Training Seminars

Cambridge Healthtech Institute 트레이닝 세미나에서는 학술적 이론으로부터 배경 등의 폭넓은 영역을 다루는 것과 동시에 실제 사례 연구 및 직면한 문제, 적용한 해결책 등을 제공하고 있습니다. 각 트레이닝 세미나는 정식 강의와 대화형 논의·활동을 조합하여 최대한의 학습 효과를 얻을 수 있도록 설계되고 있습니다. 이 트레이닝 세미나에서는 경험이 풍부한 강사진이 현재의 연구에 응용할 수 있는 내용에 초점을 맞추고, 이 분야를 처음으로 배우는 분에도 유용한 가이던스를 제공합니다.


트레이닝 세미나는 대면 형식으로만 제공됩니다.


2024년3월20일(수)  14:00 - 16:30 |  2024년3월21일(목)  08:30 - 15:20

TS5B: Comparability and Potency Assays for Cell, Gene and Biotech Products

Comparability studies following process change is an inevitable part of drug development, but with wide ramifications for CMC and process development departments alike. Robust potency assays are fundamental also for comparability studies, process validation, and for stability testing. CHI's 1.5-day training seminar, Comparability and Potency Assays for Cell, Gene Therapy and Biotech products provides an in-depth look at the application of regulatory science and biological standardization to biological products; what is potency, and how potency assays differ between biotech and cell and gene therapy products; plus principles of comparability and how their application differs between biotech, cell, and gene therapy products.

INSTRUCTOR BIOGRAPHIES:

Christopher Bravery, PhD, Consulting Regulatory Scientist, Advanced Biologicals Ltd.

Christopher founded Consulting on Advanced Biologicals Ltd. at the end of 2009, in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd. provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd., a Novartis Pharma AG Co., and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time, Christopher was involved with national implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.

* 주최측 사정에 따라 사전 예고없이 프로그램이 변경될 수 있습니다.

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