ISPE Convenes Regulators and Industry to Discuss Challenges & Solutions for Quality Risk Management

06 May, 2021

ISPE will convene regulators and industry leaders from around the world at the 2021 ISPE Global Pharmaceutical Regulatory Summit on 16 June and at the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference on 17–18 June 2021. Taking place virtually, these events focus on the sustainable implementation of and shared responsibility for quality risk management and will provide a collaborative environment that encourages sharing lessons learned and maintaining transparency among regulators and industry.

The global pandemic has impacted all operations, no matter the size or manufacturing capabilities. As companies in the Asia Pacific region and around the world adapt to changing regulatory processes, contend with remote and limited inspections, and manage increasing demands on CMOs, effective quality risk assessment and risk mitigation have become exponentially more significant. These events require a visionary approach in assessing the challenges facing pharmaceutical operations on a global basis specifically for those that are critical to the supply of essential medicines such as in the Asia Pacific region, amid unpredictable times.

Co-Chair

Collaboration and communication are a crucial element in mitigating the impact of COVID-19 on pharmaceutical operations. During both events, attendees will have the chance to ask questions to industry experts and regulators and learn about the strategies and insights other companies are using to make their operations more agile, compliant, and resilient to disruption.

Co-Chair

Confirmed Summit Speakers and Panelists:

David Churchward
Deputy Unit Manager, Inspectorate Strategy and Innovation
MHRA
Jesusa Joyce N. Cirunay, RPh
Director IV
Center for Drug Regulation & Research, Food and Drug Administration-Philippines
Brendan Cuddy
Lead Scientific Officer
EMA
Cormac Dalton
VP Quality Assurance (EU)
AbbVie
Benjamin Noyen
Assistant Secretary, Health Products Regulation Group
Therapeutic Goods Administration TGA
Ranjana B. Pathak, DHA
President-Global Quality, Medical Affairs & Pharmacovigilance
Cipla Ltd.

Confirmed Conference Speakers and Panelists:

Jila Breeze
EVP, Global Head Quality & Compliance
SUN Pharmaceutical Industries, Inc.
David Churchward
Deputy Unit Manager, Inspectorate Strategy and Innovation
MHRA
V. Ray Gaines
Branch Chief, Division of Drug Quality I
FDA
R. Derek Glover
Head of Global Quality
Viatris
Joey Gouws, PhD
Team Lead, Inspection Services, Prequalification Team
World Health Organization
Narendira Kumar
Associate Director and Site Quality Head
Dr. Reddy's Lab
Brooke Higgins
Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality
FDA/CDER/OC/OMQ
Placeholder Person Graphic
Kevin O’Donnell
Market Compliance Manager
HPRA
Ranjana B. Pathak, DHA
President-Global Quality, Medical Affairs & Pharmacovigilance
Cipla Ltd.
Aditi S. Thakur
Senior Pharmaceutical Quality Assessor
FDA/CDER/OPQ/OPF

The half-day format for the 2021 ISPE Global Pharmaceutical Regulatory Summit will give attendees access to a breadth of knowledge in a streamlined format. They will have the opportunity to interact with expert speakers during an extended panel discussion focused on the shared responsibility among all stakeholders for effective and sustainable quality risk management.

The 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference will provide attendees with unparalleled real-time engagement with regulatory leaders and industry experts as they take them through interactive case studies and panel discussions focused on implementing quality risk management principles, responding to regulatory actions, and CMO/CDMO relationships.

Learn More & Register APAC21      Learn More & Register JuneSummit21