Bay Area User Network

Bay Area User Network

John Brega

Pharmaceutical Data Standards Implementation Consultant, PharmaStat LLC


The Bay Area CDISC User Network hopes to schedule a Q3 meeting for late October/early November. Key topics will include the FDA’s implementation of the new Technical Rejection Criteria and the FDA’s and Industry’s implementation of con med coding in the WHODrug B3 format, which is now effectively a requirement.  We plan to have FDA participation for both topics.