ACUTA, ARIM, Conferences, eCTD

ACUTA RIM Shots May 18, 2018

Every once in a while there will be only short subjects to report on Regulatory Information Management-related topics, so welcome to the first ACUTA RIM Shots, where we’ll report on quick news items.

ACUTA to Present at Pharmaceutical Regulatory Affairs June 8

Joel Finkle, Director of Regulatory Innovation and IDMP Strategy, will have two presentations at the “Joint Conference on Pharmaceutical Regulatory Affairs and IPR, and Exhibition on Pharma Audit, GMP, GCP & Quality Control” in Philadelphia, June 8-9, 2018. He will be presenting a keynote titled “A Personal History of Electronic Regulatory Submissions,” and a session titled “Planning for and Complying with the IDMP Standard for Europe.” Please download the agenda, and join us at the meeting.

 

FDA eCTD Mandate Adjusted

As of two weeks ago, May 5, to be specific, all Drug Master Files and Commercial INDs were to be submitted only in eCTD format.  However, at the last moment, FDA adjusted their schedule, and have given an extra year for Drug Master Files of Type III, which are specifically for packaging material. That extends the deadline for Type III DMFs to May 5, 2019. Non-commercial INDs remain exempt from the eCTD mandate. The full list of what submissions may and must be in electronic format can be found at the FDA Website.

 

Please contact ACUTA for additional information on our conference presentations, software for regulatory submissions, and how we can help you get to compliance with the eCTD mandate.

 

Image credit: j.sutt

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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