This course provides a brief history of biologics and follow-on biologics (also known as biosimilars) and how they are regulated, describes the key aspects of chemistry, manufacturing and controls (CMC) for various types of biologic products, defines principles underlying biologics safety and clinical trial assessments, and aids in developing a planning strategy for toxicology and clinical studies supporting biological drug development. Participants will gain a broad multidisciplinary understanding of the scientific, management and regulatory decision points in the development of new biologics.
Benefits of Attendance
Continuing Education Credit
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator. Additional $35 fee applies for students who are applying for continuing education credit.
Continuing Education information forthcoming.
Date: May 3 – 4, 2018
Location: PERI Training Facility
Fairfax, VA 22031
Course Rate: $1695
Early Bird Rate: $1495
Early Bird Deadline: 03/23/18
Please have your credit card ready in order to complete registration.
Hyatt House Falls Church/Merrifield
8296 Glass Alley
Fairfax, VA 22031
PERI participants can take advantage of special rates through April 4, 2018 by when making reservations online through the Hyatt House website.
Request a Proposal
Interested in bringing this course to your company? Request a proposal and a PERI team member will be in touch about hosting this course as a Corporate Education program.
Paul Beninger, MD
VP Global Patent Safety and Risk Management, Genzyme
Jo Ann Zoul