Events
Recent Events
November 7-10, 2022
A Virtual Meeting
The application of statistics in Chemistry, Manufacturing & Control (CMC) to advance the development and commercialization of important medical products has tremendous impact. New statistical methods and digital and computing technologies are continuously emerging and must often be adapted to add value in the CMC context. Successful practitioners of CMC statistics come from a range of original disciplines, including formal training in statistics, mathematics, and many branches of science and engineering. This conference provides a forum for discussing recent advances and opportunities including Bayesian methods, artificial intelligence & machine learning, and deeper collaboration between clinical & CMC statisticians.
The 2021 PDA Innovations in Vaccines Conference, presented virtually 8-9 June, will cover a wide range of important topics related to recent dramatic changes in the vaccines landscape.
Here are a few of the highlights of this Conference, with new expert speakers just confirmed!
Plenary 2: Control Strategies
This session will provide insights on advanced control strategies for vaccines development and lifecycle, taking into account product, process, and analytical considerations. Risk-based strategies and technical innovations to enable accelerated development will be discussed.
Specific topics include:
Quality by Digital Design to Support Rapid RNA Vaccine Production against Emerging Infectious Disease
Presented by: Zoltan Kis, PhD, Research Associate, Imperial College London
Enabling Accelerated Development – Patient-Centric Specifications and Stability
Presented by: Julia O’Neill, Distinguished Fellow, Moderna, Inc.
Plenary 4: PDA Vaccine Activities
This session will provide an overview of current activities of the PDA Vaccine Task Force and PDA Vaccine Interest Group, including publications, webinars, meetings on topics of interest for both novel vaccines and more traditional products, and opportunities for volunteering for these initiatives.
Specific presentations include:
Vaccines Interest Group Update
Presented by: Jane Halpern, Consultant
PDA Vaccine Task Force Update
Presented by: Stephan Krause, PhD, Director, Product Quality, AstraZeneca
In each plenary session, the presentations will be followed by a live Q&A with the presenters who will answer questions from the audience.
For more information on all this timely Conference has to offer, view the full agenda.
Other sessions of interest include the closing regulatory panel discussion on the global perspective of lessons learned and how to further enable vaccine modernization in the future.
The Conference will also offer multiple opportunities to connect and network with presenters and peers using the video chat function.
Prepare for the future with a comprehensive look at how accelerated vaccine development and manufacture is changing the vaccines landscape.
IABS Statistics Workshop
Approaches for Improving Statistical Partnership in CMC Development, Manufacturing, and Regulation of Biologicals
November 2 – 5, 2020 | Virtual
6th IABS Statistics Workshop Agenda
(PDF Download)
Session I: CMC statistics partnerships across the entire biologicals community
Chairpersons: Julia O’NEILL, Direxa Consulting; Katherine GIACOLETTI, SynoloStats
iPresent
Interested in scheduling a talk on Quality by Design, Data Mining for Process Understanding, Specification Setting, Design of Experiments, or other topics on the science of compliance?
Accepting a limited number of speaking engagements each year. Virtual presentations a specialty.