ICH Q12: Post Approval Change Management Protocols Online Workshop
September 12th – 13th, 2023 l 09:00 – 12:00 (Korea / GMT+9)
[Description]
In line with APEC’s continuous effort to streamline regulatory requirements & reduce regulatory burden,
the ICH Q12: PACMP online workshop intends to foster deeper understanding on the benefits, design and
application of ICH Q12 guideline and PACMP as a tool to facilitate management of post-approval CMC in a
more predictable & efficient manner.
This 2-day program will focus on addressing practical considerations & strategies to use Q12 and PACMP in
a real-world scenario and discuss how it can be implemented in line with local regulatory environment &
existing regulatory frameworks with lectures, case studies and experience sharing.
| Day 1 : September 12th, 2023 | |||
|---|---|---|---|
| Time | Topic | Speaker | |
| Welcome and Introduction | |||
| 09:00 - 09:05 | Welcoming Remarks | Younjoo Park(AHC) | |
| 09:05 - 09:10 | Opening Remarks | Azuana Ramli (NPRA) | |
| Session 1: Overview on CMC requirements for Post-market Quality Control | |||
|
09:10-09:50 (40min) |
Introduction of Lifecycle Management of Pharmaceutical Products and ICH Q12 concept - How we control change management today - Evolution of ICH Q12 concept and its key aspects Q&A (5 min) |
Sarah Pope Miksinski (Gilead Science) |
|
|
09:50-10:10 (20min) |
PACMP : Post-approval Change Management Protocol - Overview on PACMP elements, structure, scope of application, types, etc. - Global Implementation Status of PACMP Q&A (5 min) |
||
|
10:10-10:50 (40min) |
Post Approval CMC Changes : How to Use ICH Q12 effectively - Global Regulatory Complexity - How can use of ICH Q12 and its tool facilitate management of post-approval CMC including • Classification of changes • Established Conditions / PLCM Q&A (5 min) |
Andrew Chang (Novo Nordisk) | |
|
10:50-11:20 (30min) |
Pharmaceutical Quality Systems(PQS) and Change Management - How Quality System supports ICH Q12 vision and the importance of quality metrics - Coordinated Regulatory Review and Investigation Q&A (5 min) |
Kyungnam Kim (Novartis Korea) |
|
|
11:20-11:50 (30min) |
Considerations & Strategic approaches for CMC - Systematic approaches & Stability data approaches to support evaluation of changes with respect to CMC - Considerations for PACMPs describing complex post-approval changes Q&A (5 min) |
Jessica Lo Surdo (Amgen) |
|
| 11:50-12:00 | Closing Day 1 | ||
| Day 2 : September 13th, 2023 | |||
|---|---|---|---|
| Time | Topic | Speaker | |
| Session II: Current Landscape & Future Perspectives on ICH Q12 and PACMP | |||
|
09:00-10:15 (75min) |
Regulatory Perspectives: - Current Status - Regulatory strategies on implementing ICH Q12 and its tool in line with local regulatory environment & framework - Lessons Learned: Unique Considerations & challenges • Health Canada • Brazil ANVISA • Japan PMDA Q&A (5 min) |
Hugo Hamel Raphael Sanches Pereira Yasuhiro Kishioka |
|
|
10:15-11:00 (45min) |
Industry perspectives - Case Study: Industry’s approaches for ICH Q12 & PACMP and its impact in manufacturing, test methods, etc. • Case 1 : GSK • Case 2 : Roche Q&A (5 min) |
Monica Perea-Velez Markus Goese |
|
|
11:00-11:45 (45min) |
[Panel Discussion] PACMP Challenges & Recommendations - Discuss the benefits & limitations of PACMP; How PACMP could bring synergy with other existing guidelines; and recommendations to facilitate its implementation • Panelist 1 : Health Canada • Panelist 2 : Brazil ANVISA • Panelist 3 : Japan PMDA • Panelist 4 : GSK • Panelist 5 : Pfizer |
Moderator: Nina Cauchon(Amgen) Hugo Hamel Raphael Sanches Pereira Yasuhiro Kishioka Monica Pera-Velez Conni S. Langer |
|
| 11:45 – 12:00 | Wrap Up & Closing Remarks | AHC / NPRA | |
