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
Download the current agenda for this comprehensive course on Biologics and Biosimilars.
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.
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider f continuing pharmacy education. ACPE Universal Activity Number is 0708-0000-17-003-L01-P. 1.0 continuing education units (CEUs) are available for this program. Initial Release Date: 04/27/17. This is a knowledge based CPE Activity.
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PERI, Inc. designates this live activity for a maximum of 10 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Course Director: Paul Beninger, MD, MBA
Dr. Beninger is Assistant Professor of Public Health & Community Medicine at Tufts University School of Medicine, where he is the Director of the MD/MBA and MBS/MBA Programs. He began his career in drug development in 1987 at the US Food and Drug Administration, first as a reviewer and manager for drugs against HIV/AIDS and opportunistic infections and then as a division director for medical devices. He joined Merck & Company in 1995 and developed experience in regulatory affairs, medical affairs and drug safety in the areas of anti-infective drug and biological products, vaccines, anti-diabetic drug products and oncology drug products, before joining Genzyme as vice-president of pharmacovigilance in 2006; Genzyme was acquired by Sanofi in 2011. Dr. Beninger retired from Genzyme-Sanofi in April, 2017. Dr Beninger trained in internal medicine and infectious diseases. He received his MD from the University of California, Davis, his BA from Claremont McKenna College in Claremont, California, his MBA from St Joseph’s University in Philadelphia, Pennsylvania, and his graduate certificate in epidemiology from Tufts. He has published and spoken extensively on regulatory science, drug and vaccine safety, and pharmacovigilance, and he is a fellow of the American College of Physicians and the Infectious Disease Society of America.
Confirmed Course Faculty
Pharmacologist, CDER/Division of Anti-Viral Products, US Food & Drug Administration
Martin Green, PhD
Supervisory Toxicology, CBER/Division of Vaccines and Related Product Applications, US Food & Drug Administration
Jaw Horrow, MD, MS, FACC
Executive Director, Global Clinical Development, Merck & Co.
Professor of Anesthesiology & Perioperative Care, Drexel University College of Medicine, Philadelphia, PA
Orest Hurko, MD
Senior Clinical Consultant, Rare Disease Unit, Pfizer
Jinhua Lu, PhD
Pharmacology/Toxicology Reviewer, CBER/Office of Tissues and Advanced Therapies, US Food & Drug Administration
Chief Scientific Officer, ViNa Pharma Consultants LLC
Gillian Woollett, MA, DPhil
Vice President, FDA Regulatory Policy, Avalere Health
Date: April 27 – 28, 2017
Location: PERI Training Facility
Fairfax, VA 22031
Course Rate: $1595
Early Bird Rate: $1395
Early Bird Deadline: 03/24/17
Hyatt House Falls Church/Merrifield
8296 Glass Alley
Fairfax, VA 22031
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