Conference Schedule

8:30 - 9:00

Networking Session

9:00 - 9:10 (10 min)

Opening Remarks / Keynote

• • Deputy Director General of Health (Pharmaceutical Services) (5min)
• • Dr. Kondo Fumiko, Senior Executive Director, PMDA (5 min)

9:10 - 10:20 (70 min)

Regulatory Review & Updates

• • Director of NPRA (20 min)
• • Director, Office of International Programs, PMDA (20 min)
• Q&A (30 min)

10:20 - 10:30

Photo Session (10 min)

10:30 - 11:40 (70 min)

Session 1: Real World Data

Chair: TBC from MHLW, Japan

Speakers:

• • Ms. Ha Suk Kwan, New Drug Product Section, NPRA (20min)
• • Ms. Matsuzaki Yu, Office of Non-Clinical and Clinical Compliance I, PMDA (20min)

Panel discussion and Q&A (30 min)

11:40 - 12:00

BREAK (20 min)

12:00 - 13:10 (70 min)

Session 2: Risk Management Plan (RMP)

Chair: Dr. Kitahara Jun, Head of PMDA Asia Office

13:10 - 14:10

Lunch (60 min)

14:10 - 15:20 (70 min)

Session 3: Facilitated Registration Pathway

Chair: Mdm. Rosliza Lajis, Deputy Director Centre of Product & Cosmetic Evaluation, NPRA

15:20 - 15:40

BREAK (20 min)

15:40 - 16:50 (70 min)

Session 4: Clinical Trial

Chair: Mr. Nicholas Leow, BE Centre & Ethics Committee Section, NPRA

16:50 - 17:00 (10 min)

Closing Remarks

• • Director of NPRA (5min)
• • PMDA (5 min)