课程

Mergers & Acquisitions and Partnerships in the Pharmaceutical Sector

GAZI Arif · 授课老师

Course overview Build your expertise to structure and execute high-stakes pharmaceutical deals with confidence while mastering the complex cross-borde…

课程内容

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

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