---

---

Agenda

Visit CDER Small Business and Industry Assistance Page

THIS WEBINAR will discuss:

• The importance of assessing the drug interactions involving therapeutic protein products, interactions cause by change of gastric pH level, and interactions affecting combined oral contraceptives.
• How to evaluate those drug interaction potentials for investigational drugs
• General considerations for designing clinical drug interaction studies and how the results may inform drug labeling
• Utility of the lists of drugs available on the FDA drug interaction websites and the relevance to drug development and clinical practice

INTENDED AUDIENCE

• Scientists and consultants involved with drug interaction assessments conducted to support IND/NDA/BLA/ANDA applications
• Academic researchers in fields investigating drugs interactions
• Regulatory reviewers and policy makers
• Healthcare providers prescribing drugs to patients or consulted by patients

TOPICS COVERED

• Updates on the FDA drug interaction websites
• When and how to evaluate the impact of investigational drugs on combined oral contraceptives
• When and how to evaluate the effects of gastric pH elevation caused by acid reducing agents on investigational drugs
• When and how to evaluate the drug interactions involving therapeutic protein drugs.

LEARNING OBJECTIVES

• Describe the FDA drug interaction website, understand the clinical relevance of the tables, and how those tables can be used by drug developer and health care providers to assess drug interaction risks.
• Discuss the framework to determine the need to conduct clinical studies to evaluate the effects of investigational drugs on combined oral contraceptives, how such studies may be performed, and how to communicate recommendations for use in drug labeling to mitigate the risk of drug interactions.
• Address the circumstances when clinical studies are needed to evaluate the impact of acid-reducing agents on investigational drugs and alternative approaches, how such assessments can be conducted, and how the results may inform drug labeling.
• Review various mechanisms of drug interactions involving therapeutic protein drug products, a framework to determine the risk of such interactions, and how to communicate the drug interaction risks and mitigation strategy in drug labeling.

FDA RESOURCES

• FDA website on Drug Interactions & Labeling: Drug Development and Drug Interactions | Table of Substrates, Inhibitors and Inducers
• FDA guidance for industry: Clinical Drug Interaction Studies with Combined Oral Contraceptives
• FDA guidance for industry: Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
• FDA guidance for industry: Drug-Drug Interaction Assessment for Therapeutic Proteins

CONTINUING EDUCATION

Each webinar has been approved for 2.00 contact hours of continuing education for physicians, pharmacists, and nurses. You can review the detailed announcement for further information. Real-time attendance is required for CE eligibility.

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 course 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.
• 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.
• 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.
• 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.