2023 AHC Workshop on ICH Q12 PACMP (with Malaysia NPRA)
September 12-13, 2023 | Online
|
| Date |
Topic |
Speaker |
Video |
Materials |
| Day 1 |
Welcoming Remarks |
Younjoo Park
(AHC) |
|
|
| Day 1 |
Opening Remarks |
Azuana Ramli
(NPRA) |
|
|
| Day 1 |
Introduction of Lifecycle Management of Pharmaceutical Products and ICH Q12 concept |
Sarah Pope Miksinski
(Gilead Science) |
|
|
| Day 1 |
PACMP : Post-approval Change Management Protocol |
Sarah Pope Miksinski
(Gilead Science) |
|
|
| Day 1 |
Post Approval CMC Changes : How to Use ICH Q12 effectively |
Andrew Chang
(Novo Nordisk) |
|
|
| Day 1 |
Pharmaceutical Quality Systems(PQS) and Change Management |
Kyungnam Kim
(Novartis Korea) |
|
|
| Day 1 |
Considerations & Strategic approaches for CMC |
Jessica Lo Surdo
(Amgen) |
|
|
| Day 2 |
Current Landscape & Future Perspectives on ICH Q12 and PACMP- Regulatory Perspectives |
Hugo Hamel
|
|
|
| Raphael Sanches Pereira |
|
|
| Yasuhiro Kishioka |
|
|
| Day 2 |
Current Landscape & Future Perspectives on
ICH Q12 and PACMP- Industry Perspectives |
Monica Perea-Velez |
|
|
| Markus Goese |
|
|
| Day 2 |
[Panel Discussion] PACMP Challenges & Recommendations |
Moderator: Nina Cauchon (Amgen) |
|
|
