2019 ISPE Global Pharmaceutical Regulatory Summit

Igniting Innovation in Development & Quality During Lifecycle Management

This forum brings together leading global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches, and solutions that will drive innovation and quality for the medicines delivered to patients worldwide. This interactive setting with expert-led regulatory and industry presentations and forums will ensure pharmaceutical industry professionals are well-prepared to develop and apply innovative solutions in today’s global regulatory environment.


Who Should Attend?

All levels will benefit from the presentations and opportunities for engagement to continue to shape the direction of the pharmaceutical industry

Regulatory Affairs Senior Executives Communities of Practice Special Interest GroupsResearchers Equipment and Services Suppliers Facilities Personnel


Program Committee Members

Brian J. Hasselbalch
Deputy Director (acting), Office of Policy for Pharmaceutical Quality
FDA/CDER/OPQ/OPPQ
Regulatory Co-Chair
George P. Millili, PhD
Senior Principal Technical Advisor
Genentech
ISPE Industry Co-Chair
Alice Redmond, PhD
Vice President, European Operations
Commissioning Agents International (CAI)
Board Ambassador
Ciby Abraham, PhD
Regulatory CMC Director
AstraZeneca
Betsy P. Fritschel
Director
J&J Corporate
Placeholder Person Graphic
Ken Nolan
Senior Advisor
FDA
Soeren T. Pedersen
Director
Novo Nordisk
Daniel Peng, PhD
Director, RA CMC Biologics
Merck & Co Inc
Keith Webber, PhD
VP, Biotechnology
Lachman Consultant Services