🟢 Therapy Area Compliance Pack · Oncology

Oncology Compliance Pack

Oncology carries the highest PMCPA exposure of any therapy area. PD-1/PD-L1 inhibitors, CDK4/6 inhibitors, PARP inhibitors and CAR-T therapies involve extraordinarily complex data landscapes — OS vs PFS claims, biomarker-driven prescribing promotion and compassionate use promotion are investigated repeatedly. This pack equips every oncology team member with the knowledge to navigate it.

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Instant access · ABPI Code 2024 · Oncology-specific guidance · Includes PMCPA case analysis

⚠️

Very high-alert therapy area: Oncology consistently generates the highest volume of PMCPA cases across all therapy areas. Checkpoint inhibitor comparisons, survival endpoint promotion, congress presentations with unpublished data and patient advocacy funding are among the most frequently investigated issues.

The specific risks your oncology team faces right now

📊 High Risk

OS vs PFS endpoint claims

Promoting overall survival data where only progression-free survival has been demonstrated — or implying OS equivalence — is one of the most common grounds for upheld PMCPA complaints in oncology. Endpoint selection must be accurate and transparent.

🧬 High Risk

Biomarker-driven prescribing promotion

Materials that effectively promote prescribing based on biomarker status beyond the licensed indication, or that imply a broader patient population than approved, are a persistent high-risk area for oncology teams.

🔬 High Risk

Combination regimen off-label use

Promotional activity that implicitly or explicitly encourages use of a product in combination regimens not approved in the licence — particularly relevant for CDK4/6 and PARP inhibitors — frequently results in PMCPA complaints.

🏛️ Medium Risk

Patient advocacy funding

Funding arrangements with cancer patient advocacy organisations require full transparency and must not create an appearance of promotional intent. Oncology patient advocacy is highly organised and visible to regulators.

📰 Medium Risk

Congress data — pre-publication use

Using data presented at oncology congresses (ASCO, ESMO) in promotional materials before full publication, or out of context from poster presentations, is a frequent source of regulatory challenge.

💊 High Risk

Compassionate use & early access promotion

Any promotional dimension to early access programme communications — including MSL involvement, materials and digital content — must be carefully managed to avoid breach of the prohibition on pre-licence promotion.

Everything your team needs in one pack

Built specifically for pharma teams working in oncology — not generic compliance content repurposed for your therapy area.

🎬
Oncology Compliance Module
45-minute e-learning module covering the six high-risk areas above, built on the ABPI Code 2024 with oncology-specific examples throughout.
📋
Curated PMCPA Case Analysis
All relevant PMCPA adjudications involving checkpoint inhibitors, CDK4/6 inhibitors, PARP inhibitors and other key oncology products, with expert commentary.
⚠️
Therapy Area Risk Profile
A structured risk assessment document mapping your team's activities against the highest-risk promotional practices in oncology — ready to take to your compliance committee.
Oncology Compliance Checklist
A pre-approval checklist covering endpoint claims, biomarker language, congress data usage, patient advocacy relationships and early access communications.
🎙️
Podcast Episode
A 30-minute podcast episode covering the most important PMCPA cases and compliance pitfalls in oncology — ideal for medical team briefings.
📄
CPD Certificate
Learners who complete the module and pass the assessment receive a CPD certificate with their name, score and date.
Oncology Compliance Pack
£599
per learner · annual access
163 PMCPA cases included
  • Oncology compliance e-learning module
  • PMCPA case library — oncology filtered
  • Therapy area risk profile document
  • Pre-approval compliance checklist
  • 30-min podcast episode
  • CPD certificate on completion
  • 12 months access
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Team pricing available
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Oncology cases that every team should know

The pack includes expert walkthroughs of all relevant PMCPA adjudications in the oncology space. Here are three landmark cases.

OS vs PFS Claims
AUTH/3288
Bristol-Myers Squibb · 2022
Upheld

Promotional materials for nivolumab presented PFS data in a manner that implied overall survival benefit not demonstrated in the relevant indication. The PMCPA found the presentation misleading and in breach of the Code.

Congress Data Usage
AUTH/3155
AstraZeneca · 2021
Upheld

An MSL shared a congress poster showing interim data from an ongoing olaparib trial with prescribers before the data had been peer reviewed. The PMCPA found this constituted pre-publication promotion.

Compassionate Use Promotion
AUTH/3502
Pfizer · 2024
Upheld

Communications associated with a palbociclib early access programme were found to contain promotional elements contrary to the prohibition on promoting unlicensed medicines and indications.

The pack includes all relevant oncology PMCPA cases with video walkthroughs, expert commentary and quiz questions.

Built for every function in your oncology team

💊

Medical Affairs

MSLs and medical advisors presenting checkpoint inhibitor and precision oncology data, managing KOL relationships and responding to off-label requests from oncologists

📈

Commercial Teams

Oncology sales specialists and brand managers responsible for promotional materials across immuno-oncology and targeted therapy portfolios

🔬

Clinical Development

Clinical teams communicating trial data at congresses, in publications and to investigators — where the boundary with promotion must be carefully managed

Regulatory & Compliance

Regulatory affairs and compliance officers reviewing oncology promotional materials, early access communications and congress content for ABPI Code compliance

Ready to reduce your oncology compliance risk?

Speak to us about the Oncology Compliance Pack. Tell us your team size and therapy area focus and we'll put together the right package.

Individual
£599
per learner · 12 months
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Team
POA
bespoke quote · bulk seats
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