返回 Agenda
Session 4 Track B: ICH Q12 Implementation
Session Chair(s)
Andrew Chang, PhD
Vice President, Quality and Regulatory Compliance
Novo Nordisk, United States
ICH Q12 guideline on technical and regulatory considerations of pharmaceutical product lifecycle management reached step 2b in November 2017. The public consultation was completed in December 2018. At this session, speakers from FDA and industry will give their perspectives on implementing ICH Q12 including , but are not limited to, practical issues, industry case studies, and current thinking on identification of Established Conditions for a continuous manufacturing process, and performance-based control strategy.
Learning Objective : At the conclusion of this session, participants should be able to:
- Understand key enablers/tools used in ICH Q12
- Understand key highlights from FDA on practical issues
- Share some experience from case studies on following elements:
- Implementing ICH Q12, e.g., for small molecule drug with parameter-based or performance-based control strategy
- Post-approval change management consideration for continuous manufacturing
- Implementing ICH Q12, e.g., for small molecule drug with parameter-based or performance-based control strategy
- Post-approval change management consideration for continuous manufacturing
Speaker(s)
Implementing ICH Q12: FDA’s Perspective
Mahesh R. Ramanadham, PharmD, MBA
FDA, United States
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Implementing ICH Q12 for a Continuous Manufacturing Process: A Case Study
Derek Vrieze, MSc
Vertex Pharmaceuticals, United States
Senior Associate Regulatory-CMC
Implementation of ICH Q12: A Case Study
Ingrid Markovic, PhD
FDA, United States
Senior Science Advisor for CMC, Office of the Center Director, CBER
Implementing ICH Q12 – A Case Study
John Groskoph, MBA
Pfizer Inc, United States
Executive Director, Global CMC