Regulatory Townhall

Navigating Change, Shaping the Future

The Regulatory Townhall at the SCDM Annual Conference in Baltimore will provide an opportunity for attendees to hear from officials at the FDA, Health Canada, MHRA, BfARM, DKMA and the Swedish Medical Products Agency.

The session will address two current regulatory trends influencing clinical research:

ICH E6(R3) in Focus

This segment will examine updates related to ICH E6(R3), with expert commentary on changes impacting data governance, trial oversight, and sponsor responsibilities.

AI and the FDA’s Scientific Review

This discussion will review the FDA’s AI pilot program, exploring the evaluation and integration of artificial intelligence into regulatory science and its implications for innovation and compliance.

Panelists include representatives from several regulatory organizations:

• Lisbeth Bregnhøj, GCP Inspector, The Danish Medicines Agency (DKMA)
• Torsten Stemmler, Head of GCP Inspection Unit, Federal Institute for Drugs and Medical Devices Germany (BfArM)
• Cheryl Grandinetti, Associate Director for Clinical Policy, Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, CDER, U.S. Food and Drug Administration
• Kassa Ayalew, Division Director, Division of Clinical Compliance Evaluation (DCCE), U.S. Food and Drug Administration
• Annie Saha, Associate Director for Strategic Initiatives, Digital Health Center of Excellence, CDRH | Associate Director for Data Science and Artificial Intelligence Policy (acting), Office of Medical Policy, CDER, U.S. Food and Drug Administration
• Daniel Bjermo, Pharmaceutical Inspector GCP at Swedish Medical Products Agency
• Rachel Mead, Senior GCP Inspector, MHRA
• Myriam Salem, National Compliance and enforcement Supervisor, Clinical Trial Compliance Program (CTCP), Health Canada
• Alicja Kasina, Senior Compliance and Enforcement Advisor, Clinical Trial Compliance Program (CTCP), Health Canada

Moderator: Marc Wartenberger, Sr. Director, Security, Corporate QA & Compliance, CRIO

Why attend:

This Townhall is designed for data managers, regulatory affairs professionals, and clinical operations specialists, and aims to deliver the following:

• Information from regulators representing various international agencies

• An opportunity for attendees to ask questions

• Insights into technological impacts on regulatory collaboration