Job Description

Date: May 19 – 20, 2026 Day1: Tue, May 19 9:00 a.m. – 04:50 p.m. ET Day2: Wed, May 20 9:00 a.m. – 03:50 p.m. ET Location:

Attend In Person or Online Virtual: Via Adobe Connect
In Person: FDA White Oak Campus

10903 New Hampshire Ave, Building 31
The Great Room
Silver Spring, MD 20903
United States

Drugs, Devices, and Biologics

Tracks will Offer an Opportunity for 1:1 Questions

Learn directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics. This course is designed to provide participants with a strong, basic foundation in the FDA’s regulatory requirements, and also create awareness of current activities.

Intended Audience

Drugs

• Regulatory affairs and other professionals working on the development and preparation of new drug submissions, drug safety and IT
• Sponsors, applicant holders, manufacturers, clinical researchers and regulatory affairs professionals wishing to gain insight on INDs, NDAs and BLAs
• Industry professionals at all levels of expertise

Devices

• A new regulatory affairs specialist wanting to learn some basics and best practices for getting started with FDA’s regulation of medical devices.
• A researcher of a medical device seeking to learn about the valid scientific evidence requirements needed to support new medical device regulatory submissions.
• An establishment seeking to understand their regulatory responsibilities for maintaining their quality system to ensure their device is stay and effective after it’s legally marketed and in commercial distribution.

Biologics

• Biotechnology product manufacturers, academic sponsors, and other stakeholders working on the development of biological products
• Regulatory affairs and other professionals working with submissions of INDs, IDEs, and BLAs, and PMAs to the Center for Biologics Evaluation and Research
• Industry and consulting professionals working with advanced therapies, allergenics, blood and vaccine products, and devices used with biological products

Topics Covered

• Advanced Drug Manufacturing in CDER
• Use of AI to Advance Drug Development
• FDA’s Quality Management System Regulation (QMSR)
• Small Business Determination Program Updates
• Use of Digital Health Technologies for Data Collection in Clinical Trials
• Benefit-Risk Framework and Analytical Methods to Inform Benefit-Risk
• …Many others

Continuing Education (CE)

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.