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...

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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...

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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.

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How Mergers & Acquisitions Impact Regulatory Operations Part 1

During the out-licensing process it is necessary for the RegOps group to organize and transfer the information and documentation to the new company. This may include the submissions, labeling, correspondence, and other documentation for the product. Additionally a chronology of the product documents, whether that be hard copy, electronic, or both should be included as an “inventory” check.

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eCTD Mandate to Follow 2-Year Implementation Timeline

The draft guidance will be open to comment for a period of 6 months followed by the release of the final version. It will then be implemented 2 years after the final version, bringing us to mandated electronic submissions in Q2 2015.

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