Conference Schedule

Networking Session

8:30 - 9:00
Networking

Welcoming Remarks / Keynote Address

9:00 - 9:10 (10 min)

    Dr. Azuana Ramli, Deputy Director General of Health (Pharmaceutical Services) Malaysia (5min)

    Dr. Kondo Emiko, Senior Executive Director of PMDA (5 min)

Session

Regulatory Review & Updates - NPRA & PMDA

9:10 - 10:20 (70 min)

    Mdm. Rosliza Lajis, Deputy Director of NPRA (20 min)

    Mr. OKUBO Takayuki, Director, Office of International Regulatory Affairs, MHLW (20 min)

    Q&A (30 min)

Session

Photo Session

10:20 - 10:30 (10 min)
Photo

BREAK

10:30 - 10:50 (20 min)
Break

Session 1: Real World Data

10:50 - 12:00 (70 min)
  • Chair: Ms. ENDO Ayumi, Office of Asia Training Center and International Cooperation (OAIC), Japan

Topic & Speakers:

1. Real-World Evidence in Regulatory Decision-Making: Malaysia's Perspective

    Ms. Hu Suk Kwan, New Drug Product Section, NPRA (20min)

2. Utilization of Real World Data in Applications for Approval and its Expectations in Japan

    Ms. Matsuzaki Yu, Office of Non-Clinical and Clinical Compliance, PMDA - (20min)

Panel discussion and Q&A

Panelist:

  • 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
Session

Session 2: Risk Management Plan (RMP)

12:00 - 13:10 (70 min)
  • Chair: Dr. Kitahara Jun, Head of PMDA Asia Office

Topic & Speakers:

1. Post Registration Risk Management Plan (RMP): An insight into the Malaysia-Specific Annex (MSA)

    Dr. Vidhya Hariraj, Pharmacovigilance Section, NPRA (20 min)

2. Overview of Japanese Risk Management Plan (RMP)

    Ms. Kobayashi Ayano, Office of Pharmacovigilance II, PMDA (20 min)

Panel discussion and Q&A

Panelist:

  • Dr. Vidhya Hariraj, Pharmacovigilance Section, NPRA
  • Ms. Kobayashi Ayano, Office of Pharmacovigilance II, PMDA
  • 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)
Session

Lunch

13:10 - 14:10 (60 min)
Break

Session 3: Facilitated Registration Pathway

14:10 - 15:20 (70 min)
  • Chair: Mdm. Rosliza Lajis, Deputy Director Centre of Product & Cosmetic Evaluation, NPRA

Topic & Speakers:

1. Advancing Regulatory Efficiency: Updates on Malaysia's FRP Implementation

    Dr. Noraisyah Mohd Sani, Head of New Drug Product Section, NPRA (20 min)

2. Utilization of Japanese review report for Malaysia's Facilitated Registration

    Mr. Shimizu Kaito, Office of International Programs, PMDA (20 min)

Panel discussion and Q&A

Panelist:

  • Dr. Noraisyah Mohd Sani, Head of New Drug Product Section, NPRA
  • Mr. Shimizu Kaito, Office of International Programs, PMDA
  • 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
Session

BREAK

15:20 - 15:40 (20 min)
Break

Session 4: Clinical Trial

15:40 - 16:50 (70 min)
  • Chair: Dr. Khairulanwar Burhanuddin, BE Centre & Ethics Committee Section, NPRA
  • Dr. Kitahara Jun, Head of PMDA Asia Office

Topic & Speakers:

1. From policy to practice : Implementing Clinical Trial Regulations in Malaysia

    Dr. Zaril Harza Zakaria, Head of Investigational Product Evaluation and Safety Section, NPRA (20 min)

2. Shaping Asia's Clinical Trial Landscape - Insights from the ATLAS Initiative and its Regulatory Collaboration

    Dr. Mitsumi Terada, Section Head, Asian Partnerships Section, Department of International Clinical Development/National Cancer Centre, Japan (20 min)

Panel discussion and Q&A

Panelist:

  • Dr. Zaril Harza Zakaria, Head of Investigational Product Evaluation and Safety Section, NPRA
  • Dr. Mitsumi Terada, Section Head, Asian Partnerships Section, Department of International Clinical Development/National Cancer Centre, Japan
  • Dr. Akhmal Yusof, CEO of Clinical Research Malaysia (CRM)
  • Dr. Kitahara Jun, Head of PMDA Asia Office
Session

Closing Remarks

16:50 - 17:00 (10 min)

    Mr. OKUBO Takayuki, Director, Office of International Regulatory Affairs, MHLW (5 min)

    Mdm. Rosliza Lajis, Deputy Director of NPRA (5 min)

Closing