Conference Schedule

Networking Session

8:30 - 9:00
Networking

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)
Session

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)
Session

Photo Session

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

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
Session

BREAK

11:40 - 12:00 (20 min)
Break

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)
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

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
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

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
Session

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)
Closing