Register Now

4th Statistical and Data Management Approaches
for Biotechnology Drug Development

Venue: USP Pharmacopeia, Rockville, Maryland
October 30 - November 1, 2017

 

This meeting is to bring together regulators, and scientists, or those interested in statistics from academia and industry, who have a background in statistics, to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use statistics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability, biosimilarity exercises and stability program development will be provided by the speakers and panel members. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

You may now register for this conferenceClick here to register and learn more about the meeting

 

Register Now

Next Generation Sequencing for
Adventitious Virus Detection in Biologics


Venue: USP Pharmacopeia, Rockville, Maryland
October 26-27, 2017

 

The 2017 NGS conference will discuss current perspectives on NGS for adventitious virus detection in biologics with focus on applications for human vaccines and lessons learnt from veterinary vaccines. The meeting will include data presentations and discussions for developing a scientific consensus to draft points for consideration for using NGS for virus detection in selected applications of biologics.  The meeting will bring together representatives from industry, academia, service providers, and regulatory bodies.

You may now register for this conference Click here to register and learn more about the meeting

 

 

REGISTRATIONS CLOSE OCTOBER 30

Advancing Analytics for Biotechnology Products

An IABS - FDA international meeting
co-sponsored by NIST

Venue: NIST, Gathersburg, Maryland
Green Auditorium
Gathersburg, Maryland
November 6-8, 2017

 

This meeting is to bring together regulators, and scientists, or those interested in analytics from academia and industry to help resolve existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use current and novel analytics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability and process development and execution will be provided by the speakers and panel members. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

NON U.S. CITIZENS PLEASE NOTE: All foreign national visitors must supply additional information. Failure to provide this information prior to arrival will result in significant delays in entering the facility. Authority to gather this information is derived from United States Department of Commerce Department Administrative Order (DAO) number 207-12. Please fax the following NIST 1260 form to Myesha Steadman as soon as registration is complete: fax (301) 975-4629.

 Click here to register and learn more about the meeting

International Alliance for Biological Standardization


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