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Why should you attend this event?

Upon completion of this workshop, attendees should be able to:

  • Understand existing and potential nanotechnology-based applications
  • Understand the special aspects of nanomedicines: development, manufacturing and characterisation
  • Identify the key regulatory challenges: borderline issues, classification, safety and pricing/reimbursement of innovative nanomedicines
  • Understand public perception and ethical considerations that apply to nanopharmaceuticals

Scroll down for the workshop timetable.

What is this workshop about?

This workshop aims to give participants an understanding nanopharmaceutical applications and regulatory considerations, including an overview of the technology, development considerations, manufacturing, safety and pricing/reimbursement issues. For example, many novel applications of medical nanotechnology will span the regulatory boundaries between medicinal products, including advanced therapy medicinal products, and medical devices. Getting the regulatory classification right is crucial in developing and commercialising products as different sets of rules govern each regime. There will be a focus on useful case studies and processes, providing a strong, practical take home message to attending delegates.

Who is leading this workshop?

Brian Kelly, Regulatory Lawyer, Covington & Burling LLP

Brian Kelly is a regulatory lawyer in the London Life Sciences group, whose practice focuses on food and drug law, public and administrative proceedings, European Union law and product liability and safety.  He has more than ten years of experience in regulatory matters having first worked as a journalist covering medical and healthcare regulatory news before joining Covington.  He has a particular interest in advising life science companies on nanotechnology regulatory matters.

Mr Kelly's advice on general regulatory matters includes borderline determinations, tissue and stem cell regulation, adverse event and other reporting obligations, manufacturing controls, labeling and promotion, pricing and reimbursement/procurement, product life cycle management and anti-bribery and corruption advice.  He has also advised on EU and national laws governing clinical research, data protection, telemedicine/eHealth, and regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.  He is an honorary lecturer at University College London.



Brian Kelly




Simon Holland, Director, Process Understanding & Control, GlaxoSAE Media GroupthKline

Simon has worked in the pharmaceutical industry for over 20 years and is an expert in the field of nanoparticle manufacture.

He studied chemistry at Bradford University (UK) followed by a PhD in polymer chemistry at Aston University (UK). He joined Beecham Pharmaceuticals, Worthing (UK) in 1986 and worked on the formulation development of topical and penicillin drug products. After the merger that formed SAE Media GroupthKline Beecham, Simon worked on the development of neurosciences drug products and has focussed on the development of bioenhanced formulations for the past 13 years including with a particular emphasis on sub micron compositions. He was the

Workshop programme

8:30 Registration & Coffee

9:00 Welcome & Introductions

9:10 Nanopharmaceuticals on the market and in clinical development

9:50 Development, manufacturing and characterisation of nanomedicines

10:30 Morning Coffee

11:00 Regulatory challenges: borderline issues, safety and other legal and ethical issues

11:50 Pricing/reimbursement of innovative nanomedicines

12:10 Interactions with regulators over nanomedicine issues

12:40 Interactive Discussion Session

13:00 Close of Workshop


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.



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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, SAE Media 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@saemediagroup.com

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Contact SAE Media Group

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smgconferences.com Email: events@saemediagroup.com
Registered in England - SMi Group Ltd trading as SAE Media Group

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