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Biosimilars Europe
29 September - 30 September 2016
Biosimilars Europe

SAE Media Group’s 7th annual Biosimilars Europe conference returns to London this September!

The development of the Biosimilars market is growing exponentially with the industry forecast to be worth $25 billion by 2020. With the regulatory landscape evolving rapidly, it is important to understand the developments in the biosimilar guideline framework and the cohesion in legislation between Europe and the US.

With Europe leading the way in the field of Biosimilar development, it is important to get to grips with all areas in the product lifecycle from early stage developments, protein characterisation and analytical comparability to patent litigation, market access, pricing and reimbursement through to emerging markets and global developments. Every angle should be considered and taken account for through the development process and with the EU the most advanced market for biosimilars, accounting for 80% of global spending on these molecules, the learning curve for biosimilars is essentially still building and there are hurdles to overcome.

FEATURED SPEAKERS

Andrea Laslop

Andrea Laslop

Head of Scientific Office, Austrian Agency for Health and Food Safety
Atanas Dimitrov

Atanas Dimitrov

Head of Merck Biosimilars Strategy & Portfolio, Merck Group
Huiguo Hu

Huiguo Hu

General Manager of International Business , 3SBio Pharmaceutical Group
Joan O'Callaghan

Joan O'Callaghan

Research Scientist for Regulatory Science Ireland, Health Products Regulatory Authority
Niraj Chhaya

Niraj Chhaya

Senior Risk Management Physician, Boehringer Ingelheim GmbH

Ad Rietveld

Director, RJW & Partners Ltd
Ad  Rietveld

Alan Sheppard

Principal, Global Generics and Biosimilars, IMS Health
Alan Sheppard

Alok Sharma

Principal Scientist & Head Analytical Development , Lupin Limited
Alok Sharma

Andrea Laslop

Head of Scientific Office, Austrian Agency for Health and Food Safety
Andrea Laslop

Atanas Dimitrov

Head of Merck Biosimilars Strategy & Portfolio, Merck Group
Atanas Dimitrov

Denis Kent

Consultant, Thought Leadership, IMS Health
Denis Kent

Dirk Kreder

Founder and CEO, Anteris Medical GmbH
Dirk Kreder

Dominic Adair

Partner, Bristows LLC
Dominic Adair

Gary Bembridge

Director Scientific Affairs, Abzena
Gary  Bembridge

Huiguo Hu

General Manager of International Business , 3SBio Pharmaceutical Group
Huiguo Hu

Jim Nelson

Senior Shareholder and Principal, Schwegman Lundberg Woessner
Jim Nelson

Joan O'Callaghan

Research Scientist for Regulatory Science Ireland, Health Products Regulatory Authority
Joan O'Callaghan

Luis Borlido

Lab Head Characterization, Sandoz International GmBH
Luis Borlido

Mourad Farouk Rezk

Global Head Medical Affairs Biosimilars, Biogen
Mourad  Farouk Rezk

Niraj Chhaya

Senior Risk Management Physician, Boehringer Ingelheim GmbH
Niraj Chhaya

Steinar Madsen

Medical Director, Norwegian Medicines Agency
Steinar Madsen

Virginia Acha

Executive Director and Research, Medical and Innovation, ABPI
Virginia Acha

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Virginia Acha

Virginia Acha, Executive Director and Research, Medical and Innovation, ABPI

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9:10

The importance of early immunogenicity and Product Quality (PQA) assessment in biosimilar development

Gary  Bembridge

Gary Bembridge, Director Scientific Affairs, Abzena

 

• Understanding the causes and variations of immunogenicity between biosimilars and originators
• Methods for preclinical immunogenicity and PQA assessment for early comparative analysis
• De-risking approaches for biosimilars and biobetters
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9:50

The effects of biosimilar competition across Europe

Ad  Rietveld

Ad Rietveld, Director, RJW & Partners Ltd

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10:30

Morning Coffee

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11:00

Bringing biosimilars closer to patients and healthcare professionals

• Ten years on: the priority is to create trust and value among stakeholders
• Removing the barriers to access by partnering for education and post marketing evidence generation is key
• Biogen: going beyond clinical and scientific excellence to build confidence and real-life experience
 

Mourad  Farouk Rezk

Mourad Farouk Rezk, Global Head Medical Affairs Biosimilars, Biogen

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11:40

Strategies to enter the emerging markets

Huiguo Hu

Huiguo Hu, General Manager of International Business , 3SBio Pharmaceutical Group

  • Regulation situation and guidelines listing
  • Pricing and reimbursement
  • Challenges and key success factors
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    12:20

    Networking Lunch

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    13:20

    Biosimilars – the second translational gap

    Virginia Acha

    Virginia Acha, Executive Director and Research, Medical and Innovation, ABPI

  • Incorporating biosimilars into healthcare practice is the next translational challenge
  • In the UK, NHS England leads a multi-stakeholder coordinating group to address this
  • Success through training and guidance and effective competition is delivering results
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    14:00

    CASE STUDY: The emerging biosimilars asset class – strategy & portfolio management in a VUCA (Volatile, Uncertain, Complex & Ambiguous) world

    Atanas Dimitrov

    Atanas Dimitrov, Head of Merck Biosimilars Strategy & Portfolio, Merck Group

  • Optimally leverage the unique characteristics of the biosimilars asset class:

                         -the lower risk vs original biologics while in a steady state expecting higher margin then in consumer healthcare
                         -the unique breadth of options for in-licensing compared to novel pharmaceuticals, i.e. potential to secure more shots at the goal

  • Create a strategically agile organizational set-up for biosimilars with a high degree of decision autonomy, strong & long-term commitment from senior management 
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    14:40

    Afternoon Tea

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    15:10

    Recent trends in the development of biosimilars and evaluation of analytical biosimilarity

    Luis Borlido

    Luis Borlido, Lab Head Characterization, Sandoz International GmBH

  • QbD driven development. Strategies for criticality assessment
  • Statistical similarity data evaluation
  • Challenges of equivalence testing
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    15:50

    Biologics and biosimilars: Trends and challenges

  • Drivers and penetration across different markets
  • Therapeutic positioning and need for cost savings
  • Effect of competition, originator response and first to market opportunities
  • Alan Sheppard

    Alan Sheppard, Principal, Global Generics and Biosimilars, IMS Health

    Denis Kent

    Denis Kent, Consultant, Thought Leadership, IMS Health

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    16:30

    Analytical Strategies in biosimilar development

    Alok Sharma

    Alok Sharma, Principal Scientist & Head Analytical Development , Lupin Limited

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    17:10

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Virginia Acha

    Virginia Acha, Executive Director and Research, Medical and Innovation, ABPI

    clock

    9:10

    European regulatory update for biosimilars

    Andrea Laslop

    Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety

  • Latest revisions of biosimilar guidelines
  • How much clinical evidence do we need
  • Lessons learned from recent approvals in Europe
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    9:50

    How can you beat the shark: end around play for the us legal battle of pharma and biotech

    Jim Nelson

    Jim Nelson, Senior Shareholder and Principal, Schwegman Lundberg Woessner

  • Traditional and new market view – worldwide
  • Alternative to BPCIA –biosimilars in USA
  • Mapping and use of IPR offensively and defensively (guide for IPR proof patents) – USA legal
  • Think BioBetters!!!! – YOU WIN
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    10:30

    Morning Coffee

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    11:00

    Regulatory Science Ireland: Biosimilars research project

    Joan O'Callaghan

    Joan O'Callaghan, Research Scientist for Regulatory Science Ireland, Health Products Regulatory Authority

     

  • Biosimilars: What are the issues for healthcare professionals?
  • Findings from survey of medical specialists, general practitioners and community pharmacists
  • Bridging the information gap on biosimilar medicines
  •  

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    11:40

    KEYNOTE ADDRESS: From biosimilars to biogenerics?

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency

  • Uptake of biosimilars in clinical practice
  • The importance of switching
  • Switching - clinical trials and practical experiences
  • clock

    12:20

    Networking Lunch

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    13:30

    Litigation update: Europe and the US

    Dominic Adair

    Dominic Adair, Partner, Bristows LLC

  • A look at the latest biosimilar litigation cases from the UK and the US
  • Assessing the drivers, strategy and outcomes
  • Looking ahead to future disputes and a new European landscape: the Unified Patent Court
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    14:10

    KEYNOTE ADDRESS: Robust Pharmacovigilance: A key to successful biosimilars

    Niraj Chhaya

    Niraj Chhaya, Senior Risk Management Physician, Boehringer Ingelheim GmbH

  • Guidelines for biosimilar pharmacovigilance in the EU and USA
  • Key considerations: Immunogenicity, interchangeability, traceability
  • Risk management plans for biosimilars
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    14:50

    Afternoon Tea

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    15:20

    The increasing importance of medical devices for regulatory and commercial success of biosimilars

    Dirk Kreder

    Dirk Kreder, Founder and CEO, Anteris Medical GmbH

  • Biosimilars offer very few opportunities for differentiation
  • Autoinjectors and other medical device components are the only area, where biosimilars can offer additional value and differentiate
  • Originators and biosimilar developers are facing an “arms race” with medical devices to secure
  • clock

    16:00

    Chairman’s Closing Remarks and Close of Day Two

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency


    Director
    RJW & Partners Ltd
    Principal, Global Generics and Biosimilars
    IMS Health
    Principal Scientist & Head Analytical Development
    Lupin Limited
    Head of Scientific Office
    Austrian Agency for Health and Food Safety
    Head of Merck Biosimilars Strategy & Portfolio
    Merck Group
    Consultant, Thought Leadership
    IMS Health
    Founder and CEO
    Anteris Medical GmbH
    Partner
    Bristows LLC
    Director Scientific Affairs
    Abzena
    General Manager of International Business
    3SBio Pharmaceutical Group
    Senior Shareholder and Principal
    Schwegman Lundberg Woessner
    Research Scientist for Regulatory Science Ireland
    Health Products Regulatory Authority
    Lab Head Characterization
    Sandoz International GmBH
    Global Head Medical Affairs Biosimilars
    Biogen
    Senior Risk Management Physician
    Boehringer Ingelheim GmbH
    Medical Director
    Norwegian Medicines Agency
    Executive Director and Research, Medical and Innovation
    ABPI

    Sponsors and Exhibitors

    Official Media Partner

    Official Publication

    Official Online Media Partners

    Supporters

    Workshops

    Maximisation of IP Regulatory Rights
    Workshop

    Maximisation of IP Regulatory Rights

    Holiday Inn Kensington Forum
    28 September 2016
    London, United Kingdom

    How is the payer environment for biosimilars evolving?
    Workshop

    How is the payer environment for biosimilars evolving?

    Holiday Inn Kensington Forum
    28 September 2016
    London, United Kingdom

    An Interview with Atanas Dimitrov, Head of Strategy & Portfolio Management Biosimilars at Merck

    Download

    An Interview with Duncan Emerton, Senior Director Syndicated Insights & Analysis, FirstWord

    Download

    Snapshot of Previous Attendees

    Download

    Sponsors and Exhibitors


    Abzena

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

    Abzena offers a suite of complementary services and technologies. Its range of technologies include immunogenicity assessment, antibody drug conjugation, protein engineering, PEGylation, cell line development , GMP manufacturing and a range of bespoke assays to enables the development of better biopharmaceuticals which will have a greater chance of reaching the market.


    Schwegman, Lundberg & Woessner

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

    Schwegman Lundberg & Woessner is a nationally recognized boutique IP firm focused on strategic patent procurement with over 140 patent practitioners that have robust backgrounds across a wide spectrum of technology areas. Schwegman's clients include multinational corporations, middle-market businesses, universities, as well as start-ups and individual inventors.

    Media Partners


    Generics Bulletin

    Official Media Partner
    https://www.generics-bulletin.com/

    Generics bulletin provides its subscribers with up-to-date commercial intelligence about business opportunities in the global generic medicines and biosimilars markets. Accurate and reliable news reports reveal the strategies of the world’s leading generics companies and analyse their business performance, plans and product portfolios. Patent and pricing issues, regulatory changes, government initiatives, market opportunities and industry consolidation provide the wider context for Generics bulletin’s comprehensive industry coverage. With subscribers in nearly 60 countries, Generics bulletin is read by senior executives in all of the world’s leading generics companies, as well as by industry watchers and those supplying active ingredients, goods and services to the global generic and biosimilar medicines industries.


    Biosimilar News

    Official Media Partner
    http://www.biosimilarnews.com

    BiosimilarNews.com is a leading international knowledge and information source about biosimilars. The site helps the industry professionals, clinicians and also the public to find timely and appropriate information about this specific area. Biosimilar News - We keep you up to date.

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    International Journal of Biotechnology

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    IJBT provides an international forum and refereed authoritative source of information in the field of Biotechnology and Biotechnics, with emphasis on management and economics, as well as the political and social issues. It aims to disseminate knowledge, provide a learned reference in the field, and establish channels of communication between academic and research experts, policy makers and executives in industry, commerce and investment institutions.


    International Journal of Medical Engineering and Informatics

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    International Journal of Computational Biology and Drug Design

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    International Journal of Bioinformatics Research and Applications

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    Bioinformatics is an interdisciplinary research field that combines biology, computer science, mathematics and statistics into a broad-based field that will have profound impacts on all fields of biology. The emphasis of IJBRA is on basic bioinformatics research methods, tool development, performance evaluation and their applications in biology. IJBRA addresses the most innovative developments, research issues and solutions in bioinformatics and computational biology and their applications.

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    The Pharma Letter

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    The Pharma Letter provides subscribers with daily, up-to-date news, business intelligence, comment and analysis for the pharmaceutical, biotechnology and generics sectors of the health care industry, backed by a team of respected writers with many years of experience in the field.

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    Inderscience Publishers

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    American Pharmaceutical Review

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    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


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    Drug Target Review

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    Swiss Biotech Association

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    SelectScience

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    BioPharm Insight

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    Copybook - Pharmaceutical

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    International Pharmaceutical Industry

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    Drug Development Technology

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    Bentham Science

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    Pharmaceutical Technology

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    European Biotechnology Network

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    Pharmacircle

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    FirstWord

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    Drug Discovery Today

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    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.


    GBI

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    PharmaVOICE

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    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.


    Pharmiweb

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    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.


    Technology Networks

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    Gate2Biotech

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    http://www.gate2biotech.com

    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.


    Labhoo

    Supporters
    http://www.labhoo.com



    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Absave

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    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    PMR

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    http://www.pmrcorporate.com

    PMR (www.pmrcorporate.com) is a British-American company providing market information, advice and services to international businesses interested in Central and Eastern European countries as well as other emerging markets. PMR's key areas of operation include business publications (through PMR Publications), consultancy (through PMR Consulting) and market research (through PMR Research ). Being present on the market since 1995, offering high international standards in projects and publications, as well as providing one of the most frequently visited and top-ranked websites, PMR is one of the largest companies of its type in the region.

    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    HOTEL BOOKING FORM

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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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