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.
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