About IRISS

IRISS received 501 c-6 designation from Internal Revenue Service (IRS) on March 7, 2012. The 501 c-6 designation recognizes IRISS Forum as a pharmaceutical industry trade organization, which provides a mechanism for IRISS to collaborate with other trade organizations within the pharmaceutical industry (i.e., PhRMA, DIA, RAPS, HL7) as well as global Health Authorities. IRISS represents a neutral forum for industry, vendors, health authorities, consultants, etc. to share information and work towards a standard method of implementing electronic submission specifications and improving interoperability of e-publishing tools, viewing tools, and systems.

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

Board of Directors

The Board of Directors exercises all powers of IRISS.

Jake Doran headshot

Jake Doran

Board Chair

Bausch Health

Founded on the premise of creating a globally diverse audience spanning the full spectrum of sponsors, regulators, vendors and other strategic partners, the IRISS forum is a great platform for critical thinkers across the Regulatory domain. If you are someone who feels very strongly about advocating for the advancement of the Regulatory environment the IRISS forum provides a unique platform for ideating the possible in a collaborative and inclusive forum. Whether it is discussing standards development, advocating for technology advancement, sharing best practices with colleagues, or just networking, the IRISS forum offers a unique opportunity. It is truly and honor and privilege to be on the board of such an impactful organization.

David Berglund headshot

David Berglund

Board Member

AstraZeneca

I engaged in IRISS to gain access to large network of regulatory professionals in the industry, regulators and solution providers. An opportunity to be at the front with the fast-changing regulatory operations landscape. Not least the digitalization that will completely transform how we operate in the future. The IRISS forum provides a unique forum to exchange ideas and get insights from colleges across the industry, both for domain experts as well as future leaders.

Dominique Lagrave headshot

Dominique Lagrave

Board Member

Accumulus Synergy

In our industry, IRISS Forum always had a unique positioning and opportunity to bring true regulatory innovation by pulling together thought leaders from sponsors, health authorities and technology vendors. This was true 15 years ago when I first became a member and still holds true today as we move our industry to the digital age to better serve patients globally.

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Joakim Hindemith

Board Member

Galencia AB

The latest pandemic was a game changer in many ways both good and bad, though mostly bad. One of the good things was that we have been forced to switch to digital borderless knowledge sharing which also creates the added benefit to reduce our carbon footprint. It can’t be better than that and IRISS is all that in a nutshell.

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Kelly Hnat

Board Member

K2 Consulting

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Vada A. Perkins

Board Member

Boehringer Ingelheim

The IRISS Forum has proven to be indispensable as an objective, international, and highly effective mechanism of communication for Industry, health authorities, consultants, and vendors to engage a very knowledgeable regulatory community. It has never been more important to have a dedicated virtual assembly area of interested parties and experts to conference on impactful regulatory information topics of interest that will shape our life sciences environment for years to come.

Executive Committee

The Executive Committee is responsible for managing the day to day operations and carrying out the direction set by the Board.

Remco Munnik headshot

Remco Munnik

President

Deloitte

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Sonja Justice

Vice President

Nestle

Jo English

Treasurer

Calyx

Steering Committee

The Steering Committee is limited to Topic Group Leads, Special Project Leads, Steering Committee Lead and the Webinar Lead.

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Cesar Vinces

Chair

Accumulus

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Lenore Palma

Website Liaison

BeiGene Ltd

Topic Group Leads

The Topic Group Lead is a member of the Steering Committee as a representative of their Topic Group.

Keith Parent

Acquisitions, Mergers, and Divestitures (AM&D)

Court Square Group

Huiping Jannie Ren

China Regional

Pfizer

Rita Algorri

Chemistry, Manufacturing and Controls (CMC)

Amgen

Cesar Vinces headshot

Cesar Vinces

Digitalization in Regulatory

Accumulus

Katja Pečjak headshot

Katja Pečjak

electronic Product Information (ePI)

Billev Pharma East Ltd

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David Ross

Global Submissions Operation (GSO)

AstraZeneca

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Frits Stulp

Identification of Medicinal Products (IDMP including xEVMPD)

Deloitte

Sponsors

We recognize our Founding Sponsors, who helped to establish IRISS over 15 years ago. Thank you!

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