Biologics/Biosimilars Webinar Series: FDA/Regulatory Overview

Jan
28
2016

Date: January 28, 2016

Time: 10:00AM - 11:00AM

Location: Webinar

Topics

  • FDA/Regulatory Overview

Event Details

In this second installment of our biologics/biosimilars series, we'll touch upon FDA and regulatory aspects facing researchers, manufacturers, and distributors of biologic-based therapeutics.  We will discuss approval pathways, give an overview of the BPCIA, and discuss post-BPCIA BsUFA, exclusivities, and naming.

Professionals

Related Industries

Speakers

Panelist

Professional Cropped Hawana Joanne Mintz

Joanne S. Hawana

Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.