It takes just four days to learn all that is useful to know to make SafetyDrugs a daily work tool. It is the safety database developed by Max Application for the management of pharmacovigilance. When a pharmaceutical company moves from an obsolete database to our system, training is the fourth phase of a path that begins with a initial analysis, continues with a ICH R2 data conversion plan and activates the validation of the entire process. For the training we recommend at least two days of coaching to the operator at the customer’s site and the rest divided into multiple webinar sessions.
It starts with a general overview of logins, menus, lists of values, products dictionary and MedDRA. We then proceed with the creation of a new case starting from the function of searching for duplicates. We continue by inserting the information of the case in the respective sections provided by the ICH and by making it advance through the chosen workflow. In all this process the automatic functions which calculate the durations and those which create the correlation matrix and the narrative are of great help.
The day ends with an in-depth analysis of the possible receivers of the case, of the related deadlines calculation function and of the reports, such as CIOMS, Quality Check, Audit Trail and Cover Case. During the day there will be practical exercises for all the users.
The chapter on case management ends by facing the creation of XML files in the new R3 format, the mask to query the ICSRs present in the safety database and the one to manage the activities linked to them such as the follow-up requests. The training then moves on to the creation of a new version of the case itself and to the related history. it concludes with the explanation of the automatic function which updates the MedDRA terms to the latest version in force.
At this point the next topics are the import and the export. Therefore the Selective Import and the Converter (XML-HL7 and HL7-XML) are shown as well the sending of cases or reports to a list of receivers through the internal Message System of SafetyDrugs.
The day is mainly devoted to reports, in particular to line listings and summary tabulation that will be part of PSURs and DSURs, to the SMQs and finally to the control reports on the cases processed, submitted, sent to partners, etc. The training for the operator user concludes with full-field exercises to shed light on any doubts.
The last day of training is exclusively dedicated to the administrator user, who in addition to having acquired the skills of the operative user, will also be trained about the general parameterization, the parameters of the search for duplicate, the dictionaries, the coding tables, the products tables and those of devoted to clinical studies, the Message System and the Audit Trail.
At the end of the training the relative Training Certificate will be provided to all participants.
For those clients who have signed up for the Business Intelligence module, a further day of training is planned dedicated to examining the various dashboards for detailed analysis, including the Signal Detection.