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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 agenda

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8:00

Registration & Coffee

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9:00

Chairs' Opening Remarks

Scott Nunn, Director, Device Development, Gilead Sciences

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

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9:10

Lifecycle management for digital combination product development

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

  • 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
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    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, Principal Engineer, Genentech

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    10:30

    Morning Coffee

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    11:00

    Leveraging Platforms for Combination Product Development

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

  • 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
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    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, Director of Biologics Device Development, Jazz Pharmaceuticals

    Michael Song, Associate Director, Takeda

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

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    12:20

    Networking Lunch

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    13:20

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

    Miles Buroker, Human Factors Engineer, UserWise

  • 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
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    14:00

    Deploying Digital Threads: Accelerating & Augmenting Device Development

    Peter Harley, Head of Technology, Crux Product Design

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

    Afternoon Tea

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    15:10

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

    Michael Song, Associate Director, Takeda

  • 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
  • clock

    15:50

    From early to late-stage development: Transitioning from vial to pre-filled syringe

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

  • Approaches to pre-filled syringe development
  • Evaluating key CMC considerations
  • Challenges in transitioning from vial to pre-filled syringe and pathways to overcome these
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    16:30

    Chairs' Closing Remarks and Close of Day One

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

    Scott Nunn, Director, Device Development, Gilead Sciences

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    8:30

    Registration & Coffee

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    9:00

    Chairs' Opening Remarks

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

    Scott Nunn, Director, Device Development, Gilead Sciences

    clock

    9:10

    An update on combination product and injection device regulatory guidance

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

  • 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
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    9:50

    Findings and Implications of U.S FDA-UserWise Training Decay Research

    Shannon Clark, CEO, UserWise, Inc.

  • 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
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    10:30

    Morning Coffee

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    11:00

    Silicone in medical application

    Simone Marquardt, Key Account Manager Silicone Europe, Raumedic AG

  • 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
  • clock

    11:40

    Global regulatory landscape and harmonization of combination products

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

  • 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
  • clock

    12:20

    Networking Lunch

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    13:20

    Large volume Injectable Delivery of Biologics

    James Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals

  • 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?
  • clock

    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, Sr. Director, Device and Packaging Development, Genentech

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

    14:40

    Afternoon Tea

    clock

    15:10

    Device Development for Long Acting Injectables

    Scott Nunn, Director, Device Development, Gilead Sciences

  • How have long-acting injectable devices evolved in recent years
  • Common pitfalls and challenges in long-acting combination product design
  • clock

    15:50

    Chairs' Closing Remarks and Close of Day Two

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

    Scott Nunn, Director, Device Development, Gilead Sciences


    Senior Director, Device Development, R&D
    AstraZeneca
    Principal Engineer
    Genentech
    Assistant Director, Injections Devices Team
    U.S. Food and Drug Administration
    Director, Human Factors
    UserWise, Inc.
    Director of Biologics Device Development
    Jazz Pharmaceuticals
    Head of DP formulation
    Alnylam Pharmaceuticals, Inc
    Associate Director
    Takeda
    Human Factors Engineer
    UserWise
    Senior Director, Medical Device and Combination Product Technology
    Pfizer
    Associate Director, CMC Regulatory Affairs
    Janssen, Pharmaceutical Companies of Johnson and Johnson
    Head of Technology
    Crux Product Design
    Sr. Director, Device and Packaging Development
    Genentech
    Director, Device Development
    Gilead Sciences
    BioPhorum
    CEO
    UserWise, Inc.
    Key Account Manager Silicone Europe
    Raumedic AG

    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.
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    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

    RAUMEDIC serves Pharma / Biopharma / Cell and Gene Therapy - with first class tubing for fluid transfer and fluid handling applications.

    Benefit from Raumedic's 70+ years of experience as a single source tubing supplier - with an in-house materials department, in-house product development and tried and trusted manufacturing expertise at five different production sites in three countries.

    With Raumedic as your supplier, you can count on:

    Standards compliance and validation

    Biocompatibility

    Low extractable values

    Increased flow rates / Cell Growth yield

    Discover innovative tubing from Raumedic - In stock and ready to ship!

    • Standards compliance and validation

    • Biocompatibility

    • Low extractable values

    • Increased flow rates / Cell Growth yield

    • Platinum cured Silicone Tubing

    • Platinum cured Braided Silicone Tubing (high pressure)

    • Thermoplastic Elastomer Tubing (TPE)

    • Tubing sets - bespoke customer design


    Media Partners


    Mednous

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    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


    Pharma Journalist

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    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.


    evvnt Ltd

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    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

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    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.


    pharmaphorum

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    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


    ONdrugDelivery Magazine

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    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.


    Pharmacircle

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    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….


    Technology Networks

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    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


    ASD MEDIA

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    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
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    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
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    Pharmiweb

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    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.


    Gene Therapy Net

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    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

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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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