16th Annual Outsourcing in Clinical Trials Europe 2026

Creating a collaborative environment where pharma & biotech leaders can find solutions to current challenges through innovations and partnerships

6 - 7

May

2026
  • Hyatt Regency Barcelona Tower, Barcelona, Spain
  • Complimentary
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  • Agenda
  • Advisory Board
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Why attend?

WHAT TO EXPECT FOR 2026?

With regulations ever changing and the innovative advancements of technology rapidly growing, this conference will address the everyday and perspective challenges faced when working within the clinical trial space. Legislations such as the CTIS review to Generative AI and leveraging our global trial footprint to accelerate clinical development, as well as building on our new and existing relationships within our industry.

This conference will bring industry professionals together to share knowledge, with a focus on collaboration, advancing clinical development and concentrating on clinical operations, innovation, technology and of course, patient centricity.

This is a unique opportunity to network and share knowledge with the region’s leading pharmaceutical firms, biotech’s and medical device companies, to discuss operationally efficient, specifically targeted clinical trials. The 2026 program boasts 3 full streams complete with key content.

Stream A: Outsourcing & Clinical Operations

Stream B: AI, l Innovation & Technology

Stream C Day 1: Biotech Strategy

500+

Attendees

80+

Exhibitors

40+

Speakers

500+

Attendees

80+

Exhibitors

40+

Speakers

See What It's All About

Agenda

  • 6 May 2026
  • 7 May 2026
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Streams

Stream one

Stream A: Clinical Operations and Outsourcing

Stream two

Stream B: AI & Tech Transformation

Stream three

Stream C: Biotech Strategy

11:30 AM

Embracing the unknown: Tips and tricks on how to grow your clinical operations

  • How to build the clin ops and QA in a biotech
  • Building a network to support your biotech through challenges
  • Identifying weak points and understanding what you need to progress
  • Balancing trust and control when navigating the unknown to curb risk and accelerate progression

Speakers

Rebeckha Magnusson
Head of Clinical Operations & Quality Assurance, Ribcure

12 PM

Reserved for Event Sponsor

12:30 PM

Choosing the right CRO: key considerations for small biotech’s

  • Evaluating CRO capabilities and experience relevant to your specific therapeutic area and development stage
  • Balancing cost, quality and timelines within tight budget constraints
  • Negotiating contracts with flexibility to protect your biotech’s goals

Speakers

Neta Tobis
Director of Clinical Operations, BiomX

1 PM

Lunch and networking

2 PM

PANEL DISCUSSION The biotech landscape in Europe 2026: growths, shifts and strategic outlook

  • Analysing current market dynamics and funding trends shaping biotech growth in 2026
  • Addressing ongoing talent shortages and evolving workforce strategies
  • Funding and investment for biotechs in various regions of Europe: how has this shifted in 2026?
  • The impact of national political and economic changes on the biotech landscape in Europe

Moderator: Kate Dokukina, Head of Clinical Trials, Eilean Therapeutics

Speakers

Dr. Kate Dokukina
Head of clinical trials, Eilean Therapeutics
Michael Zörer
Head of Clinical Operations, VarmX
Karin Nordbladh
Director Clinical Operations, Alligator Bioscience

2:45 PM

Reserved for Event Sponsor

3:15 PM

The Pursuit of Success: Driving your drug from the lab to the patient

  • Defining what do we do well & what could be improved – EU vs US focus
  • Planning & preparation within clinical trials – focus on phase 2/3
  • Choosing the right trial designs for new inpatient studies
  • How to achieve successful launch by building appropriate phase 3 program

Speakers

Dr. Kate Dokukina
Head of clinical trials, Eilean Therapeutics

3:45 PM

Afternoon refreshments and networking

4:15 PM

Reserved for Event Sponsor

4:45 PM

Navigating the Evolving Biosimilars Landscape: Case Studies, EMA Guidance, and Implications for CROs

  • Learning from real-world case studies to accelerate biosimilar development and approval.
  • Understanding the EMA’s reflection paper and its role in shaping regulatory expectations.
  • Examining how a rapidly changing regulatory environment impacts development strategies.
  • Assessing the implications for CROs in supporting sponsors through this transition.

Speakers

Andreas Seidl
Chief Scientific, Officer, Formycon

5:30 PM

Chairs closing remarks and Drinks Reception Sponsored by XXX

11:30 AM

Great expectations and how to meet them – Implementing AI into your study

  • Understanding stakeholder expectations for AI in clinical research
  • Practical steps for integrating AI into study design and operations
  • Ensuring data quality, transparency, and regulatory compliance
  • Measuring adoption, engagement, and return on investment from AI initiatives

Speakers

Dr. Fabian Kreimendahl
Associate Director, Medical Evidence Biostatistics, Johnson & Johnson Innovation Medicine

12 PM

Reserved for Event Sponsor

12:30 PM

FIESDIE CHAT From Machine Insight to Manuel Review: AI for Vendor Proposals We will focus on

Building out the RFI? What you outsource, what you need, and how many site visits? AI

  • Extracting and standardizing key details from unstructured vendor documents
  • Identifying inconsistencies, omissions, or gaps within proposals
  • Supporting decision-making while safeguarding confidentiality and protecting intellectual property contained in submissions
  • Case Study

Moderator: Silvana Giro, Senior Management, Global Medical & Regulatory Affairs, Bracco Imaging

Speakers

Silvana Giro
Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging
Piotr Maslak
Senior Director, Head of Emerging Technologies, AstraZeneca

1 PM

Lunch and networking

2 PM

PANEL DISCUSSION: The future of data management: Trends, technology and innovation

  • Overviewing current approaches and trends within clinical data management
  • Assessing challenges and identifying solutions
  • Understanding the where the industry is heading to curb competition

Speakers

Dr. Fabian Kreimendahl
Associate Director, Medical Evidence Biostatistics, Johnson & Johnson Innovation Medicine

2:45 PM

Reserved for Event Sponsor

3:15 PM

Unlocking Efficiency in ClinicalTrials: Scaling eSource for Enhanced Data Management and Collaboration

  • It’s no longer a question whether digital transformation will happen—it is how fast we can scale it.
  • When innovations such as eSource/EHR-to-EDC operate at full swing, it will allow us to perform research that otherwise wouldn’t happen and to develop medicines that otherwise would never make it to the patient
  • Scaling up the technology opens new avenues for collaboration, involving pharmaceutical companies, hospitals, along with technology vendors and academic partners.

Speakers

Peter Casteleyn
Clinical Data Strategy Advisor, The European Institute for Innovation Through Health Data (iHD)

3:45 PM

Afternoon refreshments and networking

4:15 PM

Reserved for Event Sponsor

4:45 PM

AI & SUSTAINABILITY SPOTLIGHT Scaling bio sample operations with AI – path to sustainability

Automating bio sample logistics and enabling collaboration between stakeholders - sponsors, CROs, sites - through AI powered platforms with examples and discussing the role of AI in driving long term sustainability.

Speakers

Blanka Hezelova
Associate Director, Precision Medicine Scientific Operations, Bioethics Coach, GSK

5:30 PM

Chairs closing remarks and Drinks Reception Sponsored by XXX

8 AM

Registration and refreshments

8:45 AM

Chairperson’s opening remarks

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

9 AM

KEYNOTE Just how complex and inefficient are our clinical trials; and what can be done about it?

  • Empirical Data quantifying the magnitude of the problem
  • Identification of Opportunities to optimise protocol design and improve clinical trial performance
  • Case examples of strategies and their impact

Speakers

Ken Getz
Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

9:30 AM

Reserved for Event Sponsor

10 AM

PANEL DISCUSSION New strategies to drive clinical trial efficiency and complicity

  • Opportunities most resonating within panel member companies
  • Strategies and tactics to address these opportunities
  • Implementation challenges and how to overcome them
  • Areas of future focus and opportunity

Moderator: Ken Getz, Executive Director, Research Professor (PHCM), Tufts Center for the Study of Drug Development

Speakers

Ken Getz
Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
Bernhard Glombitza
PhD, Vice President, Head of Clinical Operations & Customer Engagement, EMEA & LATM, Bayer
Estrella Garcia PhD
Executive Director Global Clinical Operations, Almirall
Joana Claverol Torres
Clinical Research Director, Hospital Sant Joan de Déu, SJD Pediatric Cancer Center Barcelona
Nicole Honigman
Global Study Director, AstraZeneca

10:30 AM

Reserved for Event Sponsor

11 AM

Morning refreshments and networking break

11:30 AM

Reimaging Clinical Operations: Navigating the Future of Efficiency and innovation….an outlook into the year 2050

Have you ever wondered what the future holds for clinical operations? Currently the industry is laser focused on decentralised trials, patient diversity, risk-based monitoring, real world evidence and digitalization but where, exactly, is all this going to lead? More importantly how can we prepare for what lies ahead? Based on experience, and market and business intelligence Bernhard will dare to give us a glimpse into the future by:

  • Exploring the challenges to come
  • Recommending solutions to implement now, in preparation for tomorrow

Speakers

Bernhard Glombitza
PhD, Vice President, Head of Clinical Operations & Customer Engagement, EMEA & LATM, Bayer

12 PM

Reserved for Event Sponsor

12:30 PM

Global Regulatory Perspectives

Gain insights from a Clinical Trials Global Regulatory Lead on navigating the evolving global regulatory landscape, from early development through to submission readiness.

  • Anticipating regulatory expectations and aligning strategies early in development
  • Integrating regulatory perspectives across Phase I–III to streamline approvals
  • Common challenges and proactive approaches in global filing preparation

Speakers

Emma Blasi Bosch
Director, Global Regulatory Strategy, Alexion Pharmaceuticals

1 PM

Lunch and networking

2 PM

PANEL DISCUSSION GeoPolitical challenges beyond our control: How pharma and biotech companies in Europe can mitigate against this

This session examines the impact of geopolitical uncertainty on clinical trials, supply chains, and market access in Europe. Experts will discuss practical strategies for risk management, operational resilience, and strategic planning, helping pharma and biotech companies navigate challenges beyond their control while maintaining continuity and compliance.

 

Moderator: Revati Tatake, PhD, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

2:45 PM

Reserved for Event Sponsor

3:15 PM

Revati Tatake

Speakers

Revati Tatake
Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

3:45 PM

Afternoon refreshments and networking

4:15 PM

Reserved for Event Sponsor

4:45 PM

PANEL DISCUSSION Choosing the Right Outsourcing Model for Your Clinical Trial

  • Overview of outsourcing models: Full-Service Outsourcing (FSO), Functional Service Provider (FSP), and in-house
  • Pros and cons of each model and how to select the best fit for your trial
  • When hybrid approaches (mixing outsourcing and in-house) are more effective than fully outsourcing or keeping trials fully internal
  • Understanding why FSP is gaining popularity among sponsors and how it can help meet trial timelines

Moderator: Sonja Weiser, PhD, Senior Director, Clinical Operations, Insmed Germany

Speakers

Sonja Weiser
PhD, Senior Director, Clinical Operations, Insmed Germany
Eva Torres Costa
Director, Alliance Management, AstraZeneca
Rebeckha Magnusson
Head of Clinical Operations & Quality Assurance, Ribcure

5:30 PM

Chairs closing remarks and Drinks Reception Sponsored by XXX

Streams

Stream one

Stream A: Clinical Operations and Outsourcing

Stream two

Stream B: AI & Tech Transformation

9 AM

Keynote: Clinical trials in the age of AI – What you’ll discover

Discover how artificial intelligence is transforming clinical research by streamlining processes from protocol design to regulatory submission. This session explores practical AI applications for overcoming recruitment challenges, ensuring ethical implementation, and shaping the future of oncology trials.

 

  • Overcome Bottlenecks: Learn how AI breaks cycle inefficiencies in trial design and patient screening.
  • Accelerate Recruitment: See how AI-driven models and molecular matching reduce screening time and failures.
  • Implement Ethically: Understand frameworks for bias mitigation, data privacy, and regulatory compliance.
  • Future Trends: Explore next-decade innovations like digital twins and foundation models.

 

Speakers

Eslam Katab
Global Clinical Development Manager, Sandoz

9:30 AM

Reserved for Event Sponsor

10 AM

CISCRP Perceptions & Insights Case Study

What Patients and the Public Think: Insights on AI and Tech in Trials

As AI and emerging technologies reshape the clinical research landscape, understanding the perceptions and experiences of trial participants, patients, and the public is critical to building trust and improving trial success when these tools are used. Drawing on the latest CISCRP Perceptions & Insights bi-annual survey of over 12,000 respondents globally, this session explores concerns, expectations, and trial experiences on the use of AI and decentralized trial technologies. Practical approaches to the planning and use of these tools in research will also be shared, aligned with emerging patient-centric regulatory and good practice expectations.

Speakers

Behtash Bahador
Senior Director, Community Engagement & Partnerships, CISCRP

10:30 AM

Reserved for Event Sponsor

11 AM

Morning refreshments and networking break

11:45 AM

Reserved for Event Sponsor

12:15 PM

AI Patient Crew – A Patient-led project for Involvement in AI Tool Design

  • Whose tool and for what purpose?
  • Risks and decisions
  • Health data and lifestyle information
  • Layers and interoperability

Speakers

Richard Stephens
Patient Advocate and Project Leader., AI Patient Crew

12:45 PM

Lunch and networking

2 PM

Reserved for event sponsor

2:30 PM

PANEL DISCUSSION: Future of Clinical Trial Professionals: How Technology Is Transforming Workforce Roles and Expectations

  • Reimagining responsibilities across clinical trial functions in an AI- and automation-driven environment
  • Evolving from task-based roles to strategic, insight-driven contributors across operations and data functions
  • Redefining entry-level roles as technology reshapes foundational skills, expectations, and career pathways
  • Identifying the new capabilities required to ensure technology enhances, not replaces the expertise of clinical trial professionals

Speakers

Piotr Maslak
Senior Director, Head of Emerging Technologies, AstraZeneca
Eslam Katab
Global Clinical Development Manager, Sandoz

3:15 PM

Afternoon refreshments and networking with Apple Prize Draw

8 AM

Registration and Breakfast Refreshments

8:45 AM

Chairperson’s opening remarks

9 AM

Implementing FDA’s Project Optimus in an ongoing trial – a case study

Speakers

Karin Nordbladh
Director Clinical Operations, Alligator Bioscience

9:30 AM

Reserved for Event Sponsor

10 AM

CRO Governance 2.0: Lead, Align, Accelerate

Speakers

Eva Torres Costa
Director, Alliance Management, AstraZeneca

10:30 AM

Reserved for Event Sponsor

11 AM

Morning refreshments and networking break

11:45 AM

Reserved for Event Sponsor

12:15 PM

CASE STUDY Pediatric Case Study: Insights for Faster, Safer Clinical Trials

Paediatric trials bring amplified risks, tighter regulations, and higher stakes for patient safety - but the lessons learned extend far beyond children’s studies. In this case study, we examine the unique challenges of conducting a paediatric clinical trial and explore how its insights can be applied to improve planning, safety oversight, and operational efficiency in any therapeutic area.

  • Navigating Complex Risk Profiles: Managing safety, dosing, and ethical considerations in vulnerable populations.
  • Pharmacovigilance in Practice: Meeting rigorous monitoring and reporting demands under high scrutiny.
  • Recruitment and Engagement Strategies: Overcoming barriers to participation with patients, caregivers, and advocacy groups.
  • Transferable Takeaways: Applying lessons from paediatric research to accelerate and safeguard trials in all therapeutic areas.

Speakers

Joana Claverol Torres
Clinical Research Director, Hospital Sant Joan de Déu, SJD Pediatric Cancer Center Barcelona

12:45 PM

Lunch and networking

2 PM

Reserved for event sponsor

2:30 PM

PANEL DISCUSSION Maximising Site Productivity: Reducing Burden and Strengthening Output

As clinical trial protocols grow more complex, sites are under increasing pressure, juggling high workloads, limited resources, and administrative overload. This panel will explore practical strategies to optimise site performance, while acknowledging the real constraints they face today.

We’ll examine:

  • The current challenges impacting site productivity
  • The consequences of site strain on trial delivery
  • Forward-thinking solutions to streamline operations and improve collaboration
  • Where electronic systems support, and where they still fall short

Moderator: Sonja Weiser, PhD,Senior Director, Clinical Operations, Insmed Germany

Speakers

Sonja Weiser
PhD, Senior Director, Clinical Operations, Insmed Germany
Michael Zörer
Head of Clinical Operations, VarmX
Nicole Honigman
Global Study Director, AstraZeneca
Joana Claverol Torres
Clinical Research Director, Hospital Sant Joan de Déu, SJD Pediatric Cancer Center Barcelona

3:15 PM

Afternoon refreshments and networking with Apple Prize Draw

3:45 PM

ROUNDTABLE DISCUSSIONS

RT 1: Vendor Oversight in Complex Trials

RT 2: AI and Vendor Proposals: Hype or Help?
Silvana Giro, Senior Management, Global Medical & Regulatory Affairs, Bracco Imaging

RT 3: Patient Engagement Tools That Actually Work
Behtash Bahador, Senior Director, Community Engagement & Partnerships, CISCRP

RT 4: Managing multi-country eConsent platforms

RT 5: Key Takeaways of Project Optimus
Karin Nordbladh, Director, Clinical Operation, Immune Oncology, Alligator Bioscience

RT 6: Sustainability in Clinical Trials

Speakers

Silvana Giro
Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging
Behtash Bahador
Senior Director, Community Engagement & Partnerships, CISCRP
Karin Nordbladh
Director Clinical Operations, Alligator Bioscience

4:45 PM

END OF CONFERENCE

Speakers

Select a speaker to learn more

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Ken Getz
Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

Ken is the Director of Sponsored Research and Associate Professor at the Tufts Center for the Study of Drug Development, and Chairman of the Center for Information and Study on Clinical Research Participation, a non-profit organization that he founded to raise public and patient awareness of the clinical research enterprise. He is founder and owner of CenterWatch, and an owner and board member of the Metrics Champion Consortium. A well-known speaker at symposia, universities, and corporations, Ken has published extensively in peer-reviewed journals, books and in the trade press.  He has been an active DIA member for 25 years and has held board appointments in the private and public sectors.  Ken earned his MBA from Northwestern University.

Session Details:

PANEL DISCUSSION New strategies to drive clinical trial efficiency and complicity

2026-05-06, 10:00 AM

Session Details:

KEYNOTE Just how complex and inefficient are our clinical trials; and what can be done about it?

2026-05-06, 9:00 AM

View In Agenda
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Bernhard Glombitza
PhD, Vice President, Head of Clinical Operations & Customer Engagement, EMEA & LATM, Bayer

With over 25 years of leadership experience in the pharmaceutical industry, I have consistently advanced in roles with increasing responsibilities in project and people management. From managing smaller-scale projects to leading the global Xarelto initiative with over 500 team members, my career is marked by significant achievements in operational excellence and innovation. As Vice President of Clinical Operations, I led teams >1000 FTE in 40 countries, have transformed organizational structures, boosting productivity by > 25% through strategic resource allocation and flattening hierarchies. Currently, I am pioneering initiatives to empower decentralized decision-making and enhance customer engagement in Clinical Operations EMEA/LATAM, this strategy contributed propelling us from the global position 7 to 1 (Top Sponser) in the CenterWatch site relation survey.
Driven by challenges and equipped with high learning agility, I am passionate about inspiring teams to explore their full potential in a psychologically safe environment.

Session Details:

PANEL DISCUSSION New strategies to drive clinical trial efficiency and complicity

2026-05-06, 10:00 AM

Session Details:

Reimaging Clinical Operations: Navigating the Future of Efficiency and innovation….an outlook into the year 2050

2026-05-06, 11:30 AM

View In Agenda
Next speaker
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Dr. Fabian Kreimendahl
Associate Director, Medical Evidence Biostatistics, Johnson & Johnson Innovation Medicine

Session Details:

Great expectations and how to meet them – Implementing AI into your study

2026-05-06, 11:30 AM

Session Details:

PANEL DISCUSSION: The future of data management: Trends, technology and innovation

2026-05-06, 2:00 PM

View In Agenda
Next speaker
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Rebeckha Magnusson
Head of Clinical Operations & Quality Assurance, Ribcure

Session Details:

PANEL DISCUSSION Choosing the Right Outsourcing Model for Your Clinical Trial

2026-05-06, 4:45 PM

Session Details:

Embracing the unknown: Tips and tricks on how to grow your clinical operations

2026-05-06, 11:30 AM

View In Agenda
Next speaker
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Silvana Giro
Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging

From 1984 to 1988 employed by Ciba-Geigy, in the Sales Marketing of chemical products, within the Customer Services.

Since 1988 employed by Bracco S.p.A. and then by Bracco Imaging S.p.A., developing different skills: Clinical Project Planning, Budget Control

Since 2000 responsible for Contract Management in Europe, including contractual negotiation for all global functions within Global Medical & Regulatory Affairs.

Since June 2002 also responsible for Global Outsourcing within Global Medical & Regulatory Affairs.

Since 2001 Silvana Giro has been invited as speaker and moderator to several conferences and seminars.

Session Details:

FIESDIE CHAT From Machine Insight to Manuel Review: AI for Vendor Proposals We will focus on

2026-05-06, 12:30 PM

Session Details:

ROUNDTABLE DISCUSSIONS

2026-05-07, 3:45 PM

View In Agenda
Next speaker
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Neta Tobis
Director of Clinical Operations, BiomX

Session Details:

Choosing the right CRO: key considerations for small biotech’s

2026-05-06, 12:30 PM

View In Agenda
Next speaker
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Sonja Weiser
PhD, Senior Director, Clinical Operations, Insmed Germany

A Clinical Research Professional (Pharmacist), PhD (Medical School - Pharmacology/Toxicology) and PMP (2016) with more than 20 years’ experience in Biotech / Health Care Industry / CRO / Drug Development / Clinical Research.

Expertise ranging from Clinical Research/Clinical Operations experience in Pharma, Biotech and CRO with focus on Oncology, Immunology, Infectious Disease, Respiratory indications and Rare/Orphan indications.

Focused on goal achievement, constant striving for improving processes on an international / global level, strong project management background.

Dedication to people management as the main success factor in clinical research/clinical development – foster open & trustful communication on a global level.

Strong believer in "Manage by example" as key to success in drug development

Session Details:

PANEL DISCUSSION Choosing the Right Outsourcing Model for Your Clinical Trial

2026-05-06, 4:45 PM

Session Details:

PANEL DISCUSSION Maximising Site Productivity: Reducing Burden and Strengthening Output

2026-05-07, 2:30 PM

View In Agenda
Next speaker
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Peter Casteleyn
Clinical Data Strategy Advisor, The European Institute for Innovation Through Health Data (iHD)

Session Details:

Unlocking Efficiency in ClinicalTrials: Scaling eSource for Enhanced Data Management and Collaboration

2026-05-06, 3:15 PM

View In Agenda
Next speaker
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Blanka Hezelova
Associate Director, Precision Medicine Scientific Operations, Bioethics Coach, GSK

Blanka is an Associate Director within Precision Medicine Scientific Operations at GSK with over ten years of experience in research spanning from clinical site to sponsor roles, and expertise in biosample operations. She leads operational aspects of trials with a focus on innovation and excellence, successfully managing complex clinical studies while ensuring compliance and participant protection. Herf passion lies in ethical research and strategic improvements for operational efficiency.

Session Details:

AI & SUSTAINABILITY SPOTLIGHT Scaling bio sample operations with AI – path to sustainability

2026-05-06, 4:45 PM

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Andreas Seidl
Chief Scientific, Officer, Formycon

Session Details:

Navigating the Evolving Biosimilars Landscape: Case Studies, EMA Guidance, and Implications for CROs

2026-05-06, 4:45 PM

View In Agenda
Next speaker
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Eva Torres Costa
Director, Alliance Management, AstraZeneca

Session Details:

PANEL DISCUSSION Choosing the Right Outsourcing Model for Your Clinical Trial

2026-05-06, 4:45 PM

Session Details:

CRO Governance 2.0: Lead, Align, Accelerate

2026-05-07, 10:00 AM

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Behtash Bahador
Senior Director, Community Engagement & Partnerships, CISCRP

Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Session Details:

CISCRP Perceptions & Insights Case Study

2026-05-07, 10:00 AM

Session Details:

ROUNDTABLE DISCUSSIONS

2026-05-07, 3:45 PM

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Richard Stephens
Patient Advocate and Project Leader., AI Patient Crew

Session Details:

AI Patient Crew – A Patient-led project for Involvement in AI Tool Design

2026-05-07, 12:15 PM

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Estrella Garcia PhD
Executive Director Global Clinical Operations, Almirall

Estrella began her ‘scientific odyssey’ at the University of Navarra, Spain, where she gained a PhD in Genetic Toxicology.  Following this, Estrella held at post-doctoral position at ICI (now Astra Zeneca) in Macclesfield, UK. At ICI Estrella’s focus was on novel anti-tumor drugs in the pre-clinical phase. Subsequently Estrella returned to Spain where she joined Almirall as a Clinical Research Scientist. Since then, Estrella has amassed a 29 year career with the company- taking on roles of increasing demand and responsibility, including Head of Allergy Therapeutic Area and Head of Clinical Development Operations- to the role she holds today.

Estrella leads her group and is responsible for clinical trials worldwide. Since Almirall do not have affiliates fully involved in clinical development, the company externalizes all clinical trials, with a strategic focus on keeping only core competencies- particularly for pivotal studies- in-house. In this capacity Estrella has worked with dozens of CROs and service providers managing Phase I to Phase IV clinical trials of all sizes, from small single centre studies to global programs involving hundreds of sites and thousands of patients. Her responsibility is covering the selecting, negotiation, contracting, managing and final evaluation of the CROs responsible for the worldwide clinical development, in order to deliver on the agreed timelines, quality and cost.

She has been responsible for ensuring Clinical Development for Aclidinium bromide in COPD was performed worldwide from the operational point of view on time, budget and quality, among other development from Almirall.

Now fully focus on Dermatology development, managing trials worldwide mainly in Psoriasis, Acné, Atopic Dermatitis, Actinic Keratosis, among other indications.

Session Details:

PANEL DISCUSSION New strategies to drive clinical trial efficiency and complicity

2026-05-06, 10:00 AM

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Michael Zörer
Head of Clinical Operations, VarmX

Michael is responsible for a team of 11 people and the overall delivery of the conducted studies. The group runs several studies in different indications with a clear focus on rare diseases. In 2016 AOP Orphan received approval for one new product (RAPIBLOC®). In 2019 AOP received the marketing authorization for their first biological (BESREMi®), after completing a series of clinical studies and successfully passing a series of EMA inspections under Michael’s responsibility.

Before joining AOP Orphan Michael has been operations manager for Haemophilia at Baxter. Michael has many years of experience as a project manager and learned the job in clinical research from scratch starting as CRA at Amgen. Michael received his Ph. D in biochemistry from the University of Vienna. 

Session Details:

PANEL DISCUSSION Maximising Site Productivity: Reducing Burden and Strengthening Output

2026-05-07, 2:30 PM

Session Details:

PANEL DISCUSSION The biotech landscape in Europe 2026: growths, shifts and strategic outlook

2026-05-06, 2:00 PM

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Karin Nordbladh
Director Clinical Operations, Alligator Bioscience

Karin has a MSc in Pharmacy and Pharmaceutical Biosciences from Uppsala University in Sweden.  She is passionate about drug development that aims to meet unmet medical needs. Karin has 19 years of experience in life science industry and has worked for Astra Zenica, McNeil AB, a Johnson&Johnson company, and currently works at Alligator Bioscience AB since 4 years as Dir ClinOps. Alligator is a company specialized in immune oncology drug development.

Session Details:

Implementing FDA’s Project Optimus in an ongoing trial – a case study

2026-05-07, 9:00 AM

Session Details:

ROUNDTABLE DISCUSSIONS

2026-05-07, 3:45 PM

Session Details:

PANEL DISCUSSION The biotech landscape in Europe 2026: growths, shifts and strategic outlook

2026-05-06, 2:00 PM

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Dr. Kate Dokukina
Head of clinical trials, Eilean Therapeutics

Dr. Kate Dokukina is an expert with 20+ years in the biopharmaceutical industry and medicine , specializing in clinical research, drug development, and regulatory strategy. She has led global clinical programs across oncology, autoimmune, and rare diseases, overseeing the launch of 50+ new molecules. Currently VP in clinical trials at Eilean Therapeutics(US), she has held leadership roles at BIOCAD, Shanghai Pharma and MedInvestGroup.

Session Details:

The Pursuit of Success: Driving your drug from the lab to the patient

2026-05-06, 3:15 PM

Session Details:

PANEL DISCUSSION The biotech landscape in Europe 2026: growths, shifts and strategic outlook

2026-05-06, 2:00 PM

View In Agenda
Next speaker
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Emma Blasi Bosch
Director, Global Regulatory Strategy, Alexion Pharmaceuticals

Emma has over 18 years of experience in the biopharmaceutical industry, spanning biotech startups, multinational companies and consultancy. She specializes in developing and implementing global regulatory strategies and successfully leading meetings with international regulatory agencies. As a global regulatory lead, she provides key insights to global programs focused on rare disease and oncology drug development, from first-in-human through late-phase clinical development and registration trials to successfully register unique, innovative, and technologically complex products.

 

Session Details:

Global Regulatory Perspectives

2026-05-06, 12:30 PM

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Piotr Maslak
Senior Director, Head of Emerging Technologies, AstraZeneca

Piotr Maślak is Senior Director and Head of Emerging Technologies at AstraZeneca. He leads global efforts to transform clinical trials with digital platforms and AI – accelerating development and making research more patient-centric. Piotr has a track record of scaling enterprise AI strategies and driving award-winning innovation. Recognized for driving digital transformation in pharmaceutical industry, he is passionate about challenging conventions and shaping the future of clinical research.

Session Details:

FIESDIE CHAT From Machine Insight to Manuel Review: AI for Vendor Proposals We will focus on

2026-05-06, 12:30 PM

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PANEL DISCUSSION: Future of Clinical Trial Professionals: How Technology Is Transforming Workforce Roles and Expectations

2026-05-07, 2:30 PM

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Nicole Honigman
Global Study Director, AstraZeneca

Nicole Honigman is a proactive clinical research leader with 13+ years of experience driving Phase IIa–IV trials from feasibility through close-out across global and local settings. She currently serves as Global Study Director at AstraZeneca, where she leads cross-functional teams, oversees outsourced delivery, and steers study planning, risk‑based quality management, and inspection readiness to meet timelines, budgets, and quality standards. Previously at Alexion (AZ RDU), she led country operations and global monitoring oversight, optimizing startup, recruitment, vendor management, and CRA resourcing across complex rare disease programs. Nicole’s therapeutic expertise spans hematology, nephrology, neurology, bone metabolism, rheumatology, gastrointestinal, metabolic diseases, oncology, and infectious disease, with recent emphasis on cardiovascular trials. She is trained in project management, and recognized for disciplined TMF governance, KPI-driven performance management, and effective stakeholder communication.

Session Details:

PANEL DISCUSSION New strategies to drive clinical trial efficiency and complicity

2026-05-06, 10:00 AM

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PANEL DISCUSSION Maximising Site Productivity: Reducing Burden and Strengthening Output

2026-05-07, 2:30 PM

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Joana Claverol Torres
Clinical Research Director, Hospital Sant Joan de Déu, SJD Pediatric Cancer Center Barcelona

Joana Claverol , is the Clinical Research Director at Barcelona Children’s Hospital Sant Joan de Déu, Spain, where she leads the clinical trials office since 2012 and the Patients engagement in research area since 2015. The Clinical Research Unit is a reference unit for pediatric patients nationally and internationally, specializing in innovative treatments for highly complex patients with rare pediatric diseases. She has more than 13 years of experience in medical and clinical research in the pharmaceutical and biotechnology industry, with special knowledge and experience in drug development and clinical trial design, and all regulatory and methodological aspects related to clinical research. She holds a postgraduate in Senior Management Program of Health Institutions by IESE Business School, a Master in Pharmaceutical Marketing by Universitat Pompeu Fabra, a Master of clinical trials at Universitat de Barcelona and a BS Degree in Biological Sciences by Universitat Autonoma de Barcelona.

Session Details:

PANEL DISCUSSION New strategies to drive clinical trial efficiency and complicity

2026-05-06, 10:00 AM

Session Details:

PANEL DISCUSSION Maximising Site Productivity: Reducing Burden and Strengthening Output

2026-05-07, 2:30 PM

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CASE STUDY Pediatric Case Study: Insights for Faster, Safer Clinical Trials

2026-05-07, 12:15 PM

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Eslam Katab
Global Clinical Development Manager, Sandoz

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PANEL DISCUSSION: Future of Clinical Trial Professionals: How Technology Is Transforming Workforce Roles and Expectations

2026-05-07, 2:30 PM

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Keynote: Clinical trials in the age of AI – What you’ll discover

2026-05-07, 9:00 AM

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Advisory Board

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Dr Alison McMorn
PH.D – VP, CLINICAL DEVELOPMENT, AMO PHARMA LTD

Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

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Behtash Bahador
Senior Director, Community Engagement & Partnerships, CISCRP

Behtash Bahador is the Senior Director of Community Engagement & Partnerships at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

Session Details:

CISCRP Perceptions & Insights Case Study

2026-05-07, 10:00 AM

Session Details:

ROUNDTABLE DISCUSSIONS

2026-05-07, 3:45 PM

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Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals

Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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Aditya Kotta
Head of Business Development, Novotech

Aditya is the Regional Director of Business Development at Novotech, the Asia Pacific specialist CRO. He has extensive experience helping sponsor companies make their trials a reality across a range of projects from first in human to phase iv.

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Martin Rodriguez
Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi

Senior executive Leader in Life Science (Biochemist) and Lean/Six Sigma Green-belt certified, with more than 20 year of experience in clinical operations, Operational Excellence (i.e., operational strategy, performance management, process optimization, risk management, Quality-by-Design and team performance), clinical quality, and Service Providers / Outsourcing management.

I developed, reengineered, automated, and optimized business processes with a risk-based and approach to produce high quality outputs and to ensure regulatory compliance. I led the development, implementation and monitoring of different operational and quality strategies and models including Outsourcing as well as new/ innovative clinical capabilities to fulfill consumers/ patients needs .

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Rosie Filling
Vice President, Senior Global Head R&D Operations, Endo
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Edwin van Vulpen
Executive Director and Head of Clinical Business Development Euro-Asia
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