Series Description

The CDER Small Business and Industry Assistance Regulatory Education for Industry training series consists of discussions and lectures by FDA subject matter experts on emerging regulations and guidances. There will be opportunities to review and discuss different types of regulatory submissions, including Investigational New Drug applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologic License Applications (BLAs) Participants will also have the opportunity to review and discuss post-market types of issues with FDA experts and hear about emerging regulatory tools.

Lecture Description
Participants will gain familiarity with the FDA's efforts to advance diverse participation in clinical trials including relevant FDA guidance and regulations, and CDER's most recent assessment of clinical trial diversity.
In this era of globalization, meeting various regulatory authorities' expectations in recruitment of diverse trial population is challenging. The need for faster drug development and shorter recruitment timelines make this important part of drug development even harder. CDER has pooled and analyzed 5-year's worth of demographic data from NME and original BLA approvals presented in Drug Trials Snapshot 2015-2019. In addition to sharing the observations and trends from trials of over 290,000 participants, the webinar will provide FDAs expectations when it comes to representation in the trials and various initiatives that were developed to help industry, recruitment sites and the public in general achieving these expectations.

References

• Collection of Race and Ethnicity Data in Clinical Trials, Guidance for Industry and Food and Drug Administration Staff https://www.fda.gov/regulatory-information/search-fda-guidance-documents/collection-race-and-ethnicity-data-clinical-trials
• Evaluation and Reporting of Age, Race and Ethnicity-Specific Data in Medical Device Clinical Studies, Guidance for Industry and Food and Drug Administration Staff https://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluation-and-reporting-age-race-and-ethnicity-specific-data-medical-device-clinical-studies
• Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trials Designs, DRAFT Guidance for Industry https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial

Series Objectives

• Solve FDA drug regulatory issues as they arise.
• Explain new FDA regulatory initiatives.

Learning Objectives After completion of this activity, the participant will be able to:

• Explain FDA’s efforts to advance diverse participation in clinical trials including relevant FDA guidance and regulations.
• Explain CDER’s most recent assessment of clinical trial diversity.

Target Audience
This activity is intended for physicians, pharmacists, and nurses.

Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

Disclosure

Faculty

• Araojo, Richardae, PharmD, Director Office of Minority Health and Health Equity, FDA - nothing to disclose
• LOLIC, MILENA, MD, Senior advisor, FDA - nothing to disclose
• Okeke, Melvyn, , Orise Fellow, FDA - nothing to disclose
• Vasisht, Kaveeta, MD, Associate Commissioner for Women's health, FDA Office of Women's Health - nothing to disclose

Planning Committee

• Kleppinger, Cynthia, MD, Medical Officer, FDA - nothing to disclose
• Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI - nothing to disclose
• Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team

• Miller, Isaac J., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
• Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose

Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.