Konten yang akan diajarkan dalam Workshop ini antara lain:
1.
Current Status of International Medical Devices Regulatory Forum (IMDRF)
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Rabu, 14 Mei 2025 pukul 01.30
-
Rabu, 14 Mei 2025 pukul 03.30
2.
Recent innovation and development of CADe/CADx medical devices in Japan
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Rabu, 14 Mei 2025 pukul 03.30
-
Rabu, 14 Mei 2025 pukul 04.30
3.
Regulatory Reliance in the field of Medical Devices
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Rabu, 14 Mei 2025 pukul 04.30
-
Rabu, 14 Mei 2025 pukul 05.30
4.
The Future of Clinical Practice: Leveraging HMI Data from Medical Devices
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Rabu, 14 Mei 2025 pukul 06.00
-
Rabu, 14 Mei 2025 pukul 07.00
5.
Current status of ASEAN-AMDC
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Rabu, 14 Mei 2025 pukul 07.00
-
Rabu, 14 Mei 2025 pukul 09.00
6.
Industries Perspectives : Strategies to Intensify Research and Development Collaboration and Promote Technology Transfer for Innovative Medical Devices
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Kamis, 15 Mei 2025 pukul 02.00
-
Kamis, 15 Mei 2025 pukul 04.00
7.
WHO Prequalification of Medical Devices and IVDs
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Kamis, 15 Mei 2025 pukul 04.00
-
Kamis, 15 Mei 2025 pukul 05.00
8.
Standard Workshop by PMDA
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Kamis, 15 Mei 2025 pukul 06.00
-
Kamis, 15 Mei 2025 pukul 07.30
9.
Introduction for ADxSSR by Director of Pharmaceuticals and Medical Devices Resilence
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Kamis, 15 Mei 2025 pukul 07.30
-
Kamis, 15 Mei 2025 pukul 09.00
10.
Current Status of MDSAP by PMDA
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Jumat, 16 Mei 2025 pukul 02.00
-
Jumat, 16 Mei 2025 pukul 04.30
11.
Industry Perspective for MDSAP by Shimazu (Japanese Medical Devices Industry)
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Jumat, 16 Mei 2025 pukul 06.00
-
Jumat, 16 Mei 2025 pukul 07.00
12.
Review of High-Risk Medical Devices by PMDA
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Jumat, 16 Mei 2025 pukul 07.00
-
Jumat, 16 Mei 2025 pukul 08.00
13.
Review of Software as Medical Devices (SaMD) by PMDA
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Jumat, 16 Mei 2025 pukul 08.00
-
Jumat, 16 Mei 2025 pukul 08.45
14.
Review of In Vitro Diagnostics (IVDs) by PMDA
Oleh:
Fasilitator Eksternal
Blended
Hotel Westin
Jumat, 16 Mei 2025 pukul 08.45
-
Jumat, 16 Mei 2025 pukul 09.45