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FEATURED LIVE WORKSHOP

Global Regulatory CMC Strategy for Biologics

From Development and Global Registration to Digital CMC Transformation

20–22 November 2026 | Live Online | Friday–Sunday

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3-Day Live Online ProgrammeExpert-Led SessionsPractical Case DiscussionsInteractive Q&AReal-World Regulatory Perspective

From development strategy to Digital CMC.

A practical, case-based programme covering the regulatory CMC journey for biologics from development strategy and global registration through lifecycle management and Digital CMC transformation.

The workshop connects scientific development, regulatory strategy and real-world decision-making, helping participants understand not only what regulatory expectations are, but how to build and execute an effective global CMC strategy.

THE PROGRAMME

Three days. A connected CMC journey.

DAY 01Friday, 20 November 2026 | 6:15 PM IST

Building the Regulatory CMC Strategy

Biologics CMC Foundations & Global Regulatory Landscape

  • Regulatory CMC landscape for biologics
  • Key US and EU regulatory frameworks
  • Understanding global expectations and regional differences
  • Phase-appropriate CMC development
  • Building a regulatory CMC strategy from early development onwards
  • QTPP, CQAs, CPPs and control strategy
  • Connecting manufacturing science with regulatory strategy
  • Introduction to digitalisation and the changing CMC regulatory environment
Day 1 Outcome

Participants should understand how to structure a phase-appropriate regulatory CMC strategy for a biologic and connect product and process understanding with regulatory expectations.

DAY 02Saturday, 21 November 2026 | Timing to be confirmed

From Development Science to a Submission-Ready CMC Package

Product, Process, Analytical & Comparability Strategy

  • Cell line development and cell-bank strategy
  • Upstream and downstream manufacturing considerations
  • Formulation and drug-product development
  • Product characterisation
  • Analytical strategy and method development
  • Specifications
  • Stability strategy
  • Impurities and adventitious-agent considerations
  • Comparability strategy for manufacturing changes
  • Process validation
  • Lifecycle considerations
  • Translating development knowledge into a coherent regulatory submission strategy
Day 2 Outcome

Participants should understand how development, manufacturing, analytical, comparability and validation strategies come together within a regulatory CMC package, and how to recognise key regulatory risks.

DAY 03Sunday, 22 November 2026 | Timing to be confirmed

Global Registration, Lifecycle Strategy & Digital CMC

From Submission Strategy to the Future of Regulatory CMC

  • Building the global CMC registration strategy
  • Country-specific regulatory considerations
  • Managing differences between major regulatory markets
  • Health-authority questions and CMC interactions
  • Managing CMC commitments and regulatory expectations
  • Post-approval changes and lifecycle strategy
  • Global change implementation considerations
  • Real-world regulatory CMC case discussions
  • Moving from document-centric CMC to structured regulatory data
  • Digital CMC and data-driven submissions
  • Role of automation and AI in regulatory CMC
  • Data quality, governance and regulatory readiness
  • The future regulatory CMC operating model
Day 3 Outcome

Participants should understand how to take a CMC strategy through global registration and lifecycle management, while preparing for the transition towards structured regulatory data, Digital CMC and AI-enabled ways of working.

20–22 November 2026 | Live Online

Register for the Workshop
PRACTICAL CASE DISCUSSIONS

Apply the strategy. Discuss the decisions.

Work through practical examples and realistic, experience-based regulatory scenarios, with opportunities for discussion and interactive Q&A.

  • Designing a phase-appropriate CMC strategy
  • Responding to development or manufacturing changes
  • Evaluating comparability risk
  • Preparing for global submissions
  • Managing different regulatory expectations across markets
  • Responding strategically to health-authority questions
  • Managing lifecycle changes
  • Identifying opportunities for structured regulatory data and Digital CMC
LEARNING OUTCOMES

What participants will learn.

By the end of the programme, participants should be better able to:

  • Build a structured regulatory CMC strategy for biologics
  • Connect development science with regulatory expectations
  • Understand how CMC strategy evolves across development phases
  • Recognise key considerations for US, EU and global registrations
  • Evaluate common CMC risks involving manufacturing, analytics, stability and comparability
  • Think strategically about health-authority interactions
  • Understand lifecycle and post-approval CMC considerations
  • Understand how structured data, Digital CMC, automation and AI are changing regulatory CMC
WHO SHOULD ATTEND

Build deeper knowledge. Broaden your perspective.

For professionals building deeper CMC knowledge and experienced professionals seeking a more strategic and global CMC perspective.

  • Regulatory CMC
  • Global Regulatory Affairs
  • Biologics development
  • Pharmaceutical development
  • Manufacturing and Technical Operations
  • Quality
  • Analytical development
  • Combination products where relevant
  • Regulatory operations
  • Regulatory data and digital transformation

20–22 November 2026 | Live Online

Register for the Workshop
WORKSHOP REGISTRATION

Register for the Workshop

Global Regulatory CMC Strategy for Biologics

20–22 November 2026 | Live Online

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