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This workshop aims to give participants a good overview of the whole topic of Biosimilars while investigating some topics in more depth. Biosimilars have attracted a great deal of interest and represent a new generic frontier as it is thought that lower levels of competition will lead to higher margins in an industry notorious for its generally low margins.

Lower regulatory barriers in less regulated markets have allowed a Biosimilars market to take off, but higher regulatory barriers in Europe and issues of interchangeability have resulted in slow progress for those already in the market. Across the Atlantic, the situation is changing with the long awaited legislation enabling the first Biosimilars registration. How will the market develop there as multinational players start to enter?

 This workshop will provide you with:-
• A good overview of the Biosimilars picture across the world
• An overview of the barriers to entry
• Insight into the varying regulatory approaches prevailing in different regions
• An understanding of the commercial situation as it is now and how it is likely to develop in the future
• Enough background to determine whether entering the Biosimilars market is an appropriate strategy for their company

Job titles include but are not restricted to:
CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, from the following roles:
• Biopharmaceuticals/ Biotherapeutics
• Follow on Biologics/Follow on Proteins/Biosimilars
• Biologics/Biotechnology/ Biogenerics
• Legal and Regulatory Affairs
• Intellectual Property
• Health Economics
• Pricing and Reimbursement
• Clinical Immunology
• Process Control and Analytical Technologies
• Analytical Characterisation
• Regulatory Compliance
• Pharmacovigilance
• Drug Safety & Risk Management
• Quality Affairs/ Quality Control
• New Product Development
• Process Science
• Portfolio Management
• Research & Development
• Business Development
• Business Operations
• Scientific Affairs
• Commercial Affairs and Strategic Planning
• Legislation and Policy Advice

Workshop LEADER

keynote-img

Peter Wittner

Senior Consultant, Interpharm Consultancy

Peter Wittner, B.Sc., is an independent consultant specialising in the commercial aspects of generics with more than 35 years’ pharmaceutical experience. In one of his industry roles, he joined the Indian generic leader Ranbaxy as Managing Director to help set up its UK business before returning to consultancy work (http://www.interpharm-consultancy.co.uk).

He previously headed the European Sales & Marketing department of the UK generics companies Evans Medical, which later became Medeva, and H.N. Norton, which later became part of IVAX and subsequently Teva.

Peter is a regular speaker at generic conferences, has run Biosimilars workshops for a number of organisations as well as conducting training seminars. He has written a number of reports on generics industry topics.

Interpharm Consultancy

Interpharm Consultancy has been serving the generic pharmaceutical industry since 1997. With a background of over 20 years in generics, we specialise in:

  • advising on growth strategies or market entry strategies
  • helping with business development
  • competitive intelligence
  • providing a link between firms in the UK and overseas companies trying to gain entry into this very competitive marketplace
  • training on understanding the generic marketplace, IP and regulatory issues
  • locating products and registration dossiers for UK companies and
  • assisting branded companies to plan their defence strategies against generics
  • offering help to companies looking for generic acquisitions

Workshop programme

8:30 Registration & Coffee

9:00 Introduction and Opening Remarks

Peter Wittner

Peter Wittner, Senior Consultant, Interpharm Consultancy
View Bio

9:15 Overview - Biosimilars? Biogenerics? Follow-on Biologicals?

10:00 The Regulatory process and its pitfalls

10:45 Morning Coffee

11:15 Biosimilars - The commercial reality

12:15 Discussion and Q&A

12:30 Close of Workshop

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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, 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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