Understanding the drug Development process
Understanding the Drug Development/Review Process
4/24/18 (10:00AM - 1:00PM EST and from 3:00PM - 6:00PM EST)
- Designed for life sciences professionals from all disciplines who require (or desire) a basic understanding of drug development from both an FDA and industry insider perspective.
- Targeted for numerous life science disciplines, including:
- Medical writers
- Utilizes a ‘backward planning’ perspective – focusing on drug development with maximum patient benefit and commercialization in mind.
Topics include, but are not limited to:
- Drug Development phases and definition
- IND and NDA (BLA)
- FDA organizational structure – Centers, Offices, Divisions, etc
- Working with FDA (meetings, preparation and follow-up, expectations, interpersonal interactions)
- FDA internal interactions
- FDA external interactions: other regulatory agencies, advisory committees, etc.
- FDA Reviewer backgrounds and roles
- PDUFA, FDAAA and other laws and their regulations
- The importance of FDA Guidances to successful drug development
- Utilizing the Targeted Product Profile to ensure maximal patient benefit, labeling, and commercialization.
- Understanding review times and special review - implications and use (breakthrough, expedited, 505b2, accelerated approval – subpart H and E, fast track, etc.)
- Action letters and responses – what do they mean?
- Best practices of working with FDA during the drug development process
- Understanding FDA’s thinking on substantial evidence standard vs. “emerging” categories of evidence like RWE and meta-analyses
To register please follow the two step process. First, fill out the registration form below and hit SUBMIT. Then click the PAY NOW button and follow the steps to pay and complete your registration.