The launch of Heacon’s own “PhedaLit” took place on April 19, 2024.
The Heacon pharmacovigilance pooling project offers a comprehensive, customer-oriented service package. It includes literature research and evaluation according to the guidelines of Good Pharmacovigilance Practices (GVP) for the identification and evaluation of case reports (ICSRs) from the literature as well as publications on the benefit-risk profile of the active substances researched in the context of signal detection and for the preparation of Periodic Safety Update Reports (PSURs).
PhedaLit” provides you with a modern, validated and powerful pharmacovigilance literature database that supports you and your team even more specifically with the help of pharmacovigilance-specific functionalities in the literature research required by the regulatory authorities:
- User-friendly interface
Intuitively usable database interface that facilitates active substance-related, worldwide literature searches - Condensed presentation of the search results
- Pre-assessment and clustering of literature findings based on European regulatory requirements
- Enhanced search and export functions
New search filters and indexing functions, such as personal comments, to quickly find relevant information, as well as the option to export search results to Excel - Email notifications
Regular updates and notifications about the latest publications on the active ingredients you have booked - Individual user settings
Configuration of the settings for the researched substances and e-mail notifications at user level - Ordering function for relevant ICSR XMLs on a case basis directly from the database
- Download Line Listings
