Pharmacovigilance always provides new challenges. The recent change is the new E2B (R3).
Furthermore, the exchange of security information has moved from paper to electronic format as a result of European regulation. Electronic submission is still made according to E2B (R2) specifications but in May of 2005, the ICH released a revised guideline: the E2B (R3). The exchange through the specifications of the E2B (R3) was published in 2015 and became effective in July 1, 2016. This change affects both the Pharmacovigilance and regulatory departments and will require modifications to comply with these requirements.
The main differences between the E2B (R2) and E2B (R3) integrated ICSR IG EU are different and have brought a new structure, new requirements and additional fields in the following activities:
- mandatory use of causality assessment through SUSARs. This method of assessment should provide evaluation and EU result of the Assessment. The same assessment is used in E2B (R2), with the free text fields, while in E2B (R3) these fields are controlled by origin, method and result of the assessment, according to ISO ICSR.
- amendment Reports: if corrections must be made, or a document needs to be attached, this can now be done before the document is sent.
- Attachments: the E2B (R3) allows attachments such as literature articles or other documentation (e.g., autopsy reports or copies of laboratory results) to be incorporated in the ICSR XML format, whereas previously it was not possible.
- The information is moved depending on the level, which varies from case to case depending on the severity, medical requirements and confirmation of the occurrence of the country.
- Characterization of the role of the drug as “Drug not administered” that can be used to subscribe to events to highlight cases of medical errors.
- additional data fields and or codes for the identification of medicinal products.
All these changes will lead companies to change their basis of “data security”. Organizations will have to plan the changes of the processes in advance, so as to follow E2B (R2) and E2B (R3) guidelines. In addition the above changes will affect the SOP and procedural documents as well as PSMF. The training of all personnel involved in the process is therefore of the upmost importance.
PM Clinical provides a complete package of security services for drug and risk management in the following sectors: collection, monitoring, evaluation and analysis of information on drug safety and the detection of new adverse events. Through a network of resources, we can provide data entry and case collection in a cost efficient manner, along with an expert advice in quality control and report preparation.