The Landscape of clinical trials in China, including ways that sponsors can address and ease common difficulties in managing a study in China:
- Highlights and impacts of recent regulatory reforms
- Regulatory challenges and solutions
- Best practices for operational oversight and governance
- ICON strategy for rapid start-up
Lina Feng
Lina Feng, about 20 years’ regulatory experience in China, work experience extends to pharmaceutical products, medical devices and pharmacovigilance. Ever worked in both local and global pharma, global CROs. Lina with her team supported hundreds of IND/NDA/ANDA/HGRA submissions as well as regulatory consultations/strategy developments for pharmaceutical products aiming to enter China market.
Lisa Zou
Lisa Zou, 20+ years clinical operation experience in China and APAC. Ever worked in both global pharma, biotech company and global CRO. Her recent 10 years worked in Paraxel, PRA and ICON. Lisa with her team supported of all China sites EC submission in ICON and has fluent experience with China sites.
Audience
This program is intended for pharmaceutical and biotech professionals involved in:
- Outsourcing
- Procurement
- Project management
- Medical affairs
- Regulatory affairs
- Clinical development