Course Overview
This introductory course focuses on the critical decisions made during a question-based label-driven approach to development of a pharmaceutical candidate from discovery through to product launch and marketing. The course highlights the decisions involved in the identification of a lead pharmaceutical candidate, conducting preclinical work to provide safety data to support the initial human clinical studies, establishing optimal therapeutic doses with an acceptable benefit-to-risk ratio, generating a label, and deciding to file an NDA or BLA. A key element of the module is a discussion of how the development of a pharmaceutical candidate is a stepwise approach of learning, confirming and affirming that together with the product label drives the pharmaceutical development process.
You should expect to spend approximately 6 hours of study time to complete the course.
Course Details
2-Month Access
Course Rate: $475.00
Please have your credit card ready in order to complete registration.
Key Topics
- History of Drug Regulation: Who Regulates and Why Contemporary, Knowledge-Based Drug Development as Compared to the Traditional, Activity-Based Approach
- Critical Drug Development and Review Decision Points
- Successful and Failed Drug Development Programs
Educational Objectives
- Understand the pharmaceutical development process
- Describe each knowledge-based phase of the pharmaceutical development process
- Understand the importance of, and differences between, Learning Studies and Confirming Studies
- Define critical decision points in the pharmaceutical development process
- Utilize the questions and critical decision points to design a pharmaceutical development plan
Who Should Attend
- Individuals from any discipline new to drug development, including pharmacists.
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 6 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 #0708-0000-20-005-H04-P; 0.6 continuing education units (CEU) are available for this program. Initial Release Date: 06/19/2020; Expiration Date: 06/19/2023. This is a knowledge based CPE activity.