Sentences with phrase «periodic safety update»

Based on the most recent Periodic Safety Update Report (PSUR), which was assessed by the European Medicines Agency (the EU equivalent to the FDA), the incidence of all adverse events remains categorized as «rare.»

Not exact matches

In addition, I attend quarterly updates, periodic refresher courses and various annual conferences on Child Passenger Safety, far beyond the basic re-certification requirements.
The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.
Hope Community Public Charter School will establish a Local Wellness Committee that meets at least two times per year to develop goals for and oversee implementation of school health and safety policies / programs, including periodic reviews and updates of this LWP.
a b c d e f g h i j k l m n o p q r s t u v w x y z