Receive hands-on experience and mentorship from pharmaceutical industry leaders in a transformative learning environment. Upon completion of our APPE rotation, you will be able to:

• Understand how drugs are developed and manufactured.
• Summarize FDA regulations applicable to manufacturing processes, including GMP, GLP, etc.
• Describe the various components involved in drug manufacturing, including facility design, raw materials sampling, testing laboratories, QA/QC management, SOP development, and others.
• Explain the development process of a new drug from laboratory to commercial distribution of the product.
• Differentiate between Code of Federal Regulations (CFR) and FDA Guidances.
• Define all the phases of clinical trials in the drug development process.
• Discuss inspections and audits of drug manufacturing facilities.
• Identify the types of applications available for drug products (e.g., NDA, ANDA, BLA, OTC Monograph).
• Recognize the United States Pharmacopeia (USP) Reference Standards that apply to drug manufacturing.

To learn more about these opportunities and more, please email Dylan DeFronzo at dylan.defronzo@sankavpharma.com.

If you are ready to apply, please complete and email us the application below.