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.

The Summit will provide attendees the unique opportunity to raise questions and engage in discussion with global regulators and industry experts. 


  • Regulatory presence at ispe event
  • Keynote speaker Amy Abernethy
  • Regulatory presence at ispe event

Conference Highlights

"Women in Pharma® Roundtable Breakfast Session

Attend the Women in Pharma® Roundtable Breakfast Session: Balance for Better in Biopharmaceutical Manufacturing. Panel of biopharmaceutical leaders share insight on achieving & the value of gender balance in biopharmaceutical manufacturing.
Register

Note: This session is included with full conference registration.

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 Groups Researchers Equipment and Services Suppliers Facilities Personnel

Learning Objectives

As a result of participating in this event, attendees will be able to:

  • Discuss emerging trends, novel approaches, and innovative solutions with global experts to stay abreast of current and evolving industry topics.
  • Explore ideas and develop strategies to advance key initiatives addressing industry innovation and ensuring quality and safety.
  • Identify opportunities for engagement with regulatory agencies to develop potential solutions to challenging issues affecting the industry.
  • Gain insights into the current perspectives of industry professionals and global regulators on the increasing complexities of the global pharmaceutical environment.

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
CAI
Board Ambassador
Ciby Abraham, PhD
Regulatory CMC Director
AstraZeneca
Nina S. Cauchon, Ph.D.
Director Regulatory Affairs - CMC
Amgen Inc.
Paul C. Collins
Senior Director, Small Molecule Design and Development
Eli Lilly & Co
Betsy P. Fritschel
Director
J&J Corporate
Kate Gillespie
Senior Director, Global Product Vigilance & Post Market Reporting
Johnson & Johnson
Placeholder Person Graphic
Ken Nolan
Senior Advisor
FDA
Soren Thuesen Pedersen
Senior Director
Novo Nordisk
Daniel Peng, PhD
Director, Regulatory Affairs CMC Biologics
Merck & Co Inc
Placeholder Person Graphic
Loni Warren-Henderson
Public Affairs Specialist, Office of Communication
CBER/FDA
Keith Webber, PhD
VP, Biotechnology
Lachman Consultant Services