Drug Safety and Pharmacovigilance

With increasing public and regulator focus on product and patient safety, regulatory requirements in this area have become more demanding. Regulatory Affairs professionals work closely with the pharmacovigilance team to comply with regulatory authority requirements and ensure product safety. Learn the essential elements of pharmacovigilance and managing risks/benefits of drugs and biologics throughout the product lifecycle. With focus on US and EU requirements and international harmonization guidelines, explore topics that include pre-marketing and postmarketing adverse event surveillance and reporting, individual case safety reports, aggregate safety reports, safety operational units, MedDRA coding, quality systems, good pharmacovigilance practices, safety inspections, electronic records, safety labeling, signal detection, risk management (REMS, RMPs), and pharmacoepidemiology.