ISPE Expert Xchange: Regulatory Summit on Modernizing Inspections
Learning Level: Intermediate
Session Length: 3 hours
Regulators and industry are in general agreement that mutual reliance amongst regulators has been a critical part of meeting health authority requirements as limitations in travel have been in place. Often using mutual reliance, the speed of approval and confirmation of acceptable status of sites supplying vaccines and therapeutics during the Covid pandemic has been unprecedented.
Additionally, on-site inspections are the preferred platform or “Gold Standard” approach to inspections from a practical and legal perspective. However, in situations where proper planning, coordination, and communication are achievable, Remote Interactive Evaluations or other remote/virtual approaches, are effective tools that may play an important part in future regulatory inspections from agencies around the world, particularly as a backlog has been built up due to the pandemic. Virtual communication tools (e.g. Zoom, MS Teams) are fully integrated into society now and are commonly used across the pharmaceutical industry as colleagues successfully navigated a remote environment while maintaining forward progress on the development, manufacture, and distribution of critical therapeutics for the public.
This session aims to explore both
First-hand Strategic Insights & Actionable Takeaways
- The current status of reliance as applied to inspections and what future steps could be.
- Industry’s experiences with reliance as applied during the pandemic.
- How remote assessments can ensure timely access to future innovation.
Small Group Discussions
Technical Presentations
Case Studies
Problem-Solving
Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!
Agenda
- 1000 – 1010
Introduction - 1010 – 1030
PIC/S Perspective: Mutual Reliance Considerations/InspectionsSpeaker
- 1030 – 1050
WHO Perspective: Mutual Reliance considerations / InspectionsSpeaker
- 1050 – 1110
ICMRA Regulatory Collaboration Pilots- Chemistry and Manufacturing Controls (CMC)
- Post-Approval Change (PAC) Submission Assessments
Speaker
- 1110 – 1130
Industry PerspectiveSpeaker
- 1130 – 1145
Break - 1145 – 1245
Panel Discussion and Q&A - 1245 – 1300
Closing
ISPE Expert Xchange Panelists & Session Speakers
Session leaders
Panelists & Session Speakers
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Group Discount Rate
Bring your team to the ISPE Expert Xchange: Regulatory Summit on Modernizing Inspections
- 3 - 5 participants - Save 10%
- 6 or more participants - Save 15%
Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.
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