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ABOUT THIS WEBINAR

In this webinar, FDA will discuss:

• Importance of assessing the effect of food on drugs and reasons for issuing the final guidance
• Timing of conducting food effect studies during drug development
• General considerations for designing food effect studies
• Other considerations related to assessing the effect of food on a drug

TOPICS COVERED

• Timing of conducting food effect studies during drug development
• Type of meals to be evaluated
• General considerations for designing food effect studies

LEARNING OBJECTIVES

• Understand the importance of assessing the effect of food on drugs
• Comprehend general considerations for designing food effect studies
• Discuss data analysis considerations related to food effect assessment

INTENDED AUDIENCE

• Drug development scientists involved with food effect studies conducted to support regulatory submissions
• Scientists assessing food effect studies submitted as part of regulatory submissions
• Foreign regulators and policy makers

FDA SPEAKERS

Presentation Title: Clinical Pharmacology Considerations for Food Effect Studies: An Overview of the FDA Food Effect Guidance

Vikram Arya, Ph.D., FCP
Associate Director for Therapeutic Review
Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology| CDER | FDA

Panelists

Vikram Arya, Ph.D., FCP
Associate Director for Therapeutic Review
Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology| CDER | FDA

Brian Booth, Ph.D.
Director
Division of Cancer Pharmacology I | Office of Clinical Pharmacology | CDER | FDA

Ethan Stier, Ph.D.
Associate Director for Lifecycle Management
Immediate Office | Office of Clinical Pharmacology | CDER | FDA

FDA RESOURCES

• Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations

CONTINUING EDUCATION

This webinar has been approved for 1.00 contact hour of continuing education for physicians, pharmacists, and nurses. Please see detailed announcement for more information. After the course concludes, that day's attendees will receive an email with instructions and a code to claim their credit. Only participants who attend the live broadcast via Adobe Connect will receive the claim code.

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This webinar has been:

• pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
• pre-approved by SOCRA who accepts documentation of candidate participation 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.
• pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
• 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 INFORMATION

• To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
• Please contact info@sbiaevents.com for all technical questions.
• If you encounter any technical issues before or during the event, please visit the Technical Issues Support.
• Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.