9:00 am – 9:30 am

 Introduction to Biopharmaceuticals

9:30 am – 10:00 am

Biologicals Product Characteristics and Regulatory Implications

10:00 am – 10:30 am

CMC Regulation and Guidances

10:30 am – 10:45 am

Break

10:45 am – 11:30 am

Quality by Design

11:30 am – 12:00 pm

Clinical Phase - Appropriate CMC

12:00 pm – 1:00 pm

 Lunch

1:00 pm – 1:30 pm

Introduction to eCTD Filing

1:30 pm – 2:15 pm

eCTD Summaries

2:15 pm – 2:30 pm

Break

2:30 pm – 3:00 pm

Upstream Considerations

3:00 pm – 3:30 pm

Downstream and Formulation Considerations

3:30 pm – 4:00 pm

Breakout Session #1