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Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, North Bethesda, MD 20852

Regulatory Submissions, Information, and Document Management Forum

Session 12: International Regulatory Updates and Insights

Session Chair(s)

Tamei  Elliott, MS

Tamei Elliott, MS

Director, Global Scientific Content, DIA, United States

Receive the latest updates from international regulators and an industry representative on recent and future developments related to data standards, analytics, electronic submissions, and health authority IT programs. This session provides attendees the opportunity to ask regulators questions directly.

Please note: due to the high volume of questions, not all will be answered live at the forum

Speaker(s)

Mick  Foy

Speaker

Mick Foy

Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Hilmar  Hamann, PhD

Speaker

Hilmar Hamann, PhD

Chief Information Officer, European Medicines Agency, Netherlands

Shenqi (Handsome)  Ji

Electric ERA (China eSubmission/eCTD): Revolution in Regulatory Affairs and Operations

Shenqi (Handsome) Ji

Publishing Regional Director, Asia, Global Regulatory & International Operations, Pfizer, China

Nick  Karitsiotis

An Update on Health Products Standards and Innovation at HPFB

Nick Karitsiotis

Director of Business Innovation, Health Canada, Canada

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