BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
Drug Approval Primer
Drug Approval Primer offers a comprehensive overview of how small molecule drugs and biologics receive the regulatory green light for human use. With greater emphasis on the FDA, this class aims to demystify the game-changing Prescription Drug User Fee Act (PDUFA) and provide step-by-step guidance on the drug development application process. From the preclinical Investigational New Drug Application (IND) to the post-clinical New Drug Application (NDA) and Biologic License Applications (BLA), this primer covers each stage. It showcases the FDA meeting and response timeline, the tools used to enforce its laws, and strategies to expedite approvals for life-saving medicines. Acquire the regulatory knowledge needed to successfully navigate the drug approval process with the Drug Approval Primer class. Grab your spot today to gain insights into the process of bringing new drugs to market!
Takeaways
- Discuss the essential components and timing of Investigational New Drug (IND) applications in the United States and Clinical Trials Application (CTA) in the European Union.
- Explain the purpose and impact of the PDUFA legislation.
- Explore the criteria for various expedited drug approval pathways and how these designations can significantly speed up the timing of the regulatory process.
- Gain insight into the intricacies of filing for a New Drug Application (NDA) or Biologics License Application (BLA) in the United States and a Marketing Authorization Application (MAA) in the European Union.
- Compare the approval pathways for generic drugs and biosimilars, highlighting each case's unique considerations and challenges.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
A digital strategy can no longer lie within a siloed digital or innovation team. It’s critical to integrate digital across the enterprise to maintain a competitive edge.
Do you need to understand the drug development process, including details about a drug's life cycle from its discovery through post-marketing studies? This is the course for you.
Explore biologics discovery: target screening, validation, optimization & transition to preclinical development.
Learn small molecule drug discovery basics: target screening, validation, lead optimization & transitioning to development