Key takeaways will include:
- The basics of an IND
- How to select your FIH dose
- General study requirements for an IND
- Pitfalls to avoid
- Strategies for your pre-IND meeting
- Tips for interacting with the FDA
Dr. Shearer has 16+ years of expertise in Pharmacokinetics, Toxicokinetics, Drug Metabolism, PK/PD, Nonclinical and Clinical Pharmacology, and Bioanalysis.
Dr. Furmanski has 10+ years of drug development experience and has recently spent 3 years as a reviewer at the FDA, where he reviewed and provided regulatory advice for over 200 INDs spanning across all phases of development.
The webinar is free of charge. Register here.