in Pharmacy from the University of Munich. After his education Mr. Werner joined the group of Prof. Dr. Gerhard Winter at the Chair of Pharmaceutical Technology and Biotechnology at the University of Munich for his PhD and visited the University of Kansas for a research stay. During his studies he took part in collaborations with the industry and gained experience in the area of protein formulation, stabilization and analysis. In the last years he focused on novel primary packaging materials and other strategies to diminish protein particles in solutions which may cause immunogenicity after administration. Mr. Werner joined Boehringer Ingelheim last year as a Scientist. He is responsible for the primary packaging and process development of parenteral drugs.

    Bjorg K Hunter

    Regulatory Manager, Devices, GSK
    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 has been with GSK since graduating and has held different roles within the Device Engineering Group. In 2015 Bjorg moved into the late stage parenterals area as device lead for key GSK parenteral devices, working closely with internal GSK project teams and external partners including device development, Human Factors and regulatory compliance. She progressed into leading a device management team in January 2017, where she has had the accountability of project management and regulatory compliance for parenteral devices. In February 2019 Bjorg moved into a key management role in CMC regulatory where she is responsible for the global regulatory and advocacy strategy for GSK’s portfolio of devices across modalities and lifecycle.

    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.

    Camille Dagallier

    Formulation and Drug Process Development Senior Scientist, Sanofi
    Camille Dagallier

    Christopher Muenzer

    Senior Device Technology Manager, Novartis
    Christopher Muenzer

    Chris Muenzer is a Senior Device Technology Manager at Novartis in Basel, Switzerland. He has almost 20 years of development experience with a focus on drug delivery devices and has filed several patents in the field. At Novartis, he leads a team supporting injectable delivery systems for Novartis' diverse portfolio of drugs. Mr. Muenzer holds a BSME from Carnegie Mellon University in Pittsburgh, Pennsylvania in the US.

    Joel Richard

    Head of Technical & Pharmaceutical Operations, 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.

    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

    Rebecca Moses

    Director, Core Human Factors Inc.
    Rebecca Moses

    Rupal Nguyen

    Principal Engineer, Allergan
    Rupal Nguyen

    Rupal Nguyen is a principal engineer in the medical device & combination products division of R&D Department. Currently she works at Allergan 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 degree 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.

    Stefania Ragone

    Pharmaceutical Assessor, Medicines & Healthcare products Regulatory Agency (MHRA)
    Stefania  Ragone

    Tiffany McIntire

    Senior Human Factors Engineer, Roche
    Tiffany McIntire

    Tiffany McIntire has been working as a Human Factors Engineer in the pharmaceutical industry for 5 years developing delivery systems, labeling strategies, co-packed products, and new solutions. After her studies in Industrial/Organizational Psychology, she started her career at Lilly where she worked on a range of combination products including dial-and-dose insulin injectors, autoinjectors, pre-filled syringes, digital products, vial adapters, and an emergency inhalation device. While working at Lilly, she began taking Human-Computer Interaction night courses to deepen her knowledge of UX in digital product development. After, she jumped across the pond to Germany to join a recently established device group within Boehringer Ingelheim (BI). Her core contributions in this position were deepening the team's knowledge of HF and advocating for QMS improvements. While there she worked on an AI and a PFS program, a transfer system, and an occular injection system. After her time at BI, she briefly freelanced before joining the Roche team in Basel where she is currently working.

    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

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    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.

     

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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 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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    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.

     

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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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