Pharmacovigilance services

 An increasing emphasis is being placed on pharmacovigilance (PV), general drug safety, and providing patients with plain information due to shifting regulations and escalating litigation.

The benefit-risk profile of treatments must be presented in detail in safety documentation, and pharmacovigilance requirements aim to provide patients with more information.

The old European ASR (Annual Safety Report) and the United States IND Annual Report have been replaced by the Development Safety Update Report (DSUR) and the Periodic Safety Update Report (PSURs), which are now published in a new format: PBRER (Periodic Benefit-Risk Evaluation Report).

After product authorisation, PSURs/PBRERs must be submitted every six months until two years after initial placement on the EU market, then annually for the subsequent two years, and then every three years thereafter.  

European Union member states have been required to have DSURs, which are internationally standardized safety documents, since September 2011. These documents provide a safety summary of medicinal products throughout their development or clinical trial phase.
The DSUR (as defined in ICH E2F guideline) took over from the IND Annual Report of the United States and the European Union ASR (Annual Safety Report).
A DSUR must be submitted annually by sponsors until all open clinical studies have concluded (i.e., the final clinical study has been completed and its study report has been submitted), beginning on the Development International Birth Date (DIBD), which is the date of first authorisation of a clinical trial in any country worldwide.
D L Global Services is ideally positioned to assist our clients with the creation of DSUR and other safety documents in their entirety.
D L Global Services can also coordinate a comprehensive clinical review and approval, summarize and analyze published literature, and offer recommendations for company comments.