Generic Drugs Forum 2022

17 Mar Generic Drugs Forum 2022

Generic Drugs Forum 2022: The Current State of Generic Drugs

The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice, presenting case studies, and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.

This year’s theme is The Current State of Generic Drugs and presentations will focus on hot topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs

TOPICS COVERED

• Data Integrity
• Facility Evaluation
• FDA’s Pre-ANDA Program
• Global Generic Drugs
• Knowledge-Aided Assessment and Structured Application (KASA)
• Overview of ANDA Program Statistics
• Pharmaceutical Quality Systems
• Post-Market Safety and Surveillance of Generic Drugs
• Product-Specific Guidances for Generic Drug Development
• Technical Considerations for Pharmaceutical Product Lifecycle Management

INTENDED AUDIENCE

The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:

• plan to submit an ANDA, are in the process of submitting an ANDA or have submitted an ANDA
• involved in generic drug development
• work on generic drug bioequivalence, facility evaluation, stability, dissolution and impurity testing

For Registeration Click Here