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 Biotherapeutics
Proposal Content
 (Describe your proposal,
including potential areas of collaboration,
purpose, and expected impact.) 		This 5-day workshop will be focused on harmonization of regulatory requirements for biotherapeutics within the Eurasian Union A special attention will be paid to development and manufacturing of biotherapeutics 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 Biotherapeutics examples of any CoE in APEC region
- Overview of Eurasian Union legislation in the field Gaps and undertaken efforts for global convergence
- WHO and ICH guidelines of the life cycle management for the biologics;
- Quality control of biological medicines
- Good Manufacturing Practice GMP-compliant manufacturing of biologics
- Non-clinical and clinical development issues specific to biologics, including immunogenicity
- Preparedness for future pandemics in the APEC region An overview of other outreach efforts
- Regulatory requirements for biosimilar medicines
- Regulatory requirements for orphan biological medicines and personalized biologics prepared on a non-routine basis
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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