Closed kee007ney closed 1 year ago
Talked to Richard Thomas, Director of the Document Control Center (DCC). He agreed to participate, and asked that we also invite his team member Dean Harris.
Other potential names: Ron Fitzmartin Virginia Hussong Marc Allard Chris Joneckis Brien Hampton Darlene Martin Victor Bagwell
Emails sent out, document tracking responses is here: https://gwu0.sharepoint.com/:w:/r/sites/BioCompute-GRP/_layouts/15/Doc.aspx?sourcedoc=%7B4E00F72D-C9B9-4B62-935D-93968CC85638%7D&file=RAB_Planning_Document.docx&action=default&mobileredirect=true
Very CBER heavy so far. Ron (CDER) said no, may approach Marc Allard (CFSAN) to participate or recommend others. For now, CBER may be the model that others can follow.
Now have two representatives from CFSAN. Luis will talk to Mark about potential representatives from CDER.
Asked Eric Donaldson if he had any suggestions. He isn't sure, but recommended I contact Khaled Bouri.
Ask Mark to walk me around FDA? Ask Dinos? Possibly Brian Hively? Possibly Elaine Johanson? Possibly Vahan has ideas?