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NiFDS-DIA Workshop 2021: Facilitating the Development and Regulations of Covid-19 Vaccines and Treatments / Current Trends in New Drug Development and Regulations

The timing is as per Korean Time Zone

Agenda

Day 1 Sep 02, 2021

9:30 AM — 9:40 AM Opening Remarks & Keynote Presentation - NIFDS’s Response and Strategy against COVID-19
9:40 AM — 10:00 AM Facilitating the Development and Availability of COVID-19 Vaccine
9:40 AM — 11:40 AM Session 1 : Regulatory Trends in Response to COVID-19
10:00 AM — 10:20 AM Efforts to Facilitate the Development of Anti-SARS-CoV-2 Monoclonal Antibodies
10:20 AM — 11:00 AM Assessment, Authorization and Monitoring of EU COVID-19 Vaccines in the Context of a Pandemic
11:00 AM — 11:40 AM Consideration on the Development of Vaccines and Treatments in terms of Expedited Review
1:00 PM — 1:40 PM Development Strategy of Molnupiravir
1:00 PM — 3:00 PM Session 2 : COVID-19 Treatment Development Experiences
1:40 PM — 2:20 PM A Case Study : History of Expedited Development of Regkirona inj (Regdanvimab)
2:20 PM — 3:00 PM Key Points in the Development of COVID-19 Treatments Based on Clinical Trial Experience
3:20 PM — 4:00 PM BNT162b2 COVID-19 Vaccine - From Hope to Reality in 9 Months
3:20 PM — 5:30 PM Session 3 : COVID-19 Vaccine Development Strategy
4:40 PM — 5:20 PM Considerations for COVID-19 Vaccine Clinic Trials

Day 2 Sep 03, 2021

9:30 AM — 9:40 AM Access to Innovative Medicines in Korea
9:30 AM — 9:40 AM Opening: Access to Innovative Medicines in Korea
9:40 AM — 11:00 AM Session 4 : Korea’s Strategy for going Global
10:00 AM — 10:20 AM New Drug Development and IP Strategy
10:20 AM — 11:00 AM Clinical Develoment Strategy
11:20 AM — 12:40 PM Session 5 : Effective Method for Accelerating Drug Development
11:20 AM — 12:00 PM Statistical Considerations in Safety Eveluation During the Life Cycle of a Drug Product
12:00 PM — 12:40 PM Use of Real-World Data and Real-World Evidence in Drug Development and Approvals
2:00 PM — 2:40 PM CMC Considerations for Accelerated Development of Advanced Therapy Products
2:00 PM — 3:30 PM Session 6 : Development of Innovative Drug
2:40 PM — 3:30 PM Clinical Trials for Expedited Review and Development Programs

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