14 rules · Last sync 4 minutes ago · Helix Therapeutics - Production
Track and disclose all transfers of value to US-licensed HCPs aggregating above $100/year per Open Payments re…
Honoraria for oncology specialist advisory boards capped at €2,100/hour with €15,000 aggregate annual disclosu…
Honoraria for general internal medicine advisory boards capped at €1,500/engagement per Helix SOP §4.2(b).…
LEEM Code: speaker honoraria, venue restrictions, and DPI disclosure requirements for French HCPs.…
Block new speaker programs Oct 1 – Dec 15 during annual compliance audit window per SOP §4.3(c).…
Unsolicited off-label inquiries routed to Medical Information; promotional response patterns blocked.…
18 Safe Harbor identifiers stripped or tokenized from any HCP-submitted content before storage or routing.…
Special-category data minimization, EU residency, and lawful-basis tagging on all HCP conversation logs.…
Seriousness, expectedness, severity, and causality assessment on every detected AE; ICSR draft generation.…
Two-step compliance + medical pre-approval for any US speaker program; routes to MLR queue.…
Serious incident reporting deadlines for combination products under EU MDR Article 87.…
No more than 4 engagements/year per Tier-1 KOL; tier reclassification requires CCO sign-off.…
UK ABPI Code 2026: subsistence £75 cap, no spousal hospitality, meeting venue appropriateness.…
Any comparative efficacy claim requires head-to-head trial citation; MLR mandatory.…
