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Building on the success of previous events, SMi proudly announces the return of its 5th Annual Biosimilars North America 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..

Fresh form the press: 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.

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.

  • Assess challenges to gaining the FDA’s Interchangeability status and debate, is it worth it?
  • Consider different device design options
  • Explore routes to take if your biosimilar has a better formulation and/or administration than the originator
  • Discuss the FDA’s CMC finger print comparability that requires a minimum of 10 batches for statistical considerations
  • Examine whether more batches lead to better clinical trial outcomes
  • Learn how to meet high GMP compliance when manufacturing outside of the US
  • Analyze whether the biosimilar industry can provide co-payments and other healthcare benefits to patients to successfully complete with originators
  • Discover how to get onto patient formularies, and the important role pharmacy benefit manages have in achieving this

Medical Directors, Scientific Directors, VP’s, Directors, Managers, Team Leaders, Partners, Consultants and Attorneys of:

Biosimilars, Biobetters, Biopharmaceuticals, Biostatistics, Business Alliances, Business Development, Clinical Operations, Commercial, Decision Analytics, Global Intelligence, Global Operations, Managed Markets and Trade Relations, Market assess, Marketing, Patient & Physician Services, R&D Policy, Regulatory Affairs, Scientific Affairs, and anyone else who works within the biosimilars industry!
 

Alexion Pharmaceuticals, Inc.; Algorithme Pharma | An Altasciences Company; Amerisourcebergen; AmeriSourceBergen (ION Solutions); BiologicTx; Bio-Rad; Choate, Hall & Stewart LLP; Covance Inc; Dyadic Nederland B V; FFF Enterprise; Fortress Biotech; GaBI Journal ; Grifols; Harvest Moon Pharmaceuticals USA, Inc.; Janssen , Johnson & Johnson; Lupin Pharmaceuticals; Lupin Pharmaceuticals, Inc.; Luye Pharma; Luye Pharma Group; Market Access Solutions; MedImmune; Merck; Momenta Pharmaceuticals; Mylan Inc; Norwegian Medicines Agency; Oncobiologics; Paragon; Pfizer; PlantForm Corp; QuintilesIMS; SAI MedPartners; Sandoz; Sandoz Biopharmaceuticals; Sandoz Inc; Sanofi-Aventis; Sapphire Therapeutics; Schiff Hardin LLP; Slack Incorporated; Teva Pharmaceuticals USA; The ABIS Group; The Center for Biosimilars; Therapeutic Proteins International, LLC; Ulteemit BioConsulting; VCN Health; ZS Associates; Zuckerman Spaeder LLP;

VENUE

Renaissance Woodbridge Hotel

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.

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Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830
USA

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.

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, SMI 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@smi-online.co.uk

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Contact SMi GROUP LTD

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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