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CPD Hours: 7
This course discusses the key regulatory requirements and issues surrounding developing and translating an advanced therapeutic medicinal product (ATMP) to the clinical trial and market authorisation application.
ATMPs represent a growing number of therapeutics entering clinical development and market authorisation application (MAA). This cutting edge therapeutic area sits with an evolving area of legislation. During this one day course you will be introduced to ATMPs and their categories, key factors to consider with your process development from bench to clinic including Good manufacturing Practices (GMP), preparation and submission of Investigative Medicinal Product Dossiers (IMPD) and Investigator Brochures (IB), quality, potency and stability assessment of your product.
At the end of this course you will have learned :
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
Lindsay’s career in the life science arena spans over 15 years, with firsthand experience in preclinical research, clinical trial design and product development within the field of cell therapy and regenerative medicine. Lindsay has experience within both the academic and industrial sectors, working as Chief Scientific Officer of a cell therapy company and Associate Professor in Stromal Cell Biology at The Karolinska Institute in Sweden. She has been presented with multiple awards for her research and is the named inventor on numerous granted patents for her research. She has extensively published in the field of regenerative medicine and the use of advanced therapies (ATMPs) for immune mediated disorders including Graft versus Host Disease, and Type I Diabetes.
Good clinical practice for ATMPs
This interactive course provides an advanced, practical detailed interactive review of the organizational fundamentals of Good Clinical Practice (GCP) specific to ATMPs.