Proposal Submission

Applicant
(Person in charge) 		Name: Roman Ivanov
Position: Vice Rector
Organization: Sirius University of Science and Technology
Economy: Russia
E-mail: ivanovra@talantiuspehru
Topic Virtual workshop on Multi-Regional Clinical Trials MRCT
Proposal Content
 (Describe your proposal,
including potential areas of collaboration,
purpose, and expected impact.) 		5-day workshop will be focused on harmonization of MRCT guidelines in the Eurasian Union The course is aimed to promote best regulatory practices and share experience among stakeholders within the Eurasian Union
Main topics will include:
- APEC progress towards regulatory convergence Strategic approaches and vision in region
- Overview and history of CoE in MRCT examples of any CoE in APEC region
- Basis of MRCT Overview of ICH E17 guidelines and other related
ICH guidelines E2, E5, E6, E8, E9, E10
- Overview of Eurasian Union legislation in the field Gaps and undertaken efforts for global convergence
- Regional variability when recruiting diverse populations in global drug development Pre-considerations of challenges and limitations in Eurasian Union
- MRCT design, statistical analysis and other related issues
- Handling of adverse drug reactions Pharmacovigilance in pre-approval phase and post-marketing safety evaluation
- GCP inspections and audits of MRCT
- Ethical considerations in MRCT
- Future perspectives in decentralized clinical trials
Course Running Time 5 days, 6 hours per day
Access Period 2023-09-01 to 2023-11-30 (Total 5 Days)
Expected Participants 100 Open
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