Biosimilars – Development Complexities and Global Regulatory Strategies
This presentation aims to build a foundational level of regulatory science around development of biosimilar drug products. We will also discuss challenges to biosimilar development and regulatory pathways. Three primary topics will be covered including:
- Exploring biological complexity of biosimilar drug development
- The science and global regulation of biosimilars
- Current state of affairs and future directions
Registration Fees & Deadlines
Member: $0 | Nonmember: $15
Speakers
Martin Mewies
Director, Regulatory Affairs, CMC Biologics, Pharmalex
Platinum Chapter Sponsors
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org