Regulatory Science for Advanced (Gene and Cell) Therapy: Advanced Therapies - Bench to Medicine
Course
In London
Description
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Type
Course
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Level
Advanced
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Location
London
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Class hours
24h
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Duration
4 Days
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Start date
Different dates available
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.
Facilities
Location
Start date
Start date
About this course
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
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
Reviews
This centre's achievements
All courses are up to date
The average rating is higher than 3.7
More than 50 reviews in the last 12 months
This centre has featured on Emagister for 14 years
Subjects
- Technology
- Production
- E-learning
- Quiz sessions
- Regulatory Science
- Advanced Therapies
- Medicine
- Science for Advanced
- Gene and Cell
- Cell-therapy medicinal
Course programme
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.
Regulatory Science for Advanced (Gene and Cell) Therapy: Advanced Therapies - Bench to Medicine