Course Overview

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

  • Learn the history of biologics and how they are regulated
  • Walk away with an understanding of the preclinical studies used to support the phases of clinical trials
  • Work with peers to develop a strategy for developing new biologics, from first in human to product launch
  • Learn from FDA and industry experts about biologics and biosimilars
  • Discuss the difference between small molecules and biologics in terms of regulatory pathways to approval
  • Describe the differences between biologics and biosimilars
  • Define manufacturing process of biologics
  • Describe key components of pre-clinical packages required for Regulatory approval of biologics
  • Describe key pharmacovigilance concepts including safety risks
  • Discuss the utility of biomarkers in the development of biologics including oncology products
  • The History of Biologics
  • The IND/BLA Regulatory Procedure
  • Chemistry, Manufacturing and Controls (CMC)I: Biologic Bulk Drug Substance
  • Chemistry, Manufacturing and Controls (CMC) II: Specified Biotechnology Drug Program
  • Biotech Toxicology
  • Special Topics in Toxicology
  • Overview of Clinical Trial Design
  • Immunogenicity
  • Getting your Biologic into Humans Workshop
  • Perspective on Preventive Vaccine Trials
  • Managing the Development Process through Multidisciplinary Project Teams
  • Marketing Authorization Application (MAA)
  • Clinical and Nonclinical Professionals
  • Manufacturing Personnel
  • Regulatory Affairs Professionals
  • Seasoned drug developers transitioning into biologics

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.

Event Details

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.

Recommended Hotel

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.

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Course Director

Paul Beninger, MD
VP Global Patent Safety and Risk Management, Genzyme

Course Information

Jo Ann Zoul
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