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
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.
www.cov.com
|
|
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
copyright ©
2024
SAE Media Group
| |