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There is a huge amount of interest across the industry about biosimilars. Due to a more economic price, they present a major opportunity to help control rising healthcare costs and to improve patient access to very expensive biologic treatments.
This masterclass will provide a detailed introduction of biosimilars: from analytical development, regulatory requirements to preclinical and clinical advances as well as manufacturing considerations.

The masterclass will also address aspects such as how biologics including monoclonal antibodies are developed and manufactured and the potential of biosimilars to provide access to patients which will released funds for innovative medicines.

 
 

 

  • This masterclass will give you valuable insights into the principles that shape this space, including its challenges and opportunities
     
  • Case study will be given about the first monoclonal antibody biosimilar in the EU
     
  • Network with your peers and gain new and valuable insights

Senior Vice Presidents, Vice Presidents, Directors, Heads of Department with responsibility in the following departments:

  • Biostatistician
  • Drug and Safety Assessment
  • Research and Development
     

Masterclass LEADER

keynote-img

Uwe Gudat

Head of Safety Biosimilars, Merck KGaA

Uwe Gudat received his medical degree from the University of Marburg, Germany. He is licensed in internal medicine and diabeteology as a sub-speciality, training under Michael Berger in Düsseldorf Germany. Uwe Gudat joined the pharmaceutical industry in 1995 with Eli Lilly and since then has held positions at Hesperion/Actelion, Novartis and Merck Serono. In this time he has led global clinical development teams, served as global medical brand director, led global clinical due diligence teams, and guided the oversight over clinical trial designs, first in man transitions and product safety assessments. Currently he is Head of Safety of the Merck Serono Biosimilars Unit.
Personal interests include Bayesian decision analysis and modelling and simulation in drug development, including that of biosimilars.

Merck KGaA

Merck is the world's oldest pharmaceutical and chemical company. Since 1668 our name has stood for innovation, business success and responsible entrepreneurship. The founding family remains the majority owner of the company to this day.

Masterclass programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Uwe Gudat

Uwe Gudat, Head of Safety Biosimilars, Merck KGaA
View Bio

9:10 The history of “biosimilars”

9:50 Biosimilar a regulatory definition

10:30 Morning Coffee

11:00 How biologics are made

11:40 The need for biosimilars

12:20 Networking Lunch

13:30 Monoclonal antibodies the next generation of biosimilars

14:10 Analytical characterisation the cornerstone of biosimilars development

14:50 Afternoon Tea

15:20 Clinical development: Studies to support translation

16:00 Totality of evidence: Bringing it all together: Case study: Infliximab a trailblazer? (The first monoclonal antibody biosimilar in the EU)

16:40 Chairman’s Closing Remarks and Close of Day One

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VENUE

Holiday Inn Regents Park

Carburton Street, London, London, United Kingdom

Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

HOTEL BOOKING FORM

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Holiday Inn Regents Park

Carburton Street
London W1W 5EE
United Kingdom

Holiday Inn Regents Park

Choose the well-connected Holiday Inn London-Regent's Park hotel, with a superb central London location and speedy transport links. Holiday Inn London-Regent's Park is in a leafy and cosmopolitan area of central London, a 10-minute walk from bustling Oxford Street. Leave your car in our NCP managed underground car park, and explore London by Tube. Great Portland Street Tube station is 25 metres from the hotel, from where you can reach the City and Canary Wharf in 30 minutes, and London Heathrow Airport in 45 minutes.

Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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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Opening Hours: 9.00 - 17.30 (local time)
SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
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