The Definitive FDA Module 1 Update – DIA eRI 2015
May05

The Definitive FDA Module 1 Update – DIA eRI 2015

This year’s DIA eRegulatory and Intelligence conference in Philadelphia, PA May 11-13 is the definitive source of information on the FDA’s transition to a new Module 1. The Agency is scheduled to provide an M1 implementation update covering timelines and expectations on Tuesday, May 12th during Session 1, Track 2. The session is scheduled to run 8:30 a.m. – 10 a.m.

Read More

Connect with GlobalSubmit at DIA 2014

The DIA conference most attuned to our segment of the industry returns to the East Coast this year September 22-24 at the Omni Shoreham Hotel in Washington, DC. GlobalSubmit will have a healthy presence at DIA EDM and ERS – exhibiting on the show floor and presenting during a number of educational sessions. We encourage you to visit us at Booth #201 during the conference or schedule a time to meet with the GlobalSubmit team on or off...

Read More

Abstract Deadline Extended for the DIA EDM and ERS Conference 2014

The call for session abstracts is open and the deadline has been extended to May 27, 2014. In years past, this meeting has served as a forum for peer-to-peer engagement. Attendees share their experiences and solutions to the challenges faced with electronic submissions and electronic document management within their respective organizations and working with partners and outsourcing providers. Case studies often make for compelling...

Read More

Annual Event Joins Electronic Data Management and Electronic Regulatory Submissions

Today’s entry was provided by Emily Onkka, Director of Project Management and Regulatory Operations at GlobalSubmit and new regular contributor to Theectdsummit.com. Based in San Diego, CA, she will be leading GlobalSubmit’s professional eCTD services, including eCTD compilation, ESG transmission, publishing, quality checking, and best practice implementation. Prior to joining GlobalSubmit, Ms. Onkka was Head of Regulatory Operations...

Read More

How Mergers & Acquisitions Impact Regulatory Operations Part II

Executive management may consider creating a strategic plan for in/out-licensing and mergers and acquisitions. This strategic plan should include the technical aspects of such an undertaking. Such topics as systems to be used, network and security, and staff involvement (including when to involve staff) are important strategies to ensure success.

Read More