14th Annual Outsourcing in Clinical Trials Europe 2024

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

7 - 8

May

2024
  • Hyatt Regency Barcelona Tower, Barcelona, Spain
  • Complimentary
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Why attend?

WHAT TO EXPECT FOR 2024?

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 2024 program boasts 4 full streams complete with key content.

Stream A: Outsourcing & Clinical Operations

Stream B: Clinical Innovation & Technology

Stream C Day 1: Patient Centricity

500+

Attendees

80+

Exhibitors

40+

Speakers

500+

Attendees

80+

Exhibitors

40+

Speakers

See What It's All About

Agenda

  • 7 May 2024
  • 8 May 2024
Expand All

Streams

Stream one

Stream A: Clinical Operations and Outsourcing

Stream two

Stream B: Clinical Technology & Innovation

Stream three

Stream C: Patient Centricity

11:15 AM

The use of technology to accelerate early drug discovery and reduce the burden for patients.

Building personalized digital healthcare solutions to support clinical claims is of great importance to the drug industry. Medical Insights generated from digital healthcare clinical studies emerged as a promising approach to help with:

  • Patient engagement and retention.
  • Collecting richer data to drive insights and accelerate drugs' early research and developments to make better drugs and early medical decisions.
  • Increase efficacy of therapies through continuous monitoring.

This session details a case study on challenges using Digital Healthcare Technologies in the clinical trials ecosystem and use of medical devices to help patients better manage their conditions.

Speakers

Abdel Dridi
Global Head of Digital Healthcare Technologies (DHT), Personalized Healthcare, Product Development, Roche

11:45 AM

Session Reserved for Event Sponsor

12:15 PM

Building clinical trials with the perspective of the patients in mind; exploring patient collaboration and the benefits it can bring to the sponsor and the patient.

  • Discussing the collaboration that has to exist between all parties (patients, coordinators, doctors) in order to have a successful trial
  • Importance of good communication to the patients and how this can streamline trial timelines
  • Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up

Speakers

Amelia Hursey
Parkinson's Research Manager, Parkinson's Europe

12:45 PM

Session Reserved for Event Sponsor

1:15 PM

Lunch and networking

2:15 PM

Site selection for increased patient recruitment and retention

  • Highlighting discrepancies in the distance between clinical trial sites and the disease prevalent populations using case studies.
  • Exploring the impact of appropriate and inappropriate site selection on a trial’s success through case studies.
  • Showcasing how patient accrual has been affected in clinical trials utilizing virtual components.

Speakers

Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData

2:45 PM

Session Reserved for Event Sponsor

3:15 PM

PATIENT ADVOCATE KEYNOTE One Voice and 101 Opinions – A Patient Perspective on the Conference Topics

  • Patient Centricity - What patients want from trials, and how we know
  • Outsourcing - Patient Groups and Patient Advocates
  • Innovation and technology - Data and AI, wearables and DCTs

Speakers

Richard Stephens
Patient Advocate since 1998; author, speaker, journal editor

3:45 PM

Afternoon refreshments and networking

4:15 PM

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

  • Discover sites with a demonstrated track record of good execution in trials
  • Uncovering a strong study workforce to ensure patient enrolment and effective study start-up
  • Analysing sites access to subject population with the required eligibility measures.
  • Understanding new landscapes from a legislative perspective
Moderator: TBC Richard Stephens, Patient Advocate

Panellists: Mireille Ermens, Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring

Nikita Sharma, Global Clinical Sciences & Operations Innovation Manager, UCB

Amelia Hursey, Parkinson's Research Manager, Parkinson's Europe

 

 

Speakers

Richard Stephens
Patient Advocate since 1998; author, speaker, journal editor
Mireille Ermens
Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring
Nikita Sharma
Global Clinical Sciences & Operations Innovation Manager, UCB
Amelia Hursey
Parkinson's Research Manager, Parkinson's Europe
Robert Kurowicki
Robert Kurowicki, Director of Feasibility and Project Strategy, Novotech Europe

5 PM

Session Reserved for Event Sponsor

5:30 PM

Chairperson’s closing remarks followed by Drinks Reception

END OF DAY 1 AND NETWORKING DRINKS RECEPTION

11:15 AM

Transforming Clinical Trials: Harnessing AI for Decentralized Study Design and Operations.

In recent years, the clinical research landscape has witnessed a paradigm shift towards decentralized clinical trials (DCTs) and the integration of artificial intelligence (AI) into various aspects of drug development. This presentation aims to explore the intersection of these two transformative trends and their potential to revolutionize the way we conduct clinical studies.

Speakers

Nikita Sharma
Global Clinical Sciences & Operations Innovation Manager, UCB

11:45 AM

How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors

  • +Why clinical technologies and product integration strategies are more important than ever
  • +How to eliminate redundant activities, such as data entry and reconciliation
  • +How to leverage clinical data quickly to generate insights and improve study optimization and decision-making
  • +Accelerate time to database lock with improved data quality

 

Speakers

Anthony Mikulaschek
Vice President, eCOA, IQVIA Technologies
Stefan Dürr
Senior Director, Client Delivery, Cenduit IRT, an IQVIA business, Head of Drug Supply Center of Excellence

12:15 PM

Clinical Validation of Digital Health Solutions

Session held for Antonella de Ceano, Digital Transformation Officer, Barcelona Health Hub

Speakers

Antonella de Ceano
Digital Transformation Officer, Barcelona Health Hub

12:45 PM

Session Reserved for Event Sponsor

1:15 PM

Lunch and networking

2:15 PM

Great expectations and how to meet them – connected devices and ePRO in clinical trials

  • Focusing on design considerations
  • Understanding the best framework for your study
  • Considering patient ePRO assessments needed for a specific study
  • Highlighting best practice for data collection
  • Avoiding expensive mistakes that undermine your trial outcome or delay your timeline
  • Outlining Regulatory restrictions around ePro
  • Comparison vs Paper Reported Outcomes – why are companies not transitioning fully to ePro?

Speakers

Dr Mar Gomis Pastor
Director of the Center for Digital Clinical Validation, Hospital de la Santa Creu i Sant Pau

2:45 PM

Session Reserved for Event Sponsor

3:15 PM

Experience with EU Clinical Trial Regulation – Updates from January 2023

  • Submitting a study within the framework of the new regulations, what are the differences?
  • Understanding the updated CTR guidelines to enable sponsors to submit one application and gain approval to run a clinical trial in several European countries
  • Working with the CTIS portal for trial applications
  • Examples and common issues
  • Sharing experiences with various Health Authorities

Speakers

Sol Yates
Associate Director, European Regulatory Affairs, Shionogi Europe

3:45 PM

Afternoon refreshments and networking

4:15 PM

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

  • Are we making the most of Technology & Innovation in the Clinical Trial space?
  • Highlighting Innovation points of interest such as Metaverse, Blockchain and Machine Learning to name but a few
  • How are these tools being utilized?
  • The importance of exploring ethical considerations, now.
  • What’s next?
Moderator:  Mats Sundgren, PhD, European Institute of Innovation through Health Data (i-HD)

Panelists: Michael Zörer, Head of Clinical Operations , VarmX

Speakers

Mats Sundgren
PhD, European Institute of Innovation through Health Data (i-HD)
Maria Reyes Boceta-Munoz
Head Of Clinical Operations Spain, GSK
Laura Jiménez Robledo
Clinical Project and Innovation Manager, Novo Nordisk
Upinder Grewal
Strategic Lead Exploration and Discovery, DS&AI, Bayer

5 PM

Session Reserved for Event Sponsor

5:30 PM

Chairperson’s closing remarks followed by Drinks Reception

END OF DAY 1 AND NETWORKING DRINKS RECEPTION

7:45 AM

Registration and refreshments

8:20 AM

Chairperson’s opening remarks

8:30 AM

KEYNOTE Revolutionizing Clinical Trials through RWD and AI: Unleashing Innovation

In the ever-evolving realm of medical research, innovation within clinical trials is instigating a transformative wave that significantly enhances patient outcomes. Harnessing the power of advancements in trial design, digital technologies, Artificial Intelligence & Machine Learning algorithms, and data analytics, this wave of innovation is driving drug development forward. It extends the reach of experimental treatments to more patients, while simultaneously elevating the overall quality and analysis of trial data.

This keynote presentation offers a deep dive into the multifaceted landscape of innovation, exploring groundbreaking approaches such as Federated EHR research platforms, eSource-supported trials, artificial intelligence, and patient-centric strategies. These pioneering methodologies not only optimize operational efficiency but also individualize medical approaches, fostering a continuous evolution in the trial process.

Key Topics Covered:

  • The Changing Landscape: Exploring Paradigm Shifts in Clinical Trials
  • Advancements in Trial Design & Digital Technologies: An In-Depth Look at Federated EHR Research Platforms
  • Emerging Impact of AI in Clinical Trials: Unpacking the Role of Artificial Intelligence in Clinical Research
  • Two Use Cases: How eSource & AI-Driven Event Adjudication Can Transform Clinical Trials
  • Outlook & Conclusions: Anticipating Future Trends and Developments in Clinical Trial Innovation

Speakers

Mats Sundgren
PhD, European Institute of Innovation through Health Data (i-HD)

9 AM

Session Reserved for Event Sponsor

9:30 AM

Governance for the European Health Data Space

Speakers

Francis P. Crawley
Executive Director, Good Clinical Practice Alliance - Europe (GCPA)

10:15 AM

Session Reserved for Event Sponsor

10:45 AM

Morning & Refreshment break

11:15 AM

Exploring the Local Care Model in Clinical Trial Operations

  • Definition & background of Local Care Model
  • Case Study: Use of U.S. Retail Clinics in Trial Conduct + Lessons Learned
  • What’s Next?

Speakers

Stephanie Casler
Director, Innovative Health, Johnson & Johnson

11:45 AM

Session Reserved for Event Sponsor

12:15 PM

Site Partnerships: Developing Site Relationships beyond Study-Level Engagement

  • Supporting the portfolio across Therapeutic Areas
  • Establishing a Strategic Role at a Regional-Level

Speakers

Christian Milliet
Head of Site and Healthcare Ambassadors, CSL Behring

12:45 PM

Session Reserved for Event Sponsor

1:15 PM

Lunch and networking

2:15 PM

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

  • Considering biotech’s limited funds
  • Defining what do we do well & what could be improved – EU vs US focus
  • Planning & preparation within clinical trials
  • Choosing the right trial designs for new studies
  • How to archive successful launch by building an appropriate program
  • Top Tips in Effective Budget Management, Forecasting and Contracting: Ensuring Your Resources Are Allocated Correctly

 

Speakers

Carmela Gómez Rodríguez
Vice President Clinical and Regulatory Affairs, Neurofix Pharma

2:45 PM

Session Reserved for Event Sponsor

3:15 PM

Fit-for-Purpose Outsourcing Strategy in Clinical Trials and Cost Optimization

  • Outsourcing clinical activities became essential to the operational success of pharmaceutical companies
  • There is a need to continuously improve operational efficiency and reduce research and development costs
  • A fit-for-purpose outsourcing strategy will ensure an improvement in operational efficiency and optimization outsourcing costs
  • Define a clear outsourcing strategy will drive cost reduction with a targeted collaboration with CROs
  • How internally can costs be optimized when outsourcing a clinical trial? How to compare costs?

Speakers

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

3:45 PM

Afternoon refreshments and networking

4:15 PM

PANEL – Outsourcing Strategies & Relationships

  • Discussing how to approach your outsourcing strategy?
  • Uncovering if your offerings are competitive, and if this is indeed value for money.
  • Looking into what is driving the increasing costs of running your study, recognising the value associated with costs and their justifications.
  • Establishing what can be done to avoid increasing budgets including the evaluation of tools required for the type of study one is conducting.
  • What are your options if the partnership is not working as planned, mid study?
  • How to keep a healthy relationship when faced with ongoing challenges, partnership by respectful collaboration.
Moderator: Silvana Giro, Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging

Panelists:

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

Dan McVeigh, Director, Clinical Project Lead, Alexion Pharma

Speakers

Silvana Giro
Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging
Martin Rodriguez
Consumer Safety & Evidence Global Quality & Excellence Head, Sanofi
Daniel McVeigh
Director, Clinical Project Lead, Alexion Pharma
Michael Zörer
Head of Clinical Operations, VarmX

5 PM

Session Reserved for Event Sponsor

5:30 PM

Chairperson’s closing remarks followed by Drinks Reception

END OF DAY 1 AND NETWORKING DRINKS RECEPTION

Streams

Stream one

Stream A: Clinical Operations and Outsourcing

Stream two

Stream B: Clinical Technology & Innovation

8:45 AM

Chair’s opening remarks

Speakers

Mats Sundgren
PhD, European Institute of Innovation through Health Data (i-HD)

9 AM

Generative AI in healthcare to speed up drug discovery

  • Addressing the potential challenges using this new technology for the development, evaluation and monitoring of medicines
  • Active pilots in Generative AI
  • Data Use & Data Discovery
  • Underlining the importance of methodological, legal and ethical considerations
  • Gen-AI to develop protocols & execute trials; understanding whom enters data prior to using this

9:30 AM

Session Reserved for Event Sponsor

10 AM

Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

  • Strategies for sourcing components from a scattered ecosystem
  • How to develop meaningful, human-centric measures
  • Pitfalls and opportunities for analytical and clinical validation
  • Novel solutions and digital pathways for scalable regulatory qualification
  • Maximizing value: how to repurpose and extend solutions across use cases in R&D and healthcare

 

Speakers

Kai Langel
Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Janssen R&D, Spain
Chris Jones
CEO, DEEP Measures

10:30 AM

Session Reserved for Event Sponsor

11 AM

Morning refreshments and networking

11:30 AM

Multi-country experience with clinical trials: A perspective from the development of complex generics.

Development of complex generics, such as those integrating drug-device combinations, or biosimilar medicines require conducting clinical trials comprising phase I to III. These trials are highly challenging due to the requirements of certain patient populations, the need of fast pace, low budgets, and fierce competition. Most of these trials demand multi-country expertise and capabilities, at both CRO and sponsor levels.. Such clinical trials require precise articulation with sites and CROs, and each country requires a different strategy for obtaining approvals, IP logistics, patient recruitment activities, local laboratories, among others. Common hurdles in running multi country trials of complex generics will be discussed. Countries for conducting such trials traditionally involved either US, Canada, India and Central European countries. Recently, other regions have arose as equally capable, such as East Europe, Jordan, Latin America and Africa, expanding the horizons for conducting clinical trials of complex generics and biosimilars.

  • Development of complex generics requires complex clinical trials
  • Trials must be fast paced, with a low budget and competition for patients.
  • Experience in multi-country studies in different regions of the world.

Speakers

Carlos W. Bertoncini
PhD, Clinical & Biopharmaceutical Development Team Leader, CHEMO

12 PM

Session Reserved for Event Sponsor

12:30 PM

Lunch and networking

1:30 PM

Session Reserved for Event Sponsor

8:10 AM

Registration and refreshments

8:45 AM

Chair’s opening remarks

Speakers

Fiona Barry
Editor in Chief & Director Pharmsource, GlobalData

9 AM

EU REGULATIONS Revision of the guidelines on good clinical practice

ICH E6 (R3) guideline has been released for consultation on the 19th May 2023 - this an opportunity to review the differences between the current version and the draft guideline.

Speakers

Silvia Perez Torres
Director, Clinical Quality Compliance, AstraZeneca

9:30 AM

Session Reserved for Event Sponsor

10 AM

Usage of private Large Language Models in Pharma use cases (Drug Discovery, Clinical Trials, Manufacturing): performance, cost saving and data protection.

Core topics: 

  • Why you shouldn’t use Generalist LLMs in mission critical industries and domain-specific tasks such as Clinical Trials.
  • Reliable and affordable alternatives to closed source LLMs.
  • Best practices for savings and efficiency when running private domain-specific LLMs.
  • Real-world use cases of domain-specific LLMs in the pharma industry (Drug Discovery, Clinical Trials, Manufacturing, other)

Speakers

Guglielmo Iozzia
Associate Director - Data Science, ML/AI, Computer Vision, MSD

10:30 AM

Session Reserved for Event Sponsor

11 AM

Morning refreshments and networking

11:30 AM

FIRESIDE CHAT – Holding session on Oversight in Clinical Trials

Clinical trial oversight is a critical element that ensures the protection of research participants and integrity of the data collected.

Speakers

Fabio Miceli
Director Global Quality Assurance / EU QPPV, Norgine
Jadwiga Janicka
Director, Study Operations, AstraZeneca

12 PM

Session Reserved for Event Sponsor

12:30 PM

Lunch and networking

1:30 PM

Session Reserved for Event Sponsor

2 PM

PANEL Maximising your Sites Productivity & how to lessen the burden

Sites are increasingly challenged with workload and resource constraints. This panel will discuss ways in which to get the best output from sites.

What can we do for them beyond an inflated budget? 

  • Addressing challenges the sites are currently facing
  • An overview of the repercussions of such challenges, and a focus on what we can do to overcome them.
  • Forward thinking to strengthen site output.
  • Limitations with electronic applications

 

Speakers

Sonja Weiser
Senior Director Clinical Operations, Insmed

2:45 PM

Afternoon refreshments and Apple Prize draw

3:15 PM

Afternoon refreshments, networking, and Apple Prize Draw

3:45 PM

INTERACTIVE THINK TANKS

Interactive think tank sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry. Hosted by industry experts and each focused on a single issue, think tanks are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. 

Each think tank session lasts for 30 minutes, and delegates may attend up to 2.

Think Tank 1:

 How do we apply GCP Compliance to Artificial Intelligence in Clinical Trials

Laia Casas, Clinical Project & GCP Compliance Leader, Noucor 

 

Think Tank 2:

Are Preferred Suppliers really an opportunity? Pros and Cons 

Silvana Giro, Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging

Think Tank 3: 

Using Real World Data in your clinical development program

Think Tank 4: 

How might European trials make use of a local care model? 

Stephanie Casler, Director of Clinical Innovation, Johnson & Johnson

Speakers

Laia Casas
Clinical Project & GCP Compliance Leader, Noucor
Silvana Giro
Responsible for Global Outsourcing & Contract Management Europe, Global Medical & Regulatory Affairs, Bracco Imaging
Stephanie Casler
Director, Innovative Health, Johnson & Johnson

4:30 PM

Chairperson’s closing remarks

END OF CONFERENCE

Speakers

Select a speaker to learn more

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Mats Sundgren
PhD, European Institute of Innovation through Health Data (i-HD)

Session Details:

KEYNOTE Revolutionizing Clinical Trials through RWD and AI: Unleashing Innovation

2024-05-07, 8:30 AM

Session Details:

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

2024-05-07, 4:15 PM

Session Details:

Chair’s opening remarks

2024-05-08, 8:45 AM

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Stephanie Casler
Director, Innovative Health, Johnson & Johnson

Stephanie is a Director in J&J’s Innovative Health Team, where she works to explore alternative options to traditional trial conduct in order to improve trial accessibility. Prior to joining Johnson & Johnson, she worked in Novartis’ Patient Experience team and spent 14 years as a management consultant with Accenture. American by birth, she has been living in Dublin, Ireland since 2016.

Session Details:

Exploring the Local Care Model in Clinical Trial Operations

2024-05-07, 11:15 AM

Session Details:

INTERACTIVE THINK TANKS

2024-05-08, 3:45 PM

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Nikita Sharma
Global Clinical Sciences & Operations Innovation Manager, UCB

Session Details:

Transforming Clinical Trials: Harnessing AI for Decentralized Study Design and Operations.

2024-05-07, 11:15 AM

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Abdel Dridi
Global Head of Digital Healthcare Technologies (DHT), Personalized Healthcare, Product Development, Roche

Abdel Dridi is the Global Head for Digital Healthcare Technologies at Roche and Genentech. In his role he oversees the global deployment of digital health solutions in late stage, clinical studies and early concepts. He is passionate about creating connected, digital healthcare platforms, and smart medical devices drawing from his deep experience from technology leadership roles at technology companies and in product and service development at technology healthcare organizations.

Session Details:

The use of technology to accelerate early drug discovery and reduce the burden for patients.

2024-05-07, 11:15 AM

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Christian Milliet
Head of Site and Healthcare Ambassadors, CSL Behring

Christian Milliet has over 25 years of experience in the pharma industry, leading Clinical Operations teams across Europe, USA, Latin America, China and Japan. His expertise encompasses all phases of drug development in a multitude of therapeutic areas.

He is currently Head of Site & Healthcare Ambassadors at CSL Behring. Previously, he worked for Vifor Pharma, Novartis, Serono and Covance.

In his current role, Christian is spearheading the development and expansion of site partnerships, leveraging CSL global presence. His focus is on creating strategic relationships to successfully deliver the CSL portfolio, including clinical development and real-world evidence.

Christian has a degree in Business Administration from Webster University in St. Louis, USA.

Session Details:

Site Partnerships: Developing Site Relationships beyond Study-Level Engagement

2024-05-07, 12:15 PM

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Antonella de Ceano
Digital Transformation Officer, Barcelona Health Hub

Session Details:

Clinical Validation of Digital Health Solutions

2024-05-07, 12:15 PM

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Carmela Gómez Rodríguez
Vice President Clinical and Regulatory Affairs, Neurofix Pharma

Session Details:

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

2024-05-07, 2:15 PM

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Dr Mar Gomis Pastor
Director of the Center for Digital Clinical Validation, Hospital de la Santa Creu i Sant Pau

Mar Gomis-Pastor

PharmD, PhD. Clinical pharmacist with specialization in hospital pharmacy. International Doctor of Medicine (UAB - Autonomous University of Barcelona). Mar is currently responsible for the Digital Impulse at St. Pau's Hospital (within the Strategic Impulse and Transformation Area). She is also the Director of the Digital Health Clinical Validation Center (a joint project with the Barcelona Health Hub). She has worked as a coordinator of interdisciplinary and comprehensive eHealth projects for the last 10 years (2013-2023). Her current activity in ambulatory healthcare is focused on heart transplant care. Experience in other areas would be Research; Health Consultancy and eHealth Consultancy; Public Administrations as vocal in the National Commission of Specialties in Hospital Pharmacy, Spanish Ministry of Health Social Services; Education and Doctoral Thesis Director; among others.

Session Details:

Great expectations and how to meet them – connected devices and ePRO in clinical trials

2024-05-07, 2:15 PM

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Sonnika Lamont
Analyst, Clinical Trials Intelligence, GlobalData

Sonnika Lamont, MRes, is a a Clinical Trials Analyst at GlobalData, where her primary responsibilities include the review and update of clinical trial information presented on GlobalData’s Trials Intelligence Platform, the production of analytical reports and insights, testing database releases, and providing comprehensive conference coverage. She has a firm understanding of all aspects of clinical research, and the drug development process. Prior to joining GlobalData, Sonnika worked as a Clinical Trials Research Assistant at University College London’s Cancer Institute. Sonnika holds a Master of Research in Drug Design with a concentration in rare diseases from University College London, and a Bachelor of Science in Biochemistry from Nottingham Trent University.

Session Details:

Site selection for increased patient recruitment and retention

2024-05-07, 2:15 PM

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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 .

Session Details:

PANEL – Outsourcing Strategies & Relationships

2024-05-07, 4:15 PM

Session Details:

Fit-for-Purpose Outsourcing Strategy in Clinical Trials and Cost Optimization

2024-05-07, 3:15 PM

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Sol Yates
Associate Director, European Regulatory Affairs, Shionogi Europe

Session Details:

Experience with EU Clinical Trial Regulation – Updates from January 2023

2024-05-07, 3:15 PM

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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:

PANEL – Outsourcing Strategies & Relationships

2024-05-07, 4:15 PM

Session Details:

INTERACTIVE THINK TANKS

2024-05-08, 3:45 PM

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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 – Outsourcing Strategies & Relationships

2024-05-07, 4:15 PM

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Mireille Ermens
Senior Director, Clinical Development Operations- Global Feasibility and Start Up Support, CSL Behring

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Silvia Perez Torres
Director, Clinical Quality Compliance, AstraZeneca

I have a PH degree in Pharmaceutical sciences by the Barcelona University. I started my career as a researcher in Neurochemical department within the Barcelona Biomedical Research Institute (IIBB), where I developed my PH degree focused on Alzheimer’s disease and Inflammation.

Once I completed my Ph Degree in Neuroscience, I moved to the clinical industry, working most of my career in Data Management, first in a small CRO company and later in the pharma industry.

For along almost 12 years, I was managing phase III clinical trials acting as Global Data Manager Lead, coordinating end-to-end data management activities (including SDTM development) mainly outsourced to global CROs. Apart of the oversight of clinical trials, part of my role as an expert in DM was to lead standardization on E2E data and processes.

On 2018, I completely changed my role and moved to the Quality area. Since then, I’m Director on Clinical Quality Compliance. On this role, I’m providing quality support to Biometrics functions (including DM, Programming and Statistics roles). Among other activities, I’m giving quality related advice and guidance, overseeing quality issues, CAPA implementation and risk management. Coordinating and supporting audit and inspections, as well as preparing teams to be inspection ready at all time.

Since 2020, I’m Regulatory Considerations Expert Group DMEG Chair on the Association for Clinical Data Management. The aim of the Regulatory Considerations Expert Group looks at providing guidance information on several areas surrounding regulations. The expectations and recommendations on implementation and what data management needs to be prepared for in readiness for inspection.

Session Details:

EU REGULATIONS Revision of the guidelines on good clinical practice

2024-05-08, 9:00 AM

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Guglielmo Iozzia
Associate Director - Data Science, ML/AI, Computer Vision, MSD

Guglielmo is a Biomedical Engineer with an extensive background in Software Engineering and ML/AI applied to different contexts, such as Biotech Manufacturing, Healthcare and DevOps, just to mention the latest, and a lifelong learner. At MSD, as part of the Data Science and Applied Mathematics Team he is currently busy unlocking business value in the lab and manufacturing through ML/AI initiatives.

He is also an international speaker and author: currently he is writing his second technical book for Manning Publishing, where he is going to share his field experience on implementing domain-specific Large Language Models that can be also executed offline, on private data and on commodity hardware

Session Details:

Usage of private Large Language Models in Pharma use cases (Drug Discovery, Clinical Trials, Manufacturing): performance, cost saving and data protection.

2024-05-08, 10:00 AM

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Kai Langel
Senior Director, Strategy and Innovation, Global Regulatory Policy and Intelligence, Janssen R&D, Spain

Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal remote clinical trial platform. Through his involvement in technical, operational and scientific roles, he has gained deep and holistic understanding of the clinical trial process and the key mechanisms of our ecosystem.

Kai brings his entrepreneurial spirit and creative mindset to support Janssen’s global regulatory policy work across a range of topics. Kai has a passion for broad pre-competitive collaboration and is motivated to modernize the ways our broader ecosystem works together to advance the adoption of novel tools and methods to support efficient and patient-centric pharmaceutical R&D.

 

Session Details:

Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

2024-05-08, 10:00 AM

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Chris Jones
CEO, DEEP Measures

Session Details:

Expert conversation: Strategic considerations for end-to-end development of fit-for-purpose digital measures of health

2024-05-08, 10:00 AM

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Carlos W. Bertoncini
PhD, Clinical & Biopharmaceutical Development Team Leader, CHEMO

Session Details:

Multi-country experience with clinical trials: A perspective from the development of complex generics.

2024-05-08, 11:30 AM

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Fabio Miceli
Director Global Quality Assurance / EU QPPV, Norgine

Fabio is a Pharmaceutical Professional with almost 25 years of experience in the industry. He graduated from the University of Amsterdam with a Master’s degree in Medical Biology. He started his career in Clinical Operations working for Pharma, Biotech and various Clinical Research Organizations. Subsequently, he moved across to the Quality Assurance arena where he has spent the last 17 years of his career in various roles of increasing importance . Currently employed at Norgine as Director Global Quality, Fabio’s responsibilities include GCP, GLP, Commercial Quality / Codes of Practice, Competent Authority Inspection Management and he acts as Clinical Development, Medical Affairs and Regulatory Affairs Quality Business Partner. Following Brexit and after a 3-year tenure as deputy, Fabio assumed the role of  EU QPPV for Norgine in 2022 – a role he executes in parallel to his Quality role.

Session Details:

FIRESIDE CHAT – Holding session on Oversight in Clinical Trials

2024-05-08, 11:30 AM

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Sonja Weiser
Senior Director Clinical Operations, Insmed

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 Maximising your Sites Productivity & how to lessen the burden

2024-05-08, 2:00 PM

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Laia Casas
Clinical Project & GCP Compliance Leader, Noucor

Biomedical Scientist with an MSc in Monitoring Clinical trials and Medical Affairs. Have worked in several positions from top to bottom: From study coordinator to RD Project Manager at a Sponsor Company, including CRA. Work through various companies: Pharmaceutical laboratories, CROs and medical device start-ups. Have worldwide experience in clinical trials, and planned, designed, and led clinical projects for EMA and FDA.

 

Session Details:

INTERACTIVE THINK TANKS

2024-05-08, 3:45 PM

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Jadwiga Janicka
Director, Study Operations, AstraZeneca

Jadwiga Janicka is holding a role of Director of Study Operations at AstraZeneca, overseeing a team responsible for the execution of global clinical trials. With an extensive background spanning more than 17 years in the field of clinical trials, Jadwiga has consistently played a pivotal role in collaborative efforts with numerous CROs. Her involvement has ranged from project management to governance-level activities, contributing to the successful execution of trials. Jadwiga's expertise is particularly focused on staying abreast of current trends in outsourcing practices and evolving oversight requirements within the industry.

Session Details:

FIRESIDE CHAT – Holding session on Oversight in Clinical Trials

2024-05-08, 11:30 AM

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Daniel McVeigh
Director, Clinical Project Lead, Alexion Pharma

A Clinical Research Professional with over 12 years’ experience across various settings such as Site, CRO, Small Biotech and Pharma. Expertise in various therapeutic areas from Oncology and Rare/Orphan Disease. Experience from early phase first in human to late phase and Nov Intervention RWE generation and Registries. Focused on Clinical Operations excellence and process improvements for the benefit of the patients we serve. Currently Director, CPL at Alexion, AZ Rare Disease leading a Cross Functional clinical team in the execution of multiple clinical studies and PASS studies.

Session Details:

PANEL – Outsourcing Strategies & Relationships

2024-05-07, 4:15 PM

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Richard Stephens
Patient Advocate since 1998; author, speaker, journal editor

Richard Stephens has been a patient advocate for 25 years, surviving two cancers and a heart emergency, plus several co-morbidities and late effects. As a patient he has participated in four interventional studies and nine others. As an Advocate he has helped design over 30 more.

Richard Chairs the UK Cancer Research Advocates Forum (formerly the NCRI Consumer Forum) and is the former Chair of BBMRI-ERIC’s Stakeholder Forum. He works with patient groups and advocates, academics and industry, and policy-makers, funders and regulators.  

Richard helped found the AllTrials campaign and useMYdata movement, and he is the founding co-Editor-in-Chief of the Journal of Research Involvement and Engagement. His professional life has included careers in education, journalism and local government.

Session Details:

PATIENT ADVOCATE KEYNOTE One Voice and 101 Opinions – A Patient Perspective on the Conference Topics

2024-05-07, 3:15 PM

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Amelia Hursey
Parkinson's Research Manager, Parkinson's Europe

Amelia joined the Parkinson’s Europe  team in Jan 2022 as Research Manager. Since then she has developed Parkinson’s Europe’s Research Strategy, embedding a Research Steering Group into the organisation and helping to increase the presence of Parkinson’s Europe in the clinical research world. She is also focused on bringing new initiatives to the table, such as the Parkinson’s Europe’s Engagement Network, which better connects the Parkinson’s

community with research across Europe. Parkinson’s Europe is now a partner member of EUPATI and the Critical Path for Parkinson’s as part of this action.

She has been working in the field of Neurodegenerative research since 2009 and is a Patient Organisations board member with EUPATI since Sept 2023.

She previously worked for the UK NIHR’s DeNDRoN delivering clinical trials and then at Parkinson’s UK from July 2015 as Research Participation Lead.  She was responsible for initiatives to increase research participation for people affected by Parkinson’s, health care professionals and researchers, and created the innovative Parkinson’s UK Take Part Hub and co-produced the Staying Connected toolkit in collaboration with the HRA UK.

Session Details:

Building clinical trials with the perspective of the patients in mind; exploring patient collaboration and the benefits it can bring to the sponsor and the patient.

2024-05-07, 12:15 PM

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Jose Manuel Ordoñez
MD, CCO Therapeutic Area Leader Onco-Haematology, Roche

I studied Medicine in Universidad de Navarra (Spain) and did my especialization in oncologist in the same site between 1997 and 2001. I have work as medical oncologist during several years in Pamplona and Madrid, and I joined Roche in 2007 as Country Study Manager. My current position is Therapeutic Area Leader in Clinical Operations for Onco-Hematology studies from 2015. I have a master in coaching and talent development and another in pharmaeconomics and health economy.

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Maria Reyes Boceta-Munoz
Head Of Clinical Operations Spain, GSK

Session Details:

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

2024-05-07, 4:15 PM

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Francis P. Crawley
Executive Director, Good Clinical Practice Alliance - Europe (GCPA)

I am a philosopher in Leuven specializing in research ethics, data/AI ethics, and clinical trials. My career began with pioneering Good Clinical Practice (GCP) implementation in Europe. I collaborated closely with researchers, regulators, and patients to tackle fundamental ethics questions while overseeing research projects.

I was invited to chair the committee that authored the first Europe-wide ethics review guidelines. The WHO then asked me to produce the inaugural global ethics guidelines for health research. I spearheaded the SIDCER program with WHO that for the implementation of best practices in ethics review globally.

Over 20+ years, I have actively served on ethics committees for HIV, cancer, global health, and pediatric research. Through European Commission projects worldwide, I significantly contributed to clinical trial registries, biobanks, patient databases, and best practices for specific populations while addressing evolving ethical issues around consent, inclusiveness and transparency.

I have extensively collaborated with international organizations (WHO, UNAIDS, UNESCO, CIOMS, European Commission, EDCTP, NIH) to advance research ethics and oversight. With the European Academy of Paediatrics, I spent two decades developing pediatric clinical and research ethics policies.

Recently, I have been at the forefront of data, AI, and open science ethics, policy, and governance. As an EOSC-Future/RDA working group co-chair, I am producing deliverables on AI regulation, consent guidelines, and bills of rights. During COVID-19, I engaged crucial research on genetics, AI, and disease severity, as well as in ethics and policy for clinical trials (vaccines and therapeutics) to address the pandemic.

Recently, I helped to establish a CODATA/UNESCO group on data policies for open science in crisis situations aimed at enriching UNESCO’s toolkit. My career has demonstrated an unwavering commitment to research ethics and integrity through impactful leadership, expertise, and global collaborations.

Session Details:

Governance for the European Health Data Space

2024-05-07, 9:30 AM

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Robert Kurowicki
Robert Kurowicki, Director of Feasibility and Project Strategy, Novotech Europe

Robert Kurowicki has over 12 years of experience in clinical research working for the Clinical Research Organization. Before that he spent over 18 years in the pharmaceutical and biotech industry managing sales and marketing activities in several companies including Behring, Sanofi and Celgene, focusing on the oncology, haematology and rare disease therapeutic areas.

At his current position, he is responsible for the feasibility research. Collaborating with investigators and various team members such as Medical Experts, Regulatory and Project Managers, as well as analysing multiple data sources, Robert is responsible for strategizing the most efficient scenarios to conduct various clinical studies.

Session Details:

PANEL – Robust feasibility for clinical trials. From protocol design to country & site selection; sharing critical success factors.

2024-05-07, 4:15 PM

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Laura Jiménez Robledo
Clinical Project and Innovation Manager, Novo Nordisk

Laura is a Clinical Research Professional. She started in Novo Nordisk in 2013 as CRA and since 2020 she's exploring and defining Clinical Innovation as Clinical Innovation Manager.

In her current position, she's leading the Innovation Strategy in her department - Clinical Operations in France, Portugal and Spain and additionally, driving the change and bringing innovation in Region Europe.

Her superpowers: communication, innovation and collaboration.

Session Details:

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

2024-05-07, 4:15 PM

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Upinder Grewal
Strategic Lead Exploration and Discovery, DS&AI, Bayer

I’ve been working in the Healthcare industry for 23 years working for various companies from Start up, mid size and large Pharma.

During the 23 years I have worked across many areas from Supply Chain, Process Improvement/Six Sigma, IT, Vendor Management and last 3 years working in Global Clin Op’s. I am now part of Clinical Trial Technology Strategy as well as part of the DCT initiative Leadership team focusing on external innovation, collaboration and identifying new solutions for trials.

Session Details:

PANEL – Exploring the transition of Innovation & technological advancements in clinical trials

2024-05-07, 4:15 PM

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Anthony Mikulaschek
Vice President, eCOA, IQVIA Technologies

As Vice President of eCOA at IQVIA, Anthony Mikulaschek manages all operations, data management, quality management, training and eCOA project work associated with IQVIA eCOA. Anthony has extensive experience in validated system implementation, systems integration, business process reengineering, IT operations, and consulting. He has successfully led the development, delivery, and management of technology solutions for over 30 years including 26 years in the Pharmaceutical sector.

Session Details:

How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors

2024-05-07, 11:45 AM

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Stefan Dürr
Senior Director, Client Delivery, Cenduit IRT, an IQVIA business, Head of Drug Supply Center of Excellence

Senior Director, Client Delivery at Cenduit IRT, an IQVIA business, Head of Drug Supply Center of Excellence

Stefan has worked in IRT for 15 years and has been with Cenduit IRT, an IQVIA business, since its inception in 2007. He has worked in various project management roles including leading the global project management team at Cenduit. Stefan currently is responsible for client delivery of key customer accounts and heads the Cenduit drug supply center of excellence. He is very passionate about finding innovative solutions for clinical supply challenges.

Stefan holds a master of science in molecular biology and an international executive MBA of the University of St. Gallen.

Session Details:

How to leverage clinical technology integrations and automation to make a positive difference for trial sites, patients and sponsors

2024-05-07, 11:45 AM

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Alina Pszczółkowska
Global Senior Director Study Management, AstraZeneca

Alina Pszczółkowska, MD – graduate of Medical Academy in Katowice and Medical Academy in Warsaw. In 2009 she obtained the diploma with distinction from the Wyższa Szkoła Zarządzania – Polish Open University and Oxford Brookes University. She has worked with clinical studies and development in Poland since 1997.

She started her carrier as the Clinical Research Associate in Parexel. Since 1999 she is responsible for organizing, monitoring, managing the processes and quality of clinical trials in AstraZeneca.
Alina was the Clinical Research Director. She was the first Director of Clinical Operations Hub in Warsaw, who was coordinating global trials.

In 2012-2015 as Global Director Site Management & Monitoring she was leading the clinical trials over the Europe, Middle East & Africa regions.

From the beginning of 2016 Alina moved to Gotheborg, Sweden as Global Senior Director Clinical Operation. While holding that position, she developed, implemented and maintained a strategy for clinical operations across Cardiovascular, Chronic Kidney and Gastrointestinal compounds, and provide portfolio-level leadership to drive clinical programs and studies.

She was leading a group of Directors Clinical Development (DCD) and Associate Directors Clinical Development (ADCD).

Afterwards, from October 2017, Alina moved back to Warsaw, after becoming appointed to the role of Global Head of Study Management Operations, taking over Warsaw, Toronto and Shanghai Hubs within over 350 global project teams in Clinical Operations.

She was focusing on research management in the area of respiratory, metabolic and cardiological diseases.

In 2023 she became Head of Late Phase Clinical Operations in R&I department.

In the meantime, Alina also became a Vice-President of AstraZeneca Pharma Poland, having the opportunity of shaping the Warsaw office and influencing its growth.

 

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