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

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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.

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.

The International Society for Pharmaceutical Engineering (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,” said Frances Zipp, President & CEO, Lachman Consultant Services, Inc., and Conference Co-Chair. “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, “said Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ, and Conference Co-Chair. “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.”

Confirmed Summit Speakers and Panelists:

  • David Churchward, Deputy Unit Manager, Inspectorate Strategy & Innovation, Medicines and Healthcare products Regulatory Agency (MHRA)
  • Jesusa Joyce N. Cirunay, RPh, 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 (EU), AbbVie
  • Benjamin Noyen, Assistant Secretary, Health Products Regulation Group, Therapeutic Goods (TGA)
  • Ranjana Pathak, PhD, Global Head of Quality, Cipla

Confirmed Conference Speakers and Panelists:

  • Jila Breeze, EVP, 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 Lab
  • 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

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.

To explore the agendas and to register, please visit ISPE.org/APAC21 and ISPE.org/JuneSummit21.

About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 Members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. Visit ISPE.org for more information.

For more information, contact:
Amy Henry
Director, Marketing and Communications
International Society for Pharmaceutical Engineering (ISPE)
Email: ahenry@ispe.org
ISPE.org

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Amy Henry
ISPE
813-960-2105
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