2021 ISPE Global Pharmaceutical Regulatory Summit

Quality Risk Management: Ensuring Shared Responsibility across Key Stakeholders

To ensure the production of safe and effective medicines, industry and regulatory leaders are challenged to work collaboratively and transparently to foster environments where shared responsibility for quality risk assessment and ongoing risk management are universal. When every key stakeholder shares that commitment, it is not only possible to meet quality expectations but to exceed them. Regulatory and industry leaders will share their diverse perspectives on maintaining and improving quality in an increasingly globalized world.

Attendees will have the opportunity to interact directly with global regulators and industry leaders during an extended panel discussion focused on the shared responsibility among all stakeholders for effective and sustainable quality risk management.

Featured Speakers


Why Attend Virtually

  • Feel like You're In-Person with a Fully Interactive Digital Experience
    Our event portal is easy to navigate and will allow you to view presentations, access PDFs of the presentations, take downloadable notes in each session, participate in polls, chat with other attendees, and participate in LIVE Q&A sessions with speakers.
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  • Build Your Experience
    Add the sessions you want to attend with the click of a button to build your own custom agenda.
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  • Gain Actionable Insights
    Global experts will be at your fingertips sharing their knowledge and lessons learned on advanced therapeutic medicinal products (ATMPs) including cell and gene therapies, digitalization, single-use technology, implications of ICH Q12 for biopharma, and much more.
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Virtual Event FAQs


Who Should Attend:

  • Professionals at all levels of the industry from emerging leaders/young professionals to senior executives
  • Developers, manufacturing, engineering, and procurement professionals involved in or interested in understanding the current state of remote/distant audits
  • Quality Assurance and Regulatory professionals
  • Process and Project Engineers
  • Regulators
  • Auditors
  • Academia
  • Stakeholders

Media Partners

IPQ media partner
The Medicine Maker media partner

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Name
Company Type

Program Committee

Carmelo Rosa, PsyD
Director, Division of Drug Quality I
FDA/CDER/OC/OMQ
Co-Chair
Frances M. Zipp
President & CEO
Lachman Consultant Services
Co-Chair and Board Ambassador
David Churchward
Deputy Unit Manager, Inspectorate Strategy and Innovation
MHRA
Antonio C. Crincoli, PE
Vice President of Global Engineering
Charles River Laboratories Inc
V. Ray Gaines
Branch Chief, Division of Drug Quality I
FDA
Brooke Higgins
Senior Policy Advisor, Office of Manufacturing Quality, Division of Drug Quality
FDA/CDER/OC/OMQ
Placeholder Person Graphic
Mr. Jose Melendez, Eng
Senior Automation Engineer
Global Automation Partners
Deva H. Puranam
Head of Global Quality Investigations
Viatris
Georg Singewald, PhD
VP, Head of Global Quality Control
Genentech, A Member of the Roche Group
Aditi S. Thakur
Senior Pharmaceutical Quality Assessor
FDA/CDER/OPQ/OPF