Latest Articles
The ICH E2B(R3) Deadline Is Here: What Small Biotechs Need to Know About ICSR Intake
IND electronic ICSRs have been required since 1 April 2026. From 1 October 2026, postmarketing files sent through ESG NextGen to AEMS, formerly FAERS, must be E2B(R3). Intake is still where small teams stall.
Read article →Follow up reports and missing information
When a later email starts a new reporting clock, and when a correction inside the company does not. The case number has to stay the same.
FAERS reporting now goes to AEMS
The FDA Adverse Event Reporting System is now named the FDA Adverse Event Monitoring System. What the rename changes for people who submit.
FDA adverse event reporting requirements for marketed drugs and biologics
Who must report under 21 CFR 314.80 and 21 CFR 600.80, the 15 calendar day alert, and what an ICSR has to contain.
Looking for a MedWatch 3500A alternative
The Safety Reporting Portal and an E2B(R3) file on ESG NextGen are the electronic paths FDA describes into AEMS, formerly FAERS.
Postmarketing safety reporting when the sponsor is still small
From an IND to a marketed product: intake on day one, a CRO, a safety database, and what Part 11 asks of the record.
ICSR intake before the case is a submission
What 21 CFR 314.80 says an ICSR includes, and how a reviewed case reaches the safety database before an E2B(R3) file.
AE reporter forms for patients and healthcare professionals
What a patient or healthcare professional report must contain before Day 0, and what an email leaves out.
PV case intake forms: what a small team should capture
Reporter, patient, product, and event. What belongs on a PV case intake form, and what the form is not.
Adverse event reporting: AE, SAE, and what the sponsor actually sends
An adverse event is any untoward occurrence. An SAE meets a seriousness criterion. Reporting is a separate decision.
SUSAR reporting: serious, unexpected, and suspected
Three tests, the 7-day and 15-day clocks, and integration with the safety database, which remains the system of record.
Product quality complaint reporting when a patient is also involved
A cloudy vial is a quality complaint. A cloudy vial plus a fever is also an adverse event until someone shows it is not.
E2B(R3) ICSR submissions start with a complete case
E2B(R3) is the electronic shape of an ICSR. AE Connect integrates the case with any safety database, which remains the system of record.
AI pharmacovigilance case processing, with a person on every field
Case processing is a set of judgments. The workspace drafts them. A person accepts or overrides each one.
Aggregate reports: PSUR, PBRER, and DSUR in plain language
How periodic safety reports differ from a single case, and why the intake workspace does not write them.
How AE Connect works with Oracle Argus
What Argus Safety is for, and what an intake workspace is not. No integration claim.
How AE Connect works with ArisGlobal LifeSphere
LifeSphere Safety, the Safety One name, and why AE Connect is not either system.
How AE Connect works with Veeva Vault Safety
What Vault Safety is for. AE Connect is not a Vault product. It integrates with Vault Safety, which remains the system of record.
Adverse Event Intake vs. Full Pharmacovigilance: What Is the Difference?
Understanding where AE intake ends and full pharmacovigilance begins, and why the distinction matters for small biotech program design.
Why Veeva Vault Safety and Oracle Argus Are Overkill for Early-Phase Biotech Programs
A practical look at why enterprise PV databases are designed for large MAHs, and what small IND sponsors actually need instead.
The Missing Layer in Pharmacovigilance: Why Adverse Event Intake Has Been the Blind Spot
Enterprise databases handle case processing. Spreadsheets handle intake. That gap is where compliance risk lives — and where AE Connect was built to operate.
The drug safety inbox at a small biotech
AE, SAE, SUSAR, and product quality complaints still arrive by email. What gets lost before a case reaches Argus, ArisGlobal, or Veeva.
The first IND PV plan: timelines, the company core data sheet, and aggregate reports
Day 0, the company core data sheet, and aggregate reports are where a first pharmacovigilance plan goes thin.