Proposal Submission

Applicant
(Person in charge) 		Name: Dr Roman Ivanov
Position: Vice Rector
Organization: Sirius University of Science and Technology
Economy: Russia
E-mail: ivanovra@talantiuspehru
Topic Virtual Workshop on regulatory requirements for advanced therapy medicinal products
Proposal Content
 (Describe your proposal,
including potential areas of collaboration,
purpose, and expected impact.) 		The goal of this 2-day workshop is to facilitate access to gene and cell therapy products in APEC countries through harmonization of regulatory requirements and exchange of information on best practices
Main topics will include:
- Development of gene, somatic-cell and tissue-engineered therapies
- Quality control of advanced therapy medicinal products ATMP
- Good Manufacturing Practice GMP specific to ATMPs
- Regulatory requirements for orphan and personalized ATMPs prepared on a non-routine basis
- Measures to support academic organizations involved in developing ATMPs
Course Running Time 2 days, 6 hours per day
Access Period 2023-07-01 to 2023-09-30 (Total 2 Days)
Expected Participants 100 Open
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