At iVigee, we strive to provide solutions to our clients which will last forever, leading to a higher standard of patient safety.
Today, let us tap into the world of Pharmacovigilance Regulations. You may call it “Regulatory Intelligence”. And instead of thinking of one or two countries, let’s imagine multiple countries in multiple continents. Use your current organization’s geographic reach to come up with a list of countries. But the key is to have a global perspective.
With a global perspective, or multiple geographic regions in place, it often becomes difficult to meet all local regulatory requirements. Often enough to create a difficult dilemma for many stakeholders who are involved in drug safety aspects of medicinal products.
Below are a few sample regulatory questions:
The answers may be simple for the countries you or your organization know well. But for other countries where your organization is less familiar as a MAH…the situation can become tricky and sometimes a guessing game at best. With affiliates or other resources responsible for compliance but not experienced with PV Regulations, the problem can be magnified and create non-compliance.
PV regulation compliance is a challenge, and fortunately, there are multiple solutions available to both pharmaceutical and biotech companies, as well as for Clinical Research Organizations.
At iVigee, we are very happy to be partnering with the Institute of Pharmacovigilance(iPV), as they are developing and pioneering a new process that we believe will revolutionize Pharmacovigilance Regulatory Intelligence.
iPV is a non-profit organization which is working with not only local PV experts, but also local health authorities and other relevant local stakeholders globally. The end goal is to develop extremely accurate recognized and confirmed regulatory interpretations that can be trusted and put-to-use. With a focus on timeliness and accuracy, the solutions we expect to benefit not only corporations, but health authorities and higher education and many other professionals in the pharmacovigilance industry.
In 2022, there is infinite opportunity to maximize technology’s ability to interconnect all corners of the globe. And in the coming days and months, iVigee along with our partners worldwide expect to uncover some monumental changes to PV Regulatory Intelligence.
To stay connected on this topic, we encourage you to join our dedicated PV Regulatory Intelligence email list, it is called iViReg. To join – CLICK HERE. You will be the first to know when our new services focused on PV Regulatory Intelligence is available.
iVigee’s iViReg Team