Conference Schedule
Networking Session
8:30 - 9:00
Welcoming Remarks / Keynote Address
9:00 - 9:10 (10 min)
Speakers:
- Dr. Azuana Ramli, Deputy Director General of Health (Pharmaceutical Services) Malaysia (5min)
- Dr. Kondo Emiko, Senior Executive Director of PMDA (5 min)
Regulatory Review & Updates - NPRA & PMDA
9:10 - 10:20 (70 min)
Speakers:
- Director of NPRA (20 min)
- Mr. OKUBO Takayuki, Director, Office of International Regulatory Affairs, MHLW (20 min)
- Q&A (30 min)
Photo Session
10:20 - 10:30 (10 min)
Session 1: Real World Data
10:30 - 11:40 (70 min)
Ms. ENDO Ayumi, Office of Asia Training Center and International Cooperation (OAIC), Japan
Speakers:
- Ms. Hu Suk Kwan, New Drug Product Section, NPRA (20min)
- Ms. Matsuzaki Yu, Office of Non-Clinical and Clinical Compliance, PMDA (20min)
- Panel discussion and Q&A (30 min)
Panelists:
- Ms. Hu Suk Kwan, New Drug Product Section, NPRA
- Ms. Matsuzaki Yu, Office of Non-Clinical and Clinical Compliance, PMDA
- Ms. Soo Li Ping, Head of Regulatory Affairs, AstraZeneca (M) Sdn. Bhd. Malaysia
- Mr Takayuki Imaeda, Vice-Chairperson, Drug Evaluation Committee, JPMA
BREAK
11:40 - 12:00 (20 min)
Session 2: Risk Management Plan (RMP)
12:00 - 13:10 (70 min)
Chair: Dr. Kitahara Jun, Head of PMDA Asia Office
Speakers:
- Dr. Vidhya Hariraj, Pharmacovigilance Section, NPRA (20 min)
- Ms. Kobayashi Ayano, Office of Pharmacovigilance II, PMDA (20 min)
- Panel discussion and Q&A (30 min)
Panelists:
- Dr. Vidhya Hariraj, Pharmacovigilance Section, NPRA (20 min)
- Ms. Kobayashi Ayano, Office of Pharmacovigilance II, PMDA (20 min)
- Dr. Evelyn Loh Yun Xi, Biologics Section, NPRA
- Dr. Maeda Daisuke, Director Office of Pharmacovigilance II, PMDA
- Dr. Matsumoto Jun, Coordination Director, Office of Asia Training Center and International Cooperation (OAIC)
Lunch
13:10 - 14:10 (60 min)
Session 3: Facilitated Registration Pathway
14:10 - 15:20 (70 min)
Chair: Mdm. Rosliza Lajis, Deputy Director Centre of Product & Cosmetic Evaluation, NPRA
Speakers:
- Dr. Noraisyah Moh Sani, Head of New Drug Product Section, NPRA (20 min)
- Mr. Shimuzu Kaito, Office of International Programs, PMDA (20 min)
- Panel discussion and Q&A (30 min)
Panelists:
- Dr. Noraisyah Moh Sani, Head of New Drug Product Section, NPRA (20 min)
- Mr. Shimuzu Kaito, Office of International Programs, PMDA (20 min)
- Ms. Long Siew Mei, Regulatory Affairs Director, Merck Sharp & Dohme Malaysia
- Ms. Ayaha Watanabe, Singapore and Malaysia Group Leader, Asian Division, International Affairs committee, JPMA
BREAK
15:20 - 15:40 (20 min)
Session 4: Clinical Trial
15:40 - 16:50 (70 min)
Chair: Dr. Khairulanwar Burhanuddin, BE Centre & Ethics Committee Section, NPRA
Speakers:
- Dr. Zaril Harza Zakaria, Head of Investigational Product Evaluation and Safety Section, NPRA (20 min)
- Dr. Mitsumi Terada, Section Head, Asian Partnerships Section, Department of International Clinical Development/National Cancer Centre, Japan (20 min)
- Panel discussion and Q&A (30 min)
Panelists:
- Dr. Zaril Harza Zakaria, Head of Investigational Product Evaluation and Safety Section, NPRA (20 min)
- Dr. Mitsumi Terada, Section Head, Asian Partnerships Section, Department of International Clinical Development/National Cancer Centre, Japan (20 min)
- Dr. Akhmal Yusof, CEO of Clinical Research Malaysia (CRM)
- Dr. Kitahara Jun, Head of PMDA Asia Office
Closing Remarks
16:50 - 17:00 (10 min)
Speakers:
- Directors of NPRA (5 min)
- Mr. OKUBO Takayuki, Director, Office of International Regulatory Affairs, MHLW (5 min)