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Biosimilars and Biobetters
30 September - 1 October 2015
Biosimilars and Biobetters

SAE Media Group’s 6th annual Biosimilars & Biobetters UKconference returns to London this Oct!

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.

 

Unlocking the potential of biosimilars will require a focused strategy along the whole value chain, from optimizing the clinical development program through developing the most suitable strategy for commercialisation.

FEATURED SPEAKERS

Alan Sheppard

Alan Sheppard

Principal, Global Generics and Biosimilars, Thought Leadership, IMS Health UK
Albin James Nelson

Albin James Nelson

Senior Principal & Owner, Adversarial Proceedings/ Pharma & Biotech, Schwegman Lundberg Woessner
Bracha Timan

Bracha Timan

Director Head of Bioassays & Technology, Teva Pharmaceuticals Ltd. Isreal
Chris Teale

Chris Teale

Vice President Europe, GfK NOP Ltd
Christopher Stothers

Christopher Stothers

Intellectual Property Litigation, Arnold and Porter
Dirk Kreder

Dirk Kreder

Founder and CEO, Anteris Medical GmbH
Karsten Roth

Karsten Roth

Director Clinical Operations, Cinfa Biotech
Kathy Osgerby

Kathy Osgerby

Associate, Intellectual Property, Arnold & Porter
Kei  Kishimoto

Kei Kishimoto

Chief Scientific Officer, Selecta Biosciences
Michael Tovey

Michael Tovey

INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan
Michel  Mikhail

Michel Mikhail

Expert in Biosimilars, Consultant, Germany
Robin Chadwick

Robin Chadwick

Principal, Biotechnology, Schwegman Lundberg Woessner
Shahin Kauser

Shahin Kauser

Senior Scientific Assessor, MHRA
Steinar Madsen

Steinar Madsen

Medical Director, Norwegian Medicines Agency
Uwe Gudat

Uwe Gudat

Head of Safety Biosimilars, Merck Serono

Alan Sheppard

Principal, Global Generics and Biosimilars, Thought Leadership, IMS Health UK
Alan Sheppard

Alan has over 40 years extensive experience within the healthcare industry, including innovator R&D pharmaceuticals, OTC and generic companies and working with Government departments, law firms, venture capital companies and industry associations.

Heading up the global generics arm of IMS Health’s Thought Leadership Alan is responsible for developing the services provided to the industry and its associations on generic medicines and biosimilars through a combination of consulting, information and market analyses.

Previous positions held include Executive Vice-President, Europe Generics, for Dr Reddy’s Laboratories Ltd. In this role he was responsible for devising and implementing Dr Reddy’s generic strategy to enter the major markets of Europe through start-ups and acquisition of companies and products. He was responsible for the development pipeline for Europe as well as establishing partnerships to form alliances.

Prior to this he was Vice-President of Global Corporate Strategy for PLIVA, responsible for the strategic approach to the businesses of NCE development, generics, specialities, OTC and diagnostics.

Earlier positions held included European Marketing Director for Medeva; General Manager, Rhône-Poulenc Rorer UK; General Manager, Institute Mérieux UK; and management roles with Servier Laboratories, SmithKline & French and Upjohn.

Alan is also Chairman of the Technical Advisory Group for the Access to Medicines Foundation; an expert witness on patent litigation issues and their commercial impact, working with leading international law firms; a guest lecturer at the University of Wales working in the medicines faculty specialising in pharmaceutical marketing and the role of clinical trials within the marketing mix.

Alan was a long serving member of the Prescription Medicines Code of Practice Authority Appeals Board, a Fellow of the Chartered Institute of Management, and Fellow of the International Doctors’ Association and a Member of the Chartered Institute of Marketing.
 

Albin James Nelson

Senior Principal & Owner, Adversarial Proceedings/ Pharma & Biotech, Schwegman Lundberg Woessner
Albin James Nelson

Bracha Timan

Director Head of Bioassays & Technology, Teva Pharmaceuticals Ltd. Isreal
Bracha Timan

Bracha Timan, Head of Bioassays & Technology at Teva Pharmaceutical Ltd. Israel, holds a PhD in Immunology and MBA from Bar Ilan University in Israel. Bracha Joined Teva in 2004 following a number of senior scientific management positions within the Life Sciences sector in the Biotechnology and Pharmaceutical industries. She has a wealth of experience and deep knowledge in bioassays and bioanalytical assays to support biologics products structural and functional characterization, as well as PK/PD and immunogenicity assessment to support innovative and biosimilar products development. She provides support for regulatory submissions and communication with the agencies. She plays a key role in bioassays and bioanalytical support for Biosimilar products development in line with up-to-date regulatory expectations.

Chris Teale

Vice President Europe, GfK NOP Ltd
Chris Teale

Chris joined GfK in 2011 bringing with him extensive practical and academic experience within the pharmaceutical industry, across both Marketing and R&D, over a 30 year career.
He has held a number of leadership positions at both Global and European level, having previously been Director of Global Pricing and Market Access (Oncology) at Astra Zeneca; Director Health Economics, Pricing, Reimbursement and Access at Allergan; Commercial Planning Manager at Fisons, and Portfolio Planning Manager at Ciba-Geigy (Novartis) in Switzerland.
In his market access roles he successfully developed global pricing strategies for a wide range of products and therapy areas including personalised healthcare products (requiring both pharmaceutical and diagnostic reimbursement) and orphan drugs. He led the “Innovate for Access” programme at AstraZeneca which identified creative and innovative approaches to overcoming market access hurdles. In his planning roles he established middle and long-range forecasting models and models to support the evaluation of in-licence and out-licence and other business development opportunities.
Within GfK Market Access, Chris leads the European Oncology and Personalised Healthcare (PHC)) Practices and is also Lead on Global Biosimilar Strategy and War Gaming / Competitive Simulation Projects. In 2014 he led a major study on behalf of the European Biosimilars Group (EBG), a sector group of the EGA, about the future sustainability of the biosimilar medicines market. In 2015 his specialist area of focus is Inflammatory Diseases (including Rheumatoid Arthritis and Psoriasis)
Chris gained a BSc degree in Mathematics from Newcastle University, and also studied at Loughborough University (Management Information Systems) and INSEAD Business School (Marketing for International Business). He is also an occasional lecturer on health economics and pricing and reimbursement, a member of ISPOR and a German speaker.
 

Christopher Stothers

Intellectual Property Litigation, Arnold and Porter
Christopher Stothers

Christopher Stothers is a Partner in Arnold & Porter (UK) LLP's Intellectual Property Litigation group in London and a Solicitor-Advocate in England and Wales. His practice concentrates on high value cross-border patent litigation (including opposition work before the European Patent Office) and antitrust litigation. He has particular experience in life sciences (including pharmaceuticals, medical devices and enzymes). He writes and speaks regularly on biotech and biosimilar issues, and is a Visiting Lecturer at University College London.

Dirk Kreder

Founder and CEO, Anteris Medical GmbH
Dirk Kreder

Dr. Dirk Kreder holds a Ph.D. from University of Stuttgart, and an International Executive MBA. He has worked for several Biotech and Pharma companies in the US, Switzerland, and Germany, and has focused the last eight years on leading teams for the development of complex generics and biosimilars (generic Copaxone®, Omnitrope®, the first biosimilar in regulated markets, and a biosimilar monoclonal antibody). Over the last several years he has shifted his focus increasingly to the development of medical devices (autoinjectors) and biosimilar drug/device combination products. In 2014 he founded anteris medical to support biosimilar developers with their medical device needs.

Fiona Greer

Global Director, Biopharmaceutical Services Development, SGS M-Scan SA
Fiona Greer

Gerry McGettigan

CEO & Regultory Expert; COO, Kinesys Consulting Ltd (UK); amp biosimilars AG (Germany)
Gerry McGettigan

Jennifer Sklenar

Partner, Arnold & Porter
Jennifer Sklenar

Karsten Roth

Director Clinical Operations, Cinfa Biotech
Karsten Roth

Karsten Roth is Director of Clinical Operations at Cinfa Biotech, leading the company’s clinical development programs. He has more than 20 years of experience in the pharmaceutical industry having held various executive positions with a strong focus on clinical development across several therapeutic areas. He completed a PhD in Biochemistry; summa cum laude, has a postgraduate degree in Pharmaceutical Medicine and a Masters in Project Management. He worked at big pharmaceutical companies in Europe like Astellas, Novartis Pharma and recently Sandoz Biopharmaceuticals in several global functions before taking up a new opportunity at Cinfa Biotech. In his current function, he is a member of the executive board and responsible for the clinical development and operational oversight of pre-clinical, clinical and post approval activities. In his role he is supervising the clinical operations teams including internal and external stakeholders. Within his function, he plays an active part in due diligence processes and long term strategic planning. In addition he is a member of international advocacy groups and presented at several scientific advice meetings at the EMA, FDA and PMDA.

Kathy Osgerby

Associate, Intellectual Property, Arnold & Porter
Kathy Osgerby

Kathy Osgerby is an Associate in Arnold & Porter (UK) LLP's London office. Kathy advises clients on contentious intellectual property matters, with a particular focus on patent disputes. Kathy has experience of patent actions in the Patents Court and opposition proceedings at the European Patent Office, and of coordinating patent litigation in multiple jurisdictions across Europe.

Kei Kishimoto

Chief Scientific Officer, Selecta Biosciences
Kei  Kishimoto

Dr. Kishimoto is the Chief Scientific Officer of Selecta Biosciences, a biotechnology company developing synthetic vaccines based on a novel self-assembling nanoparticle technology. Prior to joining Selecta, Dr. Kishimoto was Vice President of Research at Momenta Pharmaceuticals where he led multidisciplinary teams in inflammation, oncology, and cardiovascular disease. Previously he was Senior Director of Inflammation Research at Millennium Pharmaceuticals, where he provided the scientific leadership for four programs in clinical development, and an Associate Director of Immunology at Boehringer Ingelheim. Dr. Kishimoto received his doctoral degree in Immunology from Harvard University and his post-doctoral training at Stanford University. Dr. Kishimoto has published over 50 peer-reviewed articles in scientific journals, including Nature, Science, Cell, and the New England Journal of Medicine.

Michael Tovey

INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan
Michael Tovey

Michael G. TOVEY, Ph.D, is Emeritus INSERM Director of Research in the Laboratory of Biotechnology and Applied Pharmacology, CNRS UMR 8113 at the Ecole Normale Supérieure, Cachan, France. He is the author of more than 250 articles on interferon, cytokines, biotechnology, and immunogenicity. He is a member of numerous scientific boards and is French representative for the ICIS membership. He is chair of the International Cytokines Standards Committee, a member of the ICIS Meetings Committee, and a member of the European Adjuvant Advisory Committee. He is editor-in-chief of Detection and Quantification of Antibodies to Biopharmaceuticals: Practical and Applied Considerations, Associate Editor of Cytokine, Associate Editor of the Journal of Interferon and Cytokine Research, Associate Editor of The Scientific World Journal and Associate Editor of the Journal of Immunoassay & Immunochemistry. He is chair of Coral Gables Symposia.org

Michel Mikhail

Expert in Biosimilars, Consultant, Germany
Michel  Mikhail

Dr. Dr. Michel Mikhail has more than 20 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical companies as well as in the Generic industry. Dr Mikhail is a Chartered Expert in Pharmacology -Toxicology, he is a chartered Clinical Expert as well as a chartered Analytical Expert. Dr Mikhail is an Expert in Biosimilars. He served on the Safety working group and Efficacy working Group of the European Federation of pharmaceutical Industry associations (EFPIA) also as a Topic leader. He served on the Regulatory Group of the European branch of the Pharmaceutical Research and Manufacturers of America (PhRMA Europe), on the Board, Executive Committee and the Biosimilars & Regulatory and Scientific Affairs Group of the European Generic medicines Association (EGA), as well as on different associations and organisations. He is member of The Organisation for Professionals in Regulatory Affairs (TOPRA). Dr Mikhail is member of the Expert Committee for Toxicology of the United States Pharmacopea (USP), Washington DC and member of the Expert Committee of the Federal Institute for Risk Assessment, Berlin.

Richard Easton

Team Leader, Carbohydrate Analysis , SGS M-Scan Ltd.
Richard Easton

Robin Chadwick

Principal, Biotechnology, Schwegman Lundberg Woessner
Robin Chadwick

Robin Chadwick is a registered patent attorney, shareholder, and member of
the Board of Directors of Schwegman Lundberg & Woessner. Robin’s practice
is focused on client counseling, prosecution, and opinion work relating
to biotechnology and chemical patent law. She has a Ph.D. in Molecular
Biophysics and Biochemistry from Yale University and a law degree from
Hofstra University. She has worked for Biogen Inc. in protein chemistry and
was a post-doctoral fellow at the Massachusetts Institute of Technology. She
has spoken on numerous topics including, most recently, on subject matter
patent eligibility, the written description and enablement requirements,
analyses of patent claims, U.S. biosimilar laws, and recent FDA guidance on
biosimilar. Within the last year Robin has written articles on the evolving legal
standards for enablement, natural products, and natural correlations that
have been published by Cold Spring Harbor Laboratories and the American Bar
Association.

Shahin Kauser

Senior Scientific Assessor, MHRA
Shahin Kauser

Shahin Kauser completed a BSc (Hons) in Pharmaceutical and Chemical Sciences at Liverpool John Moores University in 2000. She then joined the MHRA (former MCA) in January 2001 as an Pharmacovigilance Scientist in the Post-Licensing Division. Her role covered processing yellow card forms on to the pharmacovigilance database, signal detection and assessment. Since February 2009, she has been working as a scientific assessor in the benefit-risk management group at the MHRA. Her current role covers the therapeutic areas of blood, cancer and gastrointestinal disorders. She has extensive experience of assessing risk management plans and has worked on a number of drug safety issues.

Steinar Madsen

Medical Director, Norwegian Medicines Agency
Steinar Madsen

Dr. Steinar Madsen is medical director at the Norwegian Medicines Agency. He has been working with generic substitution since it was introduced in Norway in 2001 and with biosimilars since 2006. He is member and previously chairman of the committee for generic substitution at the Agency. Dr. Madsen is also engaged in the drug information service, with a special interest in the safe and cost-effective use of drugs. He is a specialist in internal medicine and cardiology and works part time as a consultant in cardiology.

Uwe Gudat

Head of Safety Biosimilars, Merck Serono
Uwe Gudat

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Introduction and Opening Remarks

Peter Wittner

Peter Wittner, Senior Consultant, Interpharm Consultancy

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9:15

Overview - Biosimilars? Biogenerics? Follow-on Biologicals?

  • What are we actually talking about?
  • Summary of issues affecting biosimilars
    - Regulatory
    - Commercial
    - Legal/IP
  • Interchangeability - what is the issue?
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    10:00

    The Regulatory process and its pitfalls

  • Europe: A straight forward case
    - EMEA guidelines
    - Overview of successful and failed applications
  • US: The juggernaut begins to move
  • India, China and other countries?
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    10:45

    Morning Coffee

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    11:15

    Biosimilars - The commercial reality

  • What is the big attraction?
    - Biologicals market and prospects
  • The story so far...
    - Europe and the USA
    - Asian markets and Latin America
  • Patents, IP and other issues
    - What are the patent issues?
    - Interchangeability - a potential roadblock
    - Differing national legislation
  • Where do Biosimilars gof rom here?
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    12:15

    Discussion and Q&A

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    12:30

    Close of Workshop

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    13:00

    Registration & Coffee

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    13:30

    Introduction and Opening Remarks

    Lincoln Tsang

    Lincoln Tsang, Partner, Arnold and Porter

    Daniel Kracov

    Daniel Kracov, Partner, Arnold & Porter

    Jennifer Sklenar

    Jennifer Sklenar, Partner, Arnold & Porter

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    14:00

    Session 1: An overview of the legal/regulatory frameworks for biosimilar approvals in the EU and U.S.

  • Reviewing experience to date and lessons learned under current approval pathways
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    14:30

    Session 2: Addressing the Challenges currently being faced

  • Important issues and controversies, such as standards for approval, nomenclature, substitutability, extrapolation across indications, “biobetters” and exclusivities
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    15:30

    Coffee Break

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    16:00

    Session 3: Status of pathways for resolution of patent disputes relating to biosimilars

  • Overview of payment issues relating to biosimilars
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    17:00

    Discussion & Q&A

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    17:30

    End of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Alan Sheppard, Principal, Global Generics and Biosimilars, Thought Leadership, IMS Health UK

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    9:10

    Market outlook – What’s the future of biosimilars?

    Alan Sheppard, Principal, Global Generics and Biosimilars, Thought Leadership, IMS Health UK

  • Understanding and reviewing current data regarding the hurdles in commercialisation of biosimilars
  • Evaluating market entry – what’s on the horizon?
  • Assessing Cost reductions vs. demand
  • Looking at market access initiatives on globalisation 
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    9:50

    Blockades to U.S. biosimilar entry and what to do about them

    Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner

  •  The BPCIA ‘Patent Dance’ requires complex analyses of patent information to be exchanged between biosimilar and reference product manufacturers
  • We provide tools to facilitate analysis of large patent portfolios and resolution of patent issues
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    10:10

    Non-BPCIA resolution of IP litigation issues concerning biosimilars in the U.S.

    Albin James Nelson

    Albin James Nelson, Senior Principal & Owner, Adversarial Proceedings/ Pharma & Biotech, Schwegman Lundberg Woessner

  • Low cost, less time consuming quasi litigation actions including ex parte and interpartes review in the U.S. PTO
  • Declaratory Judgment Actions as an alternative to BPCIA pursuant to recent U.S. federal Case Law
  • clock

    10:30

    Morning Coffee

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    11:00

    Patent litigation of biologics - past, present and future

  • The story so far - biotech cases in the patents courts
  • What’s being litigated now?
  • Is biotech litigation so different from small molecule litigation? 
  • Does biotech litigation need a different strategy?
  • What’s next?
  • Christopher Stothers, Intellectual Property Litigation, Arnold and Porter

    Kathy Osgerby, Associate, Intellectual Property, Arnold & Porter

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    11:40

    Clinical development strategies for biosimilars - A mid-size pharma perspective

    Karsten Roth, Director Clinical Operations, Cinfa Biotech

  • Targeted clinical development strategy for biosimilars
  • Innovative clinical programme approaches
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    12:20

    Networking Lunch

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    13:30

    Case Study: Emerging markets for biosimilars

    Michel Mikhail, Expert in Biosimilars, Consultant, Germany

  • New biosimilars guidelines in China – key points and challenges
  • Assessing a global marketing strategy for a successful biosimilar business
  • What trends are we currently seeing in the biosimilars market?
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    14:10

    Case Study: Creating biobetters with improved efficacy and safety by addressing product immunogenicity with tolerogenic nanoparticles

    Kei Kishimoto , Chief Scientific Officer, Selecta Biosciences

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    14:50

    Afternoon Tea

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    15:20

    Biosimilars and the use of medical devices

    Dirk Kreder, Founder and CEO, Anteris Medical GmbH

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    16:00

    ROUND TABLE DISCUSSION - Reviewing the sustainability of the biosimilars market – “Where stakeholders align and policies collide”

    Chris Teale, Vice President Europe, GfK NOP Ltd

  • Understanding the multi-stakeholder definition of sustainability
  • Identifying the factors required for a sustainable European biosimilars medicines market
  • Reviewing the perspectives of all stakeholders; Clinicians, Patients, Payers, Politicians/Policy Makers, and Industry (biooriginal, biosmilar, and biobetter)
  • Looking to the future: Ideal World versus Real World
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    16:40

    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

    Michel Mikhail, Expert in Biosimilars, Consultant, Germany

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    9:10

    OPENING ADDRESS- Safety first! “Totality of evidence” and residual risk

    Uwe Gudat

    Uwe Gudat, Head of Safety Biosimilars, Merck Serono

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    9:50

    KEYNOTE ADDRESS – UK regulator’s experience of PV and RMP for biosimilars

    Shahin Kauser, Senior Scientific Assessor, MHRA

  • What’s new in the overarching biosimilar guideline regarding pharmacovigilance?
  • How traceable are ADRs for biosimiliars reported to the UK Pharmacovigilance database?
  • What types of post authorisation studies (e.g. registries) are requested?
  • What other enhanced pharmacovigilance activities may be necessary?
  • What types of additional risk minimisation measures may be necessary?
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    10:30

    Morning Coffee

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    11:00

    Leading the strategy to demonstrate biosimilarity as support to biosimilar projects

    Bracha Timan, Director Head of Bioassays & Technology, Teva Pharmaceuticals Ltd. Isreal

     

  • Biosimilarity assessment - from stepwise approach to fingerprint analysis

  • Strategic considerations for successful support Biosimilar Development

  • Totality of evidence – challenges and obstacles for setting an appropriate fingerprint model for biosimilarity assessment

  • Monoclonal antibodies biosimilarity assessment - Case study will be presented

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    11:40

    Reconciling EU, US and international clinical and regulatory strategies

    Gerry McGettigan

    Gerry McGettigan, CEO & Regultory Expert; COO, Kinesys Consulting Ltd (UK); amp biosimilars AG (Germany)

  • Defining the critical components of a global development programme – is it really possible?
  • Challenges to prepare for the Asian and other emerging market
  • What opportunities exist to reduce development and regulatory timelines and cost in emerging markets, if  any?
  • What changes do we need to facilitate truly global developments?
  • Which stakeholders need to make these changes happen?
  •  

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    12:20

    Structural characterisation for biosimilar comparability assessment

    Fiona Greer

    Fiona Greer, Global Director, Biopharmaceutical Services Development, SGS M-Scan SA

  • Increased requirement for analytics in the 'step-by-step' approach to establishing biosimilarity
  • Benefit of using modern instrumental methods to provide analytical data to support regulatory submissions
  • Strategies for primary and higher order structure determination - 'fingerprinting' using orthogonal techniques
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    13:00

    Networking Lunch

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    14:00

    Switching patients to biosimilars: Interchangeability/substitution

    Steinar Madsen, Medical Director, Norwegian Medicines Agency

  • Reviewing the switching study in Norway
  • Addressing the standard of bioequivalence guidance for standard generics to gain further understanding   
  • Why generics accepted and biosimilars are not?
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    14:40

    An automated high throughput platform for the assessment of potency of biosimilars

    Michael Tovey, INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan

  • Assessing a more high throughput and cost effective approach
  • What considerations should be made in the development of biosimilars?
  • Exploring Glycosylation
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    15:20

    Recap of Conference and Q&A

    Michel Mikhail, Expert in Biosimilars, Consultant, Germany

    Chairman will recap the 2-day conference and delegates can take part in the interactive discussion to ensure all Q&A are covered.

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    15:50

    Chairman’s Closing Remarks and Close of Day Two


    Principal, Global Generics and Biosimilars, Thought Leadership
    IMS Health UK
    Senior Principal & Owner, Adversarial Proceedings/ Pharma & Biotech
    Schwegman Lundberg Woessner
    Director Head of Bioassays & Technology
    Teva Pharmaceuticals Ltd. Isreal
    Vice President Europe
    GfK NOP Ltd
    Intellectual Property Litigation
    Arnold and Porter
    Founder and CEO
    Anteris Medical GmbH
    Global Director, Biopharmaceutical Services Development
    SGS M-Scan SA
    CEO & Regultory Expert; COO
    Kinesys Consulting Ltd (UK); amp biosimilars AG (Germany)
    Partner
    Arnold & Porter
    Director Clinical Operations
    Cinfa Biotech
    Associate, Intellectual Property
    Arnold & Porter
    Chief Scientific Officer
    Selecta Biosciences
    INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology
    Ecole Normale Supérieure de Cachan
    Expert in Biosimilars
    Consultant, Germany
    Team Leader, Carbohydrate Analysis
    SGS M-Scan Ltd.
    Principal, Biotechnology
    Schwegman Lundberg Woessner
    Senior Scientific Assessor
    MHRA
    Medical Director
    Norwegian Medicines Agency
    Head of Safety Biosimilars
    Merck Serono

    Sponsors and Exhibitors

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    Supporters

    Attendee list for Biosimilars and Biobetters 2015

    Download

    Biosimilars and Biobetters Interview with Cinfa Biotech

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    Interview with SGS Life Science Services

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    Biosimilars and Biobetters Interview with Harvest Moon Pharmaceuticals USA, Inc

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    Biosimilars and Biobetters Interview with Schwegman, Lundberg & Woessner

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    Sponsors and Exhibitors


    Myoderm

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

    Myoderm is a global leader in the sourcing, distribution, and management of pharmaceuticals for clinical trials. We offer two unique sourcing solutions: GlobalSource, which provides global sourcing and distribution of pharmaceuticals for clinical trials; and CentralSource, a turnkey service for sourcing, warehousing, and distributing rescue, concomitant, and standard-of-care therapies directly to clinical sites.


    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.


    SGS

    Sponsors and Exhibitors
    http://www.sgs.co.uk/lifescience

    SGS Life Science Services is a leading contract service organization providing analytical development, biologics characterization, biosafety, quality control testing, and Phase I-IV clinical services. With the largest global network of 18 laboratories in 11 countries, services include: analytical chemistry, microbiology, stability studies, bioanalysis, extractables and leachables, virology, and protein analysis.

    Media Partners


    Bio-Equip

    Official Media Partner
    http://www.bio-equip.cn/

    Established since 1998, Bio-Equip is a leading website for lab equipments, reagents, consumables and bio services. Our users come from different fields like life science, medical research, pharmaceutical, biotechnology, modern agriculture, food safety and environment monitoring. Bio-Equip offer users a complete product directory which involves 158 product ranges among lab equipments, reagents, consumables, lab animals, bio services, cell lines, bio software and books.Serving users through two websites, www.bio-equip.com (Chinese) and www.bio-equip.cn (English), we own over 20,000 registered suppliers and more than 500,000 pieces of product and technical service information with details of product description, price, sample downloading, technical articles and videos.

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    Biosave

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    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    SelectScience

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    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


    Mednous

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    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


    Biotechgate

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    Biotechgate is a global, comprehensive, life science database covering the Biotech, Pharma and Medtech industries. There are currently over 38,000 company profiles on the Biotechgate database. Biotechgate is commonly used to find product pipelines, collaboration partners, in/out-licensing opportunities and information about technology platforms, management details, new business leads and financing rounds. In addition, our licensing deals database supports companies in negotiating their licensing agreements.


    Pharmaceutical Outsourcing

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    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


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    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    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)


    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.


    PMR

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    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.


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    International Journal of Medical Engineering and Informatics

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    IJMEI promotes an understanding of the structural/functional aspects of disease mechanisms and the application of technology towards the treatment/management of such diseases. It seeks to promote interdisciplinary collaboration between those interested in the theoretical and clinical aspects of medicine and to foster the application of computers and mathematics to problems arising from medical sciences. IJMEI includes authoritative review papers, the reporting of original research, and evaluation reports of new/existing techniques and devices. Each issue also contains a comprehensive information service.


    Drug Development Technology

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    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.


    One Nucleus

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    Established in May 2010, One Nucleus is the result of the merger of ERBI and London Biotechnology Network. One Nucleus is a not-for-profit membership organisation for international life science and healthcare companies and the largest of its kind in Europe. The company is based in Cambridge UK and London, at the heart of Europe's largest cluster. The 470 members include pharmaceutical, biotech, medical device and diagnostic companies and associated technical and commercial Service Providers.


    Drug Target Review

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    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


    World Pharma Today

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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


    Medical News Today

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    Medical News Today is the largest independent medical and health news site on the web - with over 10,000,000 monthly unique users it is ranked number one for medical news on all major search engines. Medical News Today is used by pharmaceutical, biotech and health organizations, advertising agencies, PR companies and vertical ad networks to deliver targeted campaigns to HCPs, patients and caregivers. To find out how Medical News Today can help you to reach the right audience contact peter@medicalnewstoday.com or visit www.medicalnewstoday.com.


    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.


    Pharmalicensing

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    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.


    Absave

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    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!


    Farmavita

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    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    HealthEconomics.com

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    A pioneer in the field, HealthEconomics.Com is the world’s most comprehensive and credible website for resources and jobs in healthcare value and market access. A trusted resource, HealthEconomics.Com contains the hottest news, jobs, policy updates, professional development, and education resources, and offers unparalleled advertising opportunities. As the #1 Google ranked website in health economics, HealthEconomics.Com attracts 11,000 visitors every month and the well-respected Newsletter reaches 20,000 professionals every week. The comprehensive content is carefully selected by a discerning health economist editor, making us the most visited website for healthcare value and market access in the industry, with visitors encompassing all corners of the globe.


    Sociable Pharma

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    Sociable Pharma offers a tailored range of research & analysis services to help pharmaceutical companies at all stages of the product lifecycle. We provide customized research & analysis solutions that address the evolving intelligence priorities of each marketed and pipeline product to deliver commercially-focused & highly relevant insight. Our Treatment Pulse business intelligence service helps pharmaceutical companies to understand physicians' perspectives on clinical practice, unmet needs and product differentiation, and continuous primary research analyzes the impact that industry issues will have on the treatment landscape and the implications for each product's competitive positioning.


    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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    FierceBiotech

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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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    Technology Networks

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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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    GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.


    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.


    Thomson Reuters

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    Thomson Reuters is the leading source of intelligent information for professionals around the world. We provide essential information to keep you in touch with the rapidly-changing pharmaceutical and chemical markets, expert services to help you make informed, early decisions, and intuitive technology to manage and support your discovery and development activities. Our products give you the intelligence, tools and expertise to help you optimize your IP portfolio, monitor industry developments, identify licensing and partnering opportunities, deliver successful regulatory submissions, and support your scientific messaging, marketing, product positioning, and awareness campaigns.


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    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


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    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


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    IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.


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    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


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    LabRoots is a free, social networking site that enables scientists, engineers, and other technical professionals to connect, collaborate with, and learn from each other. LabRoots fosters world-wide scientific communication and incorporates the newest social networking technologies. LabRoots allows scientists to connect with each other as they describe their research interests on a myriad of unique features and tools, discovering meaningful collaborations across geographic boundaries and fields of expertise.


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    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.


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    antibodies-online.com facilitates researchers to find the appropriate antibodies for their respective research project. As an independent and multi-vendor marketplace for research antibodies and thanks to the cooperation with more than 130 different manufacturers, a large selection of Antibodies (over 700,000), ELISA Kits (over 130,000), Secondary Antibodies (17,000), Proteins (130,000), Peptides and Isotype Controls is available. By supporting the Independent Validation Initiative and the Resource Identification Initiative, antibodies-online.com also addresses the important topics of transparent product quality and scientific reproducibility. In addition scientists receive news and detailed information about the individual antibodies from databases such as the PubMed and others.


    International Journal of Computational Biology and Drug Design

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    IJCBDD, an International Society of Intelligent Biological Medicine official journal, bridges the gap between two very important, complementary disciplines, computational biology and drug design. Through advances in high-throughput genome sequencing and digital imaging technologies, biocomputing, drug design and medical research have unfolded new, predictive sciences such as genomics, proteomics, lipidomics, metabolomics, cytomics and pharmaconomics. These promote new computational, statistical and biomedical approaches to drug design/development, besides unleashing the potential of significantly more accurate, effective personalised diagnosis, therapeutics and patient care.


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    Pharma Marketing News is an independent monthly electronic newsletter focused on issues of importance to pharmaceutical marketing executives. It is a service of the Pharma Marketing Network -- The First Forum for Pharmaceutical Marketing Experts -- which brings together pharmaceutical marketing professionals from manufacturers, communications companies, and marketing service providers for wide ranging discussions and education on a multitude of current topics. Pharma Marketing Network & Pharma Marketing News provide executive-level content coupled with permission-based e-marketing opportunities.


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    Holiday Inn Kensington Forum

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    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. 

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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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