Author: Nimisha Kotecha
May 5, 2018
Global PV Requirements Collection – To Collect or Not to Collect?
Having worked within Pharmacovigilance (PV) for close to a couple of decades now, I have witnessed an assortment of creative methods for gathering global PV intelligence information from country specific legislation.
Whilst we all understand the significance of having the most current PV legislation to hand, we know full well the intense pressure surrounding the submission of a SUSAR to NCAs, Ethics Committees and Investigators (I’ve been there, and I know you have too!); or that DSUR/ASR that needs submitting to 95 countries, not to mention PSURs, aggregate reports, RMPs. “How old are these reporting requirements for Morocco?”. “When did we last update the information for Panama?”, “Has anything changed in Turkey recently”, “What do we submit to Botswana?” “Which country needs a CD-ROM?”, so on and so forth, with each new submission.
Every functioning PV department needs to have the latest updated country specific PV requirements to hand and in so doing has its own creative method for collecting this information (or not). The challenges surrounding an increasing demand for compliance within an ever-evolving global legislative framework are often insurmountable. The resource deployed to collect and update regulatory intelligence is generally constricted (I can tell you that 6 is a very reasonable number, if you have 6 spare FTE available to assign to this task on a 24/7 basis!).
Why bother? Because capturing accurate and precise country specific requirements makes for compliant expedited/periodic/aggregate reporting (after all, this is about patient safety); A few things to consider:
- Know where and who to approach within the RA/IRB/EC
- Use accredited interpreters to gather real time information, enter into dialogue with authority representatives
- Take time and effort to clear up your interpretation of local requirements with authority contacts
- Employ targeted questioning methods – create lists, scripts or forms to use with your authority contact (acts as documented evidence of discussions!)
- Ensure interim quality checks internally – check for accuracy of data capture and verification of said requirements
- Create a process to update said information on a regular basis
- If all else fails, ask IntuVigilance to assist.