Course Overview
PERI’s fundamental education course provides an overview of the pharmaceutical development process, from drug discovery, nonclinical and clinical development, and manufacturing, culminating in product launch and marketing. The course focuses on the decisions that need to be made throughout the therapeutic development process and the criteria influencing these decisions.
In addition to face-to-face 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: February 5 – 6, 2024
Location: San Diego, CA
This course has concluded. Please visit the Professional Development Calendar for the latest course offerings.
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
Course Location
The course will be held at the following venue in downtown San Diego, CA.
iQ Smart Center
Tesla Boardroom
655 West Broadway, 1st Floor
San Diego, CA 92101
- The Guild Hotel, San Diego
- The Westin San Diego Bayview
- SpringHill Suites by Marriott San Diego Downtown/Bayfront
Key Topics
- “Big Picture” of Drug Development Lifecycle
- Key Decision Points in Drug Development
- Current Industry Trends and Future Developments
- Drug Discovery and Target Identification
- Pharmacokinetics Issues & Considerations
- Nonclinical Safety and Toxicology
- Chemistry, Manufacturing, and Controls (CMC) Review
- Portfolio Management Workshops
- Regulatory Approval Pathways and Outcomes: FDA, EMA, PMDA
- Clinical Development Plan Considerations
- Pharmacoeconomics, Market Access, and Patient Reported Outcomes
- Product Launch
- Pharmacovigilance
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
Course Agenda
Download the working agenda for this live
in-person training program scheduled for February in San Diego, California.
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. PERI, Inc. designates this live activity for a maximum of 13.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
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. ACPE Universal Activity Number is 0708-0000-24-001-L01-P. 1.35 continuing education units (CEUs) are available for this program. Initial Release Date: 02/05/2024. This is an application-based CPE Activity.
Course Faculty
Noel J. Cusack, PhD
Independent Nonclinical Consultant
Dr. Cusack is an educator and independent non-clinical consultant with 26 years of pharmaceutical experience in the United States. Dr. Cusack has served in leadership roles in the industry, prior to which he had extensive experience directing academic research in biology and chemistry at the University of Cambridge and at Kings College London. He has taught for PERI for 25 years and serves as the chair of the Curriculum Committee.
Course Faculty
Allan J. Weinstein, MD
Clinical Research and Regulatory Affairs Consultant
Dr. Weinstein is a clinical research
and regulatory affairs consultant and infectious disease specialist who spent more than 20 years leading clinical research and regulatory affairs at Eli Lilly and Company. Dr. Weinstein received medical training at Columbia University College of Physicians and Surgeons and was clinically trained at Brigham and Women’s Hospital and the Massachusetts General Hospital. In his role leading Global Clinical Research and Regulatory Affairs for Eli Lilly, Dr. Weinstein established clinical research and regulatory units in more than 25 countries.
PERI Facilitator
Lauren Kirk
Education Director
571-490-8409
lkirk@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.