Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market) 2015 is a webinar that covers topics such as:
- Efficient Implementation and Communication with the FDA
- Strategic Planning for an ANDA vs Paragraph IV
- Plan for FDA-Sponsor Meetings
- Content and Format of ANDA’s
- Outline of Paragraph IV Applications and Case Studies
- FDA Expectations and CMC Data including Bioavailability/Bioequivalence
Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market) 2015 is intended for attendees from companies in the pharma/biopharma industries:
- Regulatory affairs
- Senior management
- CMC and Clinical Development
- Quality Assurance
- Scientists, R&D
- Documentation
- Product Development
