Basic Drug Development: Overview of Biopharmaceutical Research & Development (Nov 20 - 22, 2024)

Basic Drug Development: Overview of Biopharmaceutical Research & Development is organized by Pharmaceutical Education and Research Institute (PERI) and will be held from Nov 20 - 22, 2024.

Description:
PERI’s fundamental education course provides an overview of the pharmaceutical development process, include, nonclinical and clinical development, and manufacturing, culminating in exploring regulatory pathways and an interactive panel with FDA representatives. The course focuses on the decisions that need to be made throughout the therapeutic development process and the criteria influencing these decisions. Interactive workshops and ample Q&A time offer students opportunities to engage and apply information presented during the online program.

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

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

Key Topics:

• Non-Clinical Drug Development
• Decision Points in Drug Development
• Regulatory Review Process (FDA, EMEA)
• Portfolio Review
• Meeting with Regulatory Agencies
• Drug & Biologic Product Manufacturing
• Clinical Trial Design
• Safety in the Drug Development Process
• Global Considerations in Drug Development
• Panel Discussion with FDA Representatives: Putting It All Together