DIA's Regulatory Affairs: The IND, NDA, and Post-Marketing course is a five-day live virtual training on the FDA regulatory landscape for drug and biologic development, running , with daily sessions from 9:00 a.m. ET.
Dates and format
- Dates: 17–21 August 2026 (Monday–Friday)
- Format: live virtual training course, delivered online
- Daily start: 9:00 a.m. ET
- Organizer: Drug Information Association (DIA)
What it covers
The course walks the full lifecycle of a US drug regulatory submission: IND applications and amendments, safety reporting during clinical trials, NDA planning and content development, and the FDA review process from both sides of the desk. It adds the material a first IND/NDA course often skips — expedited-development mechanisms, product labeling, post-approval reporting obligations, and the standards FDA applies to promotional activity — using a mix of lecture, team workshops, an online pre-course module, and a closing Hot Topics session on recent developments.
Who should attend
DIA positions this as a basic-to-intermediate course, aimed at regulatory affairs professionals working on prescription drugs and well-characterized biological products, and useful to anyone else — clinical, quality, or safety colleagues — who needs the IND-to-NDA path explained from the FDA's own review logic outward rather than assumed.
FDA runs its own free town halls on specific final guidances too — see the CDRH toxicological risk assessment town hall in October. The full events directory lists everything we have verified.
Frequently asked questions
When does DIA's IND, NDA, and Post-Marketing course run?
Monday through Friday, 17-21 August 2026, live and virtual, with daily sessions beginning at 9:00 a.m. ET.
Is this course virtual or in person?
It is DIA's live virtual offering — delivered online over five days, not an on-demand recording.
What does the course cover?
The full lifecycle of a US drug regulatory submission: IND applications and maintenance, clinical trial safety reporting, NDA planning and content, the FDA review process, expedited-development programs, labeling, post-approval requirements, and promotional-activity standards.
Who should attend?
DIA describes it as a basic-to-intermediate course for regulatory affairs professionals working on prescription drugs and well-characterized biological products, and for others new to US drug development who need the FDA submission landscape explained end to end.
Sources & further reading
- DIA. Regulatory Affairs: The IND, NDA, and Post-Marketing — course listing, August 2026. diaglobal.org
- DIA. Regulatory Affairs: The IND, NDA, and Post-Marketing — agenda (PDF). diaglobal.org
Event details are published by the organizer and can change. Confirm dates, format and pricing with DIA before registering. Verified via cross-corroborated web search, not a direct fetch of the organizer's page — see provenance. Last verified 25 July 2026.
