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Biosimilars and Biobetters
27 September - 28 September 2017
Biosimilars and Biobetters

DOWNLOAD A BROCHURE FOR A DETAILED AGENDA AND FULL SPEAKER LINE-UP FEATURING:

BOEHRINGER INGELHEIM, CELLTRION HEALTHCARE, QUINTILESIMS, MERCK GROUP, NORWEGIAN MEDICINES AGENCY, TEVA PHARMACEUTICALS, GEDEON RICHTER + MORE!


SAE Media Group are thrilled to present the 2017 8th annual conference on Biosimilars & Biobetters taking place on 27th & 28th September in Central London, UK.

As the patents for several innovator biologics expire, biopharmaceutical companies are taking the opportunity to develop more affordable forms creating a rapidly booming biosimilars market. However, as the field of biosimilars evolves, challenges in immunogenicity studies, securing market share, exclusivity and regulations still persist.

Join us this autumn to arm yourself with the key requirements and tools for successful market entry through strategic direction on commercialisation; insight into potential therapeutic areas; and critical updates on interchangeability guidelines and patient litigation.

A must attend for principle scientists and regulatory experts involved in biotechnology, market access and compliance, Biosimilars & Biobetters 2017 will capture expert insight by honing in on current market trends through to emerging opportunities and global developments.
 

http://bit.ly/2nP31Ut

FEATURED SPEAKERS

Bernd Liedert

Bernd Liedert

Senior Clinical Program Leader Biosimilars, Boehringer Ingelheim
Harish  Pai

Harish Pai

Principal Scientific Manager, Biocon
HoUng Kim

HoUng Kim

Division Head Strategy and Operations, Celltrion Healthcare
Ildiko Aradi

Ildiko Aradi

Head, Clinical Development of Biologics, Gedeon Richter
Louis Boon

Louis Boon

Chief Scientific Officer, Bioceros
Stephen  Murby

Stephen Murby

International Advisory Board Member, Alliance for Safe Biologic Medicines
Thomas  Sachnik

Thomas Sachnik

Sr Manager Strategic Associate to the President & CEO Generics Europe , Teva Pharma BV

Bernd Liedert

Senior Clinical Program Leader Biosimilars, Boehringer Ingelheim
Bernd Liedert

Chris Teale

Vice President Europe, GfK HealthCare
Chris Teale

Dominic Adair

Partner, Bristows LLC
Dominic Adair

Glenn Kazo

President, Prolong Pharmaceuticals
Glenn Kazo

Harish Pai

Principal Scientific Manager, Biocon
Harish  Pai

HoUng Kim

Division Head Strategy and Operations, Celltrion Healthcare
HoUng Kim

Ildiko Aradi

Head, Clinical Development of Biologics, Gedeon Richter
Ildiko Aradi

Louis Boon

Chief Scientific Officer, Bioceros
Louis Boon

Martyn Hann

Partner, IP, Mishcon de Reya LLP
Martyn  Hann

Michel Mikhail

International Expert in Regulatory Affairs, International Expert in Biosimilars,
Michel  Mikhail

Natasha Pearman

Managing Associate, Mishcon de Reya LLP
Natasha Pearman

Omar Ali

Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth
Omar Ali

Richard Peck

Vice President Regulatory Affairs, Lupin (Europe)
Richard  Peck

Robert Forbes

Professor of Clinical Pharmaceutics, University Of Central Lancashire
Robert Forbes

Rodeina Challand

Director, Challand Biosimilar Consulting
Rodeina Challand

Steinar Madsen

Medical Director, Norwegian Medicines Agency
Steinar Madsen

Stephen Murby

International Advisory Board Member, Alliance for Safe Biologic Medicines
Stephen  Murby

Thomas Sachnik

Sr Manager Strategic Associate to the President & CEO Generics Europe , Teva Pharma BV
Thomas  Sachnik

Ulrike Banning

Consultant, European Thought Leadership, QuintilesIMS
Ulrike Banning

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Chris Teale

Chris Teale, Vice President Europe, GfK HealthCare

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9:10

Session 1 - Learning from the past and looking

Chris Teale

Chris Teale, Vice President Europe, GfK HealthCare

  • Tracking
  • What to track, How to track, How to use the Insights
  • Learnings from the Past:
  • The 1st wave of biosimilars (EPO, HGH; G-CSF)
  • The current wave (Anti-TNFs)
  • Implications for the future:
  • The next wave of biosimilars (Oncology and beyond)

     

  • clock

    9:50

    Session 2- Commercial Differentiation

    Chris Teale

    Chris Teale, Vice President Europe, GfK HealthCare

  • Company differentiation
  • Product differentiation
  • Data differentiation
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    10:30

    Morning Coffee

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    11:00

    Session 3 - Competitive Simulation

    Chris Teale

    Chris Teale, Vice President Europe, GfK HealthCare

  • Forecasting & Foresight
  • Market dynamics (Leveraging interchangeability, substitution & switching)
  • Pricing dynamics
  • Multi-criteria decision-making
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    11:40

    Session 4 - Discussion Session: Key Learnings

    Chris Teale

    Chris Teale, Vice President Europe, GfK HealthCare

  • Critical Success Factors
  • What to do… and what not to do
  • Tracking
  • Interpreting
  • Deciding
  • clock

    12:20

    Closing remarks

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    12:30

    End of workshop

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    13:30

    Registration & Coffee

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    14:00

    Opening remarks and introductions

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

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    14:10

    Session 1 - Biosimilar Interchangeability: The newest regulation in the USA

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

    In the USA only interchangeable products can be substituted for
    the reference product by a pharmacist without the intervention of a health care provider. The interchangeability regulation is in the form of guidance:

  • Interchangeable biologics must be biosimilar to the reference biologic
  • If administered more than once, data must show the safety and effi cacy risks of switching
  • If not administered more than once, justify the omission of a switching study
  • The clinical data must demonstrate switching risk in a ll of the reference biologic’s licensed conditions of use
  • The data must support the “totality of the evidence” and “reduction of residual uncertainty”
  • Switching study design is defined and described in the guidance
  • Guidance describes what is insuffi cient to demonstrate interchangeability
  • The use of post-marketing data from a biosimilar
  • The presentation and design attributes must be the same to enable substitution
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    14:50

    Session 2- The impact of biosimilar interchangeability in the USA

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

  • An interchangeability rating may result in the perception that the product is superior in quality to other biosimilars
  • Where will an interchangeable biosimilar have the most impact?
  • How will payors react?
  • Likely competitor response
     
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    15:30

    Afternoon Tea

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    16:00

    Session 3 - The NOR-SWITCH Study in Europe on Interchangeability

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

  • Evaluate the efficacy and safety of switching from innovator infliximab (Remicade) to biosimilar
    infliximab (Remsima)
  • Primary endpoint: disease worsening
  • Secondary endpoint: safety, immunogenicity
  • One time switch
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    16:40

    Highlighting the Differences between EU and USA in Terms of regulatory Requirements

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

  • Introducing the 3 R principle to reduce animal studies
  • Introducing the Global reference Product notion
  • Extrapolation of Indications
  • No Interchangeability Requirement: this is in the Member States responsibility
  • Post-marketing surveillance Black triangle in EU
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    17:20

    Closing Remarks

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    17:30

    End of workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairs' Opening Remarks

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

    Louis Boon

    Louis Boon, Chief Scientific Officer, Bioceros

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    9:10

    Biosimilars - the second wave

    Ulrike Banning

    Ulrike Banning, Consultant, European Thought Leadership, QuintilesIMS

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    9:50

    First biosimilar approval in osteoporosis

    Ildiko Aradi

    Ildiko Aradi, Head, Clinical Development of Biologics, Gedeon Richter

  • Key development steps for biosimilar teriparatide
  • Medical device aspects
  • Clinical development programme challenges of biosimilar teriparatide
  • Market access challenges
     
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    10:30

    Morning Coffee

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    11:00

    The role of competition and IP law in early access to market for Biosimilars

  • Overview of Competition Law
  • Barriers to entry and expansion facing biosimilars
  • Competition Authorities track record in pharma
  • Strategic use of competition and IP law

     
  • Natasha Pearman

    Natasha Pearman, Managing Associate, Mishcon de Reya LLP

    Martyn  Hann

    Martyn Hann, Partner, IP, Mishcon de Reya LLP

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    11:40

    Payers perspectives on biosimilars - impact & implications of CQUINs and Consequences for brands & biosimilars

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

  • NHS Fiscal overview and medicines funding landscape 
  • New NHS CQUINs on Biosimilars and how payers are implementing this
  • How Payers are aligning biosimilars with innovative parent brands to streamline patient care settings
  • Physician loyalty [brand v biosimilar and biosimilar v biosimilar] and how this affects formulary uptake
  • What value offerings from biosimilars resonate with payers and formulary decision makers
  • Drivers for outcomes based, innovative contracting for new medicines
  • Bridging the 'uncertainty gap' between payers & pharma - the shifting paradigm
     
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    12:20

    Networking Lunch

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    13:20

    When the market wants BioBetters – developing the next generation Anti-Neutropenic Factor

    Glenn Kazo

    Glenn Kazo, President, Prolong Pharmaceuticals

  • Neulasta is one of the most desirable targets for biosimilar development
  • Ongoing technical and market challenges to biosimilar versions of Neulasta 
  • A new paradigm—preventing neutropenia vs treating the condition
  • Commercial approach to developing ANF-RhoTM.
     
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    14:00

    The biosimilar business case

    Thomas  Sachnik

    Thomas Sachnik, Sr Manager Strategic Associate to the President & CEO Generics Europe , Teva Pharma BV

  • The profitability of the biosimilar business and its sustainability remains a major question mark for the corporate decision makers in pharma
  • The past has shown a variety of partnerships in the field driven by a high degree of uncertainty of the business model of biosimilars – While investments are high and returns uncertain, risk is shared by partnerships and collaborations along the entire value chain of biosimilars
  • Comparing the biosimilar waves, how will the business case change and how did and will the competitive landscape evolve?
     
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    14:40

    Afternoon Tea

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    15:10

    Modern biosimilar analytical methods

    Harish  Pai

    Harish Pai, Principal Scientific Manager, Biocon

  • Functional characterization is an area of immense importance
  • In-vitro methods need to be sensitive enough to pick up the differences in biosimilar assessment
  • Establishing totality of evidence based on the mechanism of action
  • Use of in-vitro functional assays for extrapolation of clinical indication
     
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    15:50

    Round Table: China's biosimilars guideline and EU requirements

    The Round Table will invite the panel of distinguished speakers to address the following topics:

  • China's biosimilars Guidelines: 2 years after - sharing experience from and with the audience
  • EU relaxing requirements: Introduction of global reference products in the overarching guidelines, 3R and reducing animal data, extrapolation of indications
  • Norswitch study and interchangeability vs US-Draft guidance on interchangeability and requirement for 3 times switch study.
     
  • Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

    Omar Ali

    Omar Ali, Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE, University Of Portsmouth

    Richard  Peck

    Richard Peck , Vice President Regulatory Affairs, Lupin (Europe)

    Ildiko Aradi

    Ildiko Aradi, Head, Clinical Development of Biologics, Gedeon Richter

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    16:30

    Latest developments in strategies to bring biosimilars to the market

    Richard  Peck

    Richard Peck , Vice President Regulatory Affairs, Lupin (Europe)

  • Challenges and opportunities faced by manufacturers in developing biosimilars
  • How to overcome challenges, increase development success and optimise results
  • Techniques in bringing the next generation biosimilars to the market
  • Ensuring market share: product differentiation
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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

    Chairs' Opening Remarks

    Michel  Mikhail

    Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars,

    Louis Boon

    Louis Boon, Chief Scientific Officer, Bioceros

    clock

    9:10

    Celltrion Healthcare case study: evidence-based approach to meet the expectations of different stakeholders

    HoUng Kim

    HoUng Kim, Division Head Strategy and Operations, Celltrion Healthcare

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    9:50

    FDA Interchangeability guideline: what does it mean to the industry?

    Rodeina Challand

    Rodeina Challand, Director, Challand Biosimilar Consulting

  • The importance of interchangeability: Patients and healthcare professionals
  • FDA Guidance on gaining interchangeable biosimilar approval - scope
  • Designing switching studies, choosing reference products and monitoring immune responses
  • Regulatory and operational challenges
  • Rest of the world status
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    10:30

    Morning Coffee

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    11:00

    Clinical data extrapolation in biosimilars development

    Bernd Liedert

    Bernd Liedert, Senior Clinical Program Leader Biosimilars, Boehringer Ingelheim

  • Across indications in immunology: Known, plausible and hypothetical modes of action
  • From metastatic to adjuvant: Across disease stages in oncology
  • Extrapolation of PK, immunogenicity and safety
  • The AIID community, anti-TNF biosimilars and extrapolation
  • Interchangeability by extrapolation
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    11:40

    From biosimilars to biogenerics

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency

  • Attitudes and acceptance in clinical practice
  • Uptake in clinical practice
  • Nor-Switch study and other clinical trials
  • Switching and interchangeability
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    12:20

    Networking Lunch

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    13:20

    SPOT and process modulation technology to reduce cost of goods (COGs) for biosimilar development

    Louis Boon

    Louis Boon, Chief Scientific Officer, Bioceros

  • Specific productivity increase by SPOT
  • Process modulation to meet CQAs
  • Costs of Goods reduction
  • Custom bio-assays
     
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    14:00

    A novel analytical approach to biosimilar characterisation

    Robert Forbes

    Robert Forbes, Professor of Clinical Pharmaceutics, University Of Central Lancashire

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    14:40

    Afternoon Tea

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    15:10

    When push comes to push back…Australia and the flaw in payerdriven substitution

    Stephen  Murby

    Stephen Murby, International Advisory Board Member, Alliance for Safe Biologic Medicines

  • Just as biologics are not chemicals so there is a need for new business models for biosimilars
  • Substitution of biosimilars is not the same as supervised clinical switching
  • Biosimilar pharmas & payers underestimate patients, prescribers and pharmacists at their risk
  • The key to access is confidence not cost
  • clock

    15:50

    Expiring patents- court cases and how these are developing

    Dominic Adair

    Dominic Adair, Partner, Bristows LLC

  • Expenses involved in development and whether these can be recovered in the current UK market
  • Overview of current IP laws in biosimilars and developments in patent expiry
  • Launching case against a biosimilar company
  • Case study of Abbvie vs Fujifilm- what might this mean for future litigation cases?
     
  • clock

    16:30

    Chairman’s Closing Remarks and Close of Day Two


    Senior Clinical Program Leader Biosimilars
    Boehringer Ingelheim
    Vice President Europe
    GfK HealthCare
    Partner
    Bristows LLC
    President
    Prolong Pharmaceuticals
    Principal Scientific Manager
    Biocon
    Division Head Strategy and Operations
    Celltrion Healthcare
    Head, Clinical Development of Biologics
    Gedeon Richter
    Chief Scientific Officer
    Bioceros
    Partner, IP
    Mishcon de Reya LLP
    International Expert in Regulatory Affairs, International Expert in Biosimilars
    Managing Associate
    Mishcon de Reya LLP
    Visiting Lecturer, Value Based Pricing & Outcomes Based Innovative Contracting and Former Advisor to NICE
    University Of Portsmouth
    Vice President Regulatory Affairs
    Lupin (Europe)
    Professor of Clinical Pharmaceutics
    University Of Central Lancashire
    Director
    Challand Biosimilar Consulting
    Medical Director
    Norwegian Medicines Agency
    International Advisory Board Member
    Alliance for Safe Biologic Medicines
    Sr Manager Strategic Associate to the President & CEO Generics Europe
    Teva Pharma BV
    Consultant, European Thought Leadership
    QuintilesIMS

    Sponsors and Exhibitors

    Official Media Partner

    Official Online Media Partners

    Supporters

    Preliminary Attendee List Biosimilars 2017

    Download

    An Interview with Prolong Pharmaceuticals

    Download

    New Interview with Celltrion Healthcare Ahead of Biosimilars 2017

    Download

    Bioceros Q&A | An Interview with CSO and Founder, Dr Louis Boon

    Download

    Sponsors and Exhibitors


    Mishcon de Reya

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    Founded in 1937, Mishcon de Reya is one of the UK's fastest growing law firms. Our Life Sciences Group comprises lawyers who are passionate and knowledgeable about all aspects of the sector, including pharmaceuticals, biotechnology and crop sciences. Our lawyers give both contentious and non-contentious advice, with our litigation practice focusing on resolving patent, regulatory, major contract and competition law disputes.

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    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.


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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.


    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.


    SciDoc Publishers

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    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    PharmaVOICE

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    http://www.pharmavoice.com

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

    Holiday Inn 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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