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Clinical Trial Logistics

The clinical trial logistics world is accelerating rapidly with trials now occurring in more than 13 strategic and emerging markets with eyes on the improvement of global health and patient care. The demand for clinical trial supply and logistics has gone global with increased outsourcing, with a predicted forecast of $14.3bn by 2017. The market demand has impacted supply chain management and our aim at the SAE Media Group is to provide a conference that will enable key opinion leaders to discuss, assess and analyse supply chain security, temperature monitoring and reflect on the globalisation of clinical trial logistics.

FEATURED SPEAKERS

Alan Dorling

Alan Dorling

Global Head - Pharmaceuticals & Life Sciences, IAG Cargo
Andrea Gruber

Andrea Gruber

Manager Business Process & Standards, IATA
Beth Freeman

Beth Freeman

Senior Program Manager, Global Clinical Trial Supply Chain, Takeda
Brice Bellin

Brice Bellin

Healthcare Regional Manager - Europe, SDV
Janice Kite

Janice Kite

Tracibility Director Healthcare , GS1
Nimer Yusef

Nimer Yusef

CEO, Trial-Brain
Olivier Simonnot

Olivier Simonnot

Strategic Market Manager, Sensitech
Sebastien Coppe

Sebastien Coppe

Head of Consulting Group, N-SIDE
Sylvie Noirault

Sylvie Noirault

Project Head, Clinical Supplies, Sanofi R&D
Tom  Harrington

Tom Harrington

Sales and Distribution Manager , Cryopak Europe
Tony Heeley

Tony Heeley

Director, Business Development CTSL, PAREXEL
Tony Wright

Tony Wright

Managing Director, Exelsius Cold Chain Management
Vladimir Anisimov

Vladimir Anisimov

Senior Strategic Biostatistics Director, Quintiles

Alan Dorling

Global Head - Pharmaceuticals & Life Sciences, IAG Cargo
Alan Dorling

Andrea Gruber

Manager Business Process & Standards, IATA
Andrea Gruber

Beth Freeman

Senior Program Manager, Global Clinical Trial Supply Chain, Takeda
Beth Freeman

Brice Bellin

Healthcare Regional Manager - Europe, SDV
Brice Bellin

Janice Kite

Tracibility Director Healthcare , GS1
Janice Kite

Nimer Yusef

CEO, Trial-Brain
Nimer Yusef

Olivier Simonnot

Strategic Market Manager, Sensitech
Olivier Simonnot

Sebastien Coppe

Head of Consulting Group, N-SIDE
Sebastien Coppe

Sylvie Noirault

Project Head, Clinical Supplies, Sanofi R&D
Sylvie Noirault

Tim Wood

Technical Service Manager, GlaxoSmithKline
Tim Wood

Tom Harrington

Sales and Distribution Manager , Cryopak Europe
Tom  Harrington

Tony Heeley

Director, Business Development CTSL, PAREXEL
Tony Heeley

Tony Wright

Managing Director, Exelsius Cold Chain Management
Tony Wright

Vladimir Anisimov

Senior Strategic Biostatistics Director, Quintiles
Vladimir Anisimov

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairs Opening Remarks

Tony Wright

Tony Wright, Managing Director, Exelsius Cold Chain Management

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9:10

A risk based monitoring approach for non-cold chain temperature-sensitive IMP products

Tim Wood

Tim Wood, Technical Service Manager, GlaxoSmithKline

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9:50

FOCUS SESSION - Simulation based decision-making for Clinical Trial Supply

Sebastien Coppe

Sebastien Coppe, Head of Consulting Group, N-SIDE

Take the best decisions throughout your study:

·          Efficient study design

·          Optimised production plan and IRT settings

·          Controllable risk 

·          Cross-departments communication points

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10:30

Morning Coffee

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11:00

GS1 Standards: Relevant to the global pharmaceutical supply chain?

Janice Kite

Janice Kite, Tracibility Director Healthcare , GS1

  • The latest in GS1 developments
  • Daily interaction is natural and unnoticed
  • Enabling regulatory compliance, supply chain security AND Patient Safety!
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    11:40

    Predictive analytics in risk-based monitoring of trial operations

    Vladimir Anisimov

    Vladimir Anisimov, Senior Strategic Biostatistics Director, Quintiles

  • Major uncertainties and risks in trial operation
  • Predictive enrolment & event’s and trial performance modelling
  • Risk-based modelling of trial costs and supply chain
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    12:20

    Networking Lunch

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    13:30

    Challenges in air freighting Clinical Trial Products across a global network

    Alan Dorling

    Alan Dorling, Global Head - Pharmaceuticals & Life Sciences, IAG Cargo

  • What has been the impact of the new EU GDP Guidelines for air cargo operators?
  • Building a vertical team for managing Time & Temperature air-freight shipments
  • Achieving Quality & Compliance across a global network
  • Maximising service performance through collaboration
  • clock

    14:10

    Joint Case Study: Global Certification: How to meet challneges and requirements of the pharmaceutical industry

  • What are the risks and the potential gaps along the supply chain affecting clinical trial logistics?
  • Regarding GDPs, what steps are carried out to ensure the requirements are met?
  • Why considering a qualification of global trade lanes from origin to destination under an international recognize certification?
  • Establishing efficient cooperation and communication ensuring a robust network
  • Andrea Gruber

    Andrea Gruber, Manager Business Process & Standards, IATA

    Brice Bellin

    Brice Bellin, Healthcare Regional Manager - Europe, SDV

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    14:50

    Afternoon Tea

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    15:20

    Good Cold Chain Management Practices for Controlled Room Temperature (CRT) Shipments

    Olivier Simonnot

    Olivier Simonnot, Strategic Market Manager, Sensitech

     Ø  Review current global regulatory developments and explore key challenges

    Ø  Outline a methodology to best approach CRT shipments exploring two key concepts : Risk Assessment and Continuous Improvement

    Ø  Define a cost-effective solution for controlled ambient logistics that helps to ensure patient safety, product quality, and regulatory compliance

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    16:00

    ROUND TABLE DISCUSSION - Supply Chain Logistics

    Tony Wright

    Tony Wright, Managing Director, Exelsius Cold Chain Management

  • Assessing how to cut costs in clinical trial supply chain logistics
  • How does this then affect the safety and efficacy of the products 
  •  What strategies can be carried out to ensure materials reach trial sites efficiently and accordingly?
  • clock

    16:40

    Chairs Closing Remarks and Close of Day One

    Tony Wright

    Tony Wright, Managing Director, Exelsius Cold Chain Management

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairs Opening Remarks

    Tim Wood

    Tim Wood, Technical Service Manager, GlaxoSmithKline

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    9:20

    KEYNOTE ADDRESS - An efficient supply chain maintained!

    Sylvie Noirault

    Sylvie Noirault, Project Head, Clinical Supplies, Sanofi R&D

  • Adapt our clinical supply chain to Bio products
  • Adapt our operations to the complexity of supply chain
  • Monitor efficiency of clinical supply chain through activities indicators and costs variance
  • clock

    10:00

    Pharma Supply Chain: Minimising Risk by Maximising Security

    Tom  Harrington

    Tom Harrington , Sales and Distribution Manager , Cryopak Europe

  • Cold Chain Packaging
  • Temperature Controlled Transport
  • Temperature Monitoring
  • Combining these elements for maximum security
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    10:40

    Morning Coffee

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    11:10

    Case Study 1: Partnerships in supporting clinical trial logistics from a pharma perspective

    Beth Freeman

    Beth Freeman, Senior Program Manager, Global Clinical Trial Supply Chain, Takeda

     

  • Analysing how a partnership works, what’s expected and how do you an maintain supply and demand
  • Evaluating what should be taken into consideration when developing and managing supplier networks to develop robust partnerships internally and externally
  •  Assessing how to deal with the current hurdles in the globalisation of Clinical Trial Logistics
  • clock

    11:50

    Case Study 2: Partnerships in the clinical trial supply chain

    Tony Heeley

    Tony Heeley, Director, Business Development CTSL, PAREXEL

  • How suppliers can support planning, operations and logistics
  • Working together to forecast and model to maintain supply and demand
  • Developing and managing supplier networks to develop robust partnerships internally and externally
  • clock

    12:30

    Networking Lunch

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    13:30

    ROUND TABLE DISCUSSION - How to integrate new technologies into IT-Systems for Clinical Logistics

    Nimer Yusef

    Nimer Yusef, CEO, Trial-Brain

    clock

    14:30

    Afternoon Tea

    clock

    15:00

    Panel Discussion - Partnering in Clinical Trial Supply

  • Planning and forecasting of outsourced trials to meet stimulated demand with great patient stratification playing a part
  • Working together to forecast and model to maintain supply and demand
  • Developing and managing supplier networks to develop robust partnerships internally and externally
  • Andrea Gruber

    Andrea Gruber, Manager Business Process & Standards, IATA

    Beth Freeman

    Beth Freeman, Senior Program Manager, Global Clinical Trial Supply Chain, Takeda

    Tony Heeley

    Tony Heeley, Director, Business Development CTSL, PAREXEL

    Tim Wood

    Tim Wood, Technical Service Manager, GlaxoSmithKline

    clock

    15:30

    Chairs Closing Remarks and Close of Day Two

    Tim Wood

    Tim Wood, Technical Service Manager, GlaxoSmithKline


    Global Head - Pharmaceuticals & Life Sciences
    IAG Cargo
    Technical Service Manager
    GlaxoSmithKline
    Sales and Distribution Manager
    Cryopak Europe
    Director, Business Development CTSL
    PAREXEL
    Managing Director
    Exelsius Cold Chain Management
    Senior Strategic Biostatistics Director
    Quintiles
    Strategic Market Manager
    Sensitech
    Manager Business Process & Standards
    IATA
    Senior Program Manager, Global Clinical Trial Supply Chain
    Takeda
    Healthcare Regional Manager - Europe
    SDV
    Tracibility Director Healthcare
    GS1
    CEO
    Trial-Brain
    Head of Consulting Group
    N-SIDE
    Project Head, Clinical Supplies
    Sanofi R&D

    Sponsors and Exhibitors

    Official Media Partner

    Key Media Partners

    Supporters

    Attendee list for Clinical Trial Logistics 2015: Is your name on the list?

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    Brice Bellin, Healthcare Regional Manager - Europe, SDV

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    Janice Kite, Traceability Director Healthcare, GS1

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    Sylvie Noirault, Projects Head, Clinical Supplies, Sanofi

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    Sponsors and Exhibitors


    ADAllen Pharma

    Sponsors and Exhibitors
    http://www.adallenpharma.com

    ADAllen Pharma is a specialist supplier of comparator drugs and ancillaries for clinical trials, offering a comprehensive first-rate service, with a proven track record. The ADAllen team has a thorough understanding of the global pharma market and a sound understanding of the many complexities involved in sourcing comparator drugs to ensure your project is successful.


    Berlinger & Co. AG

    Sponsors and Exhibitors
    http://www.berlinger.com/

    Swiss family run manufacturer of temperature monitoring devices, with over 30 years’ experience in the pharmaceutical industry. Wide range of products ranging from temperature indicators, data loggers and site monitoring devices including Fridge monitoring. SmartView is Berlinger’s cloud based data management system, combining site monitoring and shipment monitoring under 1 platform. Range of products: Temperature Indicators, Temperature Monitors: Data loggers, Wireless site Monitoring devices (including Fridge Monitoring, Real Time tracking devices, SmartView: Cloud based data management system, combining facility and shipment monitoring under 1 platform.


    Bilcare Limited

    Sponsors and Exhibitors
    http://bilcare.com

    Bilcare GCS is a first of its kind company having started the clinical trial material services in Asia

    • Bilcare GCS is engaged in offering unmatched Clinical Trial Materials Supplies (CTMs) services to the Pharmaceutical , Biotech and consumer health industry

    • Bilcare GCS provides a trusted, reliable, secure network at every stage of Clinical Trial Life Cycle by understanding your precise requirements.

    • An ISO certified company for clinical trial materials support and services since 3 decades.

    • Bilcare GCS is a trusted company for packaging and distribution of clinical material supplies & services.

    • Bilcare GCS partners with more than 25 GMP compliant depots across the globe and has built a reliable network of Clinical Trial Manufacturers and Suppliers.

    • Bilcare GCS offers next generation anti-counterfeiting labeling and intelligent packaging Solutions


    Cryopak

    Sponsors and Exhibitors
    http://www.cryopak.com

    Cryopak is dedicated to producing quality solutions to pharma and life science organizations for the safe transportation of medicines. Equipped for the design and manufacture of cold chain packaging, refrigerants and monitoring devices, Cryopak is well placed to be a valuable partner to the Pharma & Life Science industries.


    ELPRO

    Sponsors and Exhibitors
    http://www.elpro.com/

    ELPRO, founded in 1986, is a globally active Swiss provider of solutions for monitoring environmental conditions throughout the supply chain of perishable goods. While the focus is on pharmaceutical, healthcare, biobanking & life-science industry, ELPRO serves a wide range of industries. Whenever temperature, humidity, pressure, or any other environmental condition is key to the quality of products during production, storage or transport: ELPRO cares for efficiency and compliance. Monitoring means to measure, record, and manage data and – based upon stability criteria – assess the data for release or alarm.


    PHSE

    Sponsors and Exhibitors
    http://www.phse.com

    PHSE is a global biopharmaceutical courier and freight forwarder offering optimal solutions to ship and handle worldwide temperature sensitive or urgent materials such as IMP, API and finished products including DG products. We offer a complete tailored service including validated packaging systems for all temperature ranges, using its own packaging manufacturing plant in Italy, with repositories worldwide. Coupled with active cool chain, documentation, customs brokerage and storage & distribution solutions, making PHSE your ‘one stop shop'


    Sensitech

    Sponsors and Exhibitors
    http://www.sensitech.com

    Sensitech is focused on delivering supply chain visibility solutions that track, monitor and protect products for global leaders in the food, life sciences, consumer goods, and industrial markets. Our solutions are focused in three key areas: quality and compliance, supply chain security, and logistics performance management. Quality and compliance solutions address temperature-sensitive, complex supply chains focused on delivering the highest quality possible, while our supply chain security solutions help to mitigate risks associated with theft, diversion and chain of custody. Sensitech’s logistics performance solutions deliver origin-to-destination, real-time transparency to any in-transit journey.


    Sonoco ThermoSafe

    Sponsors and Exhibitors
    http://www.thermosafe.com

    Sonoco ThermoSafe understands the unique challenges and requirements when shipping temperature sensitive material for clinical trials. Whether shipping biologics, unique compounds, specialty pharmaceuticals, comparator drugs, specimens, or bulk product, our vast array of industry proven solutions are designed specifically to integrate into simple or complex closed-loop supply chains...because every degree mattersTM.


    Testo

    Sponsors and Exhibitors
    http://www.testo.com/en

    For 60 years, Testo has been known for creating innovative measuring solutions made in Germany. In 33 subsidiary companies around the world, 2,750 employees research, develop, produce and market for the high-tech company. Products from Testo help to save time and resources, to protect the environment and the health of humans, and to increase the value of goods and services. The average annual growth is over 10 % since founding in 1957, and the current turnover is more than a quarter of a billion Euros. Testo invests about a tenth of the annual turnover in Research & Development.


    TSS

    Sponsors and Exhibitors
    http://tss.se

    TSS is a leading provider of temperature monitoring solutions with more than 20 years of experience within the life science industry. Thanks to close customer interaction and an outstanding technological know-how, TSS is able to continuously introduce pioneering solutions for end-to-end supply chain visibility, facilitating the daily operations for global pharma companies around the world. TSS' cloud-based temperature monitoring system, CCIS, is developed in close collaboration with leading pharma companies. CCIS is a lean and integrated solution that provides flexibility, simplicity, reliability, and above all, full visibility, throughout the whole organization. By focusing on information, TSS enables decision makers all over the world to gain insight into the modern supply chain in order to develop an all-encompassing corporate strategy for fast and intelligent temperature monitoring. This in turn results in greater efficiency and reduced costs, while allowing for compliance with regulatory requirements.

    Media Partners


    Supply Chain Management Association (SCMA)

    Official Media Partner
    http://www.scmanational.ca

    The premier association in Canada for professionals in supply chain management, the Supply Chain Management Association (SCMA) is the national voice for advancing and promoting the profession. With nearly 8000 members working across the private and public sectors, SCMA is the principal source of supply chain training, education and professional development in the country. Through its 10 Provincial and Territorial Institutes, SCMA grants the Supply Chain Management Professional (SCMP) designation, the highest achievement in the field and the mark of strategic supply chain leadership. The SCMP is a globally recognized designation and has reciprocity with the MCIPS in the UK and with the CPSM in the U.S.

    Media Partners


    WCA Pharma

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

    The Members within WCA Pharma all have dedicated personnel fully conversant in the GDP guidelines required for the special handling of Pharmaceutical products. All have the attention to detail required that has seen them become established and recognized by the leading Pharma Industries throughout the world. From Clinical trials, Biotech, Plasma, Laboratory, Health Care, Chilled, Frozen, Controlled Ambient, Packaging, Air, Ocean and Land, you have all Pharmaceutical clusters contained within one exclusive network. Our members are able to pass on their knowledge to clients and use their skills, trust and experience in ensuring all products arrive on time and in the perfect condition. Making sure products are shipped via the correct method, temperature, atmosphere and under controlled conditions ensures these valuable shipments have the care and attention whilst being handled that they deserve.

    Media Partners


    KONGPOSH Publications

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    KONGPOSH Publications is one of India’s leading Pharma Publishers. The Pharma Review® is a bi-monthly article based journal covering various fields of pharmacy. Participation and distribution in over 30 Expos & Conferences worldwide each year. It is widely read by decision makers, middle management and the academia. Also available in E-book format. Other publications : Indian Pharma Reference Guide (Annual) – Names and address of Pharmaceuticals, Bulk Drugs, Machinery’s & Instrumentation, AYUSH Manufacturers; and much more; High Performance Thin Layer Chromatography; Elements of Pharmacovigilance; Regulation of Clinical Trials; AYUSH (CD); NDDS/AMD (CD)


    Gate2Biotech

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    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


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    FierceBiotech is the biotech industry's daily monitor. Biotech executives rely on FierceBiotech to stay up to speed on biotech corporations, FDA approvals & regulations, industry mergers & acquisitions, clinical trials, and more. Beyond the news of the day, our editors produce in-depth features on industry leaders and up-and-comers, the regulatory environment, and market trends. In addition to our comprehensive website and free email newsletter, you have the opportunity to attend our webinars, peruse our whitepaper library and benefit from our eBooks. Advance your career through our exclusive networking parties and life sciences job board.


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    Journal for Clinical Studies – Your Resource for Multisite Studies & Emerging Markets

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    Published bi-monthly.JCS is a unique journal, dedicated to providing information to the global pharmaceutical, biotechnology, medical devices and contract research organisations. JCS details practical and theoretical operational procedures, challenges, validatory and regulatory guidelines when conducting trials on a multisite basis and particularly within the emerging markets, naïve patient population, and remote access areas. JCS provides country by country objectives and uniquely brings you experiences in therapeutic areas of Liver diseases, kidney diseases, insect borne diseases, malnutrition and under nutrition. JCS is led by a strong editorial advisory board sourced out for their experiences; you will get the most practical insight for your global studies. JCS invites you to join us, write for us, feature your experiences with us, advertise your capabilities with us, and ask our advisory board for suggestions and guidelines. Let us make health care available to all.


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    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


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    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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    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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