Pharmacovigilance

Electronic Safety Reporting (ICH E2B) and Electronic Submissions

Increasingly, regulators and licensing partners require electronic reporting of individual case safety reports. Our Argus Safety™ database complies fully with the validation, MedDRA coding and security standards defined by ICH E2B and the FDA’s 21 CFR Part 11. Additionally, our electronic reporting services allow expedited reporting to authorities as well as transmission of additional data. At ACCOVION, your safety data are hosted in a protected IT environment.