Autogenous Vaccines Hybrid Meeting:
Quality of production and movement in a common market

Ludwig-Maximilians-University Munich

EARLY REGISTRATION ENDS JULY 1, 2021

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A Virtual Meeting

SAVE THE DATE

Registration Open


Accelerating Drug Development: How QbD, Regulatory Partnerships, and Pandemic Learning
Can Further Expedite Meeting Patient Needs

The pharmaceutical industry, academicians, and global regulators have demonstrated over the past year that drug development can be incredibly accelerated to address urgent, unmet needs. In addition, coupled with that acceleration, the pharmaceutical industry has been on a Quality by Design (QbD) implementation journey for nearly two decades. Acceleration has placed an emphasis on conducting and documenting risk assessments, utilizing modeling to leverage platform knowledge, incorporating digital and technological advances to improve process performance  and understanding, and continued refinement and improvement of the information that is submitted to global regulators.  What have we learned from these experiences, particularly from the vantage point of CMC statisticians, and what aspects of the near-term dramatic acceleration and longer-term development journey could/should be continued going forward?

This workshop will explore the development journeys over a series of sessions by hearing directly from the industry, professors, and global regulators. By focusing each session on themes that cover QbD, Regulatory, Continuous Manufacturing, and Case Studies, the workshop will be an opportunity to help shape the future of drug development through the role of CMC statisticians. Join us for presentations, panel discussions, and breakout sessions to engage directly with speakers, other experts, and each other.

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Maintaining the quality of vaccines through the use of references standards
Current challenges and future opportunities

Due to the uncertainties concerning the evolution
of the Covid-19 pandemic, the meeting is once again rescheduled
and will now take place on

June 2022

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Cross learning experience human and animal vaccine licensure
based on technology platforms

A Joint CEPI / IABS-EU Workshop

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MEETING RESCHEDULED


The difficult situation we are facing currently in Europe
and the uncertainties concerning the evolution

of the Covid-19 pandemic
has led us to once again postpone
the CEPI / IABS-EU Workshop.

More information will be posted shortly.

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International Alliance for Biological Standardization


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Contact Info

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CH-1204 Geneva

Switzerland
+ 41 22 301 10 36
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