The United States Food and Drug Administration (US FDA) is now accepting investigational new drug application (IND) individual case safety reports (ICSRs) submitted electronically via the Electronic Submission Gateway in ICH…
If you are attending the World Drug Safety Congress Americas in Boston October 18-19, be sure to check out the talk our global head of pharmacovigilance and drug safety, Dr….
Med Communications provides high-quality pharmacovigilance support to our clients to ensure that all individual case safety reports (ICSRs) are processed in a timely and accurate manner, independently of the source….
Aggregate reporting is a critical aspect of pharmacovigilance. Discover how it can help you detect safety signals and improve patient outcomes.
When it comes to pharmacovigilance, precision and attention to detail are key. Med Communications, Inc.’s team of highly skilled pharmacovigilance professionals has years of experience covering multiple therapeutic areas in…
Effective 30 June 2022, EudraVigilance users are required to file individual case safety reports (ICSRs) using the ISO ICSR/ICH E2B (R3) format and related ISO standard terminology for pharmaceutical form…
With the world of life sciences changing almost daily, navigating information overload in the pharmacovigilance space and keeping abreast of all relevant regulatory information has become critical — and increasingly…
Are you looking for a company with a Med Affairs staff that has a high level of experience in a remote model? Med Communications knows what it takes to be…
Patient safety is the ultimate objective of any pharmacovigilance (PV) or drug safety department. The appropriate number of qualified, trained personnel are needed to ensure quality pharmacovigilance processes and outcomes…
One of the primary causes of drug safety inspection findings include non-compliance of spontaneous adverse drug reaction reporting?
