IRISS Forum Announces Pharmaceutical Industry Veteran Jim Nichols as President and CEO

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Jim Nichols joins the Executive Committee of IRISS along with Vice President Joel Finkle, and Treasurer Gina Ross.

The IRISS Forum, a pharmaceutical industry trade organization dedicated to the implementation of regulatory submission standards around the world, welcomes Jim Nichols as its new President and CEO. After an extended search process, Jim was selected by the unanimous vote of the IRISS Board of Directors from several candidates.

IRISS collaborates with other trade organizations (ie Pharma, DIA, RAPS, HL7) as well as global regulatory bodies representing a neutral forum for industry, vendors, government agencies and consultants to share information while working toward a standard method of implementing electronic submission specifications and improving interoperability of e-publishing tools, viewing tools and submission systems.

Donna Whiting, Chairman of the Board of Directors of IRISS, stated “We’re very glad to have Jim Nichols on board. He was chosen as the candidate whose experience and capabilities the Board believed were the best match for IRISS’s future direction.”

Jim brings extensive regulatory experience to IRISS. He is currently Vice President of U.S. Operations and Life Sciences at DitaExchange Inc., and previously held leadership positions at Liquent, Thomson Reuters and ePharmaSolutions. He has been a leader in the development and adoption of eCTD and SPL.

“I’m looking forward to the opportunity to elevate the organization’s visibility in terms of what were involved in, and to get other industry experts and regulatory agencies involved in our mission,” said Mr. Nichols in an interview following the election.

Jim joins the Executive Committee of IRISS along with Vice President Joel Finkle, and Treasurer Gina Ross. Please join us in welcoming Jim, by promoting this article on social media.

The Implementation of Regulatory Information Submission Standards (IRISS) Forum is a not-for-profit organization that was formed in 2012. The mission of IRISS is to enable successful implementation and practical usage of paperless regulatory submissions environment which supports current regulatory processes and enables efficient and effective assembly, review, and maintenance of required regulatory information in support of clinical trial applications and marketing applications around the globe.

IRISS Forum was created to address the need for a single central forum for open, and broad stakeholder discussion of evolving standards, user requirements and practical, global implementation issues of these standards for the mutual benefit of both industry, government agencies and ultimately, public health.

IRISS Forum operates through a directorship structure, governed by an executive committee and board of directors.

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Harv Martens
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