- date:
- June 15, 2023
- time:
-
1:00 p.m. to 2:00 p.m. ET
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About this webinar
In this webinar, FDA will discuss:
- The Importance of Evaluating the Effects of Foods on Drugs and the Reason for the Final Guidance
- Timing of Food Effects Studies in Drug Development
- General considerations for planning food effects studies
- Other Considerations Related to Assessing Food Effects on Drugs
topics covered
- Timing of Food Effects Studies in Drug Development
- Types of Meals Evaluated
- General considerations for planning food effects studies
learning goals
- Understand the importance of evaluating the effects of food on drugs
- Understand common considerations for planning food effects studies
- Discuss data analysis considerations related to food impact assessments
Target Visitor
- Involved in food effects studies conducted by drug development scientists to support regulatory submissions
- Scientists evaluating food effects studies submitted as part of regulatory submissions
- Foreign regulators and policy makers
FDA Speaker
Presentation Title: Clinical Pharmacology Considerations in Food Effects Studies: An Overview of FDA Food Effects Guidance
Dr. Vikram Arya, FCP
Associate Director of Treatment Review
Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology | CDER | FDA
panelist
Dr. Vikram Arya, FCP
Associate Director of Treatment Review
Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology | CDER | FDA
Dr. Brian Booth
directed by
Cancer Pharmacology Division I | Clinical Pharmacology Division | CDER | FDA
Dr. Ethan Steer
Associate Director of Lifecycle Management
Direct Office | Office of Clinical Pharmacology | CDER | FDA
FDA resources
continuing education
This webinar will 1.00 Contact Time Approval for Continuing Education for Physicians, Pharmacists and Nurses. For more information, please see our detailed announcement. After the course is over, participants for the day will receive an email with instructions and a code to earn credit. Only participants who joined the live broadcast via Adobe Connect will receive the claim code..
Real-time attendance is required for attendance certificates that can be used to support CEs in the following professional organizations: Certificates will only be available for 2 weeks after the event.
This webinar is:
- pre-approved by wrap Entitled to earn up to 12 credits for the 2-day event (suitable for real-time attendance) towards RAC recertification of participants upon full completion.
- pre-approved by Socra Acceptance of documentation of the candidate’s participation in the Continuing Education Program for recertification if the program applies to the regulation, administration or administration of clinical research, or to the candidate’s therapeutic area of clinical research.
- pre-approved by SQA Each hour of instruction will qualify for one non-GCP or non-GLP unit towards the participant’s RQAP re-enrollment.
- Approved by ACRP For continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
Technical guidance
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