- April 15 - 16, 2020
8:00 AM - 4:00 PM ET
Leadership RoleDirector - Office of Generic Drugs
Michael Kopcha, Ph.D., R.Ph.
Leadership RoleDirector - Office of Pharmaceutical Quality
The meeting will not be held in person.
About This Event
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.
- 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
Office of Generic Drugs (OGD) | CDER
Office of Pharmaceutical Quality (OPQ) | CDER
Who should attend?
The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:
- Plan to submit an ANDA or are in the process of submitting an ANDA
- Involved in generic drug development
- Work on bioequivalence, stability, dissolution and impurity testing
- Submit Drug Master Files (DMFs)
- Prepare regulatory submissions
- 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.
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