Topic Groups

IRISS Forum invites open and diverse participation that affords many different perspectives to be shared in a non-competitive, collaborative environment. Topic groups are organized and operate based on needs proposed by the IRISS community.

All discussion groups are held via teleconference and occasional web-based forum. Participation details vary per discussion group and can be found on the individual topic group pages after registration. Our current topic groups are described below.

Registration is required to participate in topic group discussions and activities. Registration includes an annual participation fee of $99 USD to support operational costs of our non-profit, volunteer organization.

Concluded Topic Groups (CONCLUDED)

When a topic group is deemed no longer active (e.g. goals have been accomplished, lack of membership participation), it’s web page will transition into the Concluded category.

Global Submissions Operation (GSO)

Focusing 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. The group also seeks to identify and address issues arising from (1) the utilization of Alliance Partners, excluding technical solutions or technical interoperability, (2) differences in direction from Health Authorities and/or regional implementations (3) Implementation of global standards and submission issues/trends, including multi-disciplinary issues, e.g., Patient Safety reporting, adverse events, SDTM.

Identification of Medicinal Products (IDMP including XEVMPD)

The IDMP Topic Group addresses the long-term activities that will be associated with the implementation of the ISO IDMP standards world-wide. At present it is very much focussed sharing knowledge and expertise in preparation for implementation in the EU. Additionally it supports the implementation and maintenance of XEVMPD (Article 57) in Europe.

Advertising & Promotional eCTD Submissions (AdPromo)

The IRISS AdPromo group is intended to serve primarily as a channel of communications, or discussion forum, between agency, industry and software vendors.

The purpose of this forum is to support eCTD submissions of US advertising & promotional materials via the Electronic Submissions Gateway (ESG) to both the Office of Prescription Drug Promotion (OPDP) and the Advertising Promotion and Labeling Branch (APLB) of the FDA’s Centers for Drugs and Biologics respectively. The IRISS AdPromo group intends to support this newly evolving submission type via discussions on best practices in developing, reviewing, optimizing, and submitting AdPromo submissions in electronic format, particularly eCTD.

Electronic Medical Device Submissions (EMDS)

This technical group is an open forum to support development and implementation of harmonized electronic submissions for medical devices.

Chemistry, Manufacturing and Controls (CMC)

The CMC discussion group is an ongoing effort by industry to share thoughts, ideas and practices which enable the efficient creation and management of regulatory Chemistry, Manufacturing and Controls submissions around the world. The group is comprised of >100 members from pharmaceutical companies, a few industry service providers as well as health authority representatives. Because of the varied expertise of the members (e.g., Regulatory RCMC, Regulatory Operations, Biologics, Small Molecules, US and EU) who share a common interest in CMC submission related issues, the group is able share experience and discuss the increasingly complex issues of managing the Quality modules of electronic submissions throughout product lifecycle. The group has been meeting regularly since 2005 and is responsible for many ICH Q&As related to Quality, as well as publication of the CMC Industry Book of Knowledge on eCTD submissions.

Special Projects

Special Projects are very well defined, generally short term groups. Membership is generally limited to a project team organized by project leadership.