This webinar is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements.
Why should you Attend:This webinar is a must for those who have to have an understanding of FDA’s Drug Development Process.
Areas Covered in the Session:
- Overview of FDA’s Drug Development Process
- Nonclinical studies required
- Human clinical studies required
- IND requirements
- NDA requirements
Who Will Benefit:
- Regulatory Affairs Personnel
- Quality Personnel
- Research Personnel
- Clinical Personnel
- Project Managers
- Legal Personnel
- Those personnel that require a general understanding of the FDA’s Drug Development Process
In recent years he has filed numerous FDA drug, biologic and medical device submissions for product approval. In addition he has been involved in two of the largest clinical trials conducted, the 8,000 patient clinical trial in Africa and the 16,000 patient clinical trial in Thailand.