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SAE Media Group’s 3rd Annual Conference
Pre-Filled Syringes San Francisco
September 19 - 20, 2022 | San Francisco, CA, USA
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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 bring together big pharma, biotech and device developer leaders from the San Francisco and Southern California region to assess the latest developments in new technologies for next generation injectable drug delivery to aid your drug pipeline.

Industry case studies will delve into the growing use of computational simulation approaches forming the digital revolution of device design and the latest advances in digital combination product development will be explored through the lens of lifecycle management and user-centric combination products. Furthermore, leading experts from big pharmwill be presenting case studies on recent advances in platform approaches in drug delivery devices and smart devices, while a panel discussion will explore the emerging opportunities of platforms for injectable devices. With recent developments in industry regulations and guidance, the 2022 agenda will give an international insight into the global regulatory environment and leading FDA representatives will address the key standards to be aware of in injectable device development. 

 

As part of SAE's leading injectable drug delivery series, don't miss this unmissable opportunity to network with the pharma, biotech and device developer community of San Francisco and Southern California; the two-day agenda offers you peer-to-peer networking with Directors of Drug Delivery, Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.

We look forward to welcoming you to the conference in September 2022.

 

  • Delve into the latest technologies and digital revolution for drug delivery device design
  • Explore approaches to advanced platforms for combination products and injectable delivery
  • Engage in international insights to the pre-filled syringes landscape and harmonization
  • Hear from industry leaders on evolving injectable delivery devices for novel therapeutics
  • Assess developments in primary packaging and CMC considerations for injectable devices
     

 

  • 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:

 

Alexion Pharmaceuticals; Almac Group; Amgen; Amgen Inc; Amgen Inc.; Amgen, Inc.; AnaptysBio; Ascendis Pharma; AstraZeneca; Biogen; Boston Analytical Inc; Coherus Biosciences; Corning Inc; Corning, Inc.; Eagle Pharmaceuticals; Eagle Pharmaceuticals, Inc.; Eli Lilly and Company; Genentech; Genentech, Inc.; Glenmark Pharmaceuticals Inc.; Janssen Pharmaceuticals; Janssen R&D; Jazz Pharmaceuticals; Johnson & Johnson; Johnson & Johnson - Janssen; Johnson & Johnson Research & Development; Merck; Merck & Co. Inc.; Minapharm Pharmaceuticals; Pfizer; Pfizer Inc.; Pfizer, Inc; Regeneron; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals Inc; Regeneron Pharmaceuticals, Inc.; Sanofi Pasteur; Takeda; Takeda Pharmaceutical Company Limited; U.S. Food and Drug Administration; UserWise, Inc.; Zacros America, Inc.; Zeon Corporation; Zeon Specialty Materials ; Zeon Specialty Materials Inc;

Conference programme

8:00 Registration & Coffee

9:00 Chairs' Opening Remarks

Scott Nunn

Scott Nunn, Director, Device Development, Gilead Sciences
View Bio

Renato Ravanello

Renato Ravanello, Sr. Director, Device and Packaging Development, Genentech
View Bio

9:10 Lifecycle management for digital combination product development

Abhi Raj

Abhi Raj, Senior Director, Device Development, R&D, AstraZeneca
View Bio

  • A look back on the past year and developments in connected combination products
  • Ensuring effective risk management for a successful digital combination product
  • Regulatory considerations for the implementation of digital components in device development
  • Opportunities for enhancements of current combination products through digital tools
  • 9:50 Etrolizumab Autoinjector Development - From Concept to Marketing Application

  • Development of an autoinjector combination product and overcoming unexpected challenges
  • Improving and demonstrating product robustness
  • Conducting design validation during a pandemic
  • Developing a control strategy for EPRs
  • Ajay A Deshmukh

    Ajay A Deshmukh, Principal Engineer, Genentech
    View Bio

    10:30 Morning Coffee

    11:00 Leveraging Platforms for Combination Product Development

    Nicholas Mandala

    Nicholas Mandala, Senior Director, Medical Device and Combination Product Technology, Pfizer
    View Bio

  • Risk management for combination drug delivery portfolios
  • Quality management systems and quality system development
  • Design control documentation efficiencies
  • Clinical and Human Factors considerations and case studies
  • 11:40 Flexible approaches to injectable delivery device platforms

  • Leveraging platforms to support safety and effectiveness with other active ingredients
  • Introducing modifications in a device platform to avoid challenge of a ‘one-size-fits-all’ approach
  • Planning for the future, attempting to avoid premature platform obsolescence.
  • Planning for platform extensions to improve and extend the life cycle of the platform
  • James Leamon

    James Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals
    View Bio

    Michael Song

    Michael Song, Associate Director, Takeda
    View Bio

    Nicholas Mandala

    Nicholas Mandala, Senior Director, Medical Device and Combination Product Technology, Pfizer
    View Bio

    12:20 Networking Lunch

    13:20 The Do’s and Don’ts of Designing Effective Instructions for Use for Lay Users

    Miles Buroker

    Miles Buroker, Human Factors Engineer, UserWise
    View Bio

  • Regulatory Requirements and Guidelines for Developing an IFU for Lay Users
  • Steps to Develop Effective IFUs
  • Types of User Documentation and Instructions
  • Best Practices for IFUs
  • 14:00 Deploying Digital Threads: Accelerating & Augmenting Device Development

    Peter Harley

    Peter Harley, Head of Technology, Crux Product Design
    View Bio

  • Digital transformation: trends and insights
  • Emerging tech: successful selection for medical devices
  • Digital threads: implementation case studies
  • 14:40 Afternoon Tea

    15:10 Approaches and considerations to building an efficient and de-risk combination product development program

    Michael Song

    Michael Song, Associate Director, Takeda
    View Bio

  • Cross functional interconnection and ways to ensure program success
  • EU MDR GSPR and leveraging from program success
  • Understanding essential performance requirement
  • How an effective control strategy can help ensure program success
  • Design control and risk reduction activities
  • 15:50 From early to late-stage development: Transitioning from vial to pre-filled syringe

    Jamie Tsung

    Jamie Tsung, Head of DP formulation, Alnylam Pharmaceuticals, Inc
    View Bio

  • Approaches to pre-filled syringe development
  • Evaluating key CMC considerations
  • Challenges in transitioning from vial to pre-filled syringe and pathways to overcome these
  • 16:30 Chairs' Closing Remarks and Close of Day One

    Scott Nunn

    Scott Nunn, Director, Device Development, Gilead Sciences
    View Bio

    Renato Ravanello

    Renato Ravanello, Sr. Director, Device and Packaging Development, Genentech
    View Bio

    8:30 Registration & Coffee

    9:00 Chairs' Opening Remarks

    Scott Nunn

    Scott Nunn, Director, Device Development, Gilead Sciences
    View Bio

    Renato Ravanello

    Renato Ravanello, Sr. Director, Device and Packaging Development, Genentech
    View Bio

    9:10 An update on combination product and injection device regulatory guidance

    Alan M Stevens

    Alan M Stevens, Assistant Director, Injections Devices Team, U.S. Food and Drug Administration
    View Bio

  • A review of current guidance for pre-filled syringes and what is new from the past year
  • Updates to regulatory guidance on bridging studies for injectable devices
  • Essential performance requirements for combination products and injectable devices
  • Post market safety reporting for combination products
  • 9:50 Findings and Implications of U.S FDA-UserWise Training Decay Research

    Shannon Clark

    Shannon Clark, CEO, UserWise, Inc.
    View Bio

  • An overview of Training Decay and why it matters
  • What does the FDA say about Training Decay
  • Insights and revelations from our FDA-backed training decay research study
  • How our findings affect future regulatory policy
  • 10:30 Morning Coffee

    11:00 Silicone in medical application

    Simone Marquardt

    Simone Marquardt, Key Account Manager Silicone Europe, Raumedic AG
    View Bio

  • We would like to talk about a silicone material which we have developed which can be used in injection systems for applications which are very sensitive.
  • The trend of oral administration of medicine is increasingly being replaced by injection. In particular, we find that biopharmaceuticals and personalized medicine are growing above average. 
  • RAUMEDIC has dealt intensively with these trends in recent years and created innovations that contribute to improving a safe and easy administration of drugs. 
  • In particular in the area of syringe systems and components, we support various companies in development and manufacture. One of our innovations are our silicone syringe stoppers. These enable easier application and better dosage of the medication due to improved breakaway and gliding properties. We would like to talk about these and other innovations and introduce the new silicone stopper concept
  • 11:40 Global regulatory landscape and harmonization of combination products

    Peter Dorski

    Peter Dorski, Associate Director, CMC Regulatory Affairs, Janssen, Pharmaceutical Companies of Johnson and Johnson
    View Bio

  • Recent updates to international regulatory requirements for injectable combination products
  • Industry challenges in the evolving regulatory landscape
  • Assessing international harmonization: guidance for industry to conform to international standards
  • What we can expect in future updates to combination product international regulatory guidance and how to prepare
  • 12:20 Networking Lunch

    13:20 Large volume Injectable Delivery of Biologics

    James Leamon

    James Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals
    View Bio

  • The growing need for large volume delivery for biologics 
  • Challenges in delivery technology for biologics and what injectable devices are currently being used?
  • Overcoming formulation challenges for biologic delivery
  • How do we need the delivery system landscape to move forward meet the needs of biologic subcutaneous delivery?
  • 14:00 Challenges and opportunities for high volume sub-cutaneous drug delivery

  • Opportunities to improve patient experience.
  • Device technology challenges.
  • Tolerability and other unknowns
  • Renato Ravanello

    Renato Ravanello, Sr. Director, Device and Packaging Development, Genentech
    View Bio

    14:40 Afternoon Tea

    15:10 Device Development for Long Acting Injectables

    Scott Nunn

    Scott Nunn, Director, Device Development, Gilead Sciences
    View Bio

  • How have long-acting injectable devices evolved in recent years
  • Common pitfalls and challenges in long-acting combination product design
  • 15:50 Chairs' Closing Remarks and Close of Day Two

    Scott Nunn

    Scott Nunn, Director, Device Development, Gilead Sciences
    View Bio

    Renato Ravanello

    Renato Ravanello, Sr. Director, Device and Packaging Development, Genentech
    View Bio

    +

    FEATURED SPEAKERS

    Abhi Raj

    Abhi Raj

    Senior Director, Device Development, R&D, AstraZeneca
    Ajay A Deshmukh

    Ajay A Deshmukh

    Principal Engineer, Genentech
    Alan M Stevens

    Alan M Stevens

    Assistant Director, Injections Devices Team, U.S. Food and Drug Administration
    Denise Forkey

    Denise Forkey

    Director, Human Factors, UserWise, Inc.
    James Leamon

    James Leamon

    Director of Biologics Device Development, Jazz Pharmaceuticals
    Jamie Tsung

    Jamie Tsung

    Head of DP formulation, Alnylam Pharmaceuticals, Inc
    Michael Song

    Michael Song

    Associate Director, Takeda
    Miles Buroker

    Miles Buroker

    Human Factors Engineer, UserWise
    Nicholas Mandala

    Nicholas Mandala

    Senior Director, Medical Device and Combination Product Technology, Pfizer
    Peter Dorski

    Peter Dorski

    Associate Director, CMC Regulatory Affairs, Janssen, Pharmaceutical Companies of Johnson and Johnson
    Peter Harley

    Peter Harley

    Head of Technology, Crux Product Design
    Renato Ravanello

    Renato Ravanello

    Sr. Director, Device and Packaging Development, Genentech
    Scott Nunn

    Scott Nunn

    Director, Device Development, Gilead Sciences
    Shannon Clark

    Shannon Clark

    CEO, UserWise, Inc.
    Simone Marquardt

    Simone Marquardt

    Key Account Manager Silicone Europe, Raumedic AG

    Abhi Raj

    Senior Director, Device Development, R&D, AstraZeneca
    Abhi Raj

    Abhi Raj is a Senior Director in the device development group at AstraZeneca and is based out of the US West Coast office in South San Francisco. Abhi has 15+ years of combination product and medical device development experience and has worked at medical device and pharmaceutical companies. He has multiple granted patents in the field and is passionate about device technology development. He has successfully launched pen needles, pre-filled syringes, and auto-injectors over his career. Some of his current focus areas include smart/digital devices as well as large volume delivery technologies.

    Ajay A Deshmukh

    Principal Engineer, Genentech
    Ajay A Deshmukh

    Ajay A. Deshmukh is a Principal Engineer in the Device & Packaging Development Department of Genentech, a member of the Roche group. At Genentech, Ajay has spent 12 years developing subcutaneous injection devices such as prefilled syringes, needle-safety devices, autoinjectors, and on-body delivery devices. He has been involved in all stages from concept development through authoring sections of regulatory filing documents.
    Prior to this role, Ajay had worked for 8 years designing in vitro medical devices. Ajay holds a Ph.D. from the University of California, Berkeley and a B.S. from Columbia University, both in mechanical engineering.

    Alan M Stevens

    Assistant Director, Injections Devices Team, U.S. Food and Drug Administration
    Alan M Stevens

    CAPT Alan Stevens is the acting division director for the Division of Drug Delivery and General Hospital Devices and Human Factors, which includes the Injection Devices Team, Infusion Devices Team, General Hospital Devices Team, and the Human Factors and Reliability Engineering Team. This division regulates the product lifecycle of its devices, including premarket submission review and postmarket safety and compliance. The division also provides human factors expertise and consulting across FDA.
    Prior to becoming a manager in CDRH, CAPT Stevens spent 10 years as an engineering reviewer in the Office of Device Evaluation and three years as a compliance officer in CDRH’s Office of Compliance. CAPT Stevens received his undergraduate mechanical engineering degree and masters degree in reliability engineering from the University of Maryland.

    Denise Forkey

    Director, Human Factors, UserWise, Inc.
    Denise Forkey

    Denise Forkey is currently Director, Human Factors at UserWise, a consultancy that helps medical device and combination product manufacturers and start-ups to design safe and easy-to-use medical products. She leads a team of human factors consultants who fulfil any and all aspects of the usability engineering process.

    Denise has experience performing use-related risk analyses, conducting usability testing, designing instructions for use and implementing the usability engineering process for home-use injection products through complex robotic surgery system. Denise regularly works on human factors submission strategy and compliance documentation for FDA Human Factors Guidance, and international standards related to usability engineering (e.g., IEC 62366-1, IEC 60601-1-6, and ISO 14971). She has helped numerous UserWise clients successfully navigate FDA human factors submissions, create usability documentation for CE mark, and manage notifying body and test lab audits of the usability engineering file. Denise has been working in the medical products industry for more than 25 years and has experience in medical device testing and quality systems/engineering, with her last 6 years focusing on human factors engineering processes and testing.

    She holds a master’s degree in Biomedical Engineering and has severed as a board member of the national Biomedical Engineering Society and the Bio2Device group and was the founding President of the San Francisco Bay Area Chapter of the Biomedical Engineering Society.

    James Leamon

    Director of Biologics Device Development, Jazz Pharmaceuticals
    James Leamon

    Jim is a medical device and drug device combination product development leader, an engineering director, and a manufacturing manager. He is experienced in working across functions and business groups in varying organizations. Jim has successfully brought new and effective products to market throughout the world and has developed and implemented new engineering, quality control and manufacturing processes. Jim continues to lead product development, and contract engineering teams while working at Jazz Pharmaceuticals. He is highly experienced and proficient in CMC drug-device combination product leadership as well as strategic planning, design engineering, manufacturing engineering and new product and process development. Currently, he is working with Jazz manufacturing teams to expand the availability of a current small cell lung cancer drug product that is in high demand.

    Jim is also a community leader in social justice and feeding the hungry. As treasurer of a non-profit organization, he has used his strategic planning and financial management skills to help people in need. This correlates well with his career drive to improve the lives of cancer patients and those with other life threatening diseases.

    Jamie Tsung

    Head of DP formulation, Alnylam Pharmaceuticals, Inc
    Jamie Tsung

    Dr. Jamie Tsung received her Ph.D. in pharmaceutical sciences from the University of Connecticut. Currently, she is an Associate Director at Alnylam Pharmaceuticals. Prior to Alnylam, she worked for Momenta, Shire, Baxter, and UCB. Her biopharmaceutical experience spans preclinical to marketed products, integrating formulation, characterization, processing technology, regulatory, and quality control providing a valuable perspective and creative approach to product development.

    Michael Song

    Associate Director, Takeda
    Michael Song

    Michael currently is Associate Director of Device Development at Takeda. Prior to his current role he was head of Combination Product Manufacturing at Heron Therapeutics where he led medical device and combination product commercial readiness. Prior to Heron, he formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca where his group oversaw device functionality portion of device development; primary container science and technology; biocompatibility; container closure integrity programs; and digital connectivity. Prior to AstraZeneca, he was head of Device, Package, and Process Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

    Miles Buroker

    Human Factors Engineer, UserWise
    Miles Buroker

    Miles first joined UserWise as an intern for the summer of 2018 and came on as a full-time consultant in mid-2019. He is experienced in forming use-related risk analyses and test protocols; observing usability study sessions for formative and validation testing; preparing test reports, risk-benefit analyses and Human Factors Engineering Submission Reports for FDA; providing human factors trainings and workshops; and with establishing compliance documentation for IEC 62366:2007, IEC 62366-1:2015, and FDA Guidance Documents. His focus is predominantly on combination products. Miles brings a wide range of pertinent experience from his undergraduate career, including serving as a research assistant, developing a stress-sensing wearable device and accompanying application, and participation in design studios.

    Nicholas Mandala

    Senior Director, Medical Device and Combination Product Technology, Pfizer
    Nicholas Mandala

    Nick has spent more than 20 years in cross functional roles in the device and combination products industry including systems development, clinical manufacturing, manufacturing and process engineering, validation, and combination products quality assurance. He joined Pfizer in 2017 and currently leads the team responsible for lifecycle management of drug delivery devices, implantables, SaMDs, connected devices, and IVDs. His organization’s responsibilities include device strategy, design and development of medical devices and combination products, post market surveillance, and post market innovation and sustainability. He holds a B.S. in mechanical engineering from Cornell University.

    Peter Dorski

    Associate Director, CMC Regulatory Affairs, Janssen, Pharmaceutical Companies of Johnson and Johnson
    Peter Dorski

    Peter Dorski is an Associate Director, CMC Regulatory Affairs at Janssen, Pharmaceutical Companies of Johnson and Johnson. He has worked within the pharmaceutical and combination products industry for going on nine years, driving regulatory strategies based on industry best practices for global/major market product development and supporting advancement of complex, innovative delivery systems using leading-edge therapies.
    Within the pharma industry, Peter works to understand and influence the continuously evolving regulatory landscape surrounding combination products to serve industry stakeholders and patients. Peter holds a BS in microbiology from The Ohio State University and a MS in Health Sciences from The George Washington University.
     

    Peter Harley

    Head of Technology, Crux Product Design
    Peter Harley

    11 years since graduating as a mechanical engineer working in simulation and analytics, in that time completed a PhD while working in automotive and moved into a leadership role through time in Dyson Research. Current aim is to drive digital methods from other sectors into the medical device world to de-risk development programs early and accelerate time to market through simulation and analytics.

    Renato Ravanello

    Sr. Director, Device and Packaging Development, Genentech
    Renato Ravanello

    Renato Ravanello is responsible for Late Stage Development in the Device and Packaging team at Genentech in South San Francisco, CA. Renato leads the design of new combinations products for clinical and commercial, focusing on new technologies for sub-cutaneous and ocular drug delivery.

    Renato has been developing and commercializing combination products and medical devices for over 17 years, and has extensive experience in pre-filled syringes, needle safety devices, injector pens, patch injectors, auto-injectors, ocular drug delivery, and respiratory and transdermal drug delivery devices. He holds an M.S. in Aerospace Engineering from the University of Colorado (Boulder) and a Degree in Aeronautical Engineering from the Politecnico di Milano (Italy).
     

    Scott Nunn

    Director, Device Development, Gilead Sciences
    Scott Nunn

    Scott Nunn is responsible for Device Engineering at Gilead Sciences in Foster City, CA. Scott is passionate about developing products to improve patient’s lives. Gilead’s combination product portfolio includes both development and commercial combination products developed to treat grievous illnesses.
    Scott has been working in the pharmaceutical industry for 16 years and has experience in development of various parenteral drug delivery devices. In his free time, Scott enjoys spending time with his family, working on home renovation projects and spending time outdoors.

    Session Reserved For Biophorum

    , BioPhorum
    Session Reserved For Biophorum

    Shannon Clark

    CEO, UserWise, Inc.
    Shannon Clark

    Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

    Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is a Certified Professional Industrial Engineer, holds two patents, and has written and published three books.

    Simone Marquardt

    Key Account Manager Silicone Europe, Raumedic AG
    Simone Marquardt

    Over 28 years’ experience in technical fields in various industries and market segments.
    Experienced application engineer in the field of silicone chemistry.

    Simone joined RAUMEDIC in 2017 as Business development manager silicone for Europe.
    Since January 2021, she has worked as a Key account manager silicone Europe to promote silicone in medical application.

    The field of medical technology is an important and growing sector of industry.
    Looking at trends and new market requirements where silicone could be a beneficial solution, supporting the whole development process – from the initial idea through to the end medical-technology product.
     

    Sponsors

    Supporters

    VENUE

    Hyatt Centric Fisherman’s Wharf San Francisco

    555 North Point St, San Francisco, CA, USA

    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

    Preliminary Attendees List

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    Speaker Bios

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    Workshop Agenda

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    Conference Co-Chair Letter

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    Past Attendees

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    SURVEY RESULTS INFOGRAPHIC - STATE OF THE INDUSTRY 2022

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    Past Presentation - Paul Upham, Roche

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    Past Presentation - Larry Atupem, ZEON

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    Prefilled Syringes San Francisco Brochure 2022

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    Sponsors


    Boston Analytical

    Sponsors
    http://www.bostonanalytical.com

    Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 certified analytical laboratory located in Salem, NH. Boston Analytical provides testing services to Pharmaceutical, Biopharmaceutical and Medical Device companies worldwide including Analytical Testing and Method Development, Microbiological Testing and Environmental Monitoring Services, Biologics, Stability Testing & ICH-compliant Storage, Nitrosamines Testing and Extractables & Leachables Studies.



    Credence MedSystems

    Sponsors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    Crux

    Sponsors
    http://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..



    Raumedic

    Sponsors
    http://www.raumedic.com

    Together with its customers, the medical technology company is breaking new ground to improve the diagnosis and treatment of diseases. In doing so, Raumedic focuses on polymer-based solutions for medical and pharmaceutical applications, as well as on products for intensive care. Raumedic has a global presence and a headcount of approximately 1,000. In its core markets of Europe and North America, the company manufactures using its own clean room production facilities.

    Media Partners


    evvnt Ltd

    Supporters
    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


    Technology Networks

    Supporters
    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


    Pharmiweb

    Supporters
    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.


    Pharmacircle

    Supporters
    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….


    ASD MEDIA

    Supporters
    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


    pharmaphorum

    Supporters
    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


    Mednous

    Supporters
    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


    Gene Therapy Net

    Supporters
    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


    Pharma Journalist

    Supporters
    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.


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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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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , 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.smgconferences.com Email: events@saemediagroup.com
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