Executives shared their strategies, lessons learned, and best practices on Post-Marketing Surveillance
PP-WE-579: Inhibitor formation with sucrose-formulated recombinant factor VIII in patients with hemophilia A: Results from post-marketing surveillance
This benchmarking study examines the best practices for post-marketing surveillance
within the United States, as well as the processes for assessing reports of adverse events, follow-up activities and compliance training.
The system is easily accessed over the Internet, simple to use, requires absolutely no installation, and the interface has proved to be very appealing to professional end users," said Roland Rutschmann, General Manager and Project Sponsor for Actelion's first post-marketing surveillance
The post-marketing surveillance
study was introduced in 1987 following the introduction of Genotropin in a number of countries throughout the world.
The final results from this post-marketing surveillance
study, conducted by Dr.
Given the extensive clinical evidence covering over 70,000 patients and the results of post-marketing surveillance
arising from 24 million patient-years of experience, Sanofi-Aventis stands behind the safety of Lantus," Lehner said.
After all, drug safety and in particular post-marketing surveillance
of drugs is a hot topic nowadays, and will be for some time to come.
The conditions for approval were given as: "Because of a very limited number of the subjects treated in the domestic clinical trials, a post-marketing surveillance
of all patients who received Avastin(R) after the launch of it should be conducted until the data of a certain number of patients are accumulated in order to identify the background of the patients and collect the safety and efficacy data of them early, and take necessary measures for proper use of Avastin(R).
The approvable letter contains proposed labeling, as well as requests for data clarification, post-marketing surveillance
, and post- marketing studies.
Tokyo, Japan, Dec 21, 2005 - (JCN) - Soiken has agreed with Hakuhodo, a wholly owned subsidiary of Hakuhodo DY Holdings, to establish a joint venture company for post-marketing surveillance
(PMS) studies and marketing research for food for specified health use (FOSHU).
In addition to mandated conditional regulatory approval or post-marketing surveillance
trials, other reasons sponsors may conduct post-marketing trials include: