18 June 2026

7.00 – 8.00 CET

DELEGATE REGISTRATION AND NETWORKING BREAKFAST

8.00 – 8.10 CET

Chair's opening remarks

External Manufacturing

Carina Syring

VP, External Manufacturing
Bristol Myers Squibb

External Quality

Henry Ames

General Manager, Logistics Orchestration
TraceLink

8.10 – 8.40 CET

Keynote

Maria Rigotti

Global Quality Officer
Chiesi

Transforming Pharmaceutical Operations to Drive Efficiency, Agility, and Long-Term Supply Resilience

  • Modernizing operational models to reduce complexity and improve end-to-end execution across internal and external networks
  • Building agile manufacturing and supply structures that respond faster to demand shifts and capacity constraints
  • Embedding operational excellence principles to drive sustainable efficiency without compromising quality or compliance
  • Strengthening cross-functional collaboration between supply, quality, technical operations, and external partners
  • Improving decision-making speed through better governance, data visibility, and escalation pathways
8.40 – 9.10 CET

PLENARY

Timo Flessner

SVP, Manufacturing API and Lead, Medical Devices
Bayer

Strengthening External API Manufacturing Through Scalable Partnerships and Operational Excellence

  • Strengthening external API manufacturing strategies to ensure robust supply continuity and execution resilience
  • Aligning CDMO capabilities with internal technical and quality expectations across global manufacturing networks
  • Optimizing process scale-up and technology transfer to accelerate commercialization timelines and reduce risk
  • Enhancing GMP oversight models to maintain consistent quality performance across external API suppliers
  • Implementing data-driven performance management to improve transparency and accountability across partners
  • Leveraging strategic collaboration to enable innovation and flexibility within complex external manufacturing ecosystems
9.15 - 9.45 CET

Workshops

Room 1

Henry Ames

General Manager, Logistics Orchestration
TraceLink

Powering Seamless Supply Chain Coordination to Deliver Distinctive Strategic Impact

  • Showcasing real-world examples of companies using no-code tools to quickly connect with partners and manage joint processes in manufacturing, logistics, and trade
  • Highlighting key digital tools and systems needed to build efficient and scalable supply chain operations
  • Providing practical ideas participants can apply to their own digital supply chain journeys, based on peer experiences

Room 2

Speaker TBA


Catalent

Maximizing External Value Through Integrated CDMO Solutions for Pharma and Biologics

  • Highlighting Catalent’s approach to seamless collaboration from early development through commercial supply execution
  • Leveraging integrated drug delivery technologies to overcome formulation and bioavailability challenges
  • Streamlining technology transfers to support predictable scale-up across oral, sterile, and biologic modalities
  • Driving resilient clinical and commercial supply through optimized packaging, distribution, and cold chain strategies
  • Enhancing operational oversight across global CDMO networks to mitigate supply risk and protect timelines
9.50 – 11.10 CET

Refreshments, Networking and Pre-Arranged 1-2-1 Meetings

11.15 – 11.45 CET

STREAMS

EXTERNAL MANUFACTURING

Carolina Oliveira

Director, Global Operations Strategy
Grünenthal Group

Building Resilient External Manufacturing Ecosystems

  • Mapping external manufacturing networks to optimize agility and mitigate supply disruptions
  • Strengthening dual-sourcing and site diversification strategies to reduce geographic and operational risks
  • Aligning CDMO capabilities with long-term product lifecycle planning
  • Creating joint risk management frameworks with external partners
  • Enhancing transparency through integrated planning and performance dashboards
  • Defining business continuity plans tailored to external manufacturing contingencies

EXTERNAL QUALITY

Ridwaan Jhetam

SVP and Head, Worldwide Medical Affairs Hematology
Bristol Myers Squibb

Elevating CDMO Compliance: Aligning with Evolving Global GMP Standards

  • Ensuring CDMOs align with evolving regional and international GMP requirements
  • Conducting proactive audits to detect and prevent quality and regulatory deviations
  • Training partner teams on quality culture and global compliance expectations
  • Integrating digital tools for real-time regulatory and documentation tracking
  • Benchmarking CDMO compliance levels against global industry best practices
11.50 – 12.50 CET

Lunch & Learn Roundtable Discussions

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance is limited. Choose from:

Golo Heckmann

Head, API and Chemical Process Development, Animal Health
Boehringer Ingelheim

From External Development to Commercial Supply – Building Resilient GMP‑Compliant API Networks

Joana Gaspar

Associate Director, CMC Compliance Strategy, Integrations
Grünenthal

From Compliance to Product Excellence: Strategic Evolution of CMC in External Supply

Martin Hughes

Executive Director, CMC
Immuneering

Building Adaptive Operations to Withstand Geopolitical Shifts and Regulatory Disruptions

Katherine Barton

Senior Director, CMC Global Regulatory Affairs
Fulcrum Therapeutics

Bridging CMC Innovation and Regulatory Compliance for Global Manufacturing Agility

Linda Intoft Gauffin

Senior Director, Manufacturing Technical Operations
Calliditas Therapeutics

Strengthening Supplier Management Models to Improve Performance Across External Operations

Joseph Vu

Executive Director, Regulatory Affairs, Strategy & CMC
Taiho Oncology

Enhancing CMC Quality Assurance to Strengthen Global External Manufacturing Networks

Marina Palumbo

Senior Director/External Supply Operations Quality Global Biopharma 1 Cluster lead
Pfizer

Strengthening External Supply Quality Operations to Protect Supply and Compliance Globally

Emma Newton

Head, Product QA
Astellas Pharma Europe

Partnering for Quality: Aligning CMO Excellence with Pharma QA Expectations

Manuel Becker

Head, Digital Transformation, Core Model and Supply, Global External Manufacturing and Supply
Sanofi

Unleashing AI Potential to Drive Smarter Digital Collaboration in External Manufacturing Networks

Salomon Engels

Head, External Manufacturing
Par Health (former Mallinckrodt-Endo)

Defining the KPIs That Improve Vendor Performance and Operational Reliability

Mark Hess

Director, Supply Chain Quality Systems & Programs
AbbVie

Strengthening Supply Chain Quality Systems to Ensure Reliable and Compliant External Operations

12.55 - 13.40 CET

Panel Discussion

  • Anne‑Laure Hussenot-Bouvet

    VP and Head, Quality, Specialty Care
    Sanofi

  • Anna Löfgren

    VP and Head, Quality Assurance
    Hansa Biopharma

  • Liesbeth Foesters

    VP and Head, External and Clinical Supply Quality
    UCB

  • Heike Hardelauf, Ph.D.

    VP and Head, External Supply Management, Oncology, Cardiovascular & Women´s Healthcare
    Bayer

  • Agnes Roque-Cera

    Director, Quality Control
    Gilead Sciences

  • Beverly Smith

    Senior Director, Technical Capabilities
    Bristol Myers Squibb

Women In Leadership

  • What actionable strategies can leaders take to build a culture that empowers women in technical and manufacturing roles?
  • What has been the most significant barrier in your career, and how did you overcome it?
  • How do you push for systemic change in organizations where resistance still exists?
  • What’s one leadership lesson that has defined your career path?
  • How do you and your teams support and inspire the next generation of professionals in manufacturing and quality?
13.40 – 14.10 CET

Sessions

EXTERNAL MANUFACTURING

Christina Da Cunha, Ph.D.

VP, CMO Business Operations and Transformation, External Manufacturing and Supply
Sanofi

Strengthening CDMO Partnerships: Governance, Transparency, and Performance Alignment

  • Building trust through consistent engagement and performance transparency
  • Establishing KPIs to monitor CDMO and supplier accountability
  • Conducting joint business reviews to align on strategic goals
  • Mitigating risk by mapping tier-2 and tier-3 supplier dependencies
  • Enforcing contract terms through structured governance and audits
  • Incentivizing innovation and responsiveness through performance-based models

EXTERNAL QUALITY

Mikkel Sandorff

Senior Director, Operations, Global Contract Manufacturing Drug Product
Novo Nordisk

Driving Operational Excellence Through a Strategic Evaluation Framework for Global Contract Manufacturers

  • Developing an integrated evaluation framework to align CMO performance with strategic business goals
  • Enhancing supplier segmentation to improve visibility, accountability, and continuous improvement initiatives
  • Applying data-driven performance indicators to strengthen decision-making and network optimization
  • Balancing agility and compliance to ensure stability and long-term supply resilience
  • Fostering a culture of transparency and collaboration across internal and external manufacturing teams
  • Utilizing benchmarking insights to drive consistent quality, operational efficiency, and joint innovation
14.10 – 14.55 CET

Panel Discussion

  • Suyamburam Sathasivam

    AVP and Head, External Manufacturing
    Sun Pharmaceutical

  • Roeland Vandebrouck

    Senior Director and Head, External Supply Operations
    Grünenthal Group

  • Amanda Pergamo

    Senior Director, Operations
    Elanco

  • Catherine Seigneur

    Senior Director, External Manufacturing Business Lead
    UCB

  • Salomon Engels

    Head, External Manufacturing
    Par Health (former Mallinckrodt-Endo)

  • Carina Syring

    VP, External Manufacturing
    Bristol Myers Squibb

Optimizing CDMO Partnerships for Long-Term Success and Strategic Alignment

  • Defining what “strategic partnership” truly means in today’s outsourced manufacturing landscape
  • Balancing flexibility and control in shared responsibility models across development and commercial supply
  • Aligning technical capabilities and innovation goals with long-term portfolio strategy
  • Navigating IP, data transparency, and governance in high-value CDMO collaborations
  • Managing performance expectations, KPIs, and escalation pathways across global teams
  • Evolving from transactional models to co-creation: what drives trust and joint value creation
14.55 – 15.05 CET

Chair's Closing Remarks

External Manufacturing

Carina Syring

VP, External Manufacturing
Bristol Myers Squibb

External Quality

Henry Ames

General Manager, Logistics Orchestration
TraceLink

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