Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market) 2015

Topics

• 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

Who should Attend

Attendees from companies in the pharma/biopharma industries:

• Regulatory affairs
• Senior management
• CMC and Clinical Development
• Quality Assurance
• Scientists, R&D
• Documentation
• Product Development