课程

Finance for Non-Financial Leaders in the Pharmaceutical Industry

GAZI Arif · 授课老师

Course overview I n today’s highly regulated and cost-sensitive pharmaceutical environment, financial literacy is no longer optional for business lead…

课程内容

课程概览

Course overview

I

n today’s highly regulated and cost-sensitive pharmaceutical environment, financial literacy is no longer optional for business leaders - it’s a strategic necessity.

Every decision, from R&D investment to market access and compliance, directly impacts the Profit & Loss (P&L) and long-term value creation.

This workshop-style training course is designed specifically for non-financial leaders across the UK and global pharmaceutical sector who need to understand how financial principles integrate with the unique regulatory, pricing and compliance frameworks shaping pharma performance.

Through a mix of hands-on case studies, financial modelling exercises and a capstone simulation, participants will gain practical insight into how financial decisions interact with VPAG pricing, HTA outcomes, IFRS reporting, and compliance obligations under GxP, ABPI, and global anti-bribery frameworks.

By the end of the training course, you’ll be able to confidently interpret and explain a pharma P&L, connect operational and regulatory realities to financial outcomes, and apply accounting and compliance standards to real-world business scenarios.

You’ll also learn how to anticipate the financial impact of complex issues such as serialisation, managed entry agreements, transfer pricing and global tax reforms.

Whether you lead commercial, operational, or compliance teams, this training course will equip you with the financial fluency and strategic insight to contribute effectively to cross-functional decision-making and drive sustainable growth in a challenging global market.

During this highly interactive course, the expert trainer uses a practical, case-based learning approach that bridges technical finance with pharmaceutical operations, including:

Interactive simulations:

scenario-driven exercises where teams interpret real-life product P&Ls and cash-flow impacts

Worked models

: participants use tailored Excel tools (gross-to-net waterfall, rebate accrual engine, NPV calculator) to quantify and visualise financial outcomes

Regulatory crosslinks

: each finance topic is tied to live UK and global regulatory sources (KPMG, GOV.UK, EMA, OECD, ABPI)

Capstone session

: a group-based simulation integrating finance, compliance, and strategy to manage a hypothetical product through a complex pricing and supply chain challenge

Delegates will benefit from a toolkit for ongoing reference, including:

Excel models:

gross-to-net waterfall, rebate accrual engine, NPV scenario toolChecklists: VPAG forecasting checklist, ABPI/EFPIA disclosure template, BEPS Pillar Two readiness scan, GxP/GVP financial triggers, DSCSA/FMD compliance tracker

Reference compendium

: summaries of key regulatory and financial frameworks, including IFRS, OECD, MHRA, and ABPI updates.

Key references (standardised citations):

GOV.UK – Voluntary Scheme for Branded Medicines (2024–2028)

KPMG Pharma Accounting Updates (Revenue Recognition & IFRS Applications)

EMA – Good Manufacturing Practice and Serialization Guidelines

OECD – Base Erosion and Profit Shifting (Pillar Two Framework)

ABPI – Code of Practice (2024)

MHRA – GxP Data Integrity Guidance

All financial and regulatory frameworks used in this training reflect the latest publicly available

guidance at the time of delivery. (VPAG rates, DSCSA/FMD timelines, OECD BEPS Pillar

Two thresholds, etc., are subject to periodic revision.)

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Benefits of attending

By the end of the training course, participants will be able to:

Interpret

a pharmaceutical Profit & Loss statement, identifying the impact of rebates, chargebacks, clawbacks, and returns on gross-to-net revenue

Apply

IFRS 15, IAS 38, and IAS 37 standards to real-world pharmaceutical settings, understanding how revenue recognition, development capitalisation, and provisions interact within R&D and market access portfolios

Navigate

the UK VPAG 2024–2028 pricing framework, model revenue implications of NICE and HTA outcomes, and integrate these into business forecasts

Recognise

the financial consequences of GxP, GMP, and MHRA compliance deviations - from yield losses and write-offs to impairments

Integrate

key compliance frameworks (ABPI/EFPIA, UK Bribery Act, US FCPA, Anti-Kickback Statute, Sunshine Act/Open Payments) into SOPs and finance controls

Understand

OECD BEPS Pillar Two and global minimum tax reforms for multinational pharma operations, and model their impact on tax and transfer pricing decisions

Assess

how serialisation and traceability regulations (EU FMD and US DSCSA 2024/2025) influence financial exposure, inventory management, and working capital.

Who should attend?

This training course has been designed specifically for senior and mid-level managers, team leaders and technical specialists from R&D, clinical, regulatory, commercial, sales and marketing, manufacturing, distribution and purchasing in the pharmaceutical industry.

General managers and team leaders

Operations directors

Business unit heads of department

Technical specialists from R&D and clinical

Medical affairs professionals

Commercial and brand managers

Quality assurance managers

Regulatory affairs managers

Procurement and supply chain managers

Market access and pricing managers

Legal and compliance officers

Finance business partners transitioning into strategic finance roles

Non-financial executives preparing for senior leadership roles

This course will cover:

课程大纲

  • Day 1

    Day 2

    Welcome & diagnostics

    Poll: comfort with P&L, balance sheet, cash flow;

    ‘where finance meets pharma’ map

  • Module 1: Revenue, Costs, Inventory & GxP

    Anatomy of a pharma P&L

    Revenue lines: list price vs gross-to-net (commercial & government rebates, returns, clawbacks)

    IFRS 15: variable consideration estimation & constraint;

    typical data sources (contracting, primary sales, rebate accrual models) (KPMG)

    Exercise: Build a gross-to-net waterfall and sensitivity (volume mix, rebate %)

    Costs, inventory & GMP realities

    COGS under GMP/cGMP: batch failures, yield loss, QC release timing;

    ties to EU GMP and 21 CFR 210/211 (Public Health)

    Inventory valuation (IAS

    • 2) and impairment triggers (IAS
    • 36) when stability/deviation issues arise

    MHRA GxP data integrity → audit trails → write-offs/provisions (GOV.UK)

    Exercise: Calculate the cash impact of a 2% yield loss and a 1-month QP release delay

  • Module 2: R&D, pricing access and global compliance

    R&D, intangibles & portfolio spend

    IAS 38: expense research vs capitalise development;

    criteria & evidence packs in pharma;

    impairment testing (IFRS)

    Milestones, options, in-licensing/out-licensing - accounting touchpoints

    Exercise: Decide capitalise vs expense for a Phase III program with CMC workstreams

    UK pricing & access: VPAG and NICE

    VPAG 2024–2028: structure, 2025 headline payment % = 22.9%, budgeting and revenue guidance impacts (GOV.UK)

    budget impact and patient access agreements

    Exercise: Model a VPAG clawback and a NICE-driven price cut into a forecast

    Global compliance that hits finance

    ABPI Code / Disclosure UK, EFPIA transparency;

    controls to avoid mis-posting

    UK Bribery Act (adequate procedures;

    reasonable hospitality) (GOV.UK)

    US FCPA, Anti-Kickback Statute & Open Payments: risk areas in speaker fees, grants, research funding

    Exercise - controls lab: map these rules to finance approvals, GL tagging, and third-party due diligence steps

  • Module 3: Decisions, tax and supply chain risk

    Decision finance for leaders

    Cash vs profit;

    NPV/IRR for launch, capacity, or localization;

    scenario & sensitivity trees

    Working-capital levers in pharma (inventory turns under GMP lead times;

    serialisation buffers)

    International tax & operating models

    OECD BEPS Pillar Two (15% minimum) - who it hits, what to monitor (ETR, topup tax), and implications for site/location choices and transfer pricing (OECD)

    Exercise: Pillar Two quick-scan - where might your group face top-up tax?

    Supply-Chain Integrity & Financial Risk

    EU FMD serialisation and write-off risk;

    US DSCSA 2024/2025 interoperable traceability → revenue hold risks & chargebacks (EMA)

    Exercise: Quantify the cash impact of a serialisation/traceability non-compliance hold

  • Module 4: Revenue excellence, risk and capstone

    Revenue excellence in practice

    Contracting mechanics: tenders, patient access/MEAs, returns and recalls

    Deep dive IFRS 15: estimating rebates/returns, constraint, true-ups;

    audit trail expectations (KPMG)

    Exercise - workbook: Build a rebate accrual model (baseline vs stretch scenarios) and draft disclosure notes

    Risk, controls & governance

    Linking GxP deviations, GVP pharmacovigilance obligations and recall decisions to provisions (IAS 37) and impairment;

    board reporting (EMA)

    Exercise: Draft a finance–QA joint KPI set (deviation cost per batch, right-firsttime, stability failures, PV signal cost)

    Capstone simulation

    Team case: one product faces

    (i) VPAG clawback uplift

    (ii) DSCSA system delay at a 3PL

    (iii) PV signal requiring label change

    Teams update P&L/CF forecast, set provisions, outline controls & stakeholder comms (NHS, HTA, HCP transparency)

    Action plans and 30/60/90-day commitments

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