2019 ISPE Annual Meeting & Expo

Modernize. Globalize. Transform.

The 2019 ISPE Annual Meeting & Expo will focus on modernization, globalization, and transformation in pharmaceutical science and manufacturing across the globe, offering pharma professionals the opportunity to engage in industry-critical conversations. This signature event draws pharmaceutical and biopharmaceutical professionals at all levels of the industry from young professionals to the most senior executives in drug manufacturing, supply chain, devices equipment and services, and global regulatory agencies.

Newly Confirmed Keynotes

Amy Abernethy, MD, PhD
Principal Deputy Commissioner
FDA
Lou W. Kennedy
CEO and Owner
Nephron Pharmaceuticals
Alberto Santagostino
Senior Vice President, Head of Cell & Gene Technologies.
Lonza AG
Jessica H.
Patient Presenter

View Agenda to learn more about the presentations from each of these speakers.

Why Attend

  • 6 extensive education tracks -- Facilities & Equipment, Information Systems, Quality Systems & Regulatory, Innovation Forum, Supply Chain, Operations & Packaging and Process Development & Manufacturing
  • 85+ hours of targeted technical sessions, from industry and regulatory leaders
  • Networking opportunities, including 50+ Plenary and Technical Sessions, Facility of the Year Awards Program, Membership Awards Program, Facility Tours, 5K Charity Run/Walk, Interactive Workshops, Young Professionals Events, and Women in Pharma Events
  • 200+ exhibitors featuring the latest technologies and services
  • New! ISPE Discovery Stage showcasing cutting-edge modernization in pharma products and services.
  • 2 days of in-depth classroom training courses on 31 October–1 November


Education Tracks

  • Facilities & Equipment
  • Information Systems
  • Quality Systems & Regulatory
  • Innovation Forum
  • Supply Chain, Operations & Packaging
  • Process Development & Manufacturing

Learning Objectives

Raise your level of technical knowledge through peer-reviewed non-commercial education content from recognized experts in the field.

Expand your professional network throughout the conference in educational sessions, the exhibit hall, and numerous special events.

Enhance your individual and company’s recognition among industry colleagues through face-to-face interaction.


Conference Highlights


Featured Sessions


Who Should Attend?

Professionals at all levels of the industry from young professionals to the most senior executives, Communities of Practice, special interest groups, pharmaceutical industry equipment and services suppliers, regulatory professionals.

  • Clinical Phase Professionals
  • Consulting Engineers
  • Equipment Manufacturers
  • Information Systems Professionals
  • Manufacturing Facilities Professionals
  • Operations Professionals
  • Pharmaceutical Executives
  • Project Managers
  • Quality Systems Professionals
  • Regulatory Professionals
  • Service Providers
  • Suppliers
  • Young Professionals

Program Committee Members

Michael L. Rutherford
Executive Director, Computer Systems Quality and Data Integrity
Syneos Health
Chair and Board Ambassador
Jennifer Lauria Clark, CPIP
Executive Director, Strategic Development
CAI
Co-Chair
Britt James Petty
Vice President, Manufacturing
AveXis Inc
Immediate Past Chair
Frank Montgomery, PhD
Global Head, Regulatory CMC
AstraZeneca
Regulatory Affairs
Niranjan S. Kulkarni, PhD
Director, Operations Improvement
CRB
Education Program Chair
Education Program Co-Chair
Dante Amatangelo
Validation Specialist
VaLogic LLC
Young Professionals Representative

Track Directors

Steven J. Wisniewski
Principal Compliance Consultant
Commissioning Agents, Inc.
Facilities and Equipment - Director
Brian Pochini, CPIP
Principal Engineer
Sanofi
Facilities and Equipment - Co-Director
George T. Bass
CSV and Data Integrity Consultant
GGB SERVICES
Information Systems - Director
Christian Woelbeling
Senior Director Global Accounts
Werum IT Solutions
Information Systems - Co-Director
Michael K. O'Brien, PhD
Founder & President
NGT BioPharma Consutlants
Innovation Forum - Director
Steven R. Miller, CPIP
Director of Engineering and Facilities
Emergent BioSolutions
Innovation Forum - Co-Director
Lisa J. Graham, Ph.D., P.E.
Vice President of Analytics Engineering
Seeq Corporation
Process Development and Manufacturing - Director
Sarah Mancini, PhD
Director, Global API Technology
Zoetis
Process Development and Manufacturing - Co-Director
Timothy J.N. Watson, PhD
Executive Director and Team Leader, CMC Advisory Office
Pfizer Inc
Quality Systems and Regulatory - Director
Sarah Pope Miksinski, PhD
Senior Director, Global Regulatory Affairs
AstraZeneca
Quality Systems and Regulatory - Co-Director
Ramesh K. Sood, PhD
Director (Acting), Office of New Drug Products
CDER/FDA
Quality Systems and Regulatory - Regulatory Advisor
Rodney R. Neal
Strategic Program Manager
Werum IT Solutions
Supply Chain Management - Directory
Oliver Stauffer
CEO
PTI Inspection Systems
Supply Chain Management - Co-Director