Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market) 2015
11 Nov 2015
Webinar
Key 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
Past Events
Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market) 2015 - 11 Nov 2015, Webinar (55177)
Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market) 2026
Important
Please, check "Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)" official website for possible changes, before making any traveling arrangements
