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 

  1. The current status of reliance as applied to inspections and what future steps could be.
  2. Industry’s experiences with reliance as applied during the pandemic.
  3. How remote assessments can ensure timely access to future innovation.
Small group Discussions
Small Group Discussions
Technical Presentation
Technical Presentations
Case Studies
Case Studies
Problem-Solving
Problem-Solving

Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!


Agenda


ISPE Expert Xchange Panelists & Session Speakers

Session leaders

Peter G. Millili, PhD
Senior Director, Manufacturing Science and Technology
Bristol-Myers Squibb
Session Leader
Michael G. Higgins
Sr. Director External Engagement and Supplier Quality
Moderna Therapeutics
Session Leader

Panelists & Session Speakers

Brendan Cuddy
Lead Scientific Officer
EMA
Placeholder Person Graphic
Karl Cogan
Executive Assistant To CEO
HPRA
Matthew JH Davis
Senior GMP Inspector - Inspections Team Leader
Therapeutic Goods Administration
Joey Gouws, PhD
Team Lead, Inspection Services, Prequalification Team
World Health Organization
Placeholder Person Graphic
Susan Laska, MS
Deputy Chair
PIC/S
Fabricio Carneiro De Oliveira
Medicines, APIs and Biological Products Office Chief
ANVISA
Deborah Smith
Compliance & Quality Systems Manager
Janssen
Jason Treese
VP of Quality
BMS
Stelios Tsinontides, Ph.D., FAIChE
Director, Office of Pharmaceutical Manufacturing
FDA (US Food and Drug Administration)

ISPE Expert Xchange Rates

ON DEMAND ACCESS FOR 90 DAYS

Member $149
Nonmember   $249 
Academia/Emerging Economy/Government*  $99
Recent Graduate*  $75
Student* $25

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*ISPE Membership is required for these rates.

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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