pharmacovigilance
In the past, Inspections/ audits were synonymous with ‘travel’- both domestic and International, but it is not the norm these days. In 2020, when the Covid-19 crisis plagued the Pharmaceutical industry, many companies had to compromise on their annual audit plans and schedules. With the BCP measures in place, many companies were able to realize […]
Just Imagine! What if we had one set of Pharmacovigilance Guideline(s) for all the SAARC (South Asian Association for Regional Cooperation) Countries! Whenever we think of regional or harmonized Pharmacovigilance, the first thing that comes to our mind is the ‘European Medicines Agency,’ where we have a standard set of Pharmacovigilance Guidelines (GVP) for over […]
Pharmacovigilance requirements are constantly evolving and one may not find it difficult to monitor the requirements in EU, US, Canada, Australia, Japan, India, New Zealand, Singapore, Switzerland etc., as these are available in English and we know where to find them. However, we still need to periodically monitor if anything has changed, as any delay […]
After more than two decades in the drug safety industry, I have a confession: I still have a deep, personal apprehension about using the abbreviation ‘PV’ to denote Pharmacovigilance. It’s a two-letter identity crisis, and for many of us with a clinical background, it’s a source of genuine, albeit humorous, confusion. Here is the history […]
Very frequently do the Pharmacovigilance professionals come across terms such as RMS, MRP/DCP, CAP, CMS, etc., while interacting with the colleagues from the regulatory department. All these concepts are good to know, and are definitely relevant, as Pharmacovigilance requirements may vary across each of these terms. Besides, this is applicable to both human and veterinary […]
In the last few years, after having audited numerous service providers/ business or licensing partners/ distributors etc., I realized having developed fascination towards this off-shoot of Pharmacovigilance, that is #PhVQA. Thanks to the GVP modules as well as PSMF pre-requisites, coupled with the requirements for MAH to maintain a 2-5 yearly audit schedule, making it […]
Common questions asked by the Pharmacovigilance Inspector, with regards to Pharmacovigilance vendors
Algeria is a North African country located somewhat close to the European Union. The Centre National de Pharmacovigilance et de Materiovigilance (CNPM) updated the Pharmacovigilance guideline in 2019, and it is more or less on the lines of GVP, with some minor alterations. Some examples include: 1. ICSRs · Domestic Serious – 15 Calendar Days […]
Liechtenstein is a small country that is located between Austria and Switzerland. Liechtenstein is not a part of the European Union, but it is a part of the European Economic Area (EEA) and the European Free Trade Association (EFTA). Courtesy: Google Maps Switzerland is a part of EFTA, and not a part of EEA. On […]
In recent times, the pharmaceutical industry has been witnessing quite a few Mergers and Acquisitions (M&A) as companies want to grow organically as well as inorganically. Indeed there is intense competition in this field and companies want to sustain competition, and want to remain ahead of their peers. Considering the growing regulatory expectations, companies need […]