Safety Info Reporting Policy
Who is responsible for reporting safety info to DSPV
Everyone
Name one activity the DSPV Physicians perform
Medical Review; Provides consultation for medically related questions from participating vendors and/or affiliates; Authors analyses of similar events for select serious adverse reactions; Ensures due diligence in characterizing adverse events and provide company comments, etc
Who is responsible for managing the collection of Safety Information?
DSPV
For what indication is Zulresso approved?
Postpartum Depression in Adults
What is the time frame for reporting safety info to DSPV?
Within 24 hours of Awareness
Who is primarily responsible for writing aggregate reports?
PV Scientist
What is “any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product which does not necessarily have to have a causal relationship with this treatment”?
Adverse Event
What date was Zulresso approved by the FDA?
March 19, 2019
Where can you hear of Safety Information besides at work?
Anywhere
Name one activity DSPV Safety Operations performs
Case Processing;
Oversight of PV Vendors and study teams;
Safety Compliance and training;
What department does this group represent?
DSPV
When did Sage receive final scheduling from the DEA for Zulresso?
June 17, 2019
DAILY DOUBLE
The following is an example of what type of safety info?
Pregnancy
Who joined Sage in March 2017 as the head of DSPV?
Leslie Williams
DAILY DOUBLE
The following is an example of what type of safety info?
lack of efficacy
What does the acronym REMS stand for?
Risk Evaluation Mitigation Strategy