13th Annual Outsourcing in Clinical Trials Nordics 2025

The annual meeting place for pharmaceutical, biotechnology, and medical device communities in the Nordics to network and discuss strategies for operational success in clinical trials

21 - 22

October

2025
  • Clarion Hotel & Congress Copenhagen Airport, Denmark
  • Complimentary
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
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Featured Speakers

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Stephen Lutsch​

Senior Director Clinical Trial Digital Innovation, Genmab

In my position as Senior Director - Clinical Trial Digital Innovation at Genmab, I lead a team driving AI adoption within clinical operations, decentralized clinical trials and digital innovation in drug development. Previously, I have been working to bring the best disruptive innovation into normal clinical operations at LEO Pharma to help improve and accelerate their clinical trials. Furthermore, I am trying to solve some of the toughest challenges related to scaling digitalization, data, and automation to generate competitive advantages across business units. One aspect is driving the necessary foundational components around a scalable GxP data platform, machine learning opportunities as well as automating digital processes with robotics process automation. Besides leading the necessary change internally, focus is on a design-thinking approach where we put the patient and site at the center. I have an ambition towards “delighting” patients, investigators, and sponsors by solving the real-world challenges they face by leveraging both qualitative interviews and observation, as well as quantitative methods to reveal actionable insights

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Morten Pedersen​

VP, Head of Clinical Operations, Lundbeck

Morten completed his Master’s degree in Biotechnology at National University of Ireland, Galway, in 1997, specializing in Pharmacology. He joined Lundbeck in August 2020 as VP, Head of Clinical Operations.

Career to date Morten started at a CRO in 1997 as a CRA on an Epilepsy study.  In the subsequent years he worked in CRO’s, consultancy and big Pharma taking on roles within Project Management, Program Oversight, Innovation and Strategic Partnerships.  He joined Pfizer in 2003 and has a wide range of project management experience delivering projects across multiple therapeutic areas. From 2007 to 2011 he held a leadership role in Pfizer’s Clinical Study Management group providing Operational Oversight in various outsourcing models.  As Group Lead of Emerging Markets and Established Products Business Units he managed a team of Program Directors in a variety of Therapy Areas from Phase II to Late Phase and Non-Interventional trials. From late 2011 Morten joined an Innovation technology CRO in the role of Senior Director and Head of Strategic Partnerships with the aim of improving Clinical Trial efficiencies and supporting Trial Sites. In August 2016 he joined InVentiv Health as VP, Head of Program Delivery in Neuroscience, before the group merged with INC to become Syneos Health.

 

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Magnus Jörntén-Karlsson​

Head of Digital Patient & Site Technology, Evinova at AstraZeneca

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Caroline Sandstroem​

Head of Global Clinical Quality, Ferring Pharmaceuticals

Dr. Caroline Sandström received her PhD in Medical Science from Lund University, Sweden in 2008. She has then worked for Novo Nordisk A/S, Denmark for several years as a pharmacologist driving and executing pharmacological plans supporting pre-clinical projects.

Her interest and enthusiasm for project management, continuous improvement, streamlining initiatives and training was then later beneficially used when she moved into the compliance area managing global improvement and training initiatives within R&D Quality Management System (QMS) including Clinical. For example, she was the project manager for implementing the effective use of Root Cause Analysis in Clinical Development activities but also being highly involved in initiatives related to Quality Culture.  Ferring Pharmaceuticals A/S in Copenhagen, DK. On a daily basis she was involved in discussing, driving compliance and improvement initiatives within both Non-Clinical, Clinical and Pharmacovigilance related activities. She has taken a very active role in contributing to a collaborative and transparent organization where sharing learnings are a main focus area.

From beginning of May 2022, she moved into the position of being Head of the Global Clinical Quality Department being responsible for the QA support of global key stakeholder areas such as Clinical Development, Regulatory Affairs, Pharmacovigilance and Discovery. Her scientifically driven problem-solving skills are used for implementing global cross-functional initiatives, and for supporting and strengthening the harmonization and quality mindset in the organization.

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Joachim Lovin​

DCT Specialist, Novo Nordisk

Joachim Lövin has worked in the pharmaceutical industry for over 20 years across various therapeutic areas and organizations. During this time, Joachim has worked in different roles spanning over Data Management, Project Management, Process Development, Senior Business Analyst and Clinical Operations. In his current role as DCT Specialist, Joachim focuses on supporting trials including competence development of Clinical Operations, identifying opportunities, and operationalising Decentralised Clinical Trial Elements across Novo Nordisk. Joachim is the Workstream Lead for the Modernizing Clinical Trial Conduct workstream for TransCelerate Biopharma, and a member of the eClinical Forums Trial of the Future. All of Joachim’s work is aligned with his passion to improve patient experience and accelerating clinical trials.

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    2025 Sponsors Included:

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    Company Information

    ARENSIA Exploratory Medicine, a German-based company, is a leader in “first-in-patient” Phase IB and II/Proof-of-Concept clinical trials across a wide range of disease areas. With 14 proprietary research clinics and cutting-edge Phase I infrastructure, ARENSIA accelerates the early detection of efficacy signals for new therapies at an unparalleled speed. Its streamlined, highly efficient approach reduces patient recruitment time and costs by over 50% compared to conventional trial sites, which are often overcrowded and understaffed. This exceptional performance has resulted in a 93% repeat business rate and robust growth through collaborations with top pharmaceutical companies, biotechs, and global CROs. Headquartered in Düsseldorf, ARENSIA operates with a team of 600 professionals across 8 countries.

    Company Website

    To learn more, please visit our website - http://www.arensia-em.com/

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    Company Information

    Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 35,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

    Company Website

    To learn more, please visit our website - https://www.medidata.com

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    Company Information

    Fortrea is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas. Our talented and diverse team of more than 19,000 people working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally.

    Company Website

    To learn more, please visit our website - https://www.fortrea.com/

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    Company Information

    TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

    Company Website

    To learn more, please visit our website - www.tfscro.com.

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    Company Information

    Novotech is a globally recognized full-service clinical research organization (CRO) and scientific advisory partner for biotech and small- to mid-sized pharmaceutical companies seeking to advance drug development. With deep therapeutic and regulatory expertise and an expansive global footprint across the Asia-Pacific region, North America, and Europe, Novotech offers clients an accelerated path to bring life-changing therapies to market.

    Company Website

    To learn more, please visit our website - www.novotech-cro.com

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      Why attend?

      This is the unmissable event that the pharmaceutical, biotechnology, and medical device communities need to come together and discuss strategies for operational success in clinical trials. Combining our OCT, CTS and Medical Devices events, this is the perfect platform for professionals from across a range of clinical trial functions to meet, network, and hear about latest developments

       

      WHAT TO EXPECT FOR 2025?

      200+

      Attendees

      		30+

      Exhibitors

      		30+

      Speakers
      200+

      Attendees

      		30+

      Exhibitors
      30+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 21 Oct 2025
      • 22 Oct 2025
      Expand All

      Streams

      Stream one

      OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

      7:30 AM

      Registration and refreshments

      8:15 AM

      Chairperson’s opening remarks

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S

      8:30 AM

      Making the EU more attractive for clinical trials: how can we achieve this?

      • Sharing issues and feedback collated regarding difficulties of trials in EU
      • Discussing potential solutions to improve the appeal of running trials in EU
      • Looking at how and when these solutions could be implemented

      Speakers

      Lene Grejs Petersen
      Senior Adviser, Danish Medicines Agency

      9 AM

      Reserved for event sponsor

      9:30 AM

      Panel Discussion: Navigating updated GCP guidelines: ICH E6 (R3)

      • Highlighting the key changes in ICH E6 (R3) and their practical implications for clinical trial conduct
      • Exploring approaches to implementing new guidelines in diverse trial settings
      • Analysing challenges, opportunities, and interpretations associated with ICH E6 (R3)

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma A/S
      Cornelia Baumgartner
      Head of Clinical Operations, T-CURX

      10 AM

      Reserved for event sponsor

      10:30 AM

      Morning Refreshments & Networking

      11 AM

      Successfully outsourcing a trial from a smaller to mid-size company perspective

      • Selecting vendors suitable for smaller or mid-size companies
      • Managing the trial and oversight with a smaller team and limited resource
      • Overcoming hurdles and sharing best practice to successfully outsource trial

      Dorte Pedersen, Outsourcing Specialist
      (speaker and topic pending confirmation)

      11:30 AM

      Reserved for event sponsor

      12 PM

      Outsourcing of pharmacovigilance: risks and implications on the global PV system

      • Global and local PV set-up
      • Vendor interactions and mutual agreement on expectations
      • Potential impact on continued safety surveillance and risk management
      • Compliance risks to PV system

      Speakers

      Kira Hammershoi
      Director EU/UK QPPV, LEO Pharma

      12:30 PM

      Reserved for event sponsor

      1 PM

      Lunch and networking

      2 PM

      Implementing FDA’s Project Optimus and reviewing the impact on trials

      • Selecting the right dose in line with FDA guidance
      • Sharing implementation methods within study designs and protocols
      • Highlighting challenges and successes

      Speakers

      Karin Nordbladh
      Director Clinical Operations, Alligator Bioscience

      2:30 PM

      Reserved for event sponsor

      3 PM

      Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

      • Considering touchpoints of when and how we can reach patients
      • Collating patient input early to incorporate their perspective in protocols and trial design
      • Utilizing digitalization and technology in patient communications

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma
      Catharina Östberg
      Head of Site Management Nordics, Bayer
      Lill-Brith Wium von Arx
      RWE Lead Northern European Hub, Eli Lilly and Company
      Merete Schmiegelow
      Patient Advocate

      3:30 PM

      Afternoon refreshments, networking and prize draw

      4 PM

      Patient Perspective: Considering patient engagement in medicines R&D, approvals and life cycle

      From a patient advocate perspective, Merete will discuss the why, what, when and how of patient engagement

      Speakers

      Merete Schmiegelow
      Patient Advocate

      4:30 PM

      Reserved for event sponsor

      5 PM

      Sharing latest updates on SweTrial initiative to enhance clinical trials in Sweden

      • Creating a national partnership to enhance conditions for clinical trials
      • Collaborating between healthcare sector, academia, and the pharmaceutical industry to make Sweden more competitive in conducting clinical trials
      • Streamlining clinical study systems to improve efficiency and accessibility of clinical trials

      Speakers

      Gunilla Andrew-Nielsen
      Head of Department of Clinical Trials and Special Permissions

      5:30 PM

      Chairperson’s closing remarks

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma

      END OF DAY 1 AND NETWORKING DRINKS

      Streams

      Stream one

      OUTSOURCING IN CLINICAL TRIALS & CLINICAL OPERATIONS

      Stream two

      CLINICAL TRIALS TECHNOLOGY & INNOVATION

      8:15 AM

      Registration and refreshments

      8:30 AM

      Chairperson’s Opening Remarks

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma

      8:45 AM

      Unravelling regulatory complexity of combined studies – update from the COMBINE programme

      • Overview of the COMBINE programme and ongoing projects
      • Framework of the COMBINE ‘All in One coordination’ pilot procedure to optimise

      Speakers

      Päivi Susanna Worsøe
      Project Manager and Special Adviser in Clinical Trials, Danish Medicines Agency

      9:15 AM

      Reserved for event sponsor

      9:45 AM

      Negotiation skills during CRO and vendor selection process

      • Paying for what you need and not more
      • Ensuring that you are discussing with the right-fit-partner from the start
      • Assessing contract set-ups: milestone payments vs hourly rate, including bonus/penalty fees or opting for fixed price
      • Setting up the study from the beginning, minimizing cost

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma

      10:15 AM

      Morning Refreshments & Networking

      10:45 AM

      Clinical trials in Japan experience: from vendor selection to J-NDA approval

      • Selecting a CRO in Japan
      • Discussing PMDA negotiations, regulatory landscape and inspection readiness
      • Sharing challenges and benefits of conducting trials in Japan
      • Overcoming initial doubts and providing lessons learned from partnerships between sponsor and CRO in Japan

      Speakers

      Lisbet Groes
      Associate Director Clinical Operations, Ascendis Pharma

      11:15 AM

      Reserved for event sponsor

      11:45 AM

      Panel Discussion: Choosing an outsourcing model: FSO vs FSP vs inhouse

      • Weighing up pros and cons of different outsourcing models: which is best for your trial?
      • When is mixing and matching better than fully outsourcing or keeping trials fully in house?
      • Developing an outsourcing strategy with limited resources
      • Why is FSP becoming a popular choice among sponsor companies and how can this support meeting trial timelines?
      • How do strategic alliances impact this decision?

      Speakers

      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma
      Elisabeth Ahlmann-Ohlsen
      Director Quality Assurance, Hemispherian AS
      Cornelia Baumgartner
      Head of Clinical Operations, T-CURX

      12:30 PM

      Lunch and networking

      1:30 PM

      Preparing for close of study and commercialisation as a small biotech: submitting an NDA

      • Planning ahead: aligning clinical trial timelines with regulatory expectations
      • Discussing challenges in data readiness and submissions and how to overcome them
      • Considering pricing, reimbursement and scaling up production strategies
      • Transitioning from clinical trial to market: best practice tips
        Session reserved

      2 PM

      Reserved for event sponsor

      Speakers

      Anna Polak-Andersen
      Head of Clinical Development, Entero Target

      2:30 PM

      Sharing insights on ethical considerations for clinical trials

      • Looking at informed consent: requirements and challenges
      • Balancing risks with anticipated benefits
      • Considering diversity and accessibility
      • Complying with regulatory ethical review processes

      Speakers

      Elisabeth Ahlmann-Ohlsen
      Director Quality Assurance, Hemispherian AS

      3 PM

      Afternoon refreshments, networking and prize draw

      3:30 PM

      ROUNDTABLE SESSIONS

      During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      Roundtable 1
      Progressing your planning as a small biotech whilst in funding mode
      Judi Simonsen, CEO and Co-Founder, MERODZ

      Roundtable 2
      Selecting and managing sites: key considerations
      Catharina Östberg, Head of Site Management Nordics, Bayer

      Roundtable 3
      Considering sustainability throughout the clinical supply chain: where can we improve?
      Kamal Amin, Head of Supply Chain Management, Galderma

      4:30 PM

      End of conference

      12 AM

      Improving clinical supply chain with digital display labelling

      • Enhancing real-time data visibility and accuracy
      • Streamlining compliance and regulatory adherence
      • Boosting flexibility and efficiency in clinical supply managemen

      Speakers

      Alexander Debets
      Lead Clinical Supply Innovation, Former MSD

      8:30 AM

      Chairperson’s opening remarks

      8:45 AM

      Transforming clinical data management with AI: challenges, solutions, and ROI

      • Tapping into the unprecedented opportunities the integration of Artificial Intelligence (AI) offers in the rapidly evolving landscape of clinical research
      • Implementing AI tools to enhance the efficiency, accuracy, and compliance of clinical data management
      • Exploring the dual role of AI: Generating and reviewing clinical documents, addressing the critical challenges and proposing a robust framework for implementation

      9:15 AM

      Reserved for event sponsor

      10:15 AM

      Morning Refreshments & Networking

      10:45 AM

      Discussing importance and benefits of data-enabled clinical trial recruitment

      • Considering types of data that can be utilized to assist with patient recruitment challenges
      • Incorporating data findings into development of eligibility criteria
      • Using secondary health data to identify sites and patient cohorts
      • Complying with ethical and regulatory requirements of data usage

      Speakers

      Lill-Brith Wium von Arx
      RWE Lead Northern European Hub, Eli Lilly and Company
      Hanne Joergensen
      Clinical Trial Lead Northern European Hub, Eli Lilly and Company

      11:15 AM

      Reserved for event sponsor

      • Reserved for event sponsor (tech spotlight)
      • Reserved for event sponsor (tech spotlight

      Speakers

      Esther Marfo
      Project Leader, Health Equity And Population Sciences, Hoffman La Roche

      11:45 AM

      Beyond the spreadsheet: a practical model to align budget, milestones & cash flow

      • Track budgets in sync with timelines using a simple Excel-based model
      • Forecast cash flow and spot issues early — no finance degree needed
      • Boost transparency between sponsors and vendors, reduce surprises

      Speakers

      Cornelia Baumgartner
      Head of Clinical Operations, T-CURX

      12:30 PM

      Lunch and networking

      1:30 PM

      Digital health technologies in clinical trials

      • Session content to be confirmed

      Speakers

      Alastair Clewlow
      Senior Director, Clinical Data Management, Programming & Digital Solutions, Lundbeck
      Charlotte Sauter
      Principal Digital Health Science, Lundbeck

      2 PM

      Reserved for event sponsor

      2:30 PM

      Panel Discussion: Clinical trial innovation: insights into new technology and strategy

      • Incorporating digitalization and new technologies into your clinical trials
      • platforms: improving communication and efficiency among stakeholders
      • Success stories, transformative case studies and key takeaways

      Speakers

      Alexander Debets
      Lead Clinical Supply Innovation, Former MSD

      Speakers

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      Karin Nordbladh
      Director Clinical Operations, Alligator Bioscience

      Session Details:

      Implementing FDA’s Project Optimus and reviewing the impact on trials

      2025-10-21, 2:00 PM

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      Lisbet Groes
      Associate Director Clinical Operations, Ascendis Pharma

      Session Details:

      Clinical trials in Japan experience: from vendor selection to J-NDA approval

      2025-10-22, 10:45 AM

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      Catharina Östberg
      Head of Site Management Nordics, Bayer

      Session Details:

      Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

      2025-10-21, 3:00 PM

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      Luiz Barberini
      Head of External Manufacturing, Bayer
      • Over 25 years’ experience in Logistics, Supply Chain, Procurement and Demand Planning areas.
        Solid knowledge and experience in the whole S&OP process and its KPI´s inter-relationships with stakeholders
      • Demand Planning process management - pre-S&OP, with Sales, Marketing, Trade Marketing, Industrial Planning and Finance and customized tool design for such process
      • Management skills: experience with multidisciplinary and international teams (Brazil / Latin America / US).
      • Experience in S&OP, 3PL and Supply Chain Organization projects' implementation
      • Strong experience with Pharmaceutical and Consumer companies and Brazilian distribution model / 3PL contracts
      • Solid team management skills, as well as Customer Service relationship and management
      • Teacher for major Post Graduation Schools - Demand Planning and Procurement/Negotiation areas

      CSCP & CPIM APICS. Logistics & Supply Chain driven strategy. Distribution & Logistics, Demand Planning, S&OP, Procurement and Export experiences, focusing on Business necessities through effective leadership.

      Working as External Manufacturing Operations Manager Latin America at Bayer, in charge for external partners for CHC Division. Previously as Relationship Associated Director at Merck , Logistics Manager at Takeda/Nycomed Pharma, focusing on demand management, planning and distribution activities. Also has worked as Pfizer´s Logistic Manager and EFD´s Supply Chain Manager. Souza Cruz´s Procurement Manager and Rhodia's Logistic Supervisor.

      Specialties: Logistics, Supply Chain, Materials, Procurement , Services, Negotiation, 3PL contracts, S&OP, Demand Planning

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      Lene Grejs Petersen
      Senior Adviser, Danish Medicines Agency

      Session Details:

      Making the EU more attractive for clinical trials: how can we achieve this?

      2025-10-21, 8:30 AM

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      Päivi Susanna Worsøe
      Project Manager and Special Adviser in Clinical Trials, Danish Medicines Agency

      Session Details:

      Unravelling regulatory complexity of combined studies – update from the COMBINE programme

      2025-10-22, 8:45 AM

      View In Agenda
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      Lill-Brith Wium von Arx
      RWE Lead Northern European Hub, Eli Lilly and Company

      Session Details:

      Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

      2025-10-21, 3:00 PM

      Session Details:

      Discussing importance and benefits of data-enabled clinical trial recruitment

      2025-10-22, 10:45 AM

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      Hanne Joergensen
      Clinical Trial Lead Northern European Hub, Eli Lilly and Company

      Session Details:

      Discussing importance and benefits of data-enabled clinical trial recruitment

      2025-10-22, 10:45 AM

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      Kamal Amin
      Head of Supply Chain Management, Galderma
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      Sonnika Lamont
      Senior Analyst, GlobalData

      Sonnika Lamont, MRes, is a Clinical Trials Senior 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.

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      Elisabeth Ahlmann-Ohlsen
      Director Quality Assurance, Hemispherian AS

      Session Details:

      Sharing insights on ethical considerations for clinical trials

      2025-10-22, 2:30 PM

      Session Details:

      Panel Discussion: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2025-10-22, 11:45 AM

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      Kira Hammershoi
      Director EU/UK QPPV, LEO Pharma

      Session Details:

      Outsourcing of pharmacovigilance: risks and implications on the global PV system

      2025-10-21, 12:00 PM

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      Malene Gantzhorn Pedersen
      Senior Clinical Supply Specialist, Lundbeck
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      Alastair Clewlow
      Senior Director, Clinical Data Management, Programming & Digital Solutions, Lundbeck

      Alastair Clewlow is Senior Director for Clinical Data Management, Statistical Programming and Digital solutions at Lundbeck. He has over 25 years of experience in the pharmaceutical and IT Industry, having held positions in Data Management and Clinical Operations at LEO Pharma, Product Strategy and Development in the Oracle Health Sciences Global Business Unit before joining Lundbeck. He graduated from the University of Portsmouth with a BSc (Hons) in molecular biology.

      Session Details:

      Digital health technologies in clinical trials

      2025-10-22, 1:30 PM

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      Charlotte Sauter
      Principal Digital Health Science, Lundbeck

      Session Details:

      Digital health technologies in clinical trials

      2025-10-22, 1:30 PM

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      Judi Simonsen
      CEO and Co-Founder, MERODZ
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      Alexander Debets
      Lead Clinical Supply Innovation, Former MSD

      Dr. Alexander Debets has and more than 20 years of experience in analytical and pharmaceutical R&D, and currently chairs the Clinical Supply Chain Council, a cross-functional and cross-divisional decision-making body for the integrated clinical supply chain.

      He previously worked for Organon and Schering-Plough. He held several roles of increasing responsibility in Analytical Development, Pharmaceutical Development and Clinical Supply Operations in the Netherlands. He was site head of development manufacturing sites in Germany and in Switzerland, which involved the transition of a site from research and development into commercial.

      His educational background includes a Doctor in Chemistry, and a Master’s Degree in Analytical Chemistry and Toxicology from the Free University of Amsterdam, the Netherlands.
      He was chairman of several committees and councils, including global harmonization steering committees for Analytical Chemistry, Manufacturing and Control (CMC) processes, Quality and international Procurement Improvements. He was board-member of the Analytical Section of the Royal Dutch Chemical Society and president of the Analytical Lab Managers Association.

      Session Details:

      Panel Discussion: Clinical trial innovation: insights into new technology and strategy

      2025-10-22, 2:30 PM

      Session Details:

      Improving clinical supply chain with digital display labelling

      2025-10-22, 12:00 AM

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      Andrea Salmen
      Chief Operating Officer, NEOGAP Therapeutics AB
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      Helen Johansen Blanco
      Chief Operating Officer, Node Pharma

      Helén Johansen Blanco has 24 years of clinical development experience, managing Phase I to III clinical trials leading to the successful launch of several oncology products, as Revlimid, Xofigo and a Herceptin biosimilar. She has experience in project management and financial oversight of large global clinical trials conducted in all continents of the world, mainly within oncology, but also therapeutic areas as cardiovascular and gastrointestinal. Mrs. Blanco has previously worked for large international pharma companies such as AstraZeneca and Mylan, as well as small, medium to large sized biotechnology companies as Nordic Nanovector, Oncoinvent, Cantargia, Cytovation and Celgene. Currently she holds a position as Chief Operating Officer at Node Pharma AS, a small medium sized Norwegian biotech company. She holds a Diploma Engineer/MSc degree in Biophysics and medical technology and a MBA.

      Session Details:

      Chairperson’s Opening Remarks

      2025-10-22, 8:30 AM

      Session Details:

      Chairperson’s closing remarks

      2025-10-21, 5:30 PM

      Session Details:

      Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

      2025-10-21, 3:00 PM

      Session Details:

      Negotiation skills during CRO and vendor selection process

      2025-10-22, 9:45 AM

      Session Details:

      Panel Discussion: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2025-10-22, 11:45 AM

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      Claudia Krag
      Director Clinical Operations, Novo Nordisk
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      Tine Bülow
      Supply Chain Project Manager, Novo Nordisk
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      Merete Schmiegelow
      Patient Advocate

      Session Details:

      Panel Discussion: Discussing patient centric initiatives to enhance patient engagement in clinical trials

      2025-10-21, 3:00 PM

      Session Details:

      Patient Perspective: Considering patient engagement in medicines R&D, approvals and life cycle

      2025-10-21, 4:00 PM

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      Jonathan Crowther
      Former Head of Predictive Analytics, Pfizer

      With a keen eye for Strategic Vision, Jonathan has been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. With a prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies.

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      Arnaud Dourlens

      Arnaud Dourlens is an Arts et Métiers engineer, he began his industrial career in the FMCG sector where he held growing responsibilities. Then he joined the LVMH group where he reorganized new product launches and industrial investments in the Make-up segment in order to adapt to the need for innovation and time to market, thus providing a competitive advantage. He then managed the entire portfolio of industrial launches and investments in Perfumes, Skincare and Make-up for Parfums Christian Dior Group.

      During his career Arnaud held a wide variety of industrial roles. He joined Sanofi in 2017 as Production Director of a major solid oral form production site (>2.5 billion € turnover). He has been a key player in the development of the continuous improvement mindset and in the transformation of the site through IT projects, investments and activity growth following the acquisition of Boehringer Ingelheim consumer healthcare portfolio.

      Since the beginning of 2020, he’s been the global head of Sanofi Clinical Supply Chain Operations, managing worldwide clinical supply teams involved in more than 300 clinical studies.

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      Gunilla Andrew-Nielsen
      Head of Clinical Trials, Swedish Medical Products Agency

      Gunilla Andrew-Nielsen has held her current position as Head of Clinical Trial and Special Permission at the MPA in Sweden during seven years. Since the early 1990s, she has held various positions within global R&D in the pharma industry including project and training management and later as Director of Quality Assurance.

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      Cornelia Baumgartner
      Head of Clinical Operations, T-CURX

      Session Details:

      Panel Discussion: Choosing an outsourcing model: FSO vs FSP vs inhouse

      2025-10-22, 11:45 AM

      Session Details:

      Beyond the spreadsheet: a practical model to align budget, milestones & cash flow

      2025-10-22, 11:45 AM

      View In Agenda
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      OCT Advisory Board

      Select a member to learn more

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      Rosalie Filling
      Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

      In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

       

      Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

       

      Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

       

      Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

       

      Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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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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      THOMAS M TREMBLAY
      Vice President Of Clinical Development, Trefoil Therapeutics, Inc

      Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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      Behtash Bahador
      Director, Health Literacy, CISCRP

      Behtash Bahador is the Director of Health Literacy 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.

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      Bao Dinh
      Global Development Business Operation, Takeda

      With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

      Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

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