Challenges and Successes of ICH Q12 Related Submissions
Extended Learning
Learning Level: Advanced
Session Length: 2 hours
ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, is a transformative document that will shape global regulatory submissions and practices. Adopted in November 2019, it has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the definition of a pharmaceutical or biological product, as well as both new molecular entities and authorized products.
Learning Objectives
- Hear about case studies relating to the application of Q12 principles
- Learn about key areas of concern and interest from industry and regulatory perspectives
- Gain greater appreciation, clarity and value related to the application of Q12 principles
- Participate in an extended panel discussion with the invited experts via Q&A
Speaker
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