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Pre-Filled Syringes and Injectable Drug Devices
12 January - 13 January 2022
Pre-Filled Syringes and Injectable Drug Devices

SAE Media Group’s 14th Annual Conference
Pre-Filled Syringes and Injectable Drug Devices Europe
January 12 - 13, 2022 | Virtual Conference | All Timings are GMT
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The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products. This year’s conference will explore the exciting advances in the combination product delivery space including insights into how the industry is adapting to the delayed EU MDR, takeaways from the global pandemic and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation. Part of the leading injectables series of events, SAE Media Group’s 14th annual conference will bring you the key insights you need to grow and enhance your pre-filled syringes portfolio and discover what the future holds for the PFS and combination products industry.


Topics of discussion will include the latest updates on the EU MDR, Article 117 and UK regulatory guidance, insights into the evolving digital health landscape for connected delivery devices, containment considerations for novel delivery, patient centric approaches to device design as well as a pre-conference focus day on sustainability for drug delivery devices.
 

The 14th annual conference offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.


As Europe’s first Pre-Filled Syringes Conference of 2022, this event is not to be missed. We look forward to welcoming you to the virtual conference in January. 
 

FEATURED SPEAKERS

Andrea  Pisa

Andrea Pisa

Usability Design Lead, Crux Product Design, Ltd
Andrew Owen

Andrew Owen

Professor, Director, Centre of Excellence in Long acting Therapeutics (CELT)
Annie Zavadil

Annie Zavadil

New Technologies Device Project Leader, Novartis Pharma AG
Arabe Ahmed

Arabe Ahmed

Medicinal Technical Expert, BSI
Bjorg Kaae Hunter

Bjorg Kaae Hunter

Director, RA CMC & Device, Novo Nordisk A/S
Carolina Sunjic

Carolina Sunjic

Product Manager, Zeon Europe GmbH
Cedric Gysel

Cedric Gysel

Manager, Healthcare Solutions Design, Johnson & Johnson
Daniel Latham

Daniel Latham

Head Connected Health Product Development, Novartis Pharma AG
David Braun

David Braun

Global Head of Connected Health and Devices, MerckGroup KgAa
Eleanor Kimber

Eleanor Kimber

Device Engineer, GlaxoSmithKline
Jochen Zenker

Jochen Zenker

Head of Laboratory Process Engineering, Boehringer Ingelheim Pharma GmbH & Co. KG
Joel Richard

Joel Richard

Chief Development Officer, MedinCell
Julia Frese

Julia Frese

Director, TUV SUD Japan Ltd.
Karima Yadi

Karima Yadi

Senior Marketing Manager, Becton Dikinson
Laure Tardivel

Laure Tardivel

EMEA Chronic Marketing Manager, Becton Dickinson (BD)
Louise Place

Louise Place

Director, Devices, GlaxoSmithKline
Max Dixon

Max Dixon

Senior Life Sciences Engineer, Crux Product Design Ltd.
Michael Becker

Michael Becker

Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
Niels Otterstrom Jensen

Niels Otterstrom Jensen

Associate Director, Corporate Environmental Strategy, Novo Nordisk A/S
Raphael Nudelman

Raphael Nudelman

Sr. Director, Impurity Expert R&D Operations, Teva Pharmaceuticals
Richard Simcock

Richard Simcock

Human Factors Scientist, Teva Ltd
Sachin Dubey

Sachin Dubey

Head of Drug Product and Analytical Development, Ichnos Sciences, SA
Severine Duband

Severine Duband

Global Category Director, Devices, Nemera

Andrea Pisa

Usability Design Lead, Crux Product Design, Ltd
Andrea  Pisa

Andrea Pisa leads the Human Factors and Usability team at Crux Product Design Ltd (Bristol, UK), ensuring that the Human Factors process is seamlessly integrated into product development to produce safe, effective and user empathic solutions. She has supported leading pharmaceutical clients on projects spanning the entire design process, taking medical and drug-delivery devices from design input to market submission. With a passion for uncovering latent user needs and a global background in design engineering, Andrea brings a wealth of knowledge when tailoring usability strategies to maintain the integrity of design development whilst keeping the user at the core.

Andrew Owen

Professor, Director, Centre of Excellence in Long acting Therapeutics (CELT)
Andrew Owen

Andrew Owen is a Director of the Centre of Excellence in Long-acting Therapeutics (CELT) at the University of Liverpool. He is principal investigator for LONGEVITY, an international project that aims to translate long-acting medicines for malaria, tuberculosis, and Hepatitis C Virus. Owen co-leads a modelling core and sits on the executive group for the Long-acting/Extended-release Antiretroviral resource Program (LEAP). He is also Director and CSO for Tandem Nano Ltd. and co-inventor of patents relating to drug delivery.

Annie Zavadil

New Technologies Device Project Leader, Novartis Pharma AG
Annie Zavadil

Annie Zavadil holds a BSc and MSc in Biomedical Engineering from Boston University. Annie started her career at Boston Scientific in Preclinical Sciences and Cell Biology. In 2012, she joined Future Health Biobank, setting up a best in class stem cell isolation laboratory.
In 2014, Annie joined the Device and Packaging Development team at Novartis working as Project lead for various projects from Ophthalmic delivery to Cell and Gene to Sustainability initiatives.

Arabe Ahmed

Medicinal Technical Expert, BSI
Arabe Ahmed

Trained as a Pharmacist at the University of Aston in Birmingham, graduating with a BPharmS. Arabe has a Master’s degree in Pharmaceutical Technology at King’s College London. PhD in Pharmaceutical Sciences from Julius Maximilian University, Würzburg (JMU), Germany.

Bjorg Kaae Hunter

Director, RA CMC & Device, Novo Nordisk A/S
Bjorg Kaae 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 where she has held positions within device development, with increased resistibility both in R&D and Regulatory Affairs. In 2020 Bjorg took up a new position in NovoNordisk where she is leading the RA Device Combination Products department within RA CMC and Devices. Bjørg has also been very active in external advocacy, including driving industry positions on behalf of industry associations.

Carolina Sunjic

Product Manager, Zeon Europe GmbH
Carolina Sunjic

Carolina is Product Manager for Cyclo Olefin Polymers at Zeon Europe and she is responsible for business development and marketing of Zeon Corporation’s highly transparent resins ZEONEX® and ZEONOR® in Europe. After joining Zeon in 2013 as Sales Representative to strengthen the company's presence in Iberia, she is supporting the ambitious projects for COP business ahead in medical/pharma applications such as primary packaging in PFS & injectable drug devices. Carolina holds an MBA and a Chemical Engineering degree from IQS University in Barcelona.

Cedric Gysel

Manager, Healthcare Solutions Design, Johnson & Johnson
Cedric Gysel

Cedric Gysel is a Healthcare Solutions Manager for Johnson & Johnson Design, responsible for shaping the strategic development of products, platforms and processes in collaboration with our R&D and Supply Chain partners and driving human-centered solutions for patients and customers of Janssen. He is also engaged in a number of sustainability initiatives and leads Janssens Clean Technology Innovation Workstream as part of its Sustainability Roadmap. He has more than 15 years of experience with the development and design of devices and combination products. He holds a bachelor’s in pharmaceutical technology from the University of Basel and a master’s in medical device technology from the University of Applied Science in Bern and Stanford University with a specialization in human-centered design.

Daniel Latham

Head Connected Health Product Development, Novartis Pharma AG
Daniel Latham

Daniel Latham is the Head of Connected Health Product Development at Novartis, where he leads the organisation responsible for the development of connected health ecosystems comprising smart drug / device combinations, SaMD apps for web and mobile applications and tele-health solutions. Prior to this he was Head of Device Development and LCM for 5 years leading an organisation developing drug/device combinations for new biologic entities, biosimilars, and new chemical entities. Over the past 14 years at Novartis, he has overseen significant device and primary packaging developments and launches and has significantly supported the growth of device development and drug/device interaction within the organisation. Prior to Novartis, he worked in a variety of roles in consumer healthcare, focusing on the development of OTC medicines, transdermal patches, and medical devices. He has a Ph.D. in controlled drug delivery from Queen Mary, University of London and a bachelor’s degree and master’s degrees in Engineering from the University of Sheffield.

David Braun

Global Head of Connected Health and Devices, MerckGroup KgAa
David Braun

David Braun is Global Head of Digital Health and Connected Devices Business for Merck HealthCare. In this role David is supporting the efforts of Merck to improve patients’ journey, disease management, patient engagement, adherence monitoring and healthcare professionals decision making with smart devices and digital solutions. David is an executive leader with 20 years of experience in Strategy, R&D, Operations, business management and transformation working in Europe, USA and Asia, in small startups and large multinational companies. Through his career David gained significant experience managing strategic projects, designing winning organizations, leading and coaching cross functional teams bringing innovative products from ideation to launch, defining and implementing wining strategies.

Before joining Merck, David served as Head of EMEA Operations and Global R&D of the Technology Business unit at Newell Brands, a Fortune 500 company, where he led R&D teams and manufacturing sites across the globe, organizational transformation, growth initiatives and multimillion-dollar projects. Prior to that, he worked as Vice President of R&D and Operations at Biosafe SA a medical device company acquired by GE Healthcare, developing and launching products in the field of stem cell banking, bioprocessing and cellular therapies. David also held various senior management and engineering roles in the aerospace and high-tech industry.

David participated in Executive Leadership and General Management programs at the Harvard Business School in Boston and at IMD in Switzerland. He holds a degree in electronical and optical engineering and a master’s degree in applied physics from the Louis Pasteur University and from the Jerusalem College of Technology.
 

Eleanor Kimber

Device Engineer, GlaxoSmithKline
Eleanor Kimber

Eleanor Kimber has an MEng in Biomedical Engineering, and has worked as a project manager, clinical trial manager and device engineer. She currently works at GlaxoSmithKline in the Device Engineering department and is leading the validation of the digital twin being developed.

Jochen Zenker

Head of Laboratory Process Engineering, Boehringer Ingelheim Pharma GmbH & Co. KG
Jochen Zenker

Jochen Zenker is the head of Process Engineering Combination Products at Boehringer Ingelheim GmbH & Co Kg. Prior to BI Pharma he worked for an CMO as a leader and managing engineer in a Device Development Department.

He has had more than 13 years of experience in pharmaceutical development and has a bright range of expertise in numerous customer projects for Prefilled Syringes, Cartridges and Drug Delivery Devices.
Jochen holds several issued patented innovations in the field of combination products.

He started his career as a head and managing engineer for automotive interior design at Hymer LMB before changing to the pharmaceutical industry.
Jochen has a degree in mechanical engineering from the University of Stuttgart
 

Joel Richard

Chief Development Officer, MedinCell
Joel Richard

Dr Joël Richard is currently Chief Development Officer at MedinCell (Montpellier, France) that he joined 3 years ago. 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, non-clinical 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 (nanosystems, microspheres, self-assembling gels, implants), 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 72 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).

Julia Frese

Director, TUV SUD Japan Ltd.
Julia Frese

By education biomedical engineer with a Master degree in business administration. Julia gained experience in development, regulatory approval of combination devices and ATMP products. She was further involved in the development of standards for ATMP products. Currently Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and is responsible for the development of article 117 service within the organisation. She is further co-chair of the Team NB working group for article 117

Karima Yadi

Senior Marketing Manager, Becton Dikinson
Karima Yadi

Karima Yadi is leading Global Marketing for the high volume Autoinjector, Prefillable Syringes and Safety platforms at BD Medical Pharmaceutical Systems. She provides commercial leadership to BD’s delivery system platforms and defines, develops, and launches patient centered injection solutions in collaboration with cross functional, commercial and regional teams. She held different roles of increasing responsibility within Pfizer Inc in Marketing and Business Development and at Zoetis in Regional Marketing in the Companion Animal Business Unit. Karima Yadi has deep experience in product launches and product life cycle management, from the development phase to commercialization phase. She hold a BSc Hon in Management Science from University of Warwick Business School, and a Master degree M.Sc. International Business Management from London South Bank University

Laure Tardivel

EMEA Chronic Marketing Manager, Becton Dickinson (BD)
Laure Tardivel

Laure Tardivel is Regional Marketing manager at BD Medical - Pharmaceutical Systems. She is working at BD since 8 years and is in charge of the EMEA region for Pre-fillable Syringes, auto-injector and Safety systems dedicated to biologic drugs. She works closely with regional Sales and Global portfolio to identify the most suitable BD solutions depending on the customer project and expectation. She held different roles in national and international Marketing within medical devices companies.
Laure Tardivel has a deep experience in customer support, product launches and product life cycle management, she holds a master’s degree from Grenoble Business school and a Bachelor’s degree in Biology.

Louise Place

Director, Devices, GlaxoSmithKline
Louise Place

Originally training as a pharmaceutical scientist, Louise has over 14 years’ experience in drug delivery & medical devices with a focus on device technical management and regulatory strategy for EU & FDA submissions.
Louise joined GSK in May 2020 and leads the Device team within CMC Regulatory with responsibility for global regulatory and advocacy strategy (Devices) across the GSK portfolio.
With a solid background in inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.
 

Mathilde Barbeau

Senior Regulatory Professional, Novo Nordisk A/S
Mathilde Barbeau

Mathilde Barbeau has a BSc in Biology from McGill University and an MSc in Applied Biosciences and Biotechnology from Imperial College London. Mathilde has been at Novo Nordisk since 2016, where she has held a number of different positions within Regulatory Affairs in the clinical, CMC and device areas. For the past two years, Mathilde has been working in RA Digital Health, where she has been responsible for the regulatory activities of a number of different Software as a Medical Device (SaMD) products.

Max Dixon

Senior Life Sciences Engineer, Crux Product Design Ltd.
Max Dixon

Max Dixon is a Senior Life Sciences Engineer at Crux Product Design Ltd (Bristol, UK), where he routinely pioneers the development and application of cutting-edge numerical tools across the drug delivery and surgical spaces. He applies his knowledge and understanding of how digital tools have revolutionised other high-performance industries to the health care sector and advocates a data driven problem solving approach. He has a proven track record of generating ground-breaking insights for leading pharmaceutical clients, resulting in step changes in device performance at any point along a device’s life cycle; from concept through to mass manufacture.

Michael Becker

Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG
Michael Becker

Dr. Michael Becker (born in 1983) is working at Boehringer Ingelheim Pharma GmbH & Co. KG since 2016 as a Design Engineer for parenteral combination products and for two years for packaging and labelling. Previously, he worked for 5 years at Sanofi-Aventis GmbH in the development of Autoinjectors, Pre-filled Syringes and Injection Pens. He studied Physics at the University of Mainz and wrote his PhD thesis about the Dry Powder Inhalers supervised by Mr. Prof. Cameron Tropea (Technical University Darmstadt).
 

Niels Otterstrom Jensen

Associate Director, Corporate Environmental Strategy, Novo Nordisk A/S
Niels Otterstrom Jensen

Niels leads Novo Nordisk Take-back Program, which is the initiative in the environmental “Circular for Zero” strategy addressing end-of-life product challenge. Before joining Corporate Environmental Strategy Niels has more than 15 years of experience in supply chain and procurement within the pharmaceutical sector. This background is now used to design take-bake pilots, where reverse logistics are creating circularity in order to repurpose valuable materials with a key focus on plastics. As part of developing a circular economy approach Niels has been one of the key drives in establishing The European Federation of Pharmaceutical Industries and Associations (EFPIA) Circular Economy Network, which comprises 15 pharmaceutical companies and associations striving towards cross industry environmental projects and advocacy.

Raphael Nudelman

Sr. Director, Impurity Expert R&D Operations, Teva Pharmaceuticals
Raphael Nudelman

Raphael has over 20 years of pharmaceutical industry experience. He has a M.Sc. degree in Pharmaceutical Sciences from the Hebrew University in Jerusalem, Israel, and a Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel. After completing two postdoctoral positions, one in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, and the other in Duke University Medical Center, North Carolina. In 2001 he joined in a startup biotech company in Israel that performed rational drug design by molecular modeling. In 2003 Raphael joined the Medicinal Chemistry department at Teva Pharmaceuticals and in 2010 he established the Chemical & Computational Toxicology group in Teva, which he headed until June 2021. As of July 2021, Raphael has been appointed Sr. Director, Impurity Expert R&D Operations in the R&D Operations and Biosimilars department. Raphael's main topics of expertise are impurity and excipient qualification in drug substances and drug products.
From 2011 to 2016, Raphael was the President of the Medicinal Chemistry Section of the Israel Chemical Society, and was as a Council member of the European Federation of Medicinal Chemistry (EFMC). From 2012 to 2020 he was a member of the Advisory Council of High School Chemistry Education in the Israel Ministry of Education.
 

Rene Holm

Professor, University of Southern Denmark
Rene Holm

René Holm received his pharmaceutical training at the Royal Danish School of Pharmacy, now the school of pharmacy at University of Copenhagen, Denmark, in 1998 and his PhD in biopharmaceutics from the same institution in 2002. Dr. Holm joined Lundbeck in 2001 and changed to Janssen in 2016. Dr. Holm has worked within pharmaceutical development, formulations for non-clinical testing in drug discovery, physical chemistry and material science covering both small and large molecules and is now responsible for the functional unit ensuring development of all non-solid formulations for Janssens small molecule value stream.

Dr. Holm is (co-) author of more than 185 original articles in peer-reviewed journals and patents in the field of biopharmaceutics, preformulation, formulation and physical pharmacy and is a honorary professor in physical chemistry at the Department of Science and Environment, University of Roskilde, Denmark.
 

Richard Simcock

Human Factors Scientist, Teva Ltd
Richard Simcock

Richard is a chartered human factors specialist (Chartered Institute for Ergonomics and Human Factors (CIEHF)) with over 20 years’ experience applying human factors in high-risk sectors including nuclear decommissioning, medical device development, defence and transport.

Richard’s primary interests are usability engineering and user interface design, with experience in control room and control system design, device design and user testing, human reliability assessment, task design and organisational human factors. Outside of work Richard likes to walk, run, lift, eat, drink, play and sing.
 

Sachin Dubey

Head of Drug Product and Analytical Development, Ichnos Sciences, SA
Sachin Dubey

I am presently working with Ichnos Sciences, Switzerland (A part of Glenmark Pharmaceuticals SA, Switzerland) and heading three major functions for the company – formulation, analytical, and drug product development groups. I have more than 15 years of experience in this area with > 9 years in an industrial setting (with previous global experience with Novozymes A/S Denmark and Glenmark Pharmaceutical SA Switzerland). Twelve products developed by me and my team are currently in clinical trials. These products are in different markets including the USA, EU, and Asia – this gave us very rich hands-on experience. In addition, I have 18 PCT patents, 24 publications in high-impact journals like Trends in Biotechnology, Journal of Controlled Release, Molecular Pharmaceutics, etc., 7 book chapters, and have been invited speaker on the topic in several international conferences (> 50). Industry and academia have equally recognized my contribution with 20 research awards including prestigious industry awards from Glenmark (Best innovation team – won twice), Merck (Innovation cup), Novartis (International bio camp), and the Swiss Society of Pharmaceutical Sciences (Best publication).

 

Severine Duband

Global Category Director, Devices, Nemera
Severine Duband

Séverine Duband is Marketing Director for drug delivery Devices at Nemera, steering overall category strategy, product portfolio and innovation development for five key delivery routes. She has been leading the parenteral segment at Nemera since 2018, focusing on proprietary products such as safety systems, pen injectors and on-body injectors. Ms Duband graduated from Emlyon Business School (Lyon, France) in 2004, and joined Nemera’s Global Marketing team in 2018 as a Global Category Manager, focusing on the parenteral segment.

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Conference agenda

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8:30

Registration & Coffee

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9:00

Chairs' Opening Remarks

Bjorg Kaae Hunter, Director, RA CMC & Device, Novo Nordisk A/S

Louise Place, Director, Devices, GlaxoSmithKline

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9:10

On the regulatory interface of digitalisation and drug-device combination products

Mathilde Barbeau, Senior Regulatory Professional, Novo Nordisk A/S

  • How do we manage regulatory submissions of drug-device combination products in the interface of digitalisation ?
  • Engaging with regulators on areas of uncertainty to improve guidance for all parties
  • How can we create harmonization across global regulations that can keep up with rapid development?
  • What does the future hold in this space?
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    9:45

    Navigating Connected Health to enhance drug portfolio

    Daniel Latham, Head Connected Health Product Development, Novartis Pharma AG

  • Opportunities to enhance current treatment offerings with Connected Health
  • Development of connected ecosystems and impacting the patient journey
  • Overcoming challenges in developing a successful connected parenteral delivery portfolio
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    10:20

    Connected delivery device value creation

    David Braun, Global Head of Connected Health and Devices, MerckGroup KgAa

  • An insight into the current landscape and examples of connected health and delivery devices 
  • Design thinking and optimising value creation
  • Challenges and opportunities in data generation for personalised treatments

     

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    10:55

    Morning Coffee

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    11:25

    Can Behavioral Science be the key to unlocking patient adherence?

    Andrea Pisa, Usability Design Lead, Crux Product Design, Ltd

  • The continued challenge of patient adherence and engagement to treatment - impact on patient outcomes and health system
  • Historic informational material - one size does not fit all
  • Two applied examples - development of digital solutions effective in on boarding users onto treatments and enabling successful self-management of their treatments over time
  • Key learnings - implementation lessons learned of applying Behavioural Science to instructional material development and technologies used to assess the intervention effectiveness
  • Project significance - Generation of medical solutions that better meet user needs and engage users with their treatments
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    12:05

    Designing the First Impression of a Drug/Device Combination Product

    Michael Becker, Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG

  • Packaging and Labelling is the first interface between the user and the combination product creating the first device impression at the user.
  • To develop user centric folding boxes, labels and “Instruction for Use”s the design control process can be useful.
  • Beside the needs of the users/patients regulatory requirements and the product protection must be considered and integrated into this development process making the product safe and effective
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    12:40

    Tackling high-volume administration challenges with a smart, sustainable on-body injector platform

    Severine Duband, Global Category Director, Devices, Nemera

  • Challenges facing modern drug delivery devices
  • Delivering large volumes at home in sustainable and user-friendly way
  • A differentiated approach in the wearables’ landscape: Nemera Symbioze platform
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    13:20

    Networking Lunch

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    14:20

    Long acting injectable, application of aqueous suspensions

    Rene Holm, Professor, University of Southern Denmark

  • Long acting injectables – why?
  • Which compounds fits the technology
  • PK and formulation considerations
  • Biopharmaceutical considerations of LAIs
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    14:55

    Challenges of injectable delivery for fragile molecules

    Joel Richard, Chief Development Officer, MedinCell

  • An industry outlook of in situ forming implant technologies
  • Overcoming challenges of molecular structure for fragile molecule delivery
  • Unmet needs for delivery technologies
  • Examples of current approaches for fragile molecule delivery
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    15:30

    Assessing the landscape of delivery for novel drug products, fragile molecules and long acting injectables

  • The current landscape of fragile molecule formulations and delivery
  • Considerations and strategies for successful long acting injectable delivery
  • Key barriers facing development in industry and strategies in overcoming hurdles of novel drug product delivery
  • Selecting appropriate technology for a molecule of interest 
  • Opportunities offered by therapeutic areas where long acting injectable do not yet exist and future industry trends for optimal novel and sustained injectable delivery
  • Joel Richard, Chief Development Officer, MedinCell

    Rene Holm, Professor, University of Southern Denmark

    Raphael Nudelman, Sr. Director, Impurity Expert R&D Operations, Teva Pharmaceuticals

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    16:10

    Afternoon Tea

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    16:40

    Dealing with Nitrosamines in the Generic Drug Industry

    Raphael Nudelman, Sr. Director, Impurity Expert R&D Operations, Teva Pharmaceuticals

  • Assessing the recent regulatory guidance for industry on nitrosamine impurities 
  • Setting acceptable intake limits for nitrosamines without published carcinogenicity data
  • Update on the adequacy of the Ames test for nitrosamines
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    17:15

    Challenges in Cell & gene therapy

    Annie Zavadil, New Technologies Device Project Leader, Novartis Pharma AG

  • An introduction into the landscape of cell and gene therapy
  • Current challenges and barriers to delivery 
  • Potential benefits and challenges of a parenteral approach to delivery using pre-filled syringes
  • Future development strategies for cell and gene therapy
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    17:50

    Chairs' Closing Remarks and Close of Day One

    Bjorg Kaae Hunter, Director, RA CMC & Device, Novo Nordisk A/S

    Louise Place, Director, Devices, GlaxoSmithKline

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    8:30

    Registration & Coffee

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    9:00

    Chairs' Opening Remarks

    Bjorg Kaae Hunter, Director, RA CMC & Device, Novo Nordisk A/S

    Louise Place, Director, Devices, GlaxoSmithKline

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    9:10

    Industry Perspective: Implementation of the EU MDR

    Louise Place, Director, Devices, GlaxoSmithKline

  • Aligning with new regulatory requirements for stand-alone devices and combination products
  • Case Study examples: GSK’s vaccines/pharma portfolio
  • Considerations and challenges in implementation of the MDR for injectables
  • Assessing clarifications that are still needed to understand what is expected from industry
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    9:45

    Working with notified bodies – lessons learned and advice

    Julia Frese, Director, TUV SUD Japan Ltd.

  • Experiences and takeaways from Team-NB over the past year
  • Common challenges in applications for notified body opinions and guidance on working with notified bodies
  • How industry can work more closely with regulators and notified bodies in implementation of new regulations
  • What gaps have we seen since the EU MDR implementation and how can this be improved
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    10:20

    Notified Body Perspective: Regulatory updates following implementation of the MDR

    Arabe Ahmed

    Arabe Ahmed, Medicinal Technical Expert, BSI

  • How has industry adapted with the full implementation of the EU MDR and Article 117
  • Change management considerations for article 117 regulatory submissions
  • Key takeaways from implementation of the MDR and what guidance is still needed
  • Considerations for legacy products and implementation for device platforms
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    10:55

    Morning Coffee

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    11:25

    Selecting drug delivery systems for higher dose volume and higher viscosities

    Laure Tardivel, EMEA Chronic Marketing Manager, Becton Dickinson (BD)

  • High dose biologic formulations are pushing drug volume and viscosity beyond traditional self-injection design space limits (> 15 cP, > 1 ml dose volume), which can challenge patients’ capabilities to administer their injections based on injection time or force. 
  • We will discuss how ergonomic, manual, syringe-based injections can enable subcutaneous self-injections with characteristics that go beyond the traditional boundaries of volume and viscosity.
  • Important factors for development of combination products involving delivery of higher volumes (1-2 mL) are presented, including assembly, human factors, documentation, and platform considerations.
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    12:05

    Can you recycle an insulin pen?

    Niels Otterstrom Jensen, Associate Director, Corporate Environmental Strategy, Novo Nordisk A/S

  • What are the current challenges in re-purposing insulin drug delivery devices?
  • Overcoming the challenges in launching take-back schemes
  • Looking forward, scale up solutions
  • Case Study: Launching a take-back pilot in Denmark
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    12:40

    Driving Sustainability: New Materials and Product End of Life Solutions for Pharmaceutical Delivery Systems

    Cedric Gysel, Manager, Healthcare Solutions Design, Johnson & Johnson

  • Creating a Roadmap to enable circularity
  • Design for Sustainability
  • Product end of life solutions
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    13:15

    Networking Lunch

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    14:15

    COP in Pre-filled Syringe Applications

  • Good Reasons to consider Cyclo Olefin Polymers for pre-fillable syringes
  • New case study: Adsorption of nucleic acids
  • Carolina Sunjic, Product Manager, Zeon Europe GmbH

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    14:55

    Embedding usability engineering into design

    Richard Simcock, Human Factors Scientist, Teva Ltd

  • How to make usability a part of your normal processes
  • Considering ‘work as imagined’ and ‘work as done’
  • Examples of the importance of usability testing and iterative design
  • Getting the most out of Perception, Cognition, Action and Use-Related Risk Analysis
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    15:30

    Accelerating innovation in the drug delivery landscape

  • How have we seen drug device combination product development evolve in recent years and where are the biggest growth areas in the space?
  • Exploring takeaways of Article 117 implementation – industry experiences and where can we see improvements?
  • Understanding the relationship between connectivity and acceleration for drug delivery device development
  • Bjorg Kaae Hunter, Director, RA CMC & Device, Novo Nordisk A/S

    Richard Simcock, Human Factors Scientist, Teva Ltd

    Louise Place, Director, Devices, GlaxoSmithKline

    Arabe Ahmed, Medicinal Technical Expert, BSI

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    16:10

    Afternoon Tea

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    16:40

    The Use of Digital Twins in Pharma

    Eleanor Kimber, Device Engineer, GlaxoSmithKline

  • Potential of Digital Twins in Pharma
  • Process of developing a Digital Twin 
  • Validation, Verification and Uncertainty Quantification of the Digital Twin
  • Challenges Faced
  • clock

    17:15

    Digitalization meets assembly process

  • Lessons learned: Challenges of a machine guided PFS assembly process
  • Machine parameter, device constituent parts and physical interactions are essential inputs for a robust assembly process
  • Digital perspective on assembly processes evaluation
  • Insights of closure integrity and behavior of rubber components associated with the assembly process
  • Jochen Zenker, Head of Laboratory Process Engineering, Boehringer Ingelheim Pharma GmbH & Co. KG

    Max Dixon, Senior Life Sciences Engineer, Crux Product Design Ltd.

    clock

    17:50

    Chairs' Closing Remarks and Close of Day Two

    Bjorg Kaae Hunter, Director, RA CMC & Device, Novo Nordisk A/S

    Louise Place, Director, Devices, GlaxoSmithKline


    Usability Design Lead
    Crux Product Design, Ltd
    Professor
    Director, Centre of Excellence in Long acting Therapeutics (CELT)
    New Technologies Device Project Leader
    Novartis Pharma AG
    Medicinal Technical Expert
    BSI
    Director, RA CMC & Device
    Novo Nordisk A/S
    Product Manager
    Zeon Europe GmbH
    Manager, Healthcare Solutions Design
    Johnson & Johnson
    Head Connected Health Product Development
    Novartis Pharma AG
    Global Head of Connected Health and Devices
    MerckGroup KgAa
    Device Engineer
    GlaxoSmithKline
    Head of Laboratory Process Engineering
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Chief Development Officer
    MedinCell
    Director
    TUV SUD Japan Ltd.
    Senior Marketing Manager
    Becton Dikinson
    EMEA Chronic Marketing Manager
    Becton Dickinson (BD)
    Director, Devices
    GlaxoSmithKline
    Senior Regulatory Professional
    Novo Nordisk A/S
    Senior Life Sciences Engineer
    Crux Product Design Ltd.
    Packaging Engineer
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Associate Director, Corporate Environmental Strategy
    Novo Nordisk A/S
    Sr. Director, Impurity Expert R&D Operations
    Teva Pharmaceuticals
    Professor
    University of Southern Denmark
    Human Factors Scientist
    Teva Ltd
    Head of Drug Product and Analytical Development
    Ichnos Sciences, SA
    Global Category Director, Devices
    Nemera

    Sponsors

    Exhibitors

    Key Media Partners

    Survey Results Infographic - State of the Industry 2022

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    Interim Survey Results Survey 2021-2022

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    Preliminary Attendees

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    Speaker Interview - Severine Duband, Nemera

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    Speaker Interview - Julia Frese, TUV SUD Japan Ltd.

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    Speaker Interview - Harriet Lewis, Chiesi Ltd

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    Speaker Interview - David Braun, Merck

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    SPEAKER INTERVIEW - SRIMAN BANERJEE, TAKEDA

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    Focus Day Agenda

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    Infographic

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    PRE-FILLED SYRINGES & INJECTABLE DRUG DEVICES BROCHURE 2022

    Download

    Conference Chair Letter

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    Chair & Speaker Biographies

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    Past Attendees

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    Past Presentation - Stefano Martini, Sanofi

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    Past Presentation - Severine Duband, Nemera

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    Past Presentation - Joel Richard, MedinCell

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    Past Presentation - Abha Raveau, AstraZenca

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    Past Presentation - Carolina Sunjic, Zeon

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    Sponsors


    BD Medical

    Sponsors
    http://www.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 parenteral drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure smooth delivery regardless of drug complexity, viscosity and dosing volume.

    With an unbending emphasis on innovation and the highest 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 product launch and life cycle management through a comprehensive set of services and solutions that help you from development all the way through to launch, while accelerating time to market and helping to reduce risks.

    More information available @ drugdeliverysystems.bd.com Contact us @ drugdeliverysystems.bd.com/contact-us



    Crux

    Sponsors
    https://www.cruxproductdesign.com/

    Crux was founded to address challenging technical briefs and deliver compelling solutions for the drug delivery and medical device sectors. Based in Bristol, United Kingdom, our technical team champion evidence-based problem solving, coupling world-class equipment, software and facilities with a scientific approach to maximise success. Be it discovering unmet user needs, developing novel products or deploying new technologies, our team are dedicated to solving our client’s biggest problems..



    Nemera

    Sponsors
    http://www.nemera.net

    As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.



    Zeon

    Sponsors
    http://www.zeonex.com

    Zeon Europe GmbH is the European marketing/sales organisation of Zeon Corporation / Japan. As part of specialty materials operations Zeon produces Cyclo-Olefin Polymers (COP) under the tradenames ZEONEX® and ZEONOR®. The balance of outstanding water barrier properties in combination with high purity, excellent chemical resistance, high transparency and low interaction with drugs, put ZEONEX® and ZEONOR® as a perfect alternative to glass or other plastics solutions for pharmaceutical and biopharmaceutical containers - such as Pre-filled syringes, cartridges and vials.

    Exhibitors


    Owen Mumford

    Exhibitors
    http://www.owenmumford.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.

    For more information please visit https://www.ompharmaservices.com/


    Media Partners


    Mednous

    Key Media Partners
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Pharmacircle

    Key Media Partners
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Pharma Journalist

    Key Media Partners
    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.


    World Pharma News

    Key Media Partners
    http://www.worldpharmanews.com/



    ASD MEDIA

    Key Media Partners
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    Pharmiweb

    Key Media Partners
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    World Pharma Today

    Key Media Partners
    http://www.worldpharmatoday.com



    evvnt Ltd

    Key Media Partners
    http://www.evvnt.com

    evvnt enables people all over the world to fill their events utilising the most effective event listing sites on the web. Every minute, with little more than a click, more events and conferences appear in listings, in search engines and on mobile - discoverable by both category and location. With next to no effort customers of evvnt get better attendance, while consumers find events they previously had no idea existed. To date customers in 70 countries worldwide have submitted over 500,000 thousand event listings, created over 300,000 live links, and generated 1 million clicks to ticketing and registration pages. Learn more at www.evvnt.com


    Pharmaceutical Technology

    Key Media Partners
    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.


    ONdrugDelivery Magazine

    Key Media Partners
    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.


    Technology Networks

    Key Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Gene Therapy Net

    Key Media Partners
    http://www.genetherapynet.com

    Gene Therapy Net is the information resource for basic and clinical research in gene therapy, and the site serves as a network in the exchange of gene therapy information and breaking news items. Visitors can keep track of the latest scientific papers, conference announcements, gene therapy jobs, regulations and guidelines


    pharmanews hq

    Key Media Partners
    http://http://pharmanewshq.com

    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.


    pharmaphorum

    Key Media Partners
    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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    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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