Jul. 18 Jul. 19 Jul. 20 Jul. 21 Jul. 22 Jul. 25 Jul. 26 Jul. 27 Jul. 28 Jul.

29
Mon Tue Wed Thu Fri Mon Tue Wed Thu Fri
Current timetable is being adjusted as rolling basis.
9.00 Welcome session Types of Vaccines Vaccine R&D: Discovery to Early Vaccine Process Development – Case Study IP strategy for biomedical Basic concepts of Intellectual Basic Statistics for Clinical Case Study Presentation Pre-clinical Vaccine Development
- IVI course director Clinical Phase Development Upstream and Downstream product development and Property in Biomedical Field - Dr. Raphael Zellweger (IVI)
- Korea MoHW - Dr. Jae Ouk Kim (IVI) (purification) operations - IVI Team manufacturing - Dr. Deok Ryun Kim (IVI) - IVI Team
9.30 - WHO representative - Dr. Ravi Ganapathi - Dr. Soo Jung Lee (KIPO)
- IVI Director General (Hilleman Lab) - Dr. Ravi Ganapathi - Dr. DongKuk Kim (KIPO)
(Hilleman Lab)
Course Orientation
10.00 Vaccine development for Workflow in manufacturing Case Study Case study for IP strategy for Emerging intellectual property Introduction to Clinical Data Case Study Presentation Lessons learned from COVID-19
neglected tropical disease biomedical product issues on COVID19 mRNA Management for clinical research preparedness
- Dr. Ravi Ganapathi - IVI Team development and vaccine - IVI Team in future outbreaks
10.30 Vaccine History - Dr. Florian Marks (IVI) (Hilleman Lab) Vaccine Process Development – manufacturing - Dr. Deok Ryun Kim (IVI) - Dr. Amol Chaudhari (CEPI)
Formulation, Packaging and - Dr. Soo Jung Lee (KIPO)
- Dr. Jerome Kim (IVI) Analytical Development, and - Dr. DongKuK Kim (KIPO)
11.00 Document control and SOP Delivery Systems Case Study Product safety monitoring after Adverse event monitoring, and Post licensure vaccine safety Case Study Presentation Regulator’s perspective including
development - IVI Team marketing authorization and vaccine safety pertaining to and Value of post authorisation inspection when reviewing the
- Dr. Ravi Ganapathi guidelines in managing data COVID-19 Vaccines data - IVI Team dossier 　
- Mr. Tobin Guarnacci (IVI) (Hilleman Lab) - Dr. Allain Bouckenooghe - Dr. Sonali Kochhar (Univ. of - Dr. Gustavo Santos (IVI)
11.30
(Hilleman Lab) Washington) - Dr. Birkneh Tadesse (IVI)
Lunch Break Lunch Break
12.00

Lunch Break Lunch Break Lunch Break Lunch Break Lunch Break Lunch Break Lunch Break Lunch Break
12.30 Innate and Adaptive Immune Biomarkers and correlates of
system protection
　 　
13.00 - Prof. You Jeong Lee (SNU) Vaccine Adjuvants – Adjuvant - Dr. Hazel Dockrell (LSHTM) Standard clinical development Excursion to sites Ethical consideration for clinical Vaccine Self sufficiency: Health economics Biological standards and Establishment of animal
past , present and future pathway for vaccines development of vaccines learning from Korea experience -field-based evidence control challenge model
generation - Dr. Jung Ah Choi
13.30 - Dr. Nathalie Garcon (IVI) Immunogenicity assessment of - Dr. Anh Wartel (IVI) - IVI Team - Mr. Hanif Shaikh(IVI) - Dr. Manki Song (IVI) - Dr. Giada Mattiuzzo (NIBSC)
vaccines in clinical trials - Dr. Jungseok Lee (IVI)
14.00 Immunity to Pathogens & What it takes to develop an - Dr. Jae Seung Yang (IVI) Clinical trial for vulnerable Clinical Research of Vaccines – Ginseng and Metabolites Health economics Mechanisms, Effects, and Toxicology facility
Vaccination adjuvanted vaccines population– study design and Ethics, Risk Communication, -model-based evidence Current Challenges of mRNA
ethical considerations. Regulatory Considerations - Dr. KH Jang (KGC) generation Vaccines - Mr. Tobin Guarnacci (IVI)
14.30 - Prof. Kwangseog Ahn (SNU) - Dr. Nathalie Garcon (IVI) Case study - Dr. Flor Munoz -Dr. Sonali Kochhar (Univ. of - Prof. Ho Jeong (Ewha W.U./K-
(Baylor University) Washington) - Dr. Jungseok Lee (IVI) NIBRT)
- IVI team
15.00 Target Product Profile Integrated Product Vaccines of current Quality by Design Epidemiology activities and Why disease burden matters in Vaccine effectiveness study
Development Plan for Vaccines immunization examples of surveillance study vaccine development
- Dr. Sushant Sahastrabuddhe - Dr. Sushant Sahastrabuddhe - Dr. Suenie Park (Biowave-W) - Dr. Birkneh Tadesse (IVI)
15.30 Interactive Session (IVI) (IVI) - Dr. Suenie Park (Biowave-W) - Dr. Asma Aziz (IVI) - Dr. Asma Aziz (IVI)

- IVI Team
16.00 The Sterile BioManufacturing of Tour of IVI laboratory and Analytical Assays Development, Common Technical Document Development of conjugate mRNA vaccine research and Closing ceremony
Vaccines process development Quality Control and Stability vaccines for enteric fever development in Korea
- Ms. Trina Racine (VIDO) Studies for Vaccines. - Dr. Suenie Park (Biowave-W)
16.30 - Dr. Byoung Shik Shim (IVI) -Dr. Viliam Pavliak (gMRI) - Dr. So Jung An (IVI) - Prof. KiJong Hong
(Gachon Univ)
17.00 Clinical development pathway Introduction of faculty and IVI Setting up Analytical Control Introductory GMP Industry presentation Introduction to Good Clinical Pharmacovigilance system in
and regulatory approvals by staff Strategy – case studies for Practice (GCP) resource limited settings
National Regulatory Agencies various bacterial vaccine - Dr. Ruchir Pansuriya - Dr. Tarun Saluja (IVI)
17.30 Case study: team up and WHO - IVI team platforms (IVI) - Dr. Deok Ryun Kim (IVI)
- Ms. Trina Racine (VIDO) -Dr. Viliam Pavliak (gMRI)
- IVI team
18.00 Welcome dinner Network with Faculty Dinner at Hoam Mini convention Farewell dinner