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Titel Gene and Cell Therapy Product (ATMP) Drug Development
Kursnummer 3218
Program Utveckling och regeneration (DevReg)
Språk Engelska
Antal högskolepoäng 1.5
Datum 2020-11-16 -- 2020-11-20
Kursansvarig institution Institutionen för klinisk vetenskap, intervention och teknik
Särskild behörighet
Kursens syfte In this course, the students acquire an understanding of how to develop a gene or cell therapy product (ATMP), including Good Manufacturing Practice (GMP) production and proving efficacy through clinical trials. The course provides a broad understanding of ATMP development from a research idea to registration as an approved form of therapy where the cost of treatment is covered by the state. Students will learn about the European Medicines Agency (EMA) regulations for ATMP and requirements for commercial models and health economy considerations. This broad scope gives students access to information and contacts for a plethora of future career opportunities in ATMP development and provides an opportunity to build both national and international networks.
Kursens lärandemål After the completed course, the doctoral student can:
- fully understand and review the classification of ATMPs and the regulations associated with different stages of the ATMP development pipeline.
- understand and critically review the research, development, manufacture, clinical, and commercial aspects of ATMP.
- understand and review the need for multi-disciplinary expertise and interactions for translation of research with commercial and clinical considerations.
Kursens innehåll To achieve a better understanding of ATMP development, and to construct systems and organisations for bringing ATMP options to patients, it is necessary to understand the specific needs in terms of research, commercial and clinical aspects. In this course, leading experts in the fields of ATMP drug development will discuss different aspects of intellectual property, regulation, manufacture, clinical trials, health economy, business models and marketing approval strategy in general and more specifically using various ATMPs as examples. The nature of the course is translational and provides a wide range of knowledge from pre-clinical to GxP to patient delivery and market approval.
Arbetsformer The course is a combination of theoretical knowledge and practical skills. Some of the lecture parts of the course are based around a sandwiched conference on the same theme. There are additional lectures on basic knowledge of the field as well as practical activities and demonstrations such as some basic GMP philisophy and procedures. The course is demanding and requires full-time presence and attention.
Obligatoriska moment Full presence in all parts of the course is required. Necessary absence will be regulated with the course leader and compensated as extra tasks.
Examination The students are examined with an individual written report according to the course learning outcomes. The participants receive written feedback for their reports from the examiner. All students are also required to peer-review another student's examination report.
Kurslitteratur och övriga läromedel Recommended literature: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/advanced-therapies/advanced-therapy-classification
https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Produktomraden/Avancerade-terapier/
atmpsweden.se
Antal studenter 8 - 20
Urval av studenter Selection will be based on 1) the relevance of the course syllabus for the applicant's doctoral project (according to written motivation), 2) start date of doctoral studies (priority given to earlier start date)
Övrig information
Ytterligare kursledare
Senaste kursvärdering Not available
Kursansvarig Heather Main
Institutionen för klinisk vetenskap, intervention och teknik

heather.main@ki.se
Kontaktpersoner Heather Main
Institutionen för klinisk vetenskap, intervention och teknik

heather.main@ki.se