Field note
📍 Seton Hall Law's LATAM Healthcare Compliance Certificate Program. Bogotá.
I made an unpopular case:
The reform wave hitting Latin America — ANVISA VigiMed, ARCSA's new standard, COFEPRIS's national center, NOM-137, E2B(R3) by 2027 — is landing on RA and Pharmacovigilance teams that were already overworked and thinly staffed. There is no version of the next 18 months where they onboard enough headcount fast enough to absorb it manually. Which means the question stops being "should we use AI?" and starts being "how do we use AI without breaking the audit trail?"
My answer, what I've learned building one:
▸ Black box on the inside. Glass box on the record.
The model can be probabilistic. The audit trail cannot. Every model call gets an input hash, a version, a confidence score, and a human on the supervision layer. When ARCSA or ANVISA asks how the case was classified, you don't have to explain the model. You show the log.
Grateful to Seton Hall Law, the Cámara de Comercio de Bogotá, and every RA lead and compliance officer who stayed for the AI section instead of leaving for coffee, including the one who told me the talk "may have scared them." That was the point.
The LATAM PV/TV Reform Calendar 2026–2027
Six agencies. One direction. The dates every MAH in the region is now working against.
One page. What's already in force. What's coming through 2027. Ecuador (ARCSA), Brazil (ANVISA), Mexico (COFEPRIS), Colombia (INVIMA), Peru (DIGEMID), and regional (PAHO/AEMPS). Includes the reporting clocks quick reference and the pattern underneath.
⬇ Download the calendar (PDF, 1 page)First posted on LinkedIn · Sept 21, 2026