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.

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.

Chemistry, Manufacturing and Controls (CMC)

Mission:
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.
Who We Are:
The group is comprised of >200 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.

Digitalization in Regulatory

In the coming years, emerging technical advancements have the potential to transform the healthcare system. As part of this transformation, the pharmaceutical industry has an opportunity to leverage these advancements to improve operational processes. This includes applying digital technologies such as Robotic process automations, Artificial Intelligence including Natural Language Processing and Machine Learning. As new approaches replace traditional methods; our industry will face complex challenges to implement disruptive innovation which will inevitably force changes to existing business processes while evolve existing business models based on achieved stakeholder value.

Electronic Product Information

The need to provide enhanced product information to prescribers, product users and regulators, combined with a recognition of our increasing connectedness through technology enablement, opens up new pathways to deliver approved, high quality product information through electronic means. We see health authorities preparing to request more and more structured information, recently witnessed by the ePI (electronic Product Information) initiatives by EU EMA and Singapore HAS.

We envision a coalition across industry, regulators, health care professionals, vendors and product users, gathered together in the IRISS ePI topic group. This gives us all the opportunity to ensure that product information is delivered in line current regulatory standards. We can also identify early adopter countries for pilots, and streamline comments on evolving standards to best meet the needs of all end users of product information.

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, and (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.

China Regional - UNDER DEVELOPMENT

China Regional is intended to serve as the communication platform for China regulatory operational expertise to address the emerging regulatory operational needs with China joining ICH since May 2017. While China CDE (Center for Drug Evaluation) is targeting to launch eCTD format for submission dossier filling and reviewing 4Q 2019, IRISS China Regional will first introduce China eCTD topic series to facilitate China eCTD guidance interpretation, discussion and implementation practice within industry.

自中国2017年5月成为ICH成员之后,有关注册法规运营的需求日益增长。“IRISS中国”旨在为中国的注册法规运营人才提供交流和讨论的专业平台。基于目前CDE(国家药品监督管理局药品审评中心)正在准备实施eCTD格式用于注册文件的递交和审评,“IRISS中国”将首先推出中国eCTD专题而促进中国eCTD政策解读和行业实施的讨论。

Special Projects

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

Concluded Topic Groups

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.