In association with
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
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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.
www.cov.com
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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 agenda
Experience and backgrounds of participants and hosts
Purpose and scope of the workshop
Nanopharmaceuticals on the market and in clinical development Development, manufacturing and characterisation of nanomedicines Regulatory challenges: borderline issues, safety and other legal and ethical issues Pricing/reimbursement of innovative nanomedicines Interactions with regulators over nanomedicine issues
Manufacturing licenses
Borderline determinations
Clinical trials
Interactive Discussion Session
VENUE
Copthorne Tara Hotel
Scarsdale Place, Kensington, London, United Kingdom
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.
A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM
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