NORTH BETHESDA, Md., April 13, 2021 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (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," said Thomas Hartman, President and CEO, ISPE. "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 & Innovation, Medicines and Healthcare products Regulatory Agency (MHRA)
- Brendan Cuddy, Lead Scientific Officer, European Medicines Agency (EMA)
- Klaus Eichmueller, Darmstadt Regional Council, Regierungspräsidium Darmstadt
- Joey Gouws, PhD, Team Lead, Inspection Services, Prequalification Team, World Health Organization (WHO)
- Anne Hayes, Inspection Manager, Compliance and PIC/S Chair, Health Products Regulatory Authority (HPRA)
- Manuel Ibarra Lorente, Head of Department, Pharmaceutical Inspection & Enforcement, Spanish Agency of Medicines and Medical Products (AEMPS)
- Jacques Morenas, Technical Advisor of the Inspection Division Director, Agence nationale de sécurité du médicament et des produits de santé (ANSM)
- Carmelo Rosa, PsyD, Director, Division of Drug Quality I, FDA/CDER/OC/OMQ
- Vladislav Shestakov, Deputy Head of the Russian State GMP Inspectorate, State Institute of Drugs and Good Practices (FSI SID&GP)
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
To explore the agenda and to register, please visit ISPE.org/AprilSummit21.
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.
Amy Henry, ISPE, 8139602105, [email protected]