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Topic Groups

Acquisitions, Mergers, and Divestitures (AM&amp;D) are commonplace in life sciences, however the sophistication and complexity of on/off boarding assets is continually increasing. Focusing on these types of activities will continue to be a standard occurrence and increase in life sciences. (AM&amp;D) activities create challenges for all organizations involved; either when performing due diligence upfront or during the integration phase post-deal. The IRISS organization consists of broad membership across the sponsor, vendor, consultant, and service provider landscape. The IRISS (AM&amp;D) Topic Group is well positioned to facilitate the complexities of the (AM&amp;D) requirements across a wide array of global Regulatory and Corporate functions.

The Acquisitions, Mergers & Divestitures topic group icon

Acquisitions, Mergers &amp; Divestitures (AM&amp;D)

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 &gt;300 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&amp;As related to Quality, as well as publication of the CMC Industry Book of Knowledge on eCTD submissions.

The Chemistry, Manufacturing and Controls topic group icon

Chemistry, Manufacturing and Controls (CMC)

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。

<img class="alignleft size-medium wp-image-729" src="/wp-content/uploads/2024/01/dummy-post-square-1-1-300x300.jpg" alt="" width="300" height="300" />

China Regional

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.

The Digitialization in Regulatory topic group icon

Digitalization in Regulatory

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.

The Electronic Product Information topic group icon

electronic Product Information (ePI)

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.

The Global Submissions Operation topic group icon

Global Submissions Operation (GSO)

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.

The Identifcation of Medicinal Products (IDMP including xEVMPD) topic group icon

Identification of Medicinal Products (IDMP including xEVMPD)

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

Special Projects

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.

Concluded Topic Groups

<strong>Agentic AI: Driving Innovation in Pharma Regulatory Affairs - Dr. Daniel S. Ehmann and Jose Suarez, IBM Life Sciences</strong>

In this session, we will explore the application of agentic AI in the pharmaceutical industry, with a particular focus on a validated, enterprise-grade content generation solution. Designed to meet the rigorous demands of regulated environments, this agentic system enables dynamic, high-quality content creation at scale—supporting regulatory teams in expediting the creation of regulatory documentation. We will share real-world insights on how this solution is being used today, and discuss its potential to accelerate productivity, ensure compliance, and transform the way pharma organizations operate.

<b>Dr. Daniel S. Ehmann:</b> Daniel is the Global Agentic Apps Lead at IBM, with over a decade of experience leading international engineering teams in the development and deployment of advanced AI solutions. He holds a PhD in Applied Machine Learning from ETH Zurich and has deep expertise across predictive, causal, and generative AI, particularly in the context of large-scale, data-intensive environments. Daniel specializes in bridging cutting-edge AI research with real-world applications, helping organizations harness the full potential of emerging technologies to drive innovation and operational impact.

<b>Jose M Suarez:</b> Jose is a strategic leader with over 10 years of experience in service of global pharmaceutical organizations, with a strong focus on R&amp;D and clinical development. He brings deep functional expertise across development and has led complex global transformation initiatives that enable greater integration, agility, and innovation across the development value chain. Jose is particularly passionate about leveraging data, digital technologies, and AI to drive smarter decision-making and operational excellence in highly regulated, science-driven environments.

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Meeting Details

DGR Monthly Meeting

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