Course Overview
PERI’s newest virtual program explores the historic and current environment of biologics and biosimilars, including how they are developed, regulated, and manufactured. The course explores a variety of biotherapeutic treatments, including vaccines, cell therapy, and gene therapy, as well as explores the future of non-small molecule therapies. Participants will gain a broad multidisciplinary understanding of the scientific, management and regulatory decision points in the development of new biologics and biotech products.
Event Details
Date: April 9 – 10, 2024
Location: Virtual Training
This course has concluded. Please visit the Professional Development Calendar for the latest course offerings.
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
- Learn from FDA and industry experts about biologics and biosimilars
- Build a foundation on emerging biotech therapies and explore their importance in today’s treatment landscape
Educational Objectives
- Illustrate the differences between small molecules and biologics in terms of regulatory pathways to approval
- Distinguish the differences between biologics and biosimilars
- Describe the manufacturing process of biologics
- Analyze the utility of biomarkers in the development of biologics, including oncology products
Who Should Attend
- Regulatory Affairs Managers
- Scientists & Analysts
- Clinical Trial Associates & Managers
- Seasoned Drug Development Professionals Transitioning to Biologics
Key Topics
- Exploring the Past, Present, and Future of Biologics
- Manufacturing Challenges and Considerations for Biotherapeutic Products
- Vaccine Development
- Cell and Gene Therapy: Pharma/Tox Assessments, Clinical Development
- Global Regulatory Pathways for Biologics and Biosimilars
Course Agenda
Continuing Education Credits
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 Medical Education (CME)
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Continuing Pharmacy Education (CPE)
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Course Faculty
Christopher Ellis, PhD
Pharmacologist
Division of Anti-Viral Products
US Food and Drug Administration
David Fritsch, MBA
Principal
Biotechnology Operations
Fritsch Consulting, LLC
Martin Green, PhD
Supervisory Toxicology
Division of Vaccines
US Food and Drug Administration
Melanie Hartsough, PhD
Independent Consultant
Pashna N. Munshi, MD
Associate Professor
University of Pennsylvania
Matthew Steele, PhD
Team Leader for Biologics Medical Countermeasures
HHS/ASPR/BARDA
Gillian Woollett, MA, DPhil
Vice President, Head Regulatory Strategy and Policy US
Samsung Bioepis
PERI Facilitator
Jo Ann Zoul
Course Manager/Registrar
571-490-8409
jzoul@peri.org
Commercial Support
No monetary or in-kind financial support (faculty’s time) has been provided for this program.
Request a Proposal
Interested in bringing this course to your group of 10 or more? Request a proposal and a PERI team member will be in touch about hosting this course as a Corporate Education program.