This workshop aims to refresh delegates involved in the development of biosimilars with essential knowledge and will provide a fantastic introduction for beginners entering biosimilar development. The workshop will cover some aspects of the all-important chemistry, manufacturing and controls (CMC) for dossier for analytical similarity, non-clinical and clinical development, and regulatory requirements in the EU and the US, including the two-step approval process in the US.

  • Expand your knowledge on how best to develop biosimilars in a global market
  • Equip yourself with expert knowledge of how to approach development in order to maximize market approval potential
  • Fantastic interactive platform for delegates to share industry experience and hear from an international expert in the field

Workshop programme

8:30 Registration & Coffee

9:00 Workshop leader introduction

Michel  Mikhail

Michel Mikhail, , Global Expert in Biosimilars
View Bio

9:10 Analytical similarity form the basis of the CMC dossier

Michel  Mikhail

Michel Mikhail, , Global Expert in Biosimilars
View Bio

  • Choice of reference product
  • Batch to batch variability of the reference product
  • Representative biosimilar batch to be used in the clinical development
  • 9:50 Non-clinical development and clinical development of biosimilars

    Michel  Mikhail

    Michel Mikhail, , Global Expert in Biosimilars
    View Bio

  • The 3R concept: Replacement, reduction and refinement
  • In-vitro pre-clinical similarities vs. in-vivo animal studies
  • Phase 1 and phase 3 clinical development
  • 10:40 Morning Coffee and Networking Break

    11:10 EU vs. US regulatory requirements

    Michel  Mikhail

    Michel Mikhail, , Global Expert in Biosimilars
    View Bio

  • Using US reference product for the global EU and US development of biosimilars
  • Bridging studies vs. EU reference product
  • Cost of reference product vs. availability, blinding aspects
  • 11:50 Two-step approval in the US

    Michel  Mikhail

    Michel Mikhail, , Global Expert in Biosimilars
    View Bio

  • First step as a biosimilar
  • Second step as an interchangeable biosimilar
  • An introduction to the FDA interchangeability guidelines
  • 12:30 Close of workshop



    Michel  Mikhail

    Michel Mikhail

    , Global Expert in Biosimilars

    Michel Mikhail

    , Global Expert in Biosimilars
    Michel  Mikhail

    Dr. Dr. Michel Mikhail has more than 30 years Pharmaceutical Industry experience and track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical Companies, Biotech Companies as well as in the Generic industry. Dr Mikhail is an Expert in Biosimilars. Has been involved in the Global Development and Worldwide regulatory approval of Blockbuster Monoclonal antibodies Medicines. He was involved in shaping the EU Biosimilars Guidelines and their Review, the WHO Guidelines, ICH Guidelines and now in the US-FDA Biosimilars Guidelines.

    Copthorne Tara Hotel

    Scarsdale Place
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.




    speaker image






    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.


    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.


    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.


    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

    Event Title


    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event


    Sign up
    Forgotten Password?

    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
    Registered in England No: 3779287 VAT No: GB 976 2951 71

    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SMi.
    Full details of our privacy policy can be found here https://www.smi-online.co.uk/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data@smi-online.co.uk.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smi-online.co.uk/opt-out