Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)
June 7, 2013 - Palo Alto CA USComplianceOnline
referral@complianceonline.com
Phone:650-620-3915
Fax:650-963-2556
Areas Covered in the Webinar: Strategic Planning for an ANDA vs Paragraph IV Efficient Implementation and Communication with the FDA. Content and Format of ANDA’s Plan for FDA-Sponsor Meetings FDA Expectations and CMC Data including Bioavailability/Bioequivalence Outline of Paragraph IV Applications and Case Studies Who will Benefit: This topic applies to personnel/ companies in the pharma/biopharma industries. The employees who will benefit most include: Senior management Regulatory affairs Quality Assurance CMC and Clinical Development Documentation Scientists, R&D Product Development