Conferences and Speeches

American Conference Institute's FDA Boot Camp - Basic Training in Core Regulatory Concepts for Life Sciences Lawyers, Business Executives and Policy Analysts

Tuesday, March 19, 2013 {ml-event-to} Wednesday, March 20, 2013
01:00 AM ET

FDA & Healthcare Partner Stephen Paul Mahinka will lead a content workshop on the complexities and nuances of the Biologics Price Competition and Innovation Act of 2009, Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148).

Tuesday, March 19 to Wednesday, March 20, 2013

1:15-2:30 pm
Speaker: Stephen Paul Mahinka

Topics to be discussed include:

  • Biosimilar pathway vs. 505(b)(2) and BLAs
  • Defining "biological" and "biosimilars" under BPCIA
  • Exploring interchangeability requirements
  • Understanding the signifi cance of the methods of making claims in this legislation
  • Examining the effect of this abbreviated approval pathway on innovation
  • A look at FDA Rule making and guidance relative to biosimilars
  • How will biosimilars fit in with life cycle strategies?

Doubletree Suites
Times Square
New York, NY

CLE Credit:
Please visit event registration link below for more details regarding CLE credit.