Course Overview
PERI’s fundamental education course provides an overview of the pharmaceutical development process, from drug discovery and nonclinical development, through clinical trials and regulatory submission. The course focuses on the decisions that need to be made throughout the therapeutic development process and the criteria influencing these decisions. In addition, sessions on drug safety and pharmacovigilance, pharmacoeconomics, and project management have been added to provide a comprehensive approach to understanding the pharmaceutical industry and drug development.
In addition to the comprehensive live online training, the Decision Points in Pharmaceutical Development online component introduces the phases of development and the key concepts explored during the live course. This self-study program is included free with your paid registration.
Event Details
Date: August 4 – 6, 2025
Location: Virtual Training
Time: 10am – 4pm EST // 7am – 1pm PST (daily)
Course Rate: $1,595
Early Bird Rate: $1,795
Early Bird Deadline: July 8, 2025
Please have your credit card ready in order to complete registration.
Benefits of Attendance
- Identify the basic steps in pharmaceutical development
- Gain hands-on experience through practical pharmaceutical development workshops
- Understand team responsibilities in pharmaceutical development
- Learn key aspects and updates in the regulatory process for US, Europe and Japan
Educational Objectives
- State the basic steps in the drug development process
- Explain the difference between research and development
- Analyze the key decision points in the drug development process
- Evaluate the implications of label based drug development
- Discuss the role of interaction with FDA and other regulatory agencies
Who Should Attend
- Professionals new to drug development
- Scientific and non-scientific staff members at all levels
- Members of clinical research teams
- Pharmacists
- Medical writers and communication specialists
- Project managers and regulatory affairs personnel
Key Topics
- “Big Picture” Review of the End-to-End Lifecycle
- Non-Clinical Drug Development
- Decision Points in Drug Development
- Regulatory Review Process (FDA, EMEA)
- Portfolio Review Workshop: Decision-Making Process
- Applying Project Management Principles to Drug Development
- Clinical Trial Designs and Expectations
- Safety in the Drug Development Process
- Global Considerations in Drug Development
Course Agenda
Now available! Download the working program agenda for this comprehensive three-day virtual course.
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
Noel J. Cusack, PhD
Independent Nonclinical Consultant
Min Chen, MS, RPh
Pharmacovigilance Consulting, LLC
David Fritsch, MBA
Principal, Biotechnology Operations Consultant
Fritsch Consulting, LLC
Allan J. Weinstein, MD
Clinical Research and Regulatory Affairs Consultant
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.