PRINCETON, N.J., Aug. 18, 2015 /PRNewswire/ -- Navitas today announced that it will be a key contributor to the Submission Content Management webinar scheduled on August 19th hosted by IRISS, a non-profit forum. Dedicated to the Implementation of Regulatory Submission Standards globally, IRISS provides a neutral platform for industry, vendors, health authorities, consultants and the like to share information and work towards a standard method of implementing electronic submission specifications & improving interoperability of e-publishing tools, viewing tools and systems. It also enables collaboration for other trade organizations within the pharmaceutical industry (i.e. PhRMA, DIA, RAPS, HL7) as well as global health authorities.
David Gwyn, Practice Head of Content Management and Collaboration, Navitas will be presenting on "EDM Submission Reference Model - Shaping how Submission Content is Managed." His presentation will showcase the output of DIA's (Drug Information Association) EDM Submission Reference Model team that he leads at Navitas. It will throw light on the background of how the model was created, where it is today and the future roadmap of development. The session will conclude with information on how to obtain the model and how to participate in future activities.
The webinar is of specific relevance to the biopharmaceutical companies implementing an EDM system or a simple file share to store and prepare documents for regulatory submissions of drugs and biologic products intended for human use. While an EDM model provides the content, a regulatory publishing system is still required to assemble and publish a true regulatory submission.
The reference model is also useful for biopharmaceutical companies needing to organize and transfer documentation assets of a product to another company's repository under an acquisition or partnership scenario. In this case, the reference model provides the common document definition and structure that both companies can share. The webinar is for IRISS members only. IRISS leadership is comprised of current and former members of the pharmaceutical industry from companies such as AstraZeneca, Pfizer, Bristol-Myers Squbb, AbbVie, Johnson & Johnson and more. For more information about the webinar or to attend, visit https://www.iriss-forum.org/webinars/edm-submission-reference-model-shaping-how-submission-content-is-managed/.
The Navitas team has been assembled bringing together the proven expert teams of TAKE Life Sciences and WCI Consulting and, adding to this core, a range of experts from the worlds of Clinical Development, Regulatory, Technology, and Consulting.
We have built the Navitas team specifically to deliver insight to our clients, to develop pragmatic solutions together, and to support their deployment and operation. We deliver advice, solutions, and outsourcing services in Clinical, Regulatory, Safety, and Content Management.
We are proud that our legacy businesses have served the sector for some 15 years and have allowed us to work with 100 of the top Life Science companies. Our team has now grown to over 500 staff. For more information, visit www.navitas.net.
For further information, please contact:
Patrick Mullen, Navitas
609 454-7753 Email
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