Natcher Conference Center
National Institutes of Health
October 16-17, 2018
The meeting is co-organized by the National Toxicology Program Interagency Center
for the Evaluation of Alternative Toxicological Methods
International Alliance for Biological Standardization
North America Affiliate (IABS-NA)
Pre-Workshop Webinars – by Invitation
To help prepare attendees for engaged participation at the workshop,
the Scientific Committee Chairs have organized a series of
three dynamic, preparatory webinars.
Webinar Invitations will be sent to those registered for the workshop
and participants are strongly encouraged to attend.
CLICK HERE for the schedule of the Webinars
CLICK HERE to register
5th Statistical Approaches for CMC Development and
Lifecycle Management of Biotherapeutics and Vaccines
November 26-28, 2018
Venue: US Pharmacopeia
This meeting is to bring together regulators and scientists to discuss statistical approaches used to help develop and manage processes, which ensure the quality and availability of biotherapeutics and vaccines. Speakers and panel members will engage with meeting participants on challenges and solutions related to CMC development and lifecycle management of biologics. Areas of attention will include Quality by Design in process and analytical development, comparability and biosimilarity, stability study design and analysis, validation, and continuous process and analytical verification. Statistical challenges related to introduction of new technologies and Big Data will be discussed. Special emphasis will be devoted to collaboration and communication, between scientists and statisticians as well as industry and regulators. The meeting will bring experts together to discuss the issues and through roundtables attempt to reach conclusions that will add value to global public health.
SAVE THE DATE
Diagnostics in the Veterinary Field: The Role in Health Surveillance and Disease Identification
Dorinth Pallas Hotel
15-17 May 2019
Diagnostics are an essential tool to ensure the health of domestic and wild animals for both endemic and emerging diseases. They allow animal health professionals to understand and manage the general health status of domestic animals. They are also important tools to support public health initiatives in the case of zoonotic disease control. The meeting will provide an overview of existing systems and approaches / strategies for the use of diagnostics and to discuss the currently available diagnostics. The advantages / benefits and disadvantages / gaps of the current methods and methodologies will be identified and discussed. Proposals on how to increase the quality, efficacy, and utility of the existing strategies and methods and those under development will be made.