2019 ISPE APAC Pharmaceutical Manufacturing Conference

Regulatory Insight on Drug Discovery, Approvals, and Inspection Management 

Regulators play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry. Securing first-hand regulatory insight gives you the advantage to make informed decisions and optimal regulatory strategies. At the 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference, you’ll have the unique opportunity to tap into the minds of global regulatory decision makers in drug discovery, approvals, and inspection management. 

Our line-up of global regulatory leaders will share their insight and perspectives to help you to proactively prepare for challenges, minimize risks, and maximize quality. Don’t miss your chance to get unparalleled access to global regulatory and quality intelligence, including more than 20 presenters and attendees from these organizations: 

  • MHRA 
  • WHO 
  • USFDA 
  • Philippines FDA 
  • PIC/S 
  • PMDA 
  • Singapore Health Sciences Authority 

Rounding out our dynamic presenter line-up are experts from leading industry organizations, such as Novatek International and Takeda Pharmaceutical, and academia, including as the University of Tokyo—giving you comprehensive industry insight you can’t get elsewhere.   


Regulatory Topics from Around the World

  • PIC/S GMP Inspection Reliance Initiate 
  • Quality Culture and Inspectional Findings 
  • Quality Risk Management and Inspectional Findings in the Global Environment  
  • Facilities of the Future:  An Exploration of Pharma 4.0 and Continuous Manufacturing 
  • WHO experience in Prequalification GMP Inspections in India and China 
  • Quality & Compliance
  • Managing Root Cause Investigations
  • Cleaning Validation and Process Validation
  • Data Integrity for Manufacturing

Conference Highlights


Learning Objectives

  • Become current on industry trends in quality & quality risk management
  • Understand quality and regulatory requirements and expectations
  • Address the recent developments and innovations in manufacturing
  • Understand the necessary elements for on-going quality sustainability

Who Should Attend

  • Regulatory Affairs Experts
  • GMP Inspectors
  • Quality Assurance Experts
  • Quality Operations Experts
  • Executive Level Leaders in Pharmaceutical and Biomanufacturing
  • Pharma Senior Level Manager

Commitee Members

Joseph Stephen Micsko, Jr.
ISPE Singapore President
Co-Chair
David Bartlett, Jr.
Sr. Manager, SME Automation
No Deviation Pte Ltd
Christina Chen
Director of Operations, Singapore
Commissioning Agents International Singapore Pte Ltd
Donald A. Fraser
Technical Services Manager
Jacobs Engineering
Maurice B. Parlane, B Tech MIT
Principal/Director
New Wayz Consulting Ltd
Carmelo Rosa, PsyD
Director, Division of Drug Quality I
FDA/CDER/OC/OMQ
Vivien E. Santillan
Regional Director, Asia
Novatek International
Hirofumi Suzuki, PhD
Senior Regulatory CMC Adviser
Bayer Yakuhin Ltd
Robert W. Tribe
AP Regulatory Affairs Advisor
ISPE
Charlie C. Wakeham
Regional CSV Consultant
Waters Corporation

Board Ambassador

Chris Chen, PhD
CEO
WuXi Biologics (Shanghai) Co., Ltd.
Frances M. Zipp
President & CEO
Lachman Consultant Services, Inc