Setting up, implementing, and maintaining a global pharmacovigilance system is an on-going challenge. But don't worry, Dr. Marcela Fialova has worked with many biotech and pharmaceutical companies during her 20+ years within the pharmaceutical industry implementing multiple projects focused on global PV practices.
iVigee’s Global PSMF suite of services continues to expand, and we are happy to announce that Marcela continues to provide group trainings and presentations for the benefit of PV stakeholders globally. She also works with selected clients on specific projects overcoming Global PSMF related challenges.
Below are some details covering many ideas of what Dr. Fialova’s Global PSMF trainings and presentations address.
"Description of the pharmacovigilance system is a concept, which was introduced in the EU in 2004 through an update of Directive 2001/83/EC and reflected in Volume 9A at that time.
Later, in 2010, an additional amendment of the Directive defined PSMF as the required format of description.
In 2012, this was further detailed within EU GVP Module II. As this initially took effect in the EU, it was not long before many non-EU countries and regions started to request information about future marketing authorization holder's PV system as a part of the marketing application. Outside of Europe, some regions & countries accept and recognize the EU PSMF, usually requiring local specific annexes or amendments.
Alternatively, some countries have local requirements with a full range of differences – from slight to substantial. For countries with PSMF related requirements that are different from the EU, this poses several challenges for MAA’s & MAH’s globally.
The diversity of requirements from different regions/national competent authorities (e.g., with respect to structure, content & level of detail, geographical coverage, language etc.) cannot be avoided and must be addressed. Initial development of a regional or country specific PSMF is only one hurdle.
The ongoing maintenance of these individual but interconnected PSMF(s) is yet another constant struggle. Ensuring the descriptions are up-to-date, accurate, complete and in line with potentially changing local pharmacovigilance requirements takes large amounts of time and resources.
To help streamline and harmonize regional/country specific difficulties regarding the creation and maintenance of the PSMF, a GLOBAL APPROACH to pharmacovigilance descriptions and the PSMF specifically can become the solution."