FDA posts Draft Guidance on Innovation Meetings

The FDA has recently posted a Draft Guidance on the procedure for requesting and presenting at a meeting with the Center for Drug Evaluation and Research (CDER). One of the potential topics pharmaceutical companies may want to address at a meeting with CDER concerns development of clinical outcome assessments in the early parts of clinical development prior to a new COA being ready for formal qualification. Vector Psychometric Group has experience presenting the benefits of modern psychometric techniques to the FDA.

Nearly 100 new people to take flexMIRT courses in Korea this week

Managing partner, Li Cai, will instruct nearly 100 new users on the leading IRT software, flexMIRT®. Sessions will take place at several venues in the coming week in Korea. 9/12 Seoul National University: 1-Day IRT / flexMIRT® workshop 9/13 Korean Society for Educational Evaluation: Presentation on cognitive diagnostic and multidimensional IRT models in flexMIRT® 9/14 Korea Institute for Curriculum and Evaluation (KICE): Presentation on advanced psychometrics implemented in flexMIRT®

On 9/24 at 11AM Eastern, VPG will present a webinar: “Gathering better PRO data by using Item Response Theory”

The DIA’s Study Endpoints Community is sponsoring an educational presentation entitled, “Gathering better PRO data by using Item Response Theory” presented by Michael C. Edwards, PhD, Associate Professor, The Ohio State University. Click to download the Presentation Slides. Dial-in numbers United States Toll Free (866) 668-0721 Standard International +1(845) 977-0098 International Dial-in numbers Participant code 4703624044