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Adaptive Designs

<p>SAE Media Group&nbsp;is proud to announce the return of its <strong>9th Annual Adaptive Designs in Clinical Trials </strong>conference&nbsp;on the <strong>3rd - 4th April 2017&nbsp;</strong>in London!</p> <p>&nbsp;</p> <p><br /> Since the recent advances and successes in <strong>adaptive platform clinical trials</strong>, there has been a rejuvenated interest into adaptive designed approaches. Adaptive designed approaches to clinical trials is an exciting area of biometrics and statistics for recent <strong>statistical and computational advances</strong>, and changes to regulatory frameworks have enabled more complex, robust and flexible clinical trials not previously offered by traditional clinical trial design.</p> <p>&nbsp;</p> <p>This conference will highlight multiple topics within adaptive design encompassing the <strong>new approaches and trends </strong>amongst research and the industry. Topics will include the successes, strengths and pitfalls of key trends within drug development such as Bayesian Strategies, Seamless approaches, Dose-finding studies, and adaptive development programmes. It will also discuss pioneering research and industry-led <strong>case studies of adaptive designed clinical trials </strong>within key therapy areas, such as oncology, and the real life clinical and statistical adaptations these trials have led to.</p>

FEATURED SPEAKERS

Bo Huang

Bo Huang

Director of Biostatistics, Pfizer
James Matcham

James Matcham

Head of Biometrics, Early Clinical Development, AstraZeneca
John Warren

John Warren

Director, Medicines Assessment Ltd
Michael Davies

Michael Davies

Co-Founder & Chief Medical Officer, Blueberry Therapeutics

Alex Sverdlov

Director, Statistical Scientist, Novartis
Alex Sverdlov

Alex Sverdlov has worked as a statistical scientist in biopharmaceutical industry since 2007, in such companies as Novartis, Merck Serono and Bristol-Myers Squibb. He handled clinical trials in neurodegenerative diseases, metabolic disorders, ophthalmology, immunology, and oncology. Alex has been involved in active research on adaptive designs for clinical trials to improve efficiency of drug development. He recently edited a book “Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects” which was published by CRC Press in 2015. Alex holds PhD in Statistical Science from George Mason University.

Bo Huang

Director of Biostatistics, Pfizer
Bo Huang

Dr. Bo Huang is a Director of Biostatistics at Pfizer. Prior to joining Pfizer, Bo received his PhD in statistics from the University of Wisconsin-Madison. He has extensive drug development experiences across all stages of clinical trials and is currently working in the field of immuno-oncology. Beyond projects, Bo has approximately 30 publications in statistical and medical journals, authored 2 book chapters and contributed to over 40 external oral presentations. In addition, he currently holds a patent in the US on cancer research.

Cecile Dubois

Head of Biostatistics, Grunenthal
Cecile Dubois

I am Head of Biostatistics at Grünenthal in Aachen (Germany), a company I joined in 2011. My team is responsible for ensuring comprehensive statistical input to optimize Grünenthal Innovation from early development to submission and life cycle management. I have more than 25 years of experience as a biostatistician in clinical trials. Among other companies, I have worked at Merck Sharp & Dohme, UCB, GSK and Janssen Pharmaceutica (now Johnson & Johnson). I have experience in all four phases of clinical trials in areas such as allergy and asthma, cardiovascular, CNS, pain, inflammatory disease and osteoporosis. I have been involved in discussions with Health Authorities such as the EMEA, FDA and KIKO in Japan to develop clinical products. Additionally, I have supported NDA approvals for a number of products and have collaborated within and across various disciplines to deliver robust statistical analyses for the optimization of the labeling and approval of medical products.

Christine Fletcher

Executive Director Biostatistics, Amgen
Christine Fletcher

Chrissie is a Regional Head in Global Biostatistical Science at Amgen and she leads a Health Technology Assessment (HTA) Biostatistics group. Chrissie has worked in the Pharmaceutical Industry for over 25 years and has experience of developing and commercialising new medicines from a variety of therapeutic areas across all phases of clinical development.

Chrissie is currently the Vice-President of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI), and co-chair of the Clinical Development Expert Group for the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Chrissie is a Chartered Statistician and Chartered Scientist of the Royal Statistical Society (RSS). Chrissie has an MSc in Applied Statistics and a BSc (Hons) in Statistics with Management Science Techniques.
 

Christopher Jennison

Professor of Statistics, University Of Bath
Christopher Jennison

Christopher Jennison is Professor of Statistics at the University of Bath, UK. His PhD research at Cornell University concerned the sequential analysis of clinical trials and he has continued to work in this area for the past 30 years. His book with Professor Bruce Turnbull, "Group Sequential Methods with Applications to Clinical Trials", is a standard text on this topic and is widely used by practising statisticians.

Professor Jennison's research is informed by experience of clinical trial analysis at the Dana Farber Cancer Institute, Boston and a broad range of consultancy with Medical Research institutes and Pharmaceutical companies.

Emmanuel Pham

VP Biometrics, Ipsen
Emmanuel Pham

MD and statistician, I have been working for French University, Public Hospital and French Agencies for 10 years (in Particular in Pharmacovigilance and Poison Centers) before joining the Pharmaceutical Industry. I have been working successively for Pierre Fabre, Gencell/Centelion (Spin-off from Aventis) and Sanofi-Aventis. I joined Ipsen in 2010 as Head of Research and Translational Biostatistics. I am now Vice-President Biometry, managing Statistics, Data-management and Medical Writing team Worldwide. My experience includes management of Data and Analysis for Project from Research, CMC, Toxicology, Clinical Trials, Post-Marketing Trials, Pharmacovigilance, Genomic, BioMarkers, and more.

Frank Fleischer

Principal Methodology Statistician, Boehringer Ingelheim
Frank Fleischer

After having studied mathematics as well as business mathematics in Milwaukee and Ulm, respectively, Frank has received his PhD in statistics from Ulm University in 2007. Afterwards he acted as a project statistician for several years mostly working in oncology, immunology and biosimilars. Currently he is part of the biostatistics group at Boehringer Ingelheim as a principal methodology statistician. In this role he is working on methodological questions regarding adaptive designs, dose finding and Bayesian statistics and is supporting several projects across different therapeutic areas.
He has published several articles and book chapters on topics like multi-stage modelling in oncology, quality of central adjudication processes and spatial statistics. Apart from that he is giving lectures on topics like adaptive designs, Bayesian statistics and general clinical trial design.
 

Giacomo Mordenti

Head of Global Biometrics, Livanova
Giacomo Mordenti

After the degree in statistical sciences from the University of Florence (1998), Giacomo stared his career in drug development in Menarini where he was exposed to different therapeutic areas and development phases. In 2007 he moved to Geneva to join Merck Serono, where he lead a biostatistical team dedicated to early development in oncology. In 2013 Giacomo joined Grunenthal as global head of Biostatistics. In 2016 he moved to medical device industry in Livanova as Head of Global Biometrics. Since 2011 he is part of the scientific board of European Statistical Forum; since 2013 he is part of the European Statistical Leader group of EFSPI. His main research interests are in the field of Bayesian statistics, adaptive design and advanced safety analysis.

James Matcham

Head of Biometrics, Early Clinical Development, AstraZeneca
James Matcham

James Matcham joined AstraZeneca in November 2013 as the Head of Early Clinical Development Biometrics, where he has led the development of the group to specialise in early clinical trial design, decisions and analysis. After completing his MSc in Statistics at Imperial College, London, he began his career as a Research Fellow at the Applied Statistics Research Unit at the University of Kent, UK working for 5 years in various applications of statistics but particularly in the area of clinical cross-over trials, linear and non-linear modelling and Bayesian methods. He then completed 21 years at Amgen where he worked on the development and regulatory/reimbursement approval of many of their biotechnology products, representing the company at regulatory submissions in the US and the EU. His last few years there were spent working to improve literature review, the use of adaptive and early phase design, network meta-analysis, Bayesian methods and quantitative decision making.
James is a Chartered Statistician of the Royal Statistical Society has been a member of UK society for Pharmaceutical Statisticians (PSI) for 30 years, serving on the Scientific and Training Committees as well as the Board of Directors. He has also served on the Professional Affairs Committee of the Royal Statistical Society and the Scientific Committee of the European Federation of Pharmaceutical Statisticians.

John Warren

Director, Medicines Assessment Ltd
John Warren

John Warren is a clinical scientist who established Medicines Assessment Ltd as a pharmaceutical consultancy in 2011 (www.medicinesassessment.com).
He advises multiple pharmaceutical companies on clinical development.

He trained in medicine at Guy’s Hospital, where he wrote a thesis on the human physiology of epinephrine. He worked for the UK Medicines Healthcare products Regulatory Agency (MHRA) as an Expert Medical Assessor from 1995-2010 evaluating new drug applications for Europe across the therapeutic spectrum. Member of the European Scientific Advice Working Party 2003-2010; Pharmacokinetic Subgroup of the Efficacy Working Party 2007-2008. He contributed to the EU Notes for Guidance on Asthma, COPD, ARDS and Bioequivalence. When appointed to the MHRA in 1995 he took a concomitant Honorary Senior Lectureship in Clinical Pharmacology at St Thomas' Hospital.

Previously a Senior Lecturer at the National Heart and Lung Institute, with Honorary Consultant status at the Brompton, Charing Cross and Chelsea & Westminster Hospitals, 1990-1994. This followed a Senior Registrar post in Clinical Pharmacology at the Royal Postgraduate Medical School 1986-1990.

Specialist UK accreditation was granted in General Medicine, Clinical Pharmacology and Cardiology. He is the author of over 100 publications on pharmacology and a book on the Endothelium.

Guest speaker at the 2010 Annual Austrian Pharmacological Society meeting. British Pharmacology Society Speaker/Visitor at the 2013 Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists. For a review of drug development please see "Drug Discovery: Lessons from Evolution" BJCP 2011;71:497-503.

Previously a Member of the Editorial Board of Clinical Pharmacology & Therapeutics and Microvascular Research. Currently Executive Editor for British J Clinical Pharmacology and member of the Joint Speciality Committee for Clinical Pharmacology of the Royal College of Physicians, London.
 

Loic Darchy

Head of Statistical Methodology Group, Sanofi R&D
Loic Darchy

Loïc has been working in the pharmaceutical industry for almost 30 years in various companies. He held senior statistician positions, management positions in Biostatistics and more recently he switched to the statistical expertise field as head of statistical methodology group at Sanofi &D. He is located in Paris. His favorite research topics are adaptive designs (especially adaptive population enrichment designs and biomarker-based designs), handling of multiplicity in clinical trials, missing data, meta-analyses, dose-finding designs and analyses and use of data learning techniques for clinical development.

Michael Davies

Co-Founder & Chief Medical Officer, Blueberry Therapeutics
Michael Davies

Mike Davies is an experienced and competent professional with a significant record in all Phases of drug development whose career development to date has been achieved through an inherent thirst for knowledge and desire to achieve high impacting results that continually make a difference. Mike is the co-founder of Blueberry Therapeutics a company focussed on the nano-formulation of drugs and peptides to treat infection and inflammation. Mike has taken Blueberry’s first compound into clinic development utilising a regulatory “approved adaptive process” with the aim of reaching NDA within 3 years. Mike can be contacted at www.blueberrytherapeutics.com

Olivier Collignon

Seconded National Expert – European Medicines Agency (EMA), Luxembourg Institute of Health
Olivier Collignon

Dr Olivier Collignon is statistics consultant for researchers at LIH and external groups.

He is currently seconded at the European Medicines Agency in London, where he participates to the scientific evaluation of the design and results of clinical trials to obtain marketing authorization of new drugs in Europe. He is especially interested in adaptive designs and the use of historical controls.

His expertise also consists in developing variable selection algorithms and supervised classification methods to help biologists find new biomarkers and risk factors of different diseases, especially in cardiology and oncology. Dr Collignon has been involved in the National Cancer Registry of Luxembourg.
 

Simon Kirby

Senior Director, Pfizer
Simon Kirby

Simon Kirby is a Senior Director in the Statistical Research and Consulting Centre at Pfizer. He has worked for Pfizer for more than 17 years after previously holding the position of Principal Lecturer in Statistics at Liverpool John Moores University. He has also previously worked as a Statistician at the Institute of Food Research in the UK, Rothamsted and Revlon Healthcare. Simon has undergraduate degrees in Economics and Economic Policy and Mathematics and MSc and PhD degrees in Statistics.

Tom Parke

Director of Software Solutions, Berry Consultants, LLP
Tom Parke

Tom Parke is Director of Software Solutions for Berry Consultants. Tom’s passion and experience has been software for adaptive clinical trials. Prior to joining Berry Consultants, he was Head of Clinical Trial Solutions for Tessella Ltd. While at Tessella for nearly 20 years, he managed the development and running of the software system to support Pfizer’s ASTIN Stroke trial, and has setup multiple software systems to support different aspects of many adaptive clinical trials, mostly designed by Berry Consultants. In parallel, he managed projects to develop clinical trial simulators, first with Pfizer, then Wyeth, before acting as the expert advisor and reviewer to the joint development of FACTS with Berry Consultants. Prior to working at Tessella, he worked for Inmos, Imperial Software Technology, and Praxis on compilers, operating systems and real time control systems. He graduated with a Joint First Class Honours in Math and Computer Science from Bristol University in 1979.

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Alex Sverdlov, Director, Statistical Scientist, Novartis

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9:10

Adaptive multi-arm randomisation approaches and methodology to clinical trials

Alex Sverdlov, Director, Statistical Scientist, Novartis

  • Methodology for applying randomisation approaches to clinical trials
  • Applying multi-arm randomisation to drug development
  • Examples of randomisation application and methodology
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    9:50

    Hot topics and case studies in adaptive designs from a company’s perspective

    Frank Fleischer, Principal Methodology Statistician, Boehringer Ingelheim

  • Towards an adaptive platform based approach in oncology dose finding
  • Statistical Go / NoGos and alternative development pathways
  • Adaptive designs in the biosimilar framework
  • Case studies
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    10:30

    Morning Coffee & Networking Break

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    11:00

    Adaptive aspects in clinical development in Grünenthal

    Cecile Dubois, Head of Biostatistics, Grunenthal

  • Single trials with adaptive design vs adaptive nature of clinical development programs
  • Adaptive trial design aspects specific to indication pain/drug class opioids
  • Case studies of trials with adaptive designs in GRT
  • clock

    11:40

    Adaptive design: Historical perspective of how it arose

    John Warren, Director, Medicines Assessment Ltd

  • What was the old system?
  • Why was it insufficient?
  • What happens next?
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    12:20

    Networking Lunch

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    13:30

    Bayesian adaptive design in device development

    Giacomo Mordenti, Head of Global Biometrics, Livanova

  • The adaptive design of device clinical trials
  • Operational and logistical pitfalls common in device development
  • Important differences to consider between adaptive device and drug development
  • Case studies of Bayesian statistics in practise in devices
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    14:10

    Adaptive clinical development: From patient to market

    Michael Davies, Co-Founder & Chief Medical Officer, Blueberry Therapeutics

  • Adaptive clinical designs can speed development and cut costs
  • Upfront effort is required
  • Talk to the regulators about your ideas
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    14:50

    Testing a secondary endpoint after a group sequential test

    Christopher Jennison, Professor of Statistics, University Of Bath

  • Inference after a group sequential test needs care
  • Some plausible looking methods are not actually valid
  • We describe a general framework for multiple testing in the group sequential setting
  • We discuss testing a secondary hypothesis after stopping to reject the primary null hypothesis
  • clock

    15:30

    Chairman’s Closing Remarks and Close of Day One

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    15:40

    Afternoon Tea & Networking

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    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    James Matcham, Head of Biometrics, Early Clinical Development, AstraZeneca

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    9:10

    Building an adaptive design capability in early development

    James Matcham, Head of Biometrics, Early Clinical Development, AstraZeneca

    Describing the journey at AstraZeneca
    Building skills and confidence in designing adaptive clinical trials
    Implications for early phase decision making

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    9:50

    Adaptive designs: How preclinical, translational and big data can contribute to a better design

    Emmanuel Pham, VP Biometrics, Ipsen

  • Adaptive design often require a model underlying hypotheses
  • Developing these model is not easy when lacking of internal clinical data
  • Preclinical (non-clinical) data can be very useful, but often require to use translational expertise to be used efficiently
  • Big Data is also an incredible source of knowledge, but requires also a careful management to be integrated in a model
     
  • clock

    10:30

    Morning Coffee & Networking Break

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    11:00

    Bayesian adaptive trials for medical device and pharmaceutical trials

    Tom Parke, Director of Software Solutions, Berry Consultants, LLP

  • The design, modelling and simulation of bayesian methods in drug and device clinical trials
  • Platform / Master protocol designs
  • Case studies of bayesian statistics in practise – the EPAD trial
  • Innovative adaptive design to address immediate threats – Ebola trial 2015
  • clock

    11:40

    Adaptive design to check the dose range of a dose-ranging study

    Simon Kirby, Senior Director, Pfizer

    Studies of adaptive dose-ranging designs have not necessarily found advantages for adaptive designs however adaptive designs may have a role to play in checking that the dose range

  • The 3 parameter Emax model and empirical justification for focusing on this model
  • Adaptations to try to ensure that the dose range goes low enough and high enough
  • Simulation study
  • Results of simulation study
  • Conclusions
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    12:20

    Networking Lunch

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    13:30

    PANEL DISCUSSION: Adaptive designs in clinical trials from scientific advice to marketing authorisation: Lessons learnt from submissions to regulatory agencies

  • Analysis of the adaptive elements used in the design and their impact on trial success
  • Discussion of the potential regulatory concerns
  •  

     

    Alex Sverdlov, Director, Statistical Scientist, Novartis

    Olivier Collignon, Seconded National Expert – European Medicines Agency (EMA), Luxembourg Institute of Health

    Emmanuel Pham, VP Biometrics, Ipsen

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    14:10

    Enrichment designs in oncology

    Loic Darchy, Head of Statistical Methodology Group, Sanofi R&D

  • Overview of enrichment designs in statistical literature
  • Opportunities and challenges of enrichment design in oncology target therapies and development
  • Case Studies for adaptive enrichment
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    14:50

    Afternoon Tea & Networking

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    15:20

    Adaptive dose finding designs in oncology early phase trials: An industry experience

    Bo Huang, Director of Biostatistics, Pfizer

  • Overview of adaptive early dose-finding studies
  • A time-to-event continual reassessment method with adaptive weight function incorporating cyclical data
  • The practical implications of adaptive design on Pfizer oncology drug development with two case studies
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    16:00

    ICH E9(R1) and adaptive designs

    Christine Fletcher, Executive Director Biostatistics, Amgen

  • Introduce the new estimand and sensitivity analysis framework
  • Consider if the new framework will impact the design, conduct, analysis and reporting of adaptive trials
  • Discuss whether any new unique challenges will be introduced by the framework
  • clock

    16:40

    Chairman’s Closing Remarks and Close of Day Two


    Director, Statistical Scientist
    Novartis
    Director of Biostatistics
    Pfizer
    Head of Biostatistics
    Grunenthal
    Executive Director Biostatistics
    Amgen
    Professor of Statistics
    University Of Bath
    VP Biometrics
    Ipsen
    Principal Methodology Statistician
    Boehringer Ingelheim
    Head of Global Biometrics
    Livanova
    Head of Biometrics, Early Clinical Development
    AstraZeneca
    Director
    Medicines Assessment Ltd
    Head of Statistical Methodology Group
    Sanofi R&D
    Co-Founder & Chief Medical Officer
    Blueberry Therapeutics
    Seconded National Expert – European Medicines Agency (EMA)
    Luxembourg Institute of Health
    Senior Director
    Pfizer
    Director of Software Solutions
    Berry Consultants, LLP

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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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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