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This four-day course covers issues in regulatory science for gene and cell-therapy medicinal products.
It's accredited by the Royal College of Pathologists.
It's aimed at those involved in the production, testing and registration of advanced therapy medicinal products (ATMPs).
You'll find out about:
- the current state of gene/cell therapy development, production technology and regulation
- the ethics, clinical trial designs and commercial licensing issues
As a wide range of novel gene and/or cell therapies are developed in clinical and preclinical studies, the important question of how to deliver potentially beneficial therapies to patients is often neglected.
In this course we'll discuss the regulations required to help make future medicinal products safe and effective, which evolve alongside advances in science and technology.
You'll be taught by experts at UCL, MHRA (Medicines and Healthcare products Regulatory Agency), NIBSC (National Institute for Biological Standards and Control) and Cell and Gene Therapy Catapult (CGT).
Course structure and teaching
The course will be taught over four consecutive days.
In addition to expert lectures and panel discussions, you'll be asked to do some literature search or journal club tasks and web-based quizzes to help your understanding.
You'll also have opportunities to demonstrate your knowledge development using e-learning methods, quiz sessions (e.g. true/false questions), student poster presentations and panel discussions.
You'll benefit from lectures and e-learning materials created by experts active in:
- global frontier research
- clinical development (e.g. UCL academics running gene therapy clinical trials)
- medicinal product standards (NIBSC)
Lecturers representing MHRA will also provide information on their often neglected/misunderstood roles, tasks and abilities in therapy development.
Discussion sessions and reception/dinner/coffee breaks will give you opportunities for networking.
Download the schedule for 2019 (pdf) for more details on what the course will cover.
Who this course is for
This course is for anyone interested in the translational side of gene and cell therapy.
It will be particularly useful for those involved in producing, testing and registering ATMPs.
We welcome interest from:
- staff at pharmaceutical companies or SMEs
- staff at regulatory authorities (e.g. MHRA, Public Health England, Department of Health and equivalents from other countries)
- national ethics services (NRES in UK)
- academic clinicians and allied health professionals from research hospitals
- scientists and students from other universities and other academic institutions
By the end of this course you should:
- have updated your knowledge of regulatory science for gene and cell therapy medicinal products, including the underpinning science, GMP (good manufacturing practice) production, ethics, and first-in-man trial design and licensing
- be able to apply this knowledge in your future contribution to translational development of advanced therapy
You'll need an undergraduate-level of knowledge in biology.
A good knowledge of the principles of gene and/or cell therapies is also desirable.
Cost and concessions
The fees are:
- £1,000 - standard price
- £750 - public sector, university academics, and members of the British Society for Gene and Cell Therapy
- £500 - students
For concessions, you'll need to enter the relevant voucher code when you book (before you click 'Checkout'). Please contact Henry Hassan ([email protected]) to verify your status and be sent a voucher code.
A 10% discount is also available if you book six or more places at one time. This discount will be applied automatically, you don't need to enter a voucher code.
You can receive a full refund on cancellations up to five working days before the start of the course.
Dr Yasu Takeuchi
Yasuhiro is Reader of Molecular Virology at the Division of Infection and Immunity, UCL. He’s been based in London for 25 years, initially at the Institute of Cancer Research and then UCL. He studied Biochemistry at the University of Tokyo and obtained an MSc on the physicochemical study of nucleic acids, and then a PhD on molecular biology of small nuclear RNA. He started his research on retroviruses on being appointed as a junior lecturer at Gunma University, Japan in 1986. Since then he's been working on human viruses, HIV and HTLV and mammalian gammaretroviruses including porcine endogenous retroviruses. His research on retrovirus biology has involved several aspects of infection and evolution with an emphasis on envelope-receptor interaction. The applied side of his research has focused on the use of retroviruses as vectors for gene therapy and zoonotic infection in xenotransplantation. He started a secondment for 30% of time in the Advanced Therapy Division in NIBSC in September 2016.
Dr Christian K. Schneider
Christian is Director of the National Institute for Biological Standards and Control (NIBSC), UK, a centre of the Medicines and Healthcare products Regulatory Agency (MHRA). Previously he has been Medical Head of Division Medicines Licensing and Availability at the Danish Medicines Agency, and Head of Division 'EU Co-operation/Microbiology' at the Paul-Ehrlich-Institute, the German Federal Agency for Vaccines and Biomedicines. At the European Medicines Agency he was Chair of the Biosimilar Medicinal Products Working Party from 2007 to 2016, Chair of the Committee for Advanced Therapies from 2009 to 2013, and co-opted member of the Committee for Medicinal Products for Human Use from 2007 to 2011.
"This course is an absolute must for anyone who is interested in bringing gene and cell therapy from bench to bedside. I attended all sessions of the five-day programme and enjoyed every minute of it. The organisers put together a comprehensive and well balanced set of lectures covering both regulatory affairs and practical information offered by scientists who pioneered some of these advanced therapies. Representatives of the different regulatory bodies presented a clear overview of the regulatory aspects of gene and cell therapy removing the uncertainties/insecurities very often associated with this aspect of translational research. It was gratifying to hear that MHRA and EMA are well aligned, and that they offer exploratory meetings with researchers at early stage so that preclinical and clinical studies can be tailored to meet the regulatory standards. Lively discussions after the sessions added to the overall learning experience, and there were plenty of opportunities to interact with the speakers and attendees."[Dr Els Henckaerts, Department of Infectious Diseases, King's College London, 2016]
"The Regulatory Science for Advanced Gene and Cell Therapy course is an invaluable tool for anyone interested in translational medicine. I attended the five-day programme and was positively amazed at the ease and expertise of an absolutely astounding group of speakers, who effortlessly lead us through all stages of bench-to-bedside research. From how to appropriately design pre-clinical studies, to how to set-up a clinical trial and ultimately apply for a new therapy to be licensed, all topics were addressed in an uncomplicated and yet extremely detailed and accurate way. All speakers were experts in their field and very approachable, with a series of interactive sessions and group discussions being held, which contributed to solidify all attendees' learning even further."[Rita Rego, Division of Infection and Immunity, UCL, 2016]
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Course information last modified: 19 Feb 2021, 09:19