3rd FDA IND/NDA/ANDA Workshop

Drug discovery and development has become increasingly global in the past two decades. Many companies are establishing R&D centers in China and other regions, more are conducting multinational clinical studies and aiming for simultaneous submission of new drug applications in different countries. The globalization of the pharmaceutical industry means that it is no longer enough for drug discovery and development professionals and managers to understand only the local regulations and process. It is now essential for professionals in the field to understand the regulations, processes and trends in other countries. For several years DIA has offered trainings for FDA IND/NDA in the US. The course is very popular and many international professionals have attended. After successfully having the first edition in Beijing last year, DIA China will conduct FDA IND/NDA/ANDA workshop to Chinese professionals again in this autumn. The course will also include updated ANDA materials and DMF for those who are interested in the development of generics.
 

Learning Objectives

• Focus on US regulations and processes (IND, NDA, ANDA and DMF)
• How to work productively and efficiently with FDA
• Practical workshops providing opportunities for discussion to deepen understanding
   

Target Audience

• Drug discovery and development professionals
• Nonclinical and clinical development
• Professionals in pharmaceutical regulatory affairs
• CMC
• Project management
• Medical affairs
• Safety and pharmacovigilance
• Generics development
   

Program Chair

Janet LV
Head of Regulatory, Asia Pacific, Roche (China) Ltd.

Program Committee

Wendy YAN, MBA
Senior Vice President Head of Regulatory Affairs BeiGene (Beijing) Co., Ltd.
 

Instructors

Carol H. Danielson, MS, Dr PH, RAC
President, Regulatory Advantage International LLC

Michael R. Hamrell, RAC, FRAPS
President, MORIAH Consultants