Though pharmacovigilance has improved in recent ... which developed a national electronic system for tracking reports of AEs linked to FDA-regulated products. The initiative queries automated ...

Derek Woodcock gives an overview of the Pharmacovigilance System Master File in our safety and pharmacovigilance themed month. The requirement for a Pharmacovigilance System Master File (PSMF ...

A movement created during the pandemic wants the State to compensate people who had adverse reactions to vaccines against ...

The Board agreed to another proposal to amend the Rules to include inclusion of Pharmacovigilance System Master File (PSMF) along with other copies of documents required as appendix for the PSUR. The ...

SAHPRA noted that while medicines are essential in managing illnesses and improving health, side effects can occur, sometimes ...

ELIQUENT Life Sciences (ELIQUENT), a global regulatory consulting firm, today announced that internationally recognized pharmacovigilance (PV) expert Shelley Gandhi has joined the firm.

There are also two House bills (two House bills that recognize and attempt to remedy flaws in the system ... to vaccine ...

Through harnessing innovations in its regulatory processes, including digital transformation in health care, BPOM is ...

The National Agency for Food and Drug Administration and Control has recalled Nivea BLACK & WHITE invisible roll-on deodorant ...

“Dr. Mirza Rahman’s expertise in patient safety and pharmacovigilance ... clinical pharmacology programs across central nervous system (“CNS”) and other therapeutic areas.