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A full workshop covering all aspects of pharmaceutical regulation applicable to biosimilars. The workshop will begin with an explanation of the interplay between the various IP regulatory rights in the EU and then look at each in detail. The workshop will also reflect on the interaction between regulatory and competition law before finishing. An interactive case study will be run throughout the topics of the workshop to test the knowledge gained.

  • Regulatory Data Protection
  • Market exclusivity for orphan medicinal products
  • Supplementary protection certificates
  • Paediatric rewards


Workshop LEADER


Marie Manley

Partner, Bristows LLC

Marie Manley is a Partner and head of the IP Regulatory Department at Bristows LLP (London). She advises on both contentious and non-contentious matters, focusing on regulatory and competition law in the bio-pharma, medical devices, cosmetic and food sectors; including life cycle management issues, advertising and product liability.
Marie represents leading bio-pharma companies in litigation before the English and EU courts. Recently, Marie successfully represented both Laboratoires CTRS before the General Court in relation to the Commission’s refusal to grant a marketing authorisation for an orphan medicinal product (Case T-301/12); and Seattle Genetics Inc. in an SPC case before the Court of Justice (C-471/12); as well as Shire Pharmaceuticals which secured a Paediatric extension. Marie also regularly co-ordinates EU and overseas litigation. Marie is also representing a pharma company against a decision of the EU Commission for breach of competition rules, as well as representing them in a damage action before the English Courts.
Marie also represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). For example, Marie successfully represented Clinuvel Pharmaceuticals before the EMA in relation to their application for SCENESSE®, a breakthrough drug.
Marie is Chairperson of the Legal Affairs Community for DIA. Marie is considered as a leading practitioner for regulatory law and is described by clients as a “regulatory superstar”. She is recommended in Legal 500, Chambers and Partners; also London Top 100 & London Top 50 Women and EU Law & Super Lawyers UK(2013).

Bristows LLC

Bristows is a full service London law firm serving innovative companies and industry leaders around the world. Bristows has a true cross-disciplinary Life science team of over 60 lawyers in this space encompassing our renowned IP practice, regulatory, competition, commercial, transactional and IT/data protection teams. The strength of each individual practice complements the others to provide a fully integrated service. Many of Bristows life sciences specialists have backgrounds in chemistry, biochemistry, biotechnology, physics and engineering.

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. 



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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

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