Adam Bradbury｜Analyst | GlobalData
Stephanie Gaulding | Managing Director | Pharmatech Associates
Bree Wang | Senior Regulatory Specialist | Merck Life Science
Target Attendee: Quality Management, R&D, production management etc.
L. Xia | RA Manager | Baipharm
- How the RLD is regulated and how the RLD choice affect the ANDA pathway?
- What is the main requirement of Quality and Therapeutic Equivalence in China?
- Will overseas clinical/bioequivalence (BE) data be accepted by China CDE?
- What is the key point in China to prepare ANDA dossier?
- The timeline and registration fee for ANDA.
Dr. Ahmed Bouzidi | CEO | TRINOMAB EU
Leo Luo | Director of International Business Committee | CPEA
Sy Chyi Yeoh | Buiness Development Director | PLG
Paolo Guerra | Medical Devices Project Leader | PLG
- The cross-border partnership opportunities for biotech companies in Europe and China
- How Chinese Medtech company can explore EU market
- An integrated market access solution and plan to EU Market
- Panel discussion and Q&A
Peter Shapiro, Ph.D. | Senior Director | GlobalData
Cameron Bardliving, Ph.D. | Director of Operations | Jefferson Institute for Bioprocessing
Thomas Jefferson University
- Trends in Cell and Gene Therapy pipeline and approvals
- Trends and issues in Cell and Gene Therapy Contract Manufacturing
- The complexities of bioprocessing and manufacturing of biologics