课程概览
Course overview
Build your expertise to structure and execute high-stakes pharmaceutical deals with confidence while mastering the complex cross-border requirements driving modern M&A and licensing in the pharma sector.
This highly practical training course will strengthen your capability to deliver compliant, value-focused transactions from strategy through to integration.
This advanced course is designed for leaders and specialists who need to navigate the fast-moving regulatory, commercial and compliance landscape governing pharma M&A, licensing and partnership execution.
As deal structures grow more complex and global scrutiny intensifies, organisations need teams capable of designing transactions that are strategically sound, value-accretive and compliant from diligence through post-close integration.
This training course delivers that capability through immersive, case-driven learning built around real datasets, model templates and negotiation simulations.
Across three full days, participants work through the complete deal lifecycle - from strategic design and valuation to regulatory approvals, integration planning and compliance embedding.
Modules include deal structuring, rNPV-driven asset valuation, regulatory and antitrust execution, MAH/PV transfer mechanics, financial reporting impacts, and the latest UK and global risk frameworks (NSI Act, CMA/EU/US merger control, sanctions, ABAC, GDPR/UK GDPR).
Practical workshops and role-plays apply each concept using pharmaceutical examples and contemporary market data.
Delegates will gain a deeper strategic understanding of pharma transactions and the confidence to manage high-risk, cross-functional deal processes.
They will gain practical tools for diligence, valuation, integration planning and compliance assessment - sharpening decision-making skills and reducing execution risk.
The practical format of the training course will enable participants to return to their roles better equipped to design, negotiate and deliver successful transactions in a highly regulated and competitive sector.
During this highly interactive training course, the expert trainer uses a balanced mix of:
Case-led workshops
: Real-world transactions drawn from leading pharma M&A cases
Financial & operational modelling
: Hands-on exercises in valuation, synergy mapping, and IFRS-based purchase accounting (PPA)
Negotiation exercises
: Participants negotiate SPA and JV term sheets covering warranties, ABAC, regulatory, and PV covenants
Compliance deep dives
: Structured sessions linking finance and governance to legal frameworks and disclosure requirements
: A team-based scenario integrating regulatory clearances, ABPI/EFPIA transparency, DSCSA/FMD readiness, and integration governance.
Delegates will benefit from a toolkit for ongoing reference, including:
Financial models
: rNPV valuation, synergy/operating model, PPA/CGU template, and regulatory approvals GanttChecklists: MAH transfer & PV continuity, DSCSA/FMD readiness, ABAC/FCPA diligence, sanctions screening, GDPR/UK GDPR protocols
Clauses library
: Ready-to-adapt SPA/JV covenants for regulatory, PV/quality, sanctions, ABAC, and data protectionPlaybooks: CMA/EUMR/HSR filing guide, NSI/CFIUS templates, ABPI/EFPIA disclosure workflows
Reference compass
: Summaries of Takeover Code, CMA rules, IFRS 3/IAS 36/38, ABPI Code 2024, FCPA Resource Guide, and OECD BEPS updates.
This training course is part of our series of
Corporate Strategy Training Courses
covering the essential skills and best practices for all Company Directors and Company Secretaries, as well as business leaders and entrepreneurs.
Benefits of attending
By attending this training course, you will:
Understand
how to select appropriate deal structures - asset/share deals, carve-outs, licences, JVs - based on risk, regulatory complexity and value creation
Learn
how to map and manage an end-to-end M&A lifecycle, assigning clear accountabilities across strategy, diligence, closing and integration
Build
a pharma-specific valuation and synergy case using rNPV, LOE/8+2+1 modelling, PV/GVP cost drivers, serialisation requirements and tax considerations
Grasp
how to run regulatory, antitrust, FDI, and public-company workstreams aligned with the UK Takeover Code, NSI Act, CMA/EU/US merger control, HSR and CFIUS
Execute
MAH transfers, QPPV/PSMF changes, PV agreements, variations, serialisation readiness, and other sector-specific regulatory transitions
Integrate
compliance frameworks into deal planning, including ABPI/EFPIA, the UK Bribery Act, US FCPA/AKS/Open Payments, sanctions/exports, and data protection rules
Get to grips
with applying relevant financial reporting standards - IFRS 3, IAS 36, IAS 38 - and understand how Pillar Two tax rules affect deal design and post-close performance
Who should attend?
This training course has been designed for senior and mid-level professionals in the pharmaceutical industry involved in deal-making, commercial strategy and regulatory or financial oversight, including:
Business unit managers
Commercial & market access managers
Business development managers
Licensing managers
Regulatory affairs and quality assurance professionals
Pharmacovigilance leaders
Technical operations managers
Finance business partners and directors
Legal & compliance managers involved in deal-making or partnership governance
In-house and private practice lawyers
Board members and directors
Essentially, anyone responsible for designing, negotiating, executing, or integrating pharmaceutical transactions, including M&A, licensing, joint ventures, and strategic collaborations, will benefit from this programme.
This course will cover:
Pillar Two overview and signals for footprint/design
课程大纲
Day 1
Day 2
Day 3
Module 1: Structures, Valuation & IFRS Overlays
Orientation and Diagnostics
Heat-map of prior deal exposure;
identify priority risks (PV, MA transfers, HSR/NSI, ABAC)
Pharma deal structures and when to use them
Share vs asset deals, spin-outs/carve-outs;
licence, co-dev/co-promo, JV, options/CVRs
Exclusivities (8+2+1), orphan/paediatric extensions and how they shape value/risk transfer (SPS)
Exercise: Structure a co-dev + regional licence with milestones and MAC/termination protections
Deal thesis and valuation in pharma
rNPV for assets by phase;
success probabilities;
LOE cliffs;
PV and GxP compliance cost curves
IFRS overlays: recognising identifiable intangibles vs goodwill (IFRS
- 3), useful lives (IAS
- 38), impairment triggers (IAS
- 36)
Exercise (Model): Build a pipeline rNPV with sensitivity to access/pricing
Module 2: Clearance essentials and governance
Global merger control essentials
UK CMA process (EA02), Phase 1/2;
EU Merger Regulation (Form CO);
US HSR thresholds/fees (2025)
Snapshot: China SAMR, India CCI (deal value threshold/SBOI), Brazil CADE timelines
Exercise: Multi-jurisdiction filing map and timetable for a cross-border acquisition
UK public M&A and national security
UK Takeover Code principles, scope, key timetable/announcements
UK National Security & Investment Act - mandatory sectors, call-in power, notifications
Exercise: Draft a Heads of Terms with NSI conditions precedent
Partnerships that work
Governance of JVs and alliances (steerco, decision rights, audit, IP, PV & quality agreements)
Case clinic: Why alliances fail (mis-aligned value drivers, weak PV/QMS linkages)
Module 3: Regulatory, quality, supply chain and data
Regulatory diligence and transfers
MAH transfer mechanics (MHRA/EMA), change-of-ownership packs, variations
PV system readiness - QPPV continuity, PSMF updates, safety database migration, SDEAs
Exercise (Checklist Build): MAH transfer and PV continuity plan for Day 1/Day 100
Manufacturing, serialisation & supply chain
EU FMD safety features;
U.S. DSCSA interoperable traceability
Tech-ops diligence: QMS, data integrity, deviation trends;
cost & CapEx implications
Exercise: Quantify inventory/write-off risk from a DSCSA/FMD gap
Data, privacy and information separation
UK GDPR/GDPR principles for diligence rooms, special category health data;
clean team protocols
Integration of RWD/RWE assets
Module 4: ABAC, sanctions and documentation
ABAC, transparency and interactions with HCP/HCOs
UK Bribery Act - “adequate procedures” (6 principles);
third-party due diligence
US FCPA - M&A safe-harbour expectations;
integration timelines
ABPI 2024 Code / Disclosure UK timelines;
EFPIA Code (2025);
ToV disclosure expectations
Exercise (Controls Lab): Design a ToV capture & disclosure control for an acquired affiliate
Sanctions and export controls in cross-border deals
UK OFSI financial sanctions framework;
U.S. OFAC compliance framework
Screening counterparties/products;
red-flag escalation and SPA clauses
Exercise: Sanctions screening flow and reps/warranties schedule
Documentation essentials
SPA/JV clauses for pharma: regulatory covenants, PV agreement conditions precedent, serialisation readiness, transitional services, earn-outs/CVRs
Module 5: Approvals, accounting and integration
Clearance strategy and multi-agency sequencing
EU Form CO vs simplified;
U.S. HSR and second request;
practical timing with 2023 DOJ/FTC Merger Guidelines
FDI reviews: CFIUS scope and triggers;
UK NSI notifications
Emerging markets scan: SAMR (China), CCI (India DVT/SBOI), CADE (Brazil) process cues
Exercise: Build an integrated approvals Gantt with long-stop dates & CPs
Accounting, reporting and tax in the first 180 days
IFRS 3 purchase accounting (PPA), identifiable intangibles, contingent consideration, IPR&D
IAS 36 goodwill CGUs;
IAS 38 R&D capitalisation boundaries
Pillar Two overview and signals for foo
tprint/design
Exercise: Mini-PPA with CGU mapping for a specialty pharma target
Integration planning: day 1 to day 100
Standing up the PV system;
QMS/quality release;
regulatory & artwork change control;
serialisation repositories;
data migration;
TSA governance
Module 6: Negotiation and simulation
Negotiation Lab: SPA/JV Term Sheet
Teams negotiate reps/warranties, indemnities, risk-sharing (milestones/CVRs), antitrust/FDI covenants, sanctions/ABAC clauses, PV/quality undertakings
Debrief: what Legal, QA/PV, RA, Finance each need in “must-have” schedules
Communications, MAR and disclosure (public deals)
UK Takeover regime disclosures and announcements;
inside information and market-abuse risks
Capstone simulation
Cross-border acquisition facing: CMA/EUMR, NSI call-in, DSCSA dependency, ABPI/EFPIA ToV harmonisation, PPA for IPR&D
Teams produce: approvals plan, D1 controls, synergy tracker, and risk register
30/60/90-day action plan and ownership