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Topic Groups

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)

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.

Data

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

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)

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

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

Special Projects

<div>Topic: GSO January Topic Group</div>
<div>Time: Mar 26, 2026 10:00 AM Eastern Time (US and Canada)</div>
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