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.

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The IDMP Topic Group is now established and the Leadership team has been formed (listed below).  The meeting schedule, proposed scope initial activities, first meeting agenda and actions upon the membership are identified below also.

For details of the full scope of the IDMP Topic Group then please click here (http://www.iriss-forum.org/?page_id=419).

To sign up for membership of the Topic Group and so attend meetings then please complete the sign up details at the bottom of the page.

Meeting Schedule

The first meeting of the whole group will be a telecon on Tuesday, 3 April, 2012 at 14.00 UK time for one hour.  Subsequent meetings will be held on every first and third Tuesday of the month until at least the beginning of July after which we will reassess the frequency.  Dial in details are not yet available but will be mailed out in advance.

Proposed Scope of Initial Activities

The overall scope of the team is to support the implementation of the International Standards for Identification of Medicinal Products (IDMP) but in the shorter-term it is to support the implementation of the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) in Europe.

With the limited timescales until the XEVMPD deadlines the Leadership team feels that the following should be the focus of the group.

• Provide meetings with structured agendas to address hot topics associated with implementation.  Hot topics will be defined by the membership.
• To record discussions and any potential resolutions or actions associated with these topics as a historical record, accessible by the full membership (not just those attendees at the meetings) and to be used as a corporate memory for the future reference
• To support discussion of items by email between meetings, using the expertise available within the group.
• To consider the best practices, particularly as they will relate to the maintenance of records once submitted

We do not consider it possible to develop best practice guidance for the submission of new records required by July 2012 but this may be appropriate after that point.  However, once the July deadline has been reached, the priority of activities will be redefined in conjunction with the membership.

First Meeting Agenda

The first meeting’s agenda is to achieve two main targets :

1)      Agree on the objectives and working practices of the group

2)      Gather and list the hot topics associated with the EMA’s implementation of XEVMPD

Actions upon you

• Consider whether the proposed scope of initial activities is appropriate
• Identify by 28 March what are the hot topics and issues that you would like to have addressed at the first meeting
• Encourage others (vendors, service providers, colleagues in your company & colleagues in other organisation) to sign up for membership via the IRISS forum website : http://www.iriss-forum.org/?page_id=419

Leadership Team:

• Andrew Marr (Marr Consultancy Ltd – UK)
• Su Blakey (Reg Ops Consultancy Ltd – UK)
• Elisabeth Godet (Sanofi – FR)
• John Kiser (Abbott Laboratories – US)
• Susan Metz (Liquent – US)

IRISS Forum to Establish a Topic Group on Identification of Medicinal Products

**(Download the document: IRISS FORUM Request for participation in IDMP Topic Group)

At the IRISS Forum Board meeting on 31 January 2012 it was agreed that a new Topic Group should be established, the focus of which with be the support of implementation of the International Standards for Identification of Medicinal Products (IDMP) and in the shorter-term support for the implementation of the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) in Europe.

ISO and European Standards

A series of ISO standards for Identification of Medicinal Products (IDMP) are currently in development, shortly to enter a ballot of the Final Draft.  These ISO standards will be implemented via the International Conference on Harmonisation (ICH) and work is on-going to define the common elements that will be implemented by all regions and those that may be implemented by individual regions.  It is anticipated that a full implementation of these standards is being targeted for the 2015 timeframe.

However, in the meantime, as part of the new European Union Pharmacovigilance Legislation, under Article 57, on 1 July 2011 EMA published a series of requirements for the mandatory provision of information on medicinal products authorised in Europe.  This will cover some 500,000 authorised products in the European Economic Area (EEA) and information is to be submitted by2 July 2012.  An XML Schema and accompanying guidance was published on 1 September 2011 although these are expected to be updated in February 2012, based upon decisions made, in conjunction with industry trade associations at the end of January 2012.  The message format is known as the Extended Eudravigilance Product Report Message (XEVPRM) which will be used to populate the Extended Eudravigilance Medicinal Product Dictionary (XEVMPD).  In addition to authorised products this standard will apply to investigational medicinal products but EMA have not yet announce the transition plans for this.

This standard is regarded as an interim format and by 2015 there will be a transition to the ISO standard, some aspects of which have already been implemented in XEVPRM.

It is known that there are about 14 vendor products in development to support data management and provision of XEVPRMs to EMA.  Some pharmaceutical companies are also developing their own solutions.  In addition, EMA is developing a web-based data entry tool for use primarily by small and medium-sized enterprises.  The implementation of XEVPRM will affect every pharmaceutical company in Europe.

As the ISO standards are adopted and integrated into regional information gathering processes the number of parties affected by them will grow significantly.

Agreement to Establish an IRISS Topic Group

The urgent issue is to address and support the implementation of XEVPRM in Europe but also to take on board the longer-term activities that will be associated with the implementation of the ISO IDMP standards.

The following initial targets have been assigned to the group leading up to the July 2012 and beyond:

• To provide a forum for exchange of information relating to implementation of XEVPRM
• To share knowledge on issues encountered with EMA acceptance and validation of messages provided
• To develop best practice documentation for submission and maintenance of product information
• To ensure that interoperability is achieved between vendor solutions

Longer-term targets for the IDMP standards will be proposed from within the Topic Group.

Any shared issues or synergies with existing IRISS Topic Groups will be taken into account.

Call for Participation in the IDMP Topic Group

A call for participation in this Topic Group is hereby made.  Involvement in either of two roles is being sought.

1)      As a leadership member of Topic Group to help drive forward the programme for the group. Three or four individuals are being sought to act as a leadership group.  Due to the initial focus on Europe these individuals should have a good knowledge of EVPRM but could come from the pharmaceutical industry, vendor or regulator communities.  A mixed group with experience in regulatory affairs, regulatory operations and technology development is desirable.  Nominees should have experience in at least one of these areas.
The level of resource required to take on one of these leadership roles is anticipated to be 2 to 3 hours per week for most of 2012.

Nominations should be made to Andrew Marr (andrew@marrconsultancy.com) who has been identified as the Lead for the Topic Group. Please contact him if you wish to discuss your involvement further, or desire more information about the role.  Nominations should be made by 29 February 2012.

2)      As a member of the Topic Group, willing to take part in information exchange activities and contribute to the development of any deliverables defined by the group.  Membership is open to all comers.
To register your interest to join the Topic Group as a member then please complete the contact form below:

In 2010 we successfully received the financial support of six Founding Sponsors which has enabled this progress and made IRISS financially sound.

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)

Click here for the concept paper.   For more information or to join this group, see: http://www.iriss-forum.org/?page_id=211

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.