CDER SBIA: Registration Open for Generic Drugs Forum on April 15-16, 2020

CDER Small Business and Industry Assistance Generic Drugs Forum WEBCAST April 15-16, 2020 This webcast is FREE.

Registration and Agenda

This two-day virtual forum offers you the opportunity to interact with FDA subject matter experts from every part of the generic drug review program. The goal of the forum is to provide information to help applicants achieve success in the development of generic drug applications, known as Abbreviated New Drug Applications (ANDAs). Our presentations will offer practical advice, case studies, and discussions about scientific issues related to generic drug applications in order to assist generic drug developers with minimizing application deficiencies. 

Keynote Speakers

• Sally Choe, Director, Office of Generic Drugs (OGD) | CDER
• Michael Kopcha, Director, Office of Pharmaceutical Quality (OPQ) | CDER

Topics

• Competitive Generic Therapies (CGT)
• Application Case Studies on FDA’s Action Letter Timing
• Pre-ANDA Interactions with the FDA
• Current Global Generic Drug Landscape Harmonizing Regulatory Science through the International Council for Harmonization (ICH)
• Common CMC (Quality) Issues and How to Avoid Them
• Facility Readiness and Related Issues
• FDA’s Requirement for Electronic Submission of an ANDA Application and Study Data
• Generic Combination Products

Continuing Education

This course:

• has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion
• is eligible for SOCRA credit in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area. Candidate must provide documentation of participation.
• has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• is approved for ACRP research-specific continuing education at the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.
• Real-time attendance is required for certificate of completion. Certificates are only available two weeks after the event.