---

---

---

AGENDA

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

On October 1, 2023, FDA launched a new pilot offering meeting opportunities to prospective generic drug applicants and generic drug applicants who intend to use Model-Integrated Evidence (MIE) approaches for bioequivalence (BE) establishment in their abbreviated new drug applications (ANDAs). The use of MIE approaches for BE establishment is increasingly prevalent, particularly in the development of challenging products such as long acting injectables, orally inhaled drugs, and topically applied dermatological products. Industry regularly seeks FDA input on best practices for implementing MIE, including common model approaches, and addressing complex scientific and regulatory issues.

FDA will further discuss the MIE meeting pilot program, include considerations and expectations when meeting with FDA under the Industry Meeting Pilot MIE Program and discuss the types of potential topics that will be granted under the pilot program. Additionally, FDA will provide an overview of the submission and meeting process and a live Q&A with FDA experts to better assist generic drug applicants in their decision to submit a request for an MIE meeting under the pilot program.

INTENDED AUDIENCE

This webinar is for members of the generic drug industry, including current and prospective applicants who are interested in submitting an application for a generic drug, regulatory reviewers for generic drug assessments, consultants focused on bioequivalence, and clinical research coordinators.

TOPICS COVERED

• Goals and general principles of the MIE industry meeting pilot program
• Lessons learned from the pre-ANDA program and scope of topics to be granted under the MIE Pilot Program
• Overview of the MIE pilot program process

FDA RESOURCES

• Model-Integrated Evidence (MIE) Industry Meeting Pilot between FDA and Generic Drug Applicants
• MIE Pilot General Principles Document

CONTINUING EDUCATION

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.