Profile

Marianne Lenton

Contact Details

United States

Contributions

1 to 2 of 2 total

RE: Timing for Susar Reports

Posted By Marianne Lenton 20-Dec-2019 05:32
Found In Egroup: Regulatory Open Forum \ view thread
Thank you very much for taking the time to respond - your input is very much appreciated! ------------------------------ Marianne Lenton Senior Safety Scientist Philadelphia PA United States ------------------------------

RE: Timing for Susar Reports

Posted By Marianne Lenton 19-Dec-2019 05:26
Found In Egroup: Regulatory Open Forum \ view thread
Thank you very much for your response. However, could you kindly address the following question?​ Hypothetical Question: An initial report is received for a Phase III Clinical Trial. The event is a Life-Threatening SUSAR event (study product is a drug, not a medical device or combination product, ...