Education
Event Title
Regulatory Education for Industry (REdI): Generic Drug Forum April 3-4, 2019
April 3 - 4, 2019
Event Title
Regulatory Education for Industry (REdI): Generic Drug Forum April 3-4, 2019
April 3 - 4, 2019
- Date:
-
April 3 - 4, 2019
- Time:
-
12:00 AM - 12:00 AM ET
About This Event
This event offers practical advice, case studies, and a deep dive into the Abbreviated New Drug Application (ANDA) assessment process. FDA will also discuss science unique to generic drug applications.
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
After this course, attendees will be able to:
- Discuss requirements for an ANDA
- Understand and determine when to use a reference listed drug or a reference standard
- Determine the types of FDA meetings and when to use controlled correspondence
- Understand the factors resulting in an FDA refusal to receive decision
- Identify common deficiencies in ANDAs including bioequivalence and quality (e.g. stability, dissolution and impurity testing)
- Avoid common errors related to the Drug Master File (DMF)
- And more…