November / December 2019

ISPE Briefs - Special Interest Group Formed for Artificial Intelligence

Anthony J. Margetts, Ph.D.
Eric J. Staib
Vice President, Corporate Quality

ISPE’s newest Special Interest Group (SIG) will work on the emerging areas of artificial intelligence (AI) and machine learning (ML). The Artificial Intelligence Special Interest Group was formed under GAMP®. A conversation with Eric Staib, Vice President of Compliance and PVAI Compliance Officer with Genpact, who heads the new Special Interest Group, provides details.

Why has this Special Interest Group been formed?

The industry is increasingly relying on software to automate many functions previously performed by humans. As our computer systems become more integrated and data sets become more robust, computer science is advancing our ability to learn from data and draw conclusions about what may or should happen next.

We are now reaching a point where algorithms are sophisticated enough to begin making decisions on our behalf. This is the field of artificial intelligence, and we need guidance on how to use this technology in a GxP-compliant manner.

What are the key drivers/objectives of the Special Interest Group?

We are exploring the impact of artificial intelligence on our regulated processes and possible use cases of these technologies within the life sciences industry.

We want to educate ISPE members and the industry on what these technologies are, and what they can do. We are also considering how they im-pact regulated processes/systems and decisions, and identifying risks and potential approaches to control these risks in a regulated environment.

What regions are represented by Special Interest Group members?

The team includes owner companies, industry suppliers, service organizations, and regulators from the US, Europe, and Asia.

What are the hot topics being addressed?

Robotic process automation, artificial intelligence/machine learning, and how to validate and maintain these technologies in a compliant manner consistent with regulatory expectations.

What are the main challenges with these topics?

We have to first acknowledge the wide range of impact that these technologies will have across the breadth of our industry, embrace their adoption, and ultimately accept how patients may benefit from their implementation.

What is the expected output of the Special Interest Group, and what is the time frame?

Our first-year output will include ISPE education sessions (at events such as the Annual Meeting and local ISPE Chapter and Affiliate meetings) as well as developing ideas/concepts for articles, papers, and presentations. The Special Interest Group is established, and the plan is to define terms, technology boundaries, and formulate an initial set of risks and controls. We shall then test and share these definitions, risks, and controls with a wider audience.

ISPE Czech Republic and Slovakia Affiliate Launches Women in Pharma® Initiative

The ISPE Czech Republic and Slovakia affiliate launched its Women in Pharma® initiative with a workshop 30 May 2019. Up to 20 attendees were initially anticipated, but registration soared. Ultimately, 40 women and 5 men attended the workshop, and the session could not accommodate all who expressed interest in participating.

More workshops are planned, said Jiří Moninec, Managing Director, G.M. Project, Ltd., in the Czech Republic. The great interest indicates that women are seeking more technical and engineering knowledge, and Moninec was very pleased with the positive reaction to the program.

We’d like to feature your Chapter, Affiliate, CoP, or other ISPE group in an upcoming ISPE Briefs. Share highlights from training programs, conferences, social events, or other activities in an article of 250 to 400 words. We welcome photos (300 dpi or >1 MB). Send submissions to Susan Sandler.