Introducing the IRISS Forum
IRISS Forum
The mission of IRISS is to enable successful implementation and practical usage of a 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. The current ICH eCTD specification is the cornerstone of this effort, but other electronic regulatory submissions standards, such as CDISC and HL7 standards are also in scope.
Organizational News
It has been over 3 years since IRISS began as an ad hoc forum to fill the need for a neutral organization that was open to all which focused on the Implementation of Regulatory Information Submission Standards in the life sciences domain. We are proud of the progress we have made to date and pleased to report that IRISS has formally incorporated (the non-profit application is pending) as a 501(c)(6) organization. We currently have over 400 members enrolled in our distribution.
In 2010 we successfully received the financial support of six Founding Sponsors which has enabled this progress and made IRISS financially sound.
| IRISS Founding Sponsors |
| AstraZeneca |
| Bristol-Myers Squibb |
| Extedo |
| Liquent |
| Pfizer |
| Sanofi-aventis |
We have seated the initial Board of Directors as well as the Executive and Steering Committees.
The CMC Topic Group, founded prior to the inception of IRISS, was led by Deanna Murden Waskiewicz until recently and has been transitioned to Phyllis Thomas. The Board would like to thank Deanna for her leadership and guidance for creating this active group.As you know, the Topic Groups are where the collaborative work among the IRISS members happens, and we are pleased to report that we have four active Topic Groups: Global Submissions Operations (GSO), CMC, Life Cycle and Labeling. There is also one special project – ETICS. We invite you to explore our website (http://www.iriss-forum.org) for more information if you are not familiar with the focus of all of these groups.
The first IRISS Topic Group, the Interoperability Topic Group, was initiated under the leadership of Lenore Palma and has recently been merged into the GSO group due to overlapping areas of interest. The Board would like to thank Lenore for all of her hard work to manage this diverse group and move it in the right direction.
In addition, we would like to acknowledge the transparency the Regulators have demonstrated in this forum and thank them for providing access to their insights to ensure a more concerted understanding among the membership.
As IRISS continues to evolve as a functional organization, key positions are being identified and filled by volunteers. As we go to press, Scott Cleve of Astellas has recently accepted the responsibility for IRISS Communications, both internal and external, working under the direction of our VP, Ed Tripp. One of the key deliverables that the Board has achieved is the finalization of the first version of the IRISS by-laws. In addition, work is underway by members of the Board to both refine the by-laws as the organization is further defined as well as develop our Operating Policy. We are also planning to redesign the website to be more comprehensive.
If you are interested in contributing to the future development of the IRISS organization, we encourage you to contact any of the team members listed above or send an email to info@iriss-forum.org.
In closing, while we have singled out and thanked a few individuals in this newsletter, we wish to convey our sincere gratitude to the many contributors for their participation that has resulted in the success of IRISS to date.
Sincerely,
The IRISS Board of Directors
(Download a PDF of this article here)
(updated December 6, 2011 due to changes to Board of Directors)
New Topic Group Formed – Global Submissions Operations
Posted by harv in GSO, Topic Groups on August 15th, 2010
The IRISS Form Steering Committee is pleased to announce the formation of a new topic group – the Global Submissions Operations topic group (GSO). The Global Submissions Operation Group will primarily focus on the discussion and identification of approaches to documentation and dossier creation as well as global standards which maximize the reuse of information across markets.
Click here for the concept paper. For more information or to join this group, see: http://www.iriss-forum.org/?page_id=211
ETICS III Announcement
Posted by harv in Interoperability on February 17th, 2010
Background:
The International Conference on Harmonisation (ICH) Multi-disciplinary Group 2 Expert Working Group (M2 EWG) was established to facilitate electronic communication by evaluating electronic standards. The EWG evaluates and recommends, as far as is possible, open and non-proprietary Electronic Standards for the Transfer of Regulatory Information (ESTRI) and produces ESTRI guidelines. The standards recommended must meet the requirements of pharmaceutical companies and regulatory authorities alike. ESTRI has defined a specification for the Electronic Common Technical Document (eCTD) – see http://estri.ich.org/ectd/.
The number of eCTD submissions being filed to agencies continues to increase rapidly. It is critical that loading and processing of submissions runs smoothly. Current eCTD building & viewing tools are not always interoperable. For example, an eCTD produced by one tool may not be viewed by or imported into another tool, or the receiving tool reports errors that are not always legitimate errors (i.e. the reported condition is permitted by the specification).
In late 2005 a sub-group of ESTRI was formed to conduct a study of this problem and to report the results of this study in a session at the annual DIA meeting in June, 2006. Eight vendors participated in this first ETICS study with good results. The ETICS team received a significant amount of positive feedback from many of the participants. During ETICS II, the scope of the study was broadened to include Japanese and Canadian eCTDs, in addition to the US and EU. 14 vendors enrolled in this study. Analyses of the ETICS II results showed a significant improvement by vendors who had participated in ETICS I. We hope to build on this trend with ETICS III.
ETICS III:
During the coming few months (beginning in March), the ETICS team will prepare sample submissions to test the ability of tools to detect error conditions defined by ICH and regional validation rules (Phase 1).
In Phase 2 of the study, the team will prepare instructions and sample files with which each participant will create sample eCTDs. The resulting eCTDs will be made available to every other participant in an anonymous manner for importing / loading. In this way, interoperability issues will be identified between your tool and every other tool.
The analysis results specific to your tool(s) will be shared confidentially with you in a manner that hides the identity of competitor’s tools. This will enable you to identify the strengths and weaknesses of your tool(s). The results of our analysis will be presented in suitable public forums and meetings. Although the names of participating companies and products used in the study will be presented, study results will be analyzed and reported in an anonymous, generalized manner (e.g. a table showing type of problem encountered and incidence rate of problem).
At this time, we wish only to confirm the willingness of your organization to participate and the appropriate contact information for us to liaise. Please visit the Interoperability page of the IRISS web site (http://www.iriss-forum.org/?page_id=17 ) and fill in the contact form indicating that you wish to participate.
As the time for preparation is limited, please respond by March 1, 2010. We will follow up shortly thereafter with further information about the schedule and nature of the tests to be conducted.
ETIG Concept Paper
Posted by harv in Interoperability on December 6th, 2008
The Concept Paper for the eCTD Tools Interoperability Group has been posted. Click here to view.