DIA Regulatory Submissions, Information, and Document Management Forum Call for Topics: Submission Form

Welcome to our 2023 Regulatory Submissions, Information, and Document Management (RSIDM) Forum Call for Topics brainstorming activity!!

The topics listed below are specific to content relating to the US Food and Drug Administration (FDA).

By brainstorming together, we aim to gain a better understanding of your professional needs and the type of content DIA, and the FDA should focus on for the DIA 2023 RSIDM Forum program agenda.

Please note: Submission of a topic suggestion is not related to chairing a session or speaking at the RSIDM Forum and does not count as an abstract submission. Please refer to our call for abstract process if interested in submitting a presentation, session, or short course abstract to our 2023 forum.

What topic(s) from the FDA would you like to see at DIA’s RSIDM Forum in 2023?

Question Title

* Please select the topic(s) you would be interested in hearing about at the conference (select all that apply). If something is not listed, please add to the “other” field:

Regulatory electronic submission process

End-to-end submission process

Electronic System Gateway (ESG)

Electronic Common Technical Document (eCTD) (general)

eCTD related guidance and specifications

Data and technology-focused commitments in PDUFA VII

FDA’s target timeframe for the expected submission upload duration

FDA’s target timeframe between key milestones and notifications

FDA’s current required data standards for regulatory submissions

FDA’s Data Modernization Action Plan (DMAP), Technology Modernization Action Plan (TMAP), and Enterprise Modernization Action Plan (EMAP)

FDA CDER NextGen Portal

FDA CDER NextGen Portal FDA Forms

FDA processing challenges

FDA’s perspective on best practices for successful regulatory submissions

FDA's approach to the Identification of Medicinal Products (IDMP) standards

Knowledge-Aided Assessment and Structured Application (KASA)

Pharmaceutical quality/chemistry, manufacturing and controls (PQ/CMC) project and initiative updates from the FDA

Research Investigational New Drug (IND) Application Builder

International work-sharing initiatives and collaborations

FDA “Ask the Regulator” Session (Q&A with the regulators)

The future of regulatory submissions: opportunities and challenges

Other Topics (Please note - the suggestion may not exceed 300 characters)