2021 ISPE Global Pharmaceutical Regulatory Summit

Remote/Distant Assessments, Audits, and Regulatory Guidance

Featuring 11 Regulatory Agencies from Around the World

What can the industry do to facilitate remote and distant assessments? Are distant assessments ‘here for now’ or ‘here forever’? Will the future be a ‘Hybrid model’? Will onsite inspections be prioritized once it is safe to travel and what framework will be applied to inspections? 

These questions and more will be answered during the 2021 ISPE Global Pharmaceutical Regulatory Summit on 28 April. Watch this video to hear from Thomas Hartman, President & CEO, ISPE, as he highlights featured global health authorities and the in-depth, interactive discussions you can't join anywhere else. 

The management and assessments of inspections of manufacturing facilities or other sites relevant for medicinal products have become increasingly difficult. In March 2020, the MHRA announced a risk-based prioritization of Good Practice inspections due to the COVID-19 outbreak. Followed by the EMA, who developed, in October 2020, an EU-wide procedure on guidance related to GMP/GDP and PMF distant assessments. In addition, the WHO’s Expert Committee on Specifications for Pharmaceutical Preparations has Annex 9 in place: Guidance on good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices, and good clinical practices for medical products regulatory decisions. Other organizations such as the FDA, PIC/S ICMRA are in the process of publishing guidance as well. These guidelines/measures should ease the impact of disruptions caused by COVID-19. These measures provide guidance for stakeholders on adaptations to the regulatory framework to address COVID-19 challenges.

The concerns connected to distant assessments are multiple in terms of both the means required and the possible approaches.

  • Clarification of the respective terms in use: distant assessments, remote inspections, remote audits
  • To what extent do distant assessments contribute to meeting pharmaceutical regulatory requirements?
  • Under what conditions do distant assessments support the process to achieve pharmaceutical regulatory requirements?
  • What are the technical and organizational means necessary to carry out remote inspections and assessments?
  • What are the benefits and pitfalls to be avoided in the implementation of these assessments?
  • What are the criteria for choosing different approaches: on-site assessment, distant assessment, or "paper" assessment?

The resulting time and cost savings suggest that distant assessments may remain popular in the future; however, it is necessary to be aware of the limitations to ensure efficiency and compliance.

These are all issues that we will explore globally during this event with regulators, auditors, remote auditors, and inspectors.

Featured Speakers

Why attend:

  • Hear how regulators have adapted to these guidelines
  • Ensure you are prepared for a distant assessment and can comply with the current GMP/GDP
  • Ascertain from regulators what to anticipate when faced with distant assessments
  • Discover the benefits and pitfalls of distant assessments
  • Learn how distant assessments meet pharmaceutical regulatory requirements
  • Understand from the regulators' point of view how to facilitate distant assessments
  • And explore with us whether distant assessments could become a permanent practice.
  • Explore with regulators how industry remote audits could remain possible after the pandemic.

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

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