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Specialist compliance area: Infectious diseases combines the complexities of hospital prescribing, antibiotic stewardship responsibilities, HIV and hepatitis stigma considerations, and emergency/compassionate use rules. Off-label prophylaxis promotion, resistance barrier claims and diagnostic-linked prescribing materials all carry specific ABPI Code risks that are frequently misunderstood.
Claims about the resistance barrier, resistance profile or cross-resistance of HIV antiretrovirals or antibiotics must be supported by robust data relevant to the licensed indication and must not imply clinical superiority without head-to-head evidence.
Promotional activity that facilitates or encourages off-label use of antiretrovirals in PrEP settings, or antibiotics in surgical prophylaxis beyond the licensed indication, is a significant Code risk — particularly for materials shared at HIV or infectious diseases conferences.
Materials that link specific diagnostic tests or biomarkers to prescribing decisions in a way that promotes off-label use, or that imply a preferred prescribing pattern beyond the licence, have attracted PMCPA attention in infectious diseases.
Companies sponsoring antibiotic stewardship programmes or educational initiatives must ensure these do not contain promotional elements for their own products. Blurring the educational/promotional boundary in hospital settings is a frequent PMCPA trigger.
COVID-19 antiviral and other infectious disease products approved under emergency or conditional marketing authorisation must not be promoted as if fully licensed. Any promotional activity prior to or beyond the full licence scope is a serious breach.
Claims about sustained virologic response rates, treatment duration or simplicity of dosing regimens for hepatitis C direct-acting antivirals require careful attention to genotype-specific data and must not imply superiority without comparative trial data.
Built specifically for pharma teams working in infectious diseases — not generic compliance content repurposed for your therapy area.
The pack includes expert walkthroughs of all relevant PMCPA adjudications in infectious diseases. Here are three landmark cases.
The pack includes all relevant infectious diseases PMCPA cases with video walkthroughs, expert commentary and quiz questions.
MSLs and medical advisors presenting HIV, hepatitis C and hospital antibiotic data, where resistance profiling, guideline positioning and off-label enquiries require careful compliance management
Specialist sales teams working in infectious diseases units, HIV clinics and hospital pharmacy — where the boundary between educational and promotional activity is particularly scrutinised
Teams making formulary and budget impact claims for HIV antiretrovirals, HCV DAAs and novel antibiotics, where treatment pathway claims must be carefully qualified against licensed indications
Regulatory affairs and compliance officers reviewing infectious diseases promotional materials, conference content, stewardship programme materials and emergency/conditional use communications
Speak to us about the Infectious Diseases Compliance Pack. Tell us your team size and therapy area focus and we'll put together the right package.
Need more therapy areas? See all 12 therapy area packs →
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All 2,000+ PMCPA cases. Video. Podcast. Quiz. 5 points per case. The only case library of its kind in the UK.
12 therapy area packs covering Respiratory, Oncology, Cardiovascular, CNS, Diabetes, Immunology, Infectious Diseases, Dermatology, Musculoskeletal, Ophthalmology and more.
One real case. One key lesson. Every week — free.