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Biosimilars USA

Building on the success of previous events, SAE Media Group proudly announces the return of its 5th Annual Biosimilars USA Conference, taking place in New Jersey on the 14th and 15th November 2018.

This fifth event in the series will gather a global audience of biosimilar experts and industry-thought leaders to discuss biosimilar manufacturing and commercialization considerations specific to the U.S..

On March 7th, 2018, the U.S.-FDA’s Commissioner, Scott Gottlieb, MD, announced that Biosimilar medicines are now a top priority for the FDA. Join us this November to learn how to take advantage of the FDA’s focus on biosimilars, accelerate your biosimilar pipeline and achieve FDA approval.

This year's conference will home-in on how to circumvent regulatory hindrances and expediting the approvals process for your biosimilars pipeline. Experience will be drawn from a range of expert perspectives, to allow you to benchmark your business practices and learn how to streamline your processes.

Hear from a selection of carefully handpicked keynote addresses and case studies presented to you by top manufacturing and leading distributors of market approved biosimilars, as they offer a unique insight into the areas of manufacturing, commercialization, device design, uptake, switching, interchangeability, and regulations.

“If we’re serious about seeing the market for biosimilars take shape, it’s going to require a payment system that gives products that are currently in the pipeline a chance to enter the market once they’re approved…. The FDA will do its part by laying out an efficient path for showing how biosimilar products can demonstrate interchangeability with their branded counterparts. But we can solve only one part of this equation.”

- Quote from Scott Gottlieb, MD, Commissioner of Food and Drugs Speech titled “Capturing the Benefits of Competition for Patients” Full transcript can be found here.

FEATURED SPEAKERS

Don Stewart

Don Stewart

CEO, PlantForm Corp
Hillel Cohen

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc

Anita Burrell

VP, Global Market Access, Eversana
Anita Burrell

Anita Burrell is a dynamic, passionate and infectiously enthusiastic consultant focused on improving patient outcomes through pharmaceutical innovation. She is also an adjunct assistant professor at Rutgers University and a regular speaker in the industry on health economics, market access and mHealth.

Anita has 23 years of leadership experience in the pharmaceutical industry in a wide variety of roles and geographies. As the Global Project Lead for Aubagio, the oral MS therapy from Genzyme, she was able to bring Aubagio to market over eight months ahead of schedule becoming the second oral therapy to market in the USA and EU. Aubagio is the fastest growing MS product in the US and the #1 product in the Genzyme/Sanofi portfolio with revenue of €1.6B in 2017.

As a consultant Anita has helped companies to:
Understand market dynamics and payer behavior in diabetes and MS
Design big data platforms to deliver value in terms of regional sales variations
Develop predictive models to inform HTA submissions
Understand the implications of digital health and possibilities to use behavioural economics

Anita holds a BA (Hons) in Economics from the University of Stirling, an M.A. in Economics from Dalhousie University, Nova Scotia, Canada, and a Masters in Business Administration from Kingston University, Surrey UK. She speaks French at an advanced level.

For more insight visit https://www.linkedin.com/in/anitaburrell
 

Arun Nataraj

Business Development and Licensing Executive , Vermont Biosynthetics LLC
Arun  Nataraj

Arun Nataraj has over 17 years of Business Development & Licensing experience in the Pharma Industry. After spending a decade in pharma manufacturing organizations, most recently at Lonza, where his roles included leading licensing for Lonza’s leading mammalian expression system, Arun then switched over to the “buy side” by joining Amneal Pharma, where he worked until recently, and led BD&L activities for the US market. During his career, Arun has completed over a hundred transactions, from In/Out Licensing of Products & Technology Platforms; Technology Transfers; Manufacturing agreements for Products & Devices; and Commercial Distribution Arrangements. Arun has a PhD in Molecular Biology from the MD Anderson Cancer Center and an MBA from Cornell University.

Catherine Soo

Senior Clinical Evaluator, Health Canada
Catherine Soo

Catherine Soo holds a PhD in Pharmacology and joined Health Canada in 2011 as a Regulatory Project Manager in the Therapeutic Products Directorate (TPD), Health Products and Food Branch. Shortly after joining, she moved into a review position within the Bureau of Pharmaceutical Sciences, TPD, where she focused on the review of generic pharmaceuticals. Since 2015, Catherine has been working in the Biologics and Genetic Therapies Directorate as a Senior Clinical Evaluator on the review of biologics products, including biosimilars. Catherine therefore has extensive experience in the review of bioequivalence and comparative bioavailability studies in both the pharmaceutical and biologics areas, as well as knowledge of the regulatory requirements for filing.

Christina Yunis

Global Biosimilars Market Development Lead, Pfizer
Christina Yunis

Christopher Loh

Partner, FITZPATRICK, CELLA, HARPER & SCINTO
Christopher Loh

Don Stewart

CEO, PlantForm Corp
Don Stewart

Don Stewart, PhD

Dr. Stewart, an entrepreneur and scientist bringing 30 years’ experience in the biotechnology industry to this role. Dr. Stewart has founded a biotechnology company, PlantForm Corporation. At PlantForm Dr. Stewart has developed the company from a start-up, directing fundraising, the development of a strong intellectual property portfolio and implementation of partnerships with Pharmaceutical Companies, Government Organizations and Foundations.

Previously, as the Director Research and Development for Cangene Corporation, Dr. Stewart was responsible for the company’s research and development group. Dr. Stewart led collaborative programs developing innovative and biosimilar drugs as medical countermeasures and as traditional therapeutics.

Dr. Stewart graduated with a PhD from the University of London, UK and gained academic experience at the University of Alberta in Edmonton, Canada.
 

Edric Engert

Managing Director , Abraxeolus Consulting
Edric Engert

Edric Engert is Managing Director of Abraxeolus Consulting and has over 20 years of experience in the healthcare industry. He offers problem solving leadership and expertise in such areas as strategy, its operationalization, business development/in-licensing, portfolio strategy, selection, and management, operational improvement programs and turnarounds, and M&A. He has advised a broad range of clients in such industries as Biosimilars, Generics, Branded Pharmaceuticals, API, Healthcare Information Exchanges, distributors, trade associations, and not-for-profit agencies.

Prior roles included Head of the Biosimilars Business at Teva, leading Generics portfolio, BD, strategy, and API sourcing at companies like Sandoz and Teva, and consultant at McKinsey & Company’s health care practice. Edric holds an MBA from Wharton and a BS in Mathematics from MIT.
 

Ha Kung Wong

Partner, New York, FITZPATRICK, CELLA, HARPER & SCINTO
Ha Kung Wong

Hillel Cohen

Executive Director, Scientific Affairs, Sandoz Inc
Hillel Cohen

Dr. Hillel Cohen leads Scientific Affairs efforts for Sandoz in the Americas where he helps explain the science-based Sandoz and Novartis biosimilar policy positions to the healthcare community, the public, and health authorities. He has been active in field of biosimilars since 2002, when discussions about them were initiated in the US.

Dr. Cohen has been active in biosimilar trade associations in a variety of roles, including leadership roles at the Biosimilars Forum and at the Biosimilars Council (a division of the Association for Affordable Medicines).

Dr. Cohen has over 25 years of industry experience. He is an expert in regulatory science policy and biologic product development. Before joining Scientific Affairs at Sandoz, he was the Head of Global Strategic Labeling as well as the Head of Regulatory Affairs for the Americas at Novartis Vaccines. Hillel has held leadership positions in biotechnology QC, bioanalytical chemistry, and regulatory affairs at other firms.

Dr. Cohen received a BA from NYU and a PhD in Biology from Dartmouth.

HoUng Kim

Head of Strategy and Operations Division , Celltrion Healthcare Co, LTD.
HoUng Kim

John Kirkland

Director, Alkermes, Inc.
John Kirkland

Michel Mikhail

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

Nigel Rulewski

Vice President, Head Biosimilar Center of Excellence, IQVIA
Nigel Rulewski

Dr Nigel Rulewski MD, DCH, DRCOG is Vice President and Head of the Biosimilar Center of Excellence at IQVIA. Dr Rulewski has over 25 years of experience in the pharmaceutical industry.
He has been involved in all stages of development of biosimilar products for approval in the US, EU and major global markets. Prior to joining IQVIA, Dr. Rulewski served as Chief Medical Officer at Astra USA, Fisons, Serono, Procept and ArQule. He has managed FDA Advisory Committee meetings, and interacted with the FDA on numerous drug development projects in diverse therapeutic areas resulting in seven successful US approvals. He also served as a consultant working in venture capital in the US funding biotech startup companies. During the development of the AIDS crisis, Dr. Rulewski was media trained and acted as a company spokesperson on sensitive drug development issues handling both press and TV interviews. He received his medical training at St Bartholomew’s Medical School, University of London and completed post graduate training in Obstetrics and Gynecology, (Diploma in Child Health, Royal College of Physicians) and Pediatrics
 

Peter Waibel

Head of US Patent Litigation, Novartis
Peter Waibel

Sarfaraz Niazi

Founder, Karyo Biologics, LLC
Sarfaraz Niazi

Prof. Sarfaraz K. Niazi, Founding Chairman of Karyo Biologics, Founder and Ex-Executive Chairman of Adello Biologics, and Adj. Professor of Biopharmaceutical Sciences, University of Illinois, has developed several biosimilar products, written 50+ major textbooks and handbooks, authored 100+ research papers, and owns the largest number of bioprocessing patents. He is a major contributor to the the BPCIA and the FDA guidance that followed. Dr. Niazi’s Citizen Petitions on bioequivalence testing and biosimilar development have been accepted by the FDA. www.niazi.com; www.karyobio.com; niazi@niazi.com

Steinar Madsen

Medical Director, Norwegian Medicines Agency
Steinar Madsen

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Michel  Mikhail

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

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9:10

Sustainability is key to realizing the benefit biosimilars offer to patients, physicians, payers and healthcare systems

Christina Yunis

Christina Yunis, Global Biosimilars Market Development Lead, Pfizer

  • Biosimilars is a very dynamic market and not only from a competitive environment perspective, but the Intellectual Property (IP), Policy and Regulatory Environment will continue to evolve.
  • There are 5 main ingredients to achieving a vibrant, sustainable environment for biosimilars that benefits patients, healthcare systems and industry:
    o Fair and early access to market,
    o appropriate pricing,
    o biosimilars from several competitors on the market,
    o broad insurance coverage, and
    o educated and supportive physicians and patients.
  • As an industry, we must unite to ensure health systems are ready to realise the potential of biosimilars in the US, and around the world
     
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    9:50

    New Dance Moves: How recent caselaw has reshaped the BPCIA patent dance

    A discussion looking at several of the recent US case law rulings that have significantly altered the canonical timeline for BPCIA litigation, and how biosimilars makers can potentially navigate those changes
    A discussion on how the Amgen v. Sandoz Supreme Court case has opened the door to bypassing the patent dance and accelerating the time period for pre-launch declaratory judgment litigation
    A discussion on the potential for pre-launch damages litigation, as were awarded in the Amgen v. Hospira district court decision
    A discussion on how, whether and when to disclose biosimilar manufacturing info, as was the subject of the Amgen v. Hospira Fed Cir decision
    A discussion on the recent skirmishes in California over choice of venue, as in the pending Amgen v. Genentech and Celltrion v. Genentech matters
    A discussion of the FDA’s process for approving biosimilar applications, and how the FDA’s approval timeline syncs up (or does not) with the BPCIA’s “expected” litigation timeline 
     
     

    Christopher Loh

    Christopher Loh, Partner, FITZPATRICK, CELLA, HARPER & SCINTO

    Peter Waibel

    Peter Waibel, Head of US Patent Litigation, Novartis

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    10:30

    Morning Coffee

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    11:00

    Hasta La Vista, Baby”: The Impact of IPRs and PGRs on Biologic Products

    - IPR and PGR process, strategic differences between those and district court litigation
    - Statistics demonstrating the particular impact of these venues on biologic products
    - General strategy as to how to prepare for them from both the BLA holder and aBLA filer perspective.
     

    Ha Kung Wong

    Ha Kung Wong, Partner, New York, FITZPATRICK, CELLA, HARPER & SCINTO

    John Kirkland

    John Kirkland, Director, Alkermes, Inc.

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    11:40

    Rationalising FDA guidance on Biosimilars – Expediting approvals and acceptance

    Sarfaraz Niazi, Founder, Karyo Biologics, LLC

  •  FDA to eliminate bridging test, make statistical equivalence criteria clinically relevant and allow in vitro immunogenicity where available
  • The FDA, the prescribers and the payers jointly promote the use of biosimilars as first choice for new patients, given that there is no clinically meaningful difference
  • The developers to concentrate on fingerprint like similarity rather than offering to do studies in patients
     
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    12:20

    Networking Lunch

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    13:20

    Risk evaluation of Biosimilars and downstream implications for operations and commercialization

    Edric Engert, Managing Director , Abraxeolus Consulting

    •             External risks that are systemic to Biosimilars and internal risks that each Biosimilar firm likely faces
    •             Understanding the approaches needed for operations and commercialization in both planning and execution
    •             Examples of key drivers, incentives, and what components must be known and considered with example quantification of resulting market dynamics
    •             An outline of resulting to-do's that any Biosimilar firm engaged in commercialization needs to cover to be successful in their launch and beyond
     

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    14:00

    Switching form Reference Biologics to Biosimilars

    Hillel Cohen, Executive Director, Scientific Affairs, Sandoz Inc

  • Scientific literature was reviewed from 1993 to June 30, 2017 to identify publications that described switching from reference biologic to a biosimilar
  • Ninety studies were identified, involving 7 molecules used to treat 14 disease indications, enrolling a total of 14,225 individuals
  • The great majority of studies did not report differences in safety, efficacy or immunogenicity
  • The results suggest a low risk of either a safety concern or loss of efficacy after switching to a biosimilar
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    14:40

    Afternoon Tea

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    15:20

    Biosimilars Interchangeability: The Draft Regulatory Guidance in the USA

    Michel  Mikhail

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

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    16:00

    PANEL: How sustainable is the biosimilars market?

    Christina Yunis

    Christina Yunis, Global Biosimilars Market Development Lead, Pfizer

  • Where is the market heading?
  • Who will be the relevant players and where will they be based globally?
  • Will we see a migration of manufactures to low cost countries as we did with generics?
  • What are the short and long-term gains?
  • In 10 years’ time, will there still be a market that can make profit?
  • clock

    17:00

    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

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

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    9:10

    Recent Expected and Unexpected Developments in Biosimilar Drug Development

    Nigel Rulewski, Vice President, Head Biosimilar Center of Excellence, IQVIA

  • US interchangeability requirements in the US
  • Use of Next Generational Tools and novel paradigms to accelerate the clinical development cycle
  • Steps that innovator companies have taken to block biosimilar development
  • Steps being taken to erode the “patent dance” in the US
  • The potential for using a global reference comparator
  • The possibility of abbreviating the biosimilar development pathway
  • The emergence and ramifications of the ‘Nocebo Effect”
     
  • clock

    9:50

    Developing biosimilars with a tobacco plant expression system

    Don Stewart , CEO, PlantForm Corp

  • Drug production using plant based and other expression systems 
  • Regulatory environment for non-traditional expression systems
  • Partnerships using alternative expression systems to develop biosimilars and biobetters
  • clock

    10:30

    Morning Coffee

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    11:00

    In-licensing biosimilars: Best practices for completing diligence and executing the contract successfully

    Arun Nataraj, Business Development and Licensing Executive , Vermont Biosynthetics LLC

    • Gap analysis in the data during due diligence and Partners plans to address them. FDA correspondence following Pre-IND and pre-BLA meetings
    • The importance of outside consultants and their role in due diligence
    • Structuring a deal to de-risk your investment until there is confidence in the program
    • Critical contractual issues that need to be negotiated in a favourable manner (to you)

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    11:40

    Canadian Regulatory Perspective on Biosimilars

    Catherine Soo, Senior Clinical Evaluator, Health Canada

  • Regulatory Framework – the Canadian Food and Drugs Act and Regulations and Health Canada’s Guidance Documents on the Information and Submission Requirements for Biosimilars
  • Clinical requirements for biosimilar drug submissions
  • Intersect of Patented Medicines and the approval process for Biosimilars
  • Roles of the Federal versus Provincial Jurisdictions
  • Authorised/marketed Biosimilars in Canada
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    12:20

    Networking Lunch

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    13:20

    Biosimilars – can they all survive?

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    13:20

    Do biosimilars really need Real World Evidence?

    Anita Burrell, VP, Global Market Access, Eversana

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    14:00

    Roles of Biosimilars in Patients Access to Biologic Treatments

    HoUng Kim

    HoUng Kim, Head of Strategy and Operations Division , Celltrion Healthcare Co, LTD.

    • Improving patient access
    • Biologics in earlier stage
    • Impact of biosimilars in oncology
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    14:40

    PANEL: Forecasting uptake of biosimilars entering the market: Points to consider

    Nigel Rulewski, Vice President, Head Biosimilar Center of Excellence, IQVIA

    Edric Engert, Managing Director , Abraxeolus Consulting

    Michel  Mikhail

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

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    15:40

    Chairman’s Closing Remarks and Close of Day Two


    VP, Global Market Access
    Eversana
    Business Development and Licensing Executive
    Vermont Biosynthetics LLC
    Senior Clinical Evaluator
    Health Canada
    Global Biosimilars Market Development Lead
    Pfizer
    Partner
    FITZPATRICK, CELLA, HARPER & SCINTO
    CEO
    PlantForm Corp
    Managing Director
    Abraxeolus Consulting
    Partner, New York
    FITZPATRICK, CELLA, HARPER & SCINTO
    Executive Director, Scientific Affairs
    Sandoz Inc
    Head of Strategy and Operations Division
    Celltrion Healthcare Co, LTD.
    Director
    Alkermes, Inc.
    International Expert in Regulatory Affairs, International Expert in Biosimilars
    Independant Consultant
    Vice President, Head Biosimilar Center of Excellence
    IQVIA
    Head of US Patent Litigation
    Novartis
    Founder
    Karyo Biologics, LLC
    Medical Director
    Norwegian Medicines Agency

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    Workshops

    VENUE

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    515 US Highway 1 South, Iselin, New Jersey, USA

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Biosimilars USA 2018 Attendee List

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    Speaker Interview with Christopher E. Loh, FITZPATRICK, CELLA, HARPER & SCINTO

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    News Article on Celltrion

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    Speaker Interview Edric Engert, Abraxeolus Consulting

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    Speaker Interview HoUng Kim, Celltrion Healthcare

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    Speaker Interview Catherine Soo, Health Canada

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    The FDA’s infographic on the biosimilar development process

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    2018 Brochure

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    2017 Speaker Presentation from KARYO BIOLOGICS

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    2017 Speaker Presentation from PlantForm Corporation®

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    2017 Speaker Presentation from profecyINTEL, LLC

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    2017 Speaker Presentation from COVANCE

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    2017 Speaker Presentation Zuckerman Spaeder

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    2017 Speaker Presentation from Sandoz

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    Speaker Interview with Anita Burrell, Anita Burrell Consulting

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    Speaker Interview with Sarfaraz Niazi, Founder, Karyo Biologics

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    Press Release on FDA Biosimilar Action Plan

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    Speaker Interview Hillel Cohen, SANDOZ

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    2018 Speakers

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    2018 Agenda

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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


    American Laboratory

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    For laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.


    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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    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


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    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
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    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

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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.


    American Pharmaceutical Review

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


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    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.

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    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
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    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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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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