ISPE to Host Two Virtual Quality Risk Management Events

The International Society for Pharmaceutical Engineering (ISPE) announced on May 6, 2021 that it will virtually host the 2021 ISPE Global Pharmaceutical Regulatory Summit on June 16, 2021 and the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference from June 17–18, 2021.

According to a company press release, the virtual events will center around the sustainable implementation of and shared responsibility for quality risk management, while providing a space for regulators and industry leaders to share lessons and maintain transparency.

“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,” said Frances Zipp, president and CEO, Lachman Consultant Services, and conference co-chair, in the press release. “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.”

“Collaboration and communication are a crucial element in mitigating the impact of COVID-19 on pharmaceutical operations,” added Carmelo Rosa, director, Division of Drug Quality I, FDA/CDER/OC/OMQ, and conference co-chair in the press release. “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.”

Summit speakers and panelists include:

• David Churchward, deputy unit manager, Inspectorate Strategy & Innovation, Medicines and Healthcare products Regulatory Agency (MHRA)
• Jesusa Joyce N. Cirunay, director IV, Center for Drug Regulation and Research, Food and Drug Administration Philippines
• Brendan Cuddy, lead scientific officer, European Medicines Agency (EMA)
• Cormac Dalton, vice-president, Quality Assurance (European Union), AbbVie
• Benjamin Noyen, assistant secretary, Health Products Regulation Group, Therapeutic Goods (TGA)
• Ranjana Pathak, PhD, global head of Quality, Cipla

Conference speakers and panelists include:

• Jila Breeze, executive vice-president, global head, Quality & Compliance, SUN Pharmaceuticals Inc.
• David Churchward, deputy unit manager, Inspectorate Strategy and Innovation, MHRA
• V. Ray Gaines, branch chief, Global Compliance Branch III, CDER/FDA
• R. Derek Glover, head of Global Quality, Viatris
• Joey Gouws, PhD, team lead, Inspection Services, Prequalification Team
• Narendira Kumar, Site Quality head, Dr. Reddy’s Laboratories
• Brooke Higgins, senior policy advisor, Office of Manufacturing Quality, CDER/FDA
• Kevin O’Donnell, PhD, market compliance manager, Health Products Regulatory Authority (HPRA)
• Ranjana Pathak, PhD, global head of Quality, Cipla
• Aditi Thakur, acting quality assessment lead, FDA/CDER

Source: ISPE