Professional profile
About Jingyi
Jingyi Li advises pharmaceutical companies, biotech firms and healthcare companies on drug labeling, advertising, adverse event management and regulatory compliance from Shanghai's life-sciences corridor.
Ms. Li holds a law degree with clinical medicine background and practices at a Shanghai law firm. She was admitted in 2014 and has about twelve years of professional experience, working in English and Mandarin with Shanghai Bar Association credentials on file.
Read full profile
Drug labels, boxed warnings and advertising claims must align with approved indications. A strong warning communicates known serious risks; it does not erase manufacturing defects, delayed label updates or off-label promotion. She builds label decision records with owners and dates so silence in the file cannot be read as delay.
She works with pharmacovigilance and medical affairs teams on serious signal reviews, label update decisions and adverse event reporting, keeping China-specific requirements aligned with global CCDS documents.
When the global company core data sheet moves and the China label lags without a documented decision, enforcement and plaintiffs read the silence as delay. She institutionalizes written label decisions: update, watch or no action, with owners and dates.
Promotional materials and medical representative conduct are reviewed for consistency with approved labels. Claim language that works in English marketing often oversteps Chinese advertising standards.
She pre-clears customer-facing materials, training decks and KOL engagement plans, and builds internal approval workflows that leave an audit trail.
Adverse event and recall communications are sequenced with insurer and distributor notice duties so messages stay consistent across channels. When investigations begin, she coordinates privilege-aware response plans that preserve internal analysis.
Document holds on email and messaging begin when a dispute or regulatory inquiry is reasonably anticipated. Quiet deletions by well-meaning staff create narratives that are hard to unwind.
Provide product type, current registration status, label version history and any inspection, complaint or adverse event notice already received. Scope is confirmed in writing through this profile's inquiry channel.
Capability
