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Lyophilisation -Europe

The global market for lyophilisation is projected to be worth $3.26bn in 2015, spurred by the strong growth of new drugs and efforts to increase clinical approval. Lyophilization is an established method in the formulation of biological products, and an invaluable tool for prolonging shelf life and stability for biological drugs and vaccines.

As under met needs in drug transport and long term storage continues to prevail, robust lyophilization methods outlined in PAT and QbD principles as well as alternative technologies will continue to experience strong demand.

This conference will focus on the scale- up efforts in the pharmaceutical industry with key topics in:

• PAT
• Quality by Design
• Vaccines
• Biological drugs
• Spray drying
In addition, a panel discussion on both days will focus on sale up and engineering issues, highlight new areas of innovation and debate whether small scale results in the laboratory provide realistic results in commercial scale up.
 

FEATURED SPEAKERS

Eunice Costa

Eunice Costa

Process Developement Engineer, Hovione Sociedade Quimica SA
Yves Mayeresse

Yves Mayeresse

Director primary and secondary Expertise, GlaxoSmithKline

Andrew Bayly

Chair in Chemical Engineering, Institute of Particle Science and Engineering, Leeds University
Andrew Bayly

Andrew Tait

Postgraduate Research Engineer, Newcastle University
Andrew Tait

Bruce Williams

Chartered chemical and process engineer,, Williams Process
Bruce  Williams

Daryl Williams

Reader in Particle Science, Imperial College London
Daryl Williams

Daryl Williams

Director, Imperial College London
Daryl Williams

Edith Norrant

Innovations Technology Sciences DirectorInnovations Technology Sciences Director, UCB Pharma
Edith  Norrant

Eunice Costa

Process Developement Engineer, Hovione Sociedade Quimica SA
Eunice Costa

Jamshed Anwar

Associate Dean for Research & Professor of Computational Chemistry, Lancaster University
Jamshed  Anwar

Marc Hayes

Product Manager, Ellab UK Ltd.
Marc Hayes

Michael Dekner

Manager of Innovation, Baxter BioSciences
Michael Dekner

Mire Zloh

Head of Pharmaceutical Chemistry , University of Hertfordshire
Mire  Zloh

Patrick Garidel

Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim
Patrick  Garidel

Pierre Lebrun

Associate Statistician - Project Leader, Arlenda
Pierre Lebrun

Steve Rannard

Chair of Chemistry, Liverpool University
Steve Rannard

Sune Andersen

Principal Scientist Drying Processes, Novo Nordisk A / S
Sune Andersen

Yves Mayeresse

Director primary and secondary Expertise, GlaxoSmithKline
Yves Mayeresse

Conference agenda

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8:30

Registration & Coffee

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9:00

Welcome and Introduction

Jim  Bullock

Jim Bullock, Director, iFormulate

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9:15

Why choose spray drying?

Jim  Bullock

Jim Bullock, Director, iFormulate

 

What are the alternatives? Advantages and disadvantages. What properties do we want from our spray-dried formulated product? How are these properties measured? Particle size, shape, microstructure, moisture, flow, friability, strength., encapsulation,
                - Includes interactive session.
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9:50

Spray drying finish to start

York David

York David, Professor, Leeds University

  • Drying parameters and options, atomisation conditions, fluid properties, formulation components.
  • Drying sensitive (bio)materials. Importance of equipment design, start up and shut down.
  • Scale up to manufacture
  • clock

    11:15

    Industry Approches - A Flavour

    Jim  Bullock

    Jim Bullock, Director, iFormulate

     

    Examples of practical spray drying approaches from industry – pharma and elsewhere. Novel approaches and methods.
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    11:30

    Industry Case Study – Phase Changes and Structure

    York David

    York David, Professor, Leeds University

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    12:20

    Closing Remarks - How can you learn more?

    Jim  Bullock

    Jim Bullock, Director, iFormulate

    clock

    13:30

    Registration and Coffee

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    14:00

    Opening remarks

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    14:10

    QbD applied to pharmaceutical process

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    14:50

    Linking CPP to clinical relevance through process understanding

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    15:30

    Coffee Break

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    16:00

    Case studies: Beginning a QbD analysis from development to process valdiation

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    16:40

    Q/A + discussions

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    17:20

    Closing remarks

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    17:30

    Close of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening remarks

    Yves Mayeresse

    Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline

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    9:10

    Keynote address: Implementation of QbD in lyophilisation

    Yves Mayeresse

    Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline

  • Improving flexibility and robustness of the process design
  • Quantitative performance measures to ensure product quality
  • Identifying stabilising excipients to ensure drug stability
  •  Evaluating risk factor of material attributes
  • clock

    9:50

    The Basics of Freeze Drying

    Patrick  Garidel

    Patrick Garidel, Process Sciences Department, Head of Pharmaceutical Basic Development, Boehringer-Ingelheim

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    10:30

    Morning Coffee

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    11:00

    Considerations for scale up

    Michael Dekner

    Michael Dekner, Manager of Innovation, Baxter BioSciences

     

    ·          From lab to large scale
    ·          A generic approach to scale-up
    ·          Challenges of scale up

     

     
     
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    11:40

    Validation of the Lyophilisation process

    Marc Hayes

    Marc Hayes , Product Manager, Ellab UK Ltd.

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    12:20

    Networking Lunch

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    13:20

    Molecular dynamics simulations of freeze drying of protein therapeutics

    Mire  Zloh

    Mire Zloh, Head of Pharmaceutical Chemistry , University of Hertfordshire

     

     

           Lyophilisation of protein therapeutics

           Principles of molecular dynamics simulations

           Protocols for simulation of freeze drying process

           Case studies of freeze drying of protein therapeutics.

     

    clock

    14:00

    Spray-drying process development and scale-up for complex dosage forms: an alternative to lyophilisation

    Eunice Costa

    Eunice Costa, Process Developement Engineer, Hovione Sociedade Quimica SA

     

     
    ·          Benchmarking lyophilisation with spray drying
    ·          Challenges in spray drying process and formulation development for complex dosage forms
    ·          Maintaining product critical quality attributes across scales        
    ·          Case study: Scale-up of spray dried formulations
    clock

    14:40

    Round Table Discussion Session

  • Group introductions and discussion of challenges met
  • Examine opportunities to impliment and optimise the application of QbD principles in process development.
  • Share concerns, success stories and major areas for improvement

     

  • clock

    15:20

    Crystal nucleation: Theory and Modelling

    Jamshed  Anwar

    Jamshed Anwar, Associate Dean for Research & Professor of Computational Chemistry, Lancaster University

     

    ·         Classical nucleation theory
    ·         Multi-step nucleation
    ·         Molecular simulation of crystal nucleation
    ·         Modulation of crystal nucleation using additives
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    16:00

    Afternoon Tea

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    16:30

    The mechanical properties of lyophilised cakes

    Daryl Williams

    Daryl Williams, Reader in Particle Science, Imperial College London

     

    ·          The properties of mechanical properties of lyophilised cakes are a potential QbD property
    ·          Discussion: The mechanical properties of protein-based lyophilized cakes
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    17:10

    Panel discussion

     

    ·          Review PAT and QbD principles and discuss current challenges facing scale up and quality control
    ·          Discuss opportunities for continuous lyophilisation
    ·          Identify ways to bridge the gap between commercial and laboratory lyophilisation

    Yves Mayeresse

    Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline

    Eunice Costa

    Eunice Costa, Process Developement Engineer, Hovione Sociedade Quimica SA

    Michael Dekner

    Michael Dekner, Manager of Innovation, Baxter BioSciences

    clock

    17:50

    Chair's Closing Remarks and Close of Day One

    Yves Mayeresse

    Yves Mayeresse, Director primary and secondary Expertise, GlaxoSmithKline

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

    clock

    9:10

    Opening Address: Scale up methodologies for spray drying processes

    Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S

     

     
    ·          A viable alternative to achieving continuous production
    ·          Optimising solution/suspension properties to maintain critical quality attributes
    ·          Challenges with atomization
    ·          Case study: Spray drying of nanoparticles
     
    clock

    9:50

    Utilising Freeze Drying Screening with translation to Spray Drying for novel Nanomedicines

    Steve Rannard

    Steve Rannard, Chair of Chemistry, Liverpool University

  • Utilising freeze drying for nanoparticle formation
  • Miniaturisation of emulsion freeze drying for screening
  • Translation to spray drying and nanomedicine clinical trials
  • clock

    10:30

    Morning Coffee

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    11:00

    The value of modelling in spray dried product development

    Andrew Bayly

    Andrew Bayly, Chair in Chemical Engineering, Institute of Particle Science and Engineering, Leeds University

     

    ·          Understanding process influence and scale
    ·          Predicting product structure and product quality
    ·          Efficient approaches with models and experiments
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    11:40

    Engineering Spotlight: Engineering a continuous process to ensure end product quality

    Bruce  Williams

    Bruce Williams , Chartered chemical and process engineer,, Williams Process

     

    ·          Controlling product structure and homogeneity during freezing
    ·          Process intensification and economic factors in scale up
    ·          Integration with upstream and downstream operations
    ·          Design for scalability and robust technology transfer.
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    12:20

    Networking Lunch

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    13:20

    Enabling technologies in lyophilisation processes

    Andrew Tait

    Andrew Tait, Postgraduate Research Engineer, Newcastle University

     

    ·          New approaches and robust technology  transfer
    ·          Recognising the need for and challenges of continuous production in industry
    ·          Case study
    clock

    14:00

    KEYNOTE: Implimenting QbD tools to optimise product quality

    Pierre Lebrun

    Pierre Lebrun, Associate Statistician - Project Leader, Arlenda

     

     
    ·          Integrating risk-based approaches into QbD principles
    ·          Maintaining continuous process validation and control of process parameters.
    ·          Case study on material flow
     
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    14:40

    Round Table Discussion

    · How does PAT support scale up processes and to what degree has it been successful?

    · Discuss critical issues and major cost drivers currently faced in scale up

    · Discuss experiences with filing QbD reports and fulfilling the requirements of PAT

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    15:00

    Afternoon Tea

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    15:30

    PAT on Pharmaceutical Processes

    Edith  Norrant

    Edith Norrant , Innovations Technology Sciences DirectorInnovations Technology Sciences Director, UCB Pharma

     

     

    ·          Optimising product shelf life for biological drugs
    ·          Establishing the correct safety margins to prevent temperature collapse
    ·          Batch process vs continuous process
    ·          Product imposed limitations vs operations –imposed limitations

     

    clock

    16:10

    Panel discussion

     

    ·          Application of Quality-by-Design to process development
    o    Which steps are it most often applied to? Is it relevant to apply it to all steps?
    o    How often is it used in IMPDs/CTAs?
    o    Experience with filing equations?
    ·          Discuss the unique challenges facing design of experiments
    ·          Future prospects for continuous production processes
    ·          Critical issues and major cost drivers with technology transfer in scale up

    Andrew Tait

    Andrew Tait, Postgraduate Research Engineer, Newcastle University

    Bruce  Williams

    Bruce Williams , Chartered chemical and process engineer,, Williams Process

    Edith  Norrant

    Edith Norrant , Innovations Technology Sciences DirectorInnovations Technology Sciences Director, UCB Pharma

    clock

    16:50

    Chair’s Closing Remarks and Close of Day Two

    Sune Andersen

    Sune Andersen, Principal Scientist Drying Processes, Novo Nordisk A / S


    Chair in Chemical Engineering, Institute of Particle Science and Engineering
    Leeds University
    Postgraduate Research Engineer
    Newcastle University
    Chartered chemical and process engineer,
    Williams Process
    Reader in Particle Science
    Imperial College London
    Director
    Imperial College London
    Innovations Technology Sciences DirectorInnovations Technology Sciences Director
    UCB Pharma
    Process Developement Engineer
    Hovione Sociedade Quimica SA
    Associate Dean for Research & Professor of Computational Chemistry
    Lancaster University
    Product Manager
    Ellab UK Ltd.
    Manager of Innovation
    Baxter BioSciences
    Head of Pharmaceutical Chemistry
    University of Hertfordshire
    Process Sciences Department, Head of Pharmaceutical Basic Development
    Boehringer-Ingelheim
    Associate Statistician - Project Leader
    Arlenda
    Chair of Chemistry
    Liverpool University
    Principal Scientist Drying Processes
    Novo Nordisk A / S
    Director primary and secondary Expertise
    GlaxoSmithKline

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    Workshops

    Spray drying and Formulation

    Spray drying and Formulation

    Holiday Inn Regents Park
    1 July 2015
    London, United Kingdom

    An interview with Pierre Lebrun, an experienced Statistician and Project Leader from Arlenda

    Download

    Lyophilisation Europe Attendee List 2015

    Download

    An interview with iFormulate and University of Leeds – Spray Dry Formulation workshop leaders

    Download

    An interview with Sune Klint Andersen, Principle Scientist, Novo Nordisk

    Download

    An interview with Baxter Biosciences

    Download

    Interview on QbD in Lyophilisation with GSK

    Download

    QbD explained by Takeda Principle Scientist, Poul Bertelsen

    Download

    SMi presents it’s global Lyophilisation series for 2015

    Download

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    www.PharmCast.com is the world leading website designed specifically for pharmaceutical, clinical and biotechnology professionals. www.PharmCast.com brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. Visit www.PharmCast.com and discover for yourself why it is so popular among professionals.


    Bioportfolio Limited

    Supporters
    http://www.bioportfolio.com

    BioPortfolio.com is a leading news, information and knowledge resource covering the global life science industries impacted by biotechnology. The site aims to provide the lay person, the researcher and the management executive with a single location to source core information on specific bio-related topics, to collate relevant data associated with each topic and to point the user to relevant knowledge resources


    Pharmalicensing

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    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    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.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    Pharmaceutical Technology

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    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.

    Holiday Inn Regents Park

    Carburton Street
    London W1W 5EE
    United Kingdom

    Holiday Inn Regents Park

    Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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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
    Registered in England - SMi Group Ltd trading as SAE Media Group




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