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Respiratory Drug Delivery
13 November - 14 November 2023
Respiratory Drug Delivery

Conference Overview

SAE Media Group’s Inaugural Respiratory Drug Delivery will be coming to London in November 2023 to bring together big pharma, device developers and innovative biotech to discuss emerging trends and innovations within respiratory drug delivery device development. The conference will bring the opportunity for experts to discuss emerging trends and innovations in the inhalator drug delivery space.

With an increasing need for respiratory medicines and pulmonary delivery providing an alternative to common routes of delivery such as injection and oral administration, there have been significant advances in nasal and inhalation devices in recent years.

Why Attend? 

The conference is set to explore the design and development of respiratory drug delivery devices, opportunities for enhancing the patient experience and the digital integration of inhaler devices. Furthermore, with the growing need for circular economy, the conference will assess case studies of sustainable approaches for device life cycle management and packaging. The conference will also address challenges in regulations with case studies on labelling and best practices for successful submissions.


This is the only event that will:

Bring you the key insights needed to expand you device portfolio and the opportunity to network with senior players throughout the industry. We hope to welcome you to this must attend event in November 2023.
 

FEATURED SPEAKERS

Abtin Rad

Abtin Rad

Global Director Digitization, TUV SUD Product Service GmbH
Arabe Ahmed

Arabe Ahmed

Medicinal Technical Specialist, BSI
Dan Hardy

Dan Hardy

Assistant Course Manager, University Of Bristol
Herbert Wachtel

Herbert Wachtel

Senior Principal Scientist, Boehringer Ingelheim
Louisa Harvey

Louisa Harvey

Founder and Principal, Harvey Medical
Lucas Silva

Lucas Silva

Senior Specialist, Nanopharm Ltd
Mark Milton-Edwards

Mark Milton-Edwards

Head of Health Solutions, Teva Pharmaceuticals
Markus Friden

Markus Friden

Director, AstraZeneca
Orla Ni Ogain

Orla Ni Ogain

Pharmaceutical Assessor, MHRA
Ryan Noble

Ryan Noble

Associate Director, GlaxoSmithKline
Sune Klint  Andersen

Sune Klint Andersen

Associate Director/Principal Scientist, Janssen Pharmaceutica R&D

Abtin Rad

Global Director Digitization, TUV SUD Product Service GmbH
Abtin Rad

Dr. Abtin Rad has a background in biomedical engineering and electrical engineering. He holds a PHD in electrical engineering. Abtin has 15 years of professional experience as a software and hardware developer with focus on medical Software, medical Cybersecurity and Artificial Intelligence (AI). Abtin is Lead Auditor for ISO 13485, ISO 9001, MDSAP and MDD/MDR. Since 2020 Abtin is leading strategic business development for AI, software and Cybersecurity at the notified body TÜV SÜD.

 

Arabe Ahmed

Medicinal Technical Specialist, BSI
Arabe Ahmed

Arabe Ahmed is a Medicinal Expert in drug–device combination products at BSI, where his role is to provide specialist pharmaceutical affairs, regulatory and strategic support to medical devices and pharmaceutical companies. Prior to joining BSI, Arabe worked for more than 10 years for GSK and Novartis in the UK, and Germany respectively in various pharmaceutical development roles. He holds a doctorate degree in drug delivery research from Julius Maximilian University of Würzburg, Germany, and masters degree in Pharmaceutical Technology form King's College London. In addition, Arabe is a UK registered pharmacist and member of the Royal Pharmaceutical Society of Great Britain.

Dan Hardy

Assistant Course Manager, University Of Bristol
Dan Hardy

Dan Hardy studied for his PhD in aerosol science at the University of Bristol. He specialised in understanding microparticle formation with experimental and computation methods. Dan developed a novel technique for studying freefalling microdroplets and co-developed a new software package for the accurate simulation of aerosol droplet evaporation. In 2020 Dan was awarded the Aerosol Society Doctoral Student Award.

Having recently completed his PhD, Dan is now the assistant course manager EPSRC CDT in Aerosol Science and has also founded a start-up, Microsol. Microsol provides single-particle aerosol characterisation capability to industry and is developing a digital platform for the prediction of inhaled aerosol properties.
 

Herbert Wachtel

Senior Principal Scientist, Boehringer Ingelheim
Herbert Wachtel

Dr. Wachtel’s current focus is Drug Delivery based on Medical Devices. Working as a Senior Principal Scientist at Boehringer Ingelheim he has gained experience in the design and testing of complex drug delivery systems, e.g. inhalers and autoinjectors. He is interested in the interface between devices and the respective parts of the body, be it for humans or animals. His aim is basic modelling of drug delivery processes and in doing so he relies on structural and functional modelling e.g. computer aided design, CAD (Solid Works), finite element modelling, FMEA (Solid Works), and computational fluid dynamics, CFD (ANSYS Fluent).
By training, Dr. Wachtel is a physicist. Connecting industry and university, Dr. Wachtel is also affiliated to the Department of Biopharmaceutics and Pharmaceutical Technology at the University of Mainz.
 

Louisa Harvey

Founder and Principal, Harvey Medical
Louisa Harvey

Louisa founded Harvey Medical Consulting in 2012, having worked in the pharmaceutical and medical device industry for over 15 years. She is passionate about usability of medical devices and, in 2018, co-founded Medical Human Factors Network whose mission is to raise the bar of human factors work in the UK. Louisa spends time both in the UK office and The Netherlands office.

 

Louisa also regularly presents at international conferences on the subject of device usability and ethics. Louisa has an MSc in Industrial Pharmaceutical Science and is an accomplished moderator, facilitating on average 600 interviews a year. Her project experience spans across many different products areas, from handheld auto-injectors through to large surgical systems. Louisa’s personable, can-do attitude and determination to get to the bottom of clients’ business questions, ensure that every project is a success!

Lucas Silva

Senior Specialist, Nanopharm Ltd
Lucas Silva

Lucas Silva is a molecular and cellular Biologist by academic training and currently is working as a Senior Specialist leading the Analytical services at Nanopharm.
He has over 7 years of experience in the pharmaceutical industry, from analytical services to formulation technology to drug delivery devices, mostly in the research and development space focused on orally inhaled and nasal drug products.
His key research areas are the development of clinically relevant analytical methods, the application of specialized in vitro performance data to de-risk and accelerate drug product development.
 

Mark Milton-Edwards

Head of Health Solutions, Teva Pharmaceuticals
Mark Milton-Edwards

Mark is responsible for the Product & Health Solutions within Digital Health at TEVA Pharmaceuticals. Over ten years with TEVA and prior to that sixteen with AstraZeneca. Mark has held various positions including R&D Project Leader, VP Sales & Marketing, Strategic Planning & Business Development, and Global Brand Lead. Graduated in Aeronautical Sciences and completed his MBA at Durham University, UK. During his career he has led technology & especially inhaler development teams through engineering, CMC characterisation, clinical evidence generation, registration within US, EU and International Markets and ultimately to successful global launch. Total Brand Leadership value >$2.5bn. Mark has numerous patents granted and pending in electronic communications, sports technologies, inhaled pharmaceutical development, and respiratory physiological function & predictive AI. Mark is the inventor of Digihaler®, the first FDA approved digital inhaler with built-in sensors.

 

Markus Friden

Director, AstraZeneca
Markus Friden

Dr. Markus Fridén earned his PhD in 2010 from Uppsala University with a thesis on experimental and computational approaches to quantify drug exposure in the brain. In the department of Drug Metabolism and Pharmacokinetics (AstraZeneca) Markus subsequently focused on characterizing various aspects of inhaled drug exposure in the lung following inhalation, including mathematical modelling thereof. He held various leading roles including head of modelling and simulation section and interim department head. In addition, Markus holds a part-time position as co-opted associate professor at Uppsala University. Since 2020 Markus is Director and leader of biopharmaceutics team in the department of Inhalation Product Development at AstraZeneca, Gothenburg, Sweden.

Orla Ni Ogain

Pharmaceutical Assessor, MHRA
Orla Ni Ogain

Dr Ní Ógáin is a Pharmaceutical Assessor at the Medicines and Healthcare Products Regulatory Agency (MHRA). She is responsible for assessing the chemical and pharmaceutical data in relation to applications for topical products including inhaled products, dermatological products; and products for endocrine systems. Dr Ní Ógáin has been involved in the assessment of applications for dry powder inhalers and MDIs, and provision of Scientific Advice for both national and European procedures. Dr Ní Ógáin is a UK registered pharmacist and holds a PhD in pharmaceutical science.

Ryan Noble

Associate Director, GlaxoSmithKline
Ryan Noble

Ryan Noble is an Associate Director at GSK in the Global Regulatory Affairs Devices Team. He is currently focused on integrating device engineering and drug product development to ensure regulatory compliance with the ever-changing regulatory landscape. Ryan has been working in combination product development for 25 years and has experience in testing, formulation, manufacturing, quality systems, and regulatory processes throughout the lifecycle of both respiratory and parenteral systems.

Sune Klint Andersen

Associate Director/Principal Scientist, Janssen Pharmaceutica R&D
Sune Klint  Andersen

Principal Scientist in Particle Engineering, Janssen Research & Development, Belgium.

Ph.D. in Chemical Engineering – Nanoparticle Technology
MBA in Management & Technology

Main interests and professional experience include:

  • Drying processes for small & large molecules/ biopharmaceuticals
  • Application of particle engineering in the pharmaceutical industry
    • Spray drying, Electro-spraying/spinning, Spray-Freeze drying, Atomic Layer Deposition, Aseptic drying
    • Scale-up, Modelling, QbD
  • Oral delivery of small & large molecules
    • Amorphous Solid Dispersions, Absorption Enhancers, Nanoparticles
  • Continuous manufacturing – Tableting, Freeze Drying, Spray Drying

Been with Janssen since Apr-2017 and before that 10 years at Novo Nordisk (spray and freeze drying of peptides & proteins) and 8 years with GEA Niro A/S (spray drying, fluid bed drying, equipment design).

 

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

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9:10

Streamlining product development through correct CMC practices and regulatory governance

Ryan Noble, Associate Director, GlaxoSmithKline

  • Key considerations for drug product strategies from pre-NME to post-NDA/MAA approval, including Life Cycle Management (LCM)
  • A review of current European regulatory guidance for drug delivery devices and lessons from MDR implementation
  • Strengthening device optimisation with a review of article 117 and available EMA guidance
  • Future labelling requirements and next steps in regulatory guidance
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    9:50

    Utilising Device Performance Data for User-Driven Devices

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

  • Approaches for producing numeric values for forces required to operate inhalers
  • Understanding usability several patient populations
  • Case study on research on actuation forces
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    10:30

    Morning Coffee

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    11:00

    Overcoming Regulatory Hurdles for Successful Ihaled Product and Device Submissions

  • Ensuring effective collaboration across teams such as development and regulatory for speed to market
  • Discussion of producing devices for a global market and tackling varying regulatory requirements
  • Best practices for updating legacy devices so they are in line with new regulatory requirements
  • Sharing challenges and experiences in regulatory submissions and how hurdles can be overcome
     
  • Arabe Ahmed, Medicinal Technical Specialist, BSI

    Ryan Noble, Associate Director, GlaxoSmithKline

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

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    12:00

    Networking Lunch

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    13:00

    SmartTrack™: An Alternative Pathway to the development of Dry Powder Inhalers

    Lucas Silva, Senior Specialist, Nanopharm Ltd

  • SmartTrack™ Platform: combination of in vitro and in silico methodologies to accelerate and de-risk drug product development.
  • In vitro tools used to generate clinically relevant results
  • In silico approach employing Rapid Deposition Analysis & Computational Fluid Dynamics
  • Presentation of 2 Case Studies
  • High Payload Dry Powder Inhaler Development utilising the Orbital device.
  • Bioequivalence of two tiotropium dry powder inhalers and the utility of realistic impactor testing.
     
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    13:40

    Digital Inhaler Case Study – and lessons from Aircraft Crashes!

    Mark Milton-Edwards, Head of Health Solutions, Teva Pharmaceuticals

  • Healthcare Lessons can be learnt from outside Healthcare
  • Real-World User Design and enduring needs must be clearly defined
  • Machine Learning & Prospective Research can be used to predict attacks
  • Validation pathway for digital inhaler product and best practises for gaining regulatory approval
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    14:20

    Afternoon Tea

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    14:50

    Panel Discussion: Present and Future Opportunities in Respiratory Devices

  • Re-inventing inhalers for a digital age
  • Main challenges in developing respiratory devices and what can be done to overcome them
  • Regulatory uncertainties and how can collaboration in industry drive innovation forward
  • Mark Milton-Edwards, Head of Health Solutions, Teva Pharmaceuticals

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

    Louisa Harvey, Founder and Principal, Harvey Medical

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    15:30

    Chair’s Closing Remarks and Close of Day One

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim

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    9:10

    Drug-Device Combination Products Under MDR (Article 117)

    Arabe Ahmed, Medicinal Technical Specialist, BSI

  • Introduction to Article 117 and what it means
  • Discussion of the impact of MDR on connected devices and drug combination products
  • Insight into manufacturer responsibilities
  • Exploring evidence and fulfi lment of the General Safety and Performance Requirements (GSPRs)
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    9:50

    Navigating Regulations in the Respiratory Field

    Orla Ni Ogain, Pharmaceutical Assessor, MHRA

  • Reviewing the most important regulatory updates
  • Comparison of international guidelines for inhaled products: oral and nasal
  • Guidance on best practices for a successful application and approval
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    10:30

    Morning Coffee

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    11:00

    Particle Engineering Technologies for Inhalable Biopharmaceuticals

    Sune Klint Andersen, Associate Director/Principal Scientist, Janssen Pharmaceutica R&D

  • Challenges for inhalable delivery of biopharmaceuticals
  • Strategies for designing stable formulations for inhalation
  • Particle engineering formulation and process technologies for inhalable biopharmaceuticals
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    11:40

    Use of physiologically-based biopharmaceutic modelling (PBBM) to evaluate in vivo comparability of inhaled drug products

    Markus Friden, Director, AstraZeneca

  • Overview of PBBM model structures and strategies for model development/parameterisation
  • Challenges of validating model predictivity for systemic and local lung pharmacokinetics
  • Case studies of successful prediction of relative bioavailability
  • Outlook on requirements for future advancement in the field
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    12:20

    Networking Lunch

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    13:20

    Describing aerosol plume response to physiological conditions

    Dan Hardy, Assistant Course Manager, University Of Bristol

  • There is a lack of accurate descriptions of the state of plumes of aerosol particles when exposed to physiological conditions.
  • Phenomena such as hygroscopic growth, crystallisation and particle dissolution may all significantly change the aerodynamic properties of inhaled particles - modifying the deposition profile
  • Thus, without accurate representation of the aerosol kinetics, it is not possible to describe the deposition of particles within the lung
  • We will present accurate, time-resolved simulations of size distributions relevant to soft mist inhalers in conditions representative of inhalation
  • Such simulations reveal the range of time-scales over which hygroscopic response occurs and how these are comparable to the timescales of deposition.
  • We will then present a methodology by which the coupled processes of aerosol kinetics and deposition may be represented by integrating a deposition model (ICRP 66) with Microsol’s aerosol kinetics model.
  • With accurate and time-resolved predictions of the properties of the full particle size distribution, it is then possible to suggest modifications to the formulation properties which modulate the dynamics of hygroscopic growth and tune the deposition profile
  • clock

    14:00

    Combining sustainability with usability

    Louisa Harvey, Founder and Principal, Harvey Medical

  • Overview of global research conducted by Harvey Medical
  • Methods used and results found
  • Plans for future research
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    14:40

    Afternoon Tea

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    15:10

    Round Table Discussion Session

  • Article 117 and MDR Requirements
  • Designing the Next Generation of Respiratory Devices
  • Accelerating Drug Product and Device Development
  • Arabe Ahmed, Medicinal Technical Specialist, BSI

    Louisa Harvey, Founder and Principal, Harvey Medical

    Lucas Silva, Senior Specialist, Nanopharm Ltd

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    16:10

    Chair’s Closing Remarks and Close of Day Two

    Herbert Wachtel, Senior Principal Scientist, Boehringer Ingelheim


    Global Director Digitization
    TUV SUD Product Service GmbH
    Medicinal Technical Specialist
    BSI
    Assistant Course Manager
    University Of Bristol
    Senior Principal Scientist
    Boehringer Ingelheim
    Founder and Principal
    Harvey Medical
    Senior Specialist
    Nanopharm Ltd
    Head of Health Solutions
    Teva Pharmaceuticals
    Director
    AstraZeneca
    Pharmaceutical Assessor
    MHRA
    Associate Director
    GlaxoSmithKline
    Associate Director/Principal Scientist
    Janssen Pharmaceutica R&D

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    Nanopharm

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    Nanopharm, an Aptar Pharma Company, is a world leading specialist contract research organization (CRO) offering product design and development services for orally inhaled and nasal drug products (OINDPs). Nanopharm operates a fee-for-service model, helping its clients navigate the scientific, technical and regulatory challenges in developing nasal and respiratory drug products The company’s unique processing technologies and formulation development tools enable seamless translation from discovery and pre-clinical development through to clinical manufacturing. Its service offerings provide the most efficient path to success for its clients by providing an integrated drug product development service covering:

    • Advanced materials characterization and preformulation studies

    • Formulation development and device selection

    • Analytical development and aerosol performance testing

    • In silico modelling of deposition and bioavailability

    • In vitro and in silico bioequivalence studies

    • cGMP analytical and stability studies

    These services aid successful product development by understanding how material properties and processing conditions influence aerosolised product functionality and clinical performance, and therefore reduce risks and expedite drug development timelines.

    The technology platforms for advanced materials characterization, formulation & device development and in-silico modelling of in vivo behavior, have provided Nanopharm a technical competitive edge, helping it become an international market leader. For more information visit: www.nanopharm.co.uk


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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.

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    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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