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Biosimilars & Biobetters USA
November 16 - November 17, 2015
Biosimilars & Biobetters USA

Building on last year's success, SAE Media Group's 2nd Annual Biosimilars & Biobetters USA returns to New Jersey in November! 

Biologic Therapeutics have revolutionised the treatment of many diseases and biosimilars are having a similar therapeutic efficacy with potentially lower costs to the health care system.


The approval of the first biosimilar in the US is expected to save the healthcare industry and patients $5.7 billion over the next decade. However, it is a complex landscape with complexity of manufacturing biologics making the development of biosimilars more challenging than the development of generics.


In addition to this, the upcoming patent cliffs facing manufacturers of blockbuster biologics are daunting – with over $60bn in branded biologic sales coming off patent in the next several years.


The biosimilars and biobetters industry is likely to become a lot more dynamic and strategic than we’ve seen with small molecule generics; there will begin to become a premium on flexibility and willingness to take chances in an ever-shifting competitive and regulatory environment.
 

The US biosimilars market is expected to reach $2 billion by 2018 and with the first biosimilar approved recently in America, this is an exciting time for the biosimilar field with approval in the US expected to increase during the next ten years. The regulatory landscape is evolving rapidly so it is important to understand the developments in the biosimilar guideline framework and the cohesion in legislation between the US and Europe.

The learning objectives in the US should be to fully understand the product lifecycle and all aspects of biosimilar research and development.

 

Watch this space…

 

Source - http://www.financierworldwide.com/competitive-strategies-in-life-sciences-biobetters-versus-biosimilars/#.VYBBtmVwbcs

FEATURED SPEAKERS

Andrea Laslop

Andrea Laslop

Head of Scientific Office, Austrian Agency for Health and Food Safety
Carsten Brockmeyer

Carsten Brockmeyer

CEO, Formycon AG
Cliff Mintz

Cliff Mintz

Senior Writer/Correspondent, Life Science Leader
Dominic Adair

Dominic Adair

Partner, Patent Litigation, Bristows
Gerry McGettigan

Gerry McGettigan

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

Jim Nelson

Senior Principal and Owner, Adversarial Proceedings/Pharma & Biotech, Schwegman Lundberg Woessner
Magdalena Leszczyniecka

Magdalena Leszczyniecka

Founder and CEO, STC Biologics Inc
Michael Kleinrock

Michael Kleinrock

Research, Director, IMS Health Inc
Michael Tovey

Michael Tovey

INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan
Raju Shantha

Raju Shantha

Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.
Richard Dicicco

Richard Dicicco

Chairman, Harvest Moon Pharmaceuticals
Robin Chadwick

Robin Chadwick

Principal, Biotechnology, Schwegman Lundberg Woessner
Steinar Madsen

Steinar Madsen

Medical Director, Norwegian Medicines Agency
Takashi Kei  Kishimoto

Takashi Kei Kishimoto

Chief Scientific Officer, Selecta Biosciences

Andrea Laslop

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

Carsten Brockmeyer

CEO, Formycon AG
Carsten Brockmeyer

Catherine Godrecka-Bareau

Director of Portfolio Management & Strategy, Biosimilars, Merck Group
Catherine Godrecka-Bareau

Cliff Mintz

Senior Writer/Correspondent, Life Science Leader
Cliff Mintz

Dominic Adair

Partner, Patent Litigation, Bristows
Dominic Adair

Gerry McGettigan

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

Graeme Deuchar

Product Development Expert, Kinesys Consulting Ltd
Graeme Deuchar

Jim Nelson

Senior Principal and Owner, Adversarial Proceedings/Pharma & Biotech, Schwegman Lundberg Woessner
Jim Nelson

Jordanis Joy

Biopharmaceutical Regulatory Affairs, Sandoz Inc
Jordanis Joy

Liz Yamashita

VP, Regulatory & Clinical Affairs, Oncobiologics
Liz Yamashita

Magdalena Leszczyniecka

Founder and CEO, STC Biologics Inc
Magdalena Leszczyniecka

Michael Kleinrock

Research, Director, IMS Health Inc
Michael Kleinrock

Michael Tovey

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

Raju Shantha

Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.
Raju Shantha

Rakesh Dixit

Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc
Rakesh Dixit

Richard Dicicco

Chairman, Harvest Moon Pharmaceuticals
Richard Dicicco

Robin Chadwick

Principal, Biotechnology, Schwegman Lundberg Woessner
Robin Chadwick

Sam Mukherjee

Associate Director Biosimilar Commercial Strategy and Portfolio Management, Dr. Reddy's Laboratories Inc.
Sam Mukherjee

Steinar Madsen

Medical Director, Norwegian Medicines Agency
Steinar Madsen

Takashi Kei Kishimoto

Chief Scientific Officer, Selecta Biosciences
Takashi Kei  Kishimoto

Ted Carver

Principal Consultant, PAREXEL
Ted Carver

sponsors

Conference agenda

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8:30

Registration & Coffee

Ted Carver

Ted Carver, Principal Consultant, PAREXEL

Lotte McNamara

Lotte McNamara, Principal Consultant, PAREXEL

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9:00

Workshop Leader's Opening Remarks

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9:10

Evaluating How to Avoid Regulatory Pitfalls in Analytical Similarity Assessments

  • Quality systems/GMPs for biosimilar programs
  • Handling R&D analytical data for inspections
  • Documenting method qualification studies for similarity tests
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    10:45

    Morning Coffee

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    11:15

    Assessing the Regulatory Quality Compliance Required for Biosimilars Approval

  • Distinctions between product comparability studies and similarity studies
  • Designing and conducting similarity studies- choosing adequate test attributes, comparators, and number of batches for similarity assessment
  • Addressing residual uncertainties in the analytical similarity programs
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    12:00

    Discussion & Q&A

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    12:30

    Close of Workshop

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    13:30

    Registration & Coffee

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    14:00

    Introductions and Opening Remarks

    Gerry McGettigan

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

    Graeme Deuchar

    Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

    Liz Yamashita

    Liz Yamashita, VP, Regulatory & Clinical Affairs, Oncobiologics

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    14:15

    Session 1: Regulatory fundamentals and expedients

    Gerry McGettigan

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

    Graeme Deuchar

    Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

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    15:00

    Session 2: Commercial imperatives

    Gerry McGettigan

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

    Graeme Deuchar

    Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

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    15:30

    Coffee break

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    16:00

    Session 3: Development requirements and options

    Gerry McGettigan

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

    Graeme Deuchar

    Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd

    clock

    17:00

    Discussion & Q&A

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    17:30

    Close of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

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    9:10

    FDA's views on statistical analysis of quality attributes to establish biosimilarity

    Ted Carver

    Ted Carver, Principal Consultant, PAREXEL

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    9:50

    What can the US learn from European experiences?

    Steinar Madsen

    Steinar Madsen, Medical Director, Norwegian Medicines Agency

  • Nine years of biosimilars in Europe – safety and efficacy
  • What are the regulatory differences between Europe and the US?
  • How important  is labelling and naming?
  • Uptake of biosimilars in clinical practice – lessons from Europe
  • clock

    10:30

    Morning Coffee

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    11:00

    SPOTLIGHT PRESENTATION: The first biosimilar approved by the FDA

    Jordanis Joy

    Jordanis Joy, Biopharmaceutical Regulatory Affairs, Sandoz Inc

  • Looking at this case in detail, how did it progress and how will it develop
  • How did the FDA interpret their own guidelines
  • What can we learn from this first approval?
  • Looking ahead, what’s the future regarding more complex molecules?
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    11:40

    Panel Debate: Assessing the success criteria for commercialization for global biosimilars

  • Gain insights as to what an optimal business model is for global commercialization of biosimilars: 1)  stand alone; 2) generic partnered with Big Pharma or Big Bio; 3)geographical or regional licensees; 4) distributors; 5) consortia; 6) contract development/ manufacturing for fingerprint-like similarity
  • Which model for which products?   1) first wave biosimilars 2) second wave biosimilars 3)  Third wave biosimilars and PD-1s
  • Geographical location – which model for which region?  1) Europe; 2) USA; 3) LATAM; 4) APAC; 5) Russia and CIS 

     

  • Magdalena Leszczyniecka

    Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc

    Robin Chadwick

    Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner

    Rakesh Dixit

    Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc

    Catherine Godrecka-Bareau

    Catherine Godrecka-Bareau, Director of Portfolio Management & Strategy, Biosimilars, Merck Group

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    12:20

    Networking Lunch

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    13:30

    Perspectives on the evolving biosimilars landscape

    Michael Kleinrock

    Michael Kleinrock, Research, Director, IMS Health Inc

  • The Global Biologic Market: understanding the place of biologics in medicine use around the world
  • Learning from the biosimilar experience: European experience can offer some insights into the U.S. future (and some confusion too)
  • Looking ahead to the next five years of biosimilar and biologic evolution
  • clock

    14:10

    Understanding the blurred lines between traditional innovators and generics

    Andrea Laslop

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

  • Scientific and quality considerations in demonstrating biosimilarity between the biosimilar and the reference product
  • Reviewing the need to show bioequivalence to the innovator drug based on pharmacokinetic parameters such as rate absorption and bioavailability
  • Understanding the complexity of biosimilar models from a clinical perspective
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    14:50

    Case Study: The First International Reference Standard

    Michael Tovey

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

  • Importance of reference Standards for the Development of biosimilars      
  • First WHO International Standard (IS) for the TNF-alpha sRII receptor-Fc fusion protein (Etanercept). 
  • First International Reference (IR) Preparation for anti-drug (anti-Eprex) antibodies
  • Other WHO IS & IRs for biosimilars currently in development
  • clock

    15:30

    Afternoon Tea

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    16:00

    Update: Can biobetters or biosuperiors meet the challenges of best in class molecules and cheaper biosimilars

    Rakesh Dixit

    Rakesh Dixit, Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc

  • Making biobetters or biosuperiors successful and cost effective through advances in protein engineering and pioneering technologies - case studies of biosuperior vs. biosimilars
  • Evaluating the current innovations in improving existing biologics therapies in diseases with unmet medical needs
  • Identifying which products have significant potential for ‘biosuperior’ development
  • Developing biosuperior protein therapeutics that address sub-optimal, in-market characteristics of currently licensed biologics
  • Examining current active projects in research and development of biosimilar and novel biobetter/biosuperior therapeutic proteins 
  • clock

    16:40

    Impact of Glycosylation on the Biological Functions of Therapeutic Antibodies

    Raju Shantha

    Raju Shantha, Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.

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    17:20

    The Great Debate - Interchangeability

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

  • The determination of interchangeability: satisfying the FDA definition to achieve automatic substitution by the pharmacy without physician consultation
  • Will interchangeability minimize the uncertainty of biosimilar adoption?
  • How does INN naming affect automatic substitution?
  • What will the FDA interchangeability guideline look like?
  • Considerations in the design of switching studies #
  • How will interchangeability affect pricing and reimbursement?
  • Differentiation between the designation or practice of interchangeability in the US and EU
  • Which is more desirable for success: switching existing patients or interchangeability?
  • clock

    18:00

    Chairman’s Closing Remarks and Close of Day One

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

    clock

    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals

    clock

    9:10

    The litigation landscape in Europe: where are we now?

    Dominic Adair

    Dominic Adair, Partner, Patent Litigation, Bristows

  • The patent cliff and the patent hurdle – is it real?
  • When litigation begins, are the rules different?
  • Patent challenges in Europe – the EPO and the national courts
  • The future landscape – the Unified Patent Court
  • clock

    9:50

    Challenging the BPCIAs dispute resolution process

    Jim Nelson

    Jim Nelson, Senior Principal and Owner, Adversarial Proceedings/Pharma & Biotech, Schwegman Lundberg Woessner

  • Reviewing the use of IPR at the US PTO PTAB as an alternative to the Patent Dance of the BPCI Act
  • Claim term interpretation, what do these words mean?
  • Touching on the use of amendments
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    10:10

    Assessing the BPCI and FDA requirements for obtaining the right to sell a Biosimilar in the US

    Robin Chadwick

    Robin Chadwick, Principal, Biotechnology, Schwegman Lundberg Woessner

  • Discussing semi-automated processes to identify and analyze US patents of interest to answer the question whether such patents should be listed on the biosimilar applicant’s proposed list of patents during the BPCI exchange
  • clock

    10:30

    Morning Coffee

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    11:00

    Case Study: Creating Biobetters with Improved Efficacy and Safety by Addressing Product Immunogenicity with Tolerogenic Nanoparticles

    Takashi Kei  Kishimoto

    Takashi Kei Kishimoto , Chief Scientific Officer, Selecta Biosciences

  • The forthcoming flood of biosimilars will create a highly competitive, low margin marketplace. There will be a competitive advantage for biobetters that are differentiated based on their efficacy and safety profile
  • Anti-drug antibodies compromise the utility of many biologic drugs by neutralizing drug efficacy, modulating pharmacokinetics, and/or causing adverse events
  • We have developed tolerogenic synthetic vaccine particles (SVP) that are capable of inducing durable immune tolerance to biologic drugs. We will present case examples using tolerogenic SVP with adalimumab and pegylated uricase
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    11:40

    The fingerprinting approach - Expediting development of Biosimilars

    Magdalena Leszczyniecka

    Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc

  • Because of the very high cost and length of time associated with biologics development, access to biosimilars at a lower cost with shorter development timelines would make these treatments more accessible to a greater number of patients
  • To realize cost and time savings from biosimilars, the current development model needs to change to follow the generic product development paradigm which requires only one bioequivalence trial
  • STC is currently working on fingerprinting approach to obtain approval on a biosimilar antibody product with only one clinial trial through the use of fingerprinting platform. This concept is described in a detailed publication by FDA’s Steve Kozlowski, indicating that a rigorous “fingerprint” like analytical and nonclinical pharmacological similarity could help lift many of the uncertainties/risks of the biosimilar product compared to the originator, which would decrease the burden of clinical trials conducted only to address any “residual uncertainty” not addressable by in vitro studies
  • clock

    12:20

    Networking Lunch

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    13:30

    What are the opportunities in America - Where will we be in 2018?

    Cliff Mintz

    Cliff Mintz, Senior Writer/Correspondent, Life Science Leader

  • Strengthening long-term strategy to maximise return on investment and to benefit patients
  • How to seek partnership to develop and execute risk mitigation strategies
  • Forecasting market penetration – What are the factoring barriers to entry?
  • clock

    14:10

    Clinical & Regulatory Strategies Encompassing the Needs of East and West

    Gerry McGettigan

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

  • What are the key features of a truly global development programme?
  • What obstacles should US / EU biosimilars companies be aware of in Asia and emerging markets
  • What changes do we need in development and regulatory requirements to facilitate truly global developments, and which stakeholders need to make these changes happen?
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    14:50

    Industry partnerships: Key Success Factors in Biosimilar Space

    Catherine Godrecka-Bareau

    Catherine Godrecka-Bareau, Director of Portfolio Management & Strategy, Biosimilars, Merck Group

  •  Stand-alone situation: high R&D costs, unclear regulatory pathways, uncertain business model, incomplete portfolio
  • We will win together through innovative partnership models
  • Case study of the Airline industry: high fixed costs but low marginal costs
  • Translation to the biosimilar space
  • clock

    15:30

    Afternoon Tea

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    16:00

    Case Study: Where are we now and how will we develop?

  • Biosimilars will soon become number one products – but how to get there?
  • Lessons learned from the first European & US biosimilars
  • Creating a true global biosimilars strategy
  • Similarity exercise, clinical data, extrapolation
  • Monoclonal antibodies, a new milestone for the biosimilars market
  • Why biosimilars have been more successful than biobetters
  • Challenges and opportunities with third wave biosimilars
  • Carsten Brockmeyer

    Carsten Brockmeyer, CEO, Formycon AG

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    16:40

    Assessing emerging markets and enhancing strategies

    Sam Mukherjee

    Sam Mukherjee, Associate Director Biosimilar Commercial Strategy and Portfolio Management, Dr. Reddy's Laboratories Inc.

  • How are emerging markets shifting in BRIC countries
  • Dealing with cost containment
  • How do emerging markets compare to the EU and US regulations
  • clock

    17:20

    Chairman’s Closing Remarks and Close of Day Two

    Richard Dicicco

    Richard Dicicco, Chairman, Harvest Moon Pharmaceuticals


    Head of Scientific Office
    Austrian Agency for Health and Food Safety
    CEO
    Formycon AG
    Director of Portfolio Management & Strategy, Biosimilars
    Merck Group
    Senior Writer/Correspondent
    Life Science Leader
    Partner, Patent Litigation
    Bristows
    CEO & Regultory Expert; COO
    Kinesys Consulting Ltd (UK); amp biosimilars AG (Germany)
    Product Development Expert
    Kinesys Consulting Ltd
    Senior Principal and Owner, Adversarial Proceedings/Pharma & Biotech
    Schwegman Lundberg Woessner
    Biopharmaceutical Regulatory Affairs
    Sandoz Inc
    VP, Regulatory & Clinical Affairs
    Oncobiologics
    Founder and CEO
    STC Biologics Inc
    Research, Director
    IMS Health Inc
    INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology
    Ecole Normale Supérieure de Cachan
    Scientific Director, Biologics Research
    Janssen Pharmaceuticals, Inc.
    Vice President, R&D, Global Head, Biologics Safety Assessment
    MedImmune Inc
    Chairman
    Harvest Moon Pharmaceuticals
    Principal, Biotechnology
    Schwegman Lundberg Woessner
    Associate Director Biosimilar Commercial Strategy and Portfolio Management
    Dr. Reddy's Laboratories Inc.
    Medical Director
    Norwegian Medicines Agency
    Chief Scientific Officer
    Selecta Biosciences
    Principal Consultant
    PAREXEL

    Sponsors and Exhibitors

    Platinum Media Partners

    Supporters

    International Clinical and Regulatory Strategies to meet Global Commercial Needs Workshop Preview

    Download

    SMi Speaker Interview Series:Ted Carver, Principal Consultant from PAREXEL

    Download

    SMi Speaker Interview Series: Michael Kleinrock, Director Research Development, IMS Institute for Healthcare Informatics

    Download

    Preliminary List of Attending Organisations in 2015

    Download

    SMi Speaker Interview Series: Gerry McGettigan, CEO & Regulatory Expert from Kinesys Consulting Ltd

    Download

    SMi Speaker Interview Series: Schwegman Lundberg and Woessner P.A

    Download

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    Biosimilar News

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    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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    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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    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
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