<초청강연> US regulation of Drug Development and Commercialization 등

- 일시 : 2012년 12월 3일(월) 오전9시 - 오후6시 

- 강사 : 미국 USC Department of Regualtory Science, College of Pharmacy Director, Professor Frances Richmond 

- 강의내용 : 

 ◦ 주제 1 :

 　• US regulation of Drug Development and Commercialization

 　• Regulatory stages in innovative drug development

 　• IND and NDA processes

 　• Update on generic drug regulation

 　• Drug and device master files 

 ◦ 주제 2 :

 　• The changing regulatory and reimbursement landscape in the US

 　• FDA global initiatives

 　• Anticounterfeiting efforts

 　• Reimbursement in the US

 　• Biosimilar legislation and regulation