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