ISPE Gathers Global Health Authorities to Discuss Remote/Distant Assessments, Audits, and Regulatory Guidance

13 April, 2021

ISPE will convene regulators, auditors, remote auditors, and inspectors representing 11 regulatory agencies from around the world at the 2021 ISPE Global Pharmaceutical Regulatory Summit for critical discussions on onsite inspection challenges due to COVID-19. Taking place virtually on 28 April 2021, this event will focus on the theme Remote/Distant Assessments, Audits, and Regulatory Guidance, exploring good practice guidance, drafts, challenges, and more during interactive, content-rich sessions.

Global enforcement priorities for regulating and inspecting pharmaceutical manufacturing facilities has been a key point of discussion for both industry and regulators as we navigate the current and post-pandemic environment. This event is another means for ISPE to provide a platform to enable these transparent conversations in the industry that includes representatives and perspectives from worldwide regulatory authorities.


Featured Regulatory Speakers:

David Churchward
Deputy Unit Manager, Inspectorate Strategy and Innovation
MHRA
Brendan Cuddy
Lead Scientific Officer
EMA
Klaus Eichmueller
Darmstadt Regional Council
Regierungspräsidium Darmstadt
Joey Gouws, PhD
Team Lead, Inspection Services, Prequalification Team
World Health Organization
Anne Hayes
Inspection Manager, Compliance and PIC/S Chair
HPRA and PIC/S Chair
Manuel Ibarra Lorente
Head of Pharmaceutical Inspection & Enforcement,
Spanish Agency of Medicines and Healthcare Products
Jacques Morenas
Technical Advisor of the Inspection Division Director
ANSM
Carmelo Rosa, PsyD
Director, Division of Drug Quality I
FDA/CDER/OC/OMQ
Vladislav Shestakov
Deputy Head of the Russian State GMP Inspectorate
Russia State Institute of Drugs and Good Practices

The 2021 ISPE Global Pharmaceutical Regulatory Summit will provide attendees with unparalleled insights on how regulators have adapted to distant assessments and remote audits and what they can anticipate when faced with an inspection. Thought-provoking discussions will examine the benefits and pitfalls of distant assessments, how to prepare and can comply with the current GMP/GDP, and how industry remote audits could remain possible after the pandemic

Explore Agenda & Register