Clinical Trial Supply Europe 2024

2024 will see the return of the Clinical Trial Supply Europe conference to Barcelona where pharma, large and small, alongside biotechs will have the opportunity to discuss, debate and consider new technologies and processes to streamline supply chain operations.

6 - 7

March

2024
  • Barcelona, Spain
  • Complimentary
  • Why attend?
  • 2023 Agenda
  • 2023 Speakers
  • Sponsors
  • Media Centre
  • Contact Us
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Featured Speakers

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Vanessa Dekou​

Managing Director, CSI

Vanessa is the MD of Clinical Services International (CSI) a leading provider of Clinical Trial Supplies to the Biopharmaceutical Industry. Vanessa started her career as a research associate at Scotland Yard. Subsequently she worked for leading CROs and with some of the largest biopharmaceutical and Biotechscompanies to provide innovative solutions. She has extensive experience in drug development from Preclinical to registration and commercialization strategies and has secured product registration for several orphans and first in class drugs. She has a PhD in Cardiovascular Genetics from UCL, an MBA from Cambridge and Masters in Market Access from University m University of Lyon.

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Gary Cunnington​

Global Leader Clinical Trial Supplies Business Consultancy, Boehringer Ingelheim

Gary Cunnington is a Global Development Manager at Boehringer Ingelheim with over 30 years Pharma experience, he prefers however, to describe himself as an innovation coach, helping staff, vendors and Business Partners to deliver the future business needs in the heavily regulated healthcare world where risk is usually to be avoided.  More recently his efforts have focused on patient centric technology solutions that deliver improvements in recruitment, retention and adherence in global clinical studies.

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Sam Mulligan​

Digital Lead, Clinical Manufacturing And Supply, AstraZeneca

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Landry Giardina​

Global Head of Clinical Supply Chain Operations Innovation and Technology, Sanofi

20y experience within pharmaceutical industry and specially within clinical supply chain & digital development.

Knowledge acquired via several jobs such as vaccine supply manager, unit head of alignment supply (Drug product/marketed product) and more recently as Digital supply chain leader.

Technology, innovation and data & team management are the main drivers of Landry’s career.

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Laura Gibbons​

Director of Business Strategy and Portfolio Management, AstraZeneca

Laura Gibbons is the Senior Director for Strategy & Transformation within Clinical Manufacturing & Supply at AstraZeneca.

Having held numerous roles spanning across Operations and Supply Chain over the last 17 years, Laura brought her broad supply chain experience to Clinical Supply Chain two years ago. As a leader that has a passion for driving sustained change and developing people, Laura has led the strategic transformation with the Clinical Manufacturing & Supply Leadership Team.

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    2023 Sponsors Include:

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    Company Information

    Medidata is leading the digital transformation of life science, with the world’s most used platform for clinical development, commercial, and real-world data. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/

    Company Website

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

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    Company Information

    TecEx Medical is an Importer of Record (IOR) and customs compliance specialist in the international clinical trial sector. With a team of professionals dedicated to successful importation (or exportation) of clinical trial supplies, we work with Sponsors, CROs, CMOs and Vendors to manage the clinical trial lifecycle.

    Company Website

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

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    Company Information

    N-SIDE is a deeptech company that empowers organizations in the life sciences to make better decisions and optimize the use of critical resources. We’re doing so by combining deep industry expertise with applied mathematics and artificial intelligence into easy to use and cutting-edge software that transforms uncertainty and complexity into deterministic outcomes. We are an active player in clinical trial supply chain management for over 20 years and have the majority of the top 20 pharmaceutical companies as clients.

    With our software solution, the N-SIDE Suite, and expert services, we streamline the clinical supply of pharmaceutical and biotech companies by accelerating clinical plans, mitigating risks and curbing drug waste. We empower clinical leaders to make better, faster and safer decisions for patients waiting for life-changing medications.

    Company Website

    To learn more , please visit our website - https://lifesciences.n-side.com/

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    Company Information

    Suvoda is a global clinical trial technology company specializing in highly complex, life-sustaining studies in therapeutic areas like oncology, CNS, and rare disease. Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through IRT, eConsent, and eCOA solutions delivered on a single platform.

    Company Website

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

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    Company Information

    We acknowledge that your products are highly sensitive to temperature and need strictly controlled shipping solutions.

    T°Safe’s precise planning, careful risk assessment and rigorous performance ensures a high quality supply chain of API and an effective, IT-powered (iDEX) clinical trial distribution of IMP. This is key for a successful partnership with our customers.

    Company Website

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

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    Company Information

    Abacus Medicine Pharma Services is the new name for the healthcare and pharma services company previously known as Aposave. The company has three service lines: Clinical Trial Solutions (CTS), Commercial Partnerships and Unlicensed Medicines.

    The CTS service focuses on comparator sourcing solutions for clinical trials as well as bespoke batch-specific sourcing of pre-clinical samples. We specialize in partnering biosimilar manufacturers, biotechnology and innovative pharma companies

    Company Website

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

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    Company Information

    The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

    Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

    The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

    The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

    To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

    Company Website

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

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    Company Information

    4G Clinical is a leader in randomization and trial supply management (RTSM) for the global life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solution utilizing natural language processing (NLP) and integrated supply forecasting. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia. For more information, please visit www.4gclinical.com

    Company Website:http://www.4gclinical.com/

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    Company Information

    Berlinger & Co. AG develops, produces, and distributes temperature monitoring solutions for pharmaceutical, biotechnology and research organizations. With over 30 years’ experience, our innovative site and in-transit temperature recording devices, along with our data management software, improves efficiency for excursion management and increases patient safety. Berlinger offers a fully integrated temperature monitoring solution based around our SmartView platform and temperature devices, allowing full integration with your IRT system. Swiss Innovation, R & D investment and quality are key for us to deliver customer success. Our aim is to deliver the highest quality, to stand out with our service and to create relationships with the unmistakable Berlinger style.

    Company Website

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

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    Company Information

    IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Formed through the merger of IMS Health and Quintiles, IQVIA has more than 58,000 employees worldwide. Learn more at www.iqvia.com.

    Company Website

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

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      Why attend?

       

      2024 will see the return of the Clinical Trial Supply Europe conference to Barcelona where pharma, large and small, alongside biotechs will have the opportunity to discuss, debate and consider new technologies and processes to streamline supply chain operations.

      After the disruption to the global clinical supply chain over the past two years, attendees will once again be able to benefit from networking and learning in a safe, face-to-face environment. There’s never been a better time to exchange case studies, meet socially-distanced thought leaders, and discover the latest solutions from our selection of experienced exhibitors to create a robust clinical supply chain.

      Clinical Trial Supply Europe will be co-located with the & Temperature Controlled Logistics of Biopharmaceuticals Europe.

      It’s time to build relationships and take away valuable lessons for clinical trial success moving forward so we look forward to seeing you there!

      WHAT TO EXPECT FOR 2023?

      Clinical Trial Supply Europe is the meeting place for the pharmaceutical and biotechnology community to discover how to excel in clinical supply strategy as well as form key connections for long-term success.

      500+

      Attendees

      		55+

      Exhibitors

      		30+

      Speakers
      500+

      Attendees

      		55+

      Exhibitors
      30+

      Speakers

      Testimonials

      See What It's All About

      2023 Agenda

      • 15 Mar 2023
      • 16 Mar 2023
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      Streams

      Stream one

      Clinical Supply Logistics and Operations

      Stream two

      Clinical Supply Technology and Innovation

      11:15 AM

      PANEL DISCUSSION: Uncovering new trends and technological advancements for the European clinical supply chain: what’s new for 2023?

      • Considerations for clinical supply chains in Europe for 2023: how have Brexit, the Russia-Ukraine conflict, and other factors impacted trial supply?
      • An overview of emerging technologies and processes to support clinical supply chains in Europe
      • How the Clinical Trial Regulation and other regulatory factors are impacting European clinical supply chains
      • Opportunities created by data-driven technologies such as AI and machine learning for clinical supply chains
      • Linking everything back to the patient: how new clinical supply technology will benefit patients in clinical trials

      Speakers

      11:45 AM

      How best-in-class biopharma companies reduced their drug waste by 50%.

      • Drug waste? We don’t have that in my company! - Review of industry trends
      • Identifying root causes of waste in clinical trials
      • Comparing different forecasting methods and their impact on waste & budgets
      • Case study: action plan to sustainably reduce waste

      Speakers

      12:15 PM

      CASE STUDY: Designing a direct-to-patient distribution model for your clinical supply chain

      • Benefits to patients of direct-to-patient models: how can DTP make clinical trials more accessible?
      • Implementing a DTP strategy that works for your clinical study
      • Understanding how DTP can optimise supply chain flexibility for clinical trials

      Speakers

      12:45 PM

      How your RTSM experienced team can help with the strategy and execution of a successful trial

      It takes more than reading a protocol to design and implement RTSM for a successful clinical trial. It takes years of knowledge and experience to fully understand the risks and provide insights to best practices and ensure all stakeholders achieve their goals.

      Before and during a clinical trial requires planning and decisions across many complex processes. Areas of discussion will include how the expertise of an RTSM team can set your organization up for success in all phases including study design recommendations, blinding concerns, mid-study changes and supply management.

      Speakers

      1:15 PM

      Lunch and networking

      2:30 PM

      PANEL DISCUSSION: Making a success of direct-to-patient for your clinical trials

      • Considerations when designing a DTP strategy
      • Navigating regulatory frameworks, both in Europe and beyond
      • Identifying vendors and partners in order to deliver DTP successfully
      • Understanding the benefits of DTP from a patient perspective and the importance of this
      • Overcoming common pitfalls and hurdles in DTP

      Speakers

      3 PM

      Leveraging RTSM and new technologies to enhance supply chain visibility

      • Understand trial complexity in 2023 and its downstream impacts
      • Discuss how the RTSM enables complex trials and improves end-user experiences
      • Walk through a use case for track and trace

      Speakers

      3:30 PM

      How clinical trial supply managers can reduce the patient burden from a fear reduction perspective

      • Understanding where patient concerns lie when participating in clinical trials and what pharma companies can do to mitigate against these
      • Aiming to reduce the burden of trial participation on patients as much as possible: where are pharma companies falling short?
      • What more needs to be done when it comes to patient accessibility for clinical trials?
      • The benefits of systems like direct-to-patient for increasing patient accessibility for clinical trials

      Speakers

      4:30 PM

      Incorporating technology to increase clinical supply chain efficiency

      • Assessing emerging technologies: what is available for improving supply chain efficiency?
      • How effective use of data and data management tools can help streamline your supply chain
      • Training staff and logistics partners on up to date technology: overcoming hurdles surrounding this

      Speakers

      5 PM

      Reducing the impact of emerging macroeconomic pressures on trial supply

      • Clinical supply management in IRT: the past, the present and the future
      • Why optimizing your trial supply is more critical than ever
      • Automating the optimization of clinical trial supply
      • How sponsors are saving every day: with no extra effort
      • Cold chain case study: how to achieve even more automation and savings

      Speakers

      7:30 AM

      Registration and refreshments

      8:20 AM

      Chairperson’s opening remarks

      Speakers

      8:30 AM

      Removing transportation as a barrier to health: improving equity, increasing retention, achieving decentralised trials

      Speakers

      9 AM

      Practical innovation: powering IRT for supply chain agility and improved patient management by applying technology best practices to a clinical trials platform

      • Clinical trials today are becoming increasingly complex, and the technology landscape to manage them can be complicated and overwhelming.
      • Seamlessly connecting IRT with eConsent and eCOA in a single platform enables trial data to be centrally managed and shared, and workflows to be streamlined with a completely controlled process safeguarding quality and compliance.
      • Explore an example of how interoperable systems increase visibility to patient data, more accurately project supply and resupply needs, and support timely outcomes data collection, all through your IRT.

      Speakers

      9:30 AM

      Clinical supply performance and resilience

      Speakers

      10 AM

      Reserved for Edo Madussi

      Speakers

      10:30 AM

      Morning refreshments and networking

      11:15 AM

      Transforming our supply chain by investing in key capabilities: processes, people and digital

      • Developing a new strategy to build a leading supply organisation capable of dealing with an ever increasing and complex portfolio
      • How a digital transformation will enable significant business value in terms of increasing efficiency and driving down waste

      Speakers

      11:45 AM

      CASE STUDY: End-to-end condition monitoring for clinical trial supply chain

      • How full end-to-end temperature monitoring helps to improve patient safety and increase process efficiency
      • How open condition monitoring platforms allow for seamless integration with IRT for end-to-end monitoring
      • Practical considerations when implementing end-to-end condition monitoring - lessons learned
      • Outlook of implementing end-to-end temperature monitoring using modular real-time, bringing an even higher level of control, with real-time oversight, quicker decision making, quicker corrections in a more cost-effective manner whilst allowing for more sustainable processes and reducing environmental impact

      Speakers

      12:15 PM

      Forecasting and demand planning in the supply chain: preparing for uncertainty

      • Ensuring flexibility in your budget supply strategy to cater for unexpected situations
      • Demand planning when there is uncertainty around patient enrolment: the importance of communicating with your clinical operations team
      • Learnings from the COVID-19 pandemic and the Russia-Ukraine conflict in terms of managing clinical supply in times of uncertainty

      Speakers

      12:45 PM

      Managed Access Programmes: how to get unlicensed medicine to those in need, no matter where they are in the world

      • Navigating the global regulatory landscape: understanding and maintaining compliance with country-specific regulations
      • Overcoming the challenges: identify the key challenges standing in the way of running an efficient and effective MAP and how to avoid them
      • Transitioning from a clinical trial to a MAP: key considerations for the sponsor

      Speakers

      1:15 PM

      Lunch and networking

      2:30 PM

      Important steps to take to help expedite the clearance of pharmaceutical products and biological materials into the U.S.: what you need to know

      • Breaking down all that you need to know about CBP and other agency importation requirements to facilitate clinical supply shipments
      • Receive detailed information on how to correctly declare biological products at the U.S. border (Ports of Entry)
      • Discover which biological products may have transportation restrictions that must be factored into your clinical supply chain strategy
      • Review case examples of non-compliant shipments

      Speakers

      3 PM

      Holistic approach to effective clinical trial supply strategies: beyond comparator sourcing

      • Biosimilar and generic product benefits and regulatory framework
      • Competitive advantage: Bolar exemption in practice
      • Why science and not wholesale mindset should drive your approach

      Speakers

      3:30 PM

      PANEL DISCUSSION: Running your clinical trial internationally: overcoming logistical challenges to maximise supply chain efficiency

      • Regulatory considerations when shipping across borders, both within Europe and cross-continent
      • Shipping biologics cross-border: what you need to know, and how to prepare in advance for this
      • How geopolitical factors have influenced clinical supply chains in Europe and how to mitigate the impact of this
      • Assessing the benefits of air, sea, road and rail as methods of transporting drugs around Europe

      Speakers

      4 PM

      Afternoon refreshments and networking

      4:30 PM

      Effective strategies for sourcing comparators for clinical trials

      • Accessing supply: ensuring your supply chain is robust and planning timelines to avoid delays
      • Managing regulatory hurdles when importing comparators from overseas
      • What to consider in order to ensure your comparator sourcing processes meet cost and waste targets

      Speakers

      5 PM

      Obstacles and solutions to managing comparator supply for your clinical trial life-cycle

      • Real case studies, real solutions
      • Lead-time inaccuracy
      • Continuity of supply
      • Expiry date limitations
      • Waste

      6 PM

      Chairperson’s closing remarks

      Speakers

      Streams

      Stream one

      Clinical Supply Logistics and Operations

      Stream two

      Clinical Supply Technology and Innovation

      9 AM

      PANEL DISCUSSION: Automation in clinical supply chains: what level of automation can you incorporate?

      • Analysing cost vs benefit of automation in supply chains: at what point does automation become cost effective?
      • Understanding risks associated with automating supply chains
      • How IRT and simulation system capabilities can help manage supply chains automatically

      Speakers

      9:30 AM

      What is the right level of self-service in IRT?

      • Learn which supply chain settings are available in IRT
      • Understand how each setting impacts the supply chain and potential risks associated with them
      • Review example applications for setting updates
      • Share your opinion on relevance of making those settings self-service

      Speakers

      10 AM

      FIRESIDE CHAT: The clinical to commercial transition in packaging: managing and aligning different prime directives

      • Choosing packaging options when taking your drug from a clinical trial to market: an overview of key considerations to take into account
      • Should we be designing packing for trial drugs with commercialisation in mind?
      • Communicating effectively with your commercial department: how to ensure design of the best possible commercial packaging

      Speakers

      10:30 AM

      Managed Access programs: challenges and opportunities

      • Understanding MAP / compassionate access programs, their regulatory requirements and challenges associated with supply chains and technology
      • Choosing a clinical supply vendor to support regional and global access programs: an overview of key points to consider
      • Simplifying the logistics behind physician enrollment, patient enrollment, and drug shipment
      • Maintaining a “Patient First” mentality by having a clear and well-defined exit strategy from the MAP into commercial

      11 AM

      Morning refreshments and networking

      11:30 AM

      CASE STUDY: Incorporating e-labelling into your clinical trial supply processes

      • Navigating regulatory hurdles around e-labelling, in particular the new Clinical Trial Regulation
      • How e-labelling can improve the patient experience and thus engagement and retention in trials
      • Using e-labels as a way to increase efficiency and reduce costs: where are the main benefits and opportunities?

      Speakers

      12 PM

      Session available for sponsor

      12:30 PM

      Strategic partnerships: the importance of aligning strategic partners and sponsors under one shared goal to deliver to our trial

      • How much oversight do you need to have over your strategic partner, and how involved should you be in the process?
      • Overcoming challenges involved when working with multiple strategic partners, rather than one strategic partner in order to ensure everyone's goals are in line
      • Handling strategic partners when working remotely: tips for fostering a strong relationship virtually

      Speakers

      8 AM

      Registration and Refreshments

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      9 AM

      Choosing a manufacturing partner: what to consider when selecting a CMO

      • Preparing for a clinical trial: choosing the right CMO to manufacture your product
      • Balancing cost with quality when selecting a CMO
      • Understanding increasing complexity in clinical setup with different CMOs and shared sponsoring
      • Ensuring the best setup to work constructively with your CMO
      • Handling expectations and getting the relationship right

      Speakers

      9:30 AM

      Bringing innovation to clinical trial supply chains

      • How Europe’s growth in clinical trials has impacted the need for innovation within supply chains
      • Responding to the challenges of a multi-site clinical trial collection
      • How packaging has aided with innovation in clinical trial supply chains

      Speakers

      10 AM

      Harnessing the benefits of e-labelling: accelerating packaging and labelling processes through technological innovation

      • E-labelling as a patient friendly solution
      • Emphasizing the value of e-labelling for your supply chain planning: overcoming the expiration date hurdle
      • Navigating the risks and the rewards; considering costs, timelines, contingency plans and patient safety
      • Understanding the drive behind the development of e-label technology: success stories vs lessons learned

      Speakers

      10:30 AM

      3 steps to accelerate decentralized trials and release to patients faster

      • How to achieve a 93% time reduction in temperature management
      • How to boost site efficiency in temperature monitoring by 90%
      • How to enhance patient experience with unified digital release

      Speakers

      11 AM

      Morning refreshments and networking

      11:30 AM

      PANEL DISCUSSION: Operational agility: the importance of maintaining flexibility in your clinical supply chain

      • With trials more and more complex, how do you ensure supply chain operations are agile and flexible?
      • What can we do to be as flexible as possible to handle changes in demand, particularly when shipping internationally?
      • Ensuring you are prepared for a crisis: what the pandemic has taught us about being prepared for every eventuality

      Speakers

      12 PM

      Bringing your clinical supply chain and transportation to the next level with simplicity and sustainability

      • Driving efficiency and global supply chain simplicity through an integrated global depot network
      • Increasing global transportation flexibility, transparency, and control
      • Driving waste reduction by utilizing sustainable solutions

      12:30 PM

      IMP during the Ukrainian conflict: an inspiring story of humanity

      • A case study of how Galapagos kept their clinical supplies running in Ukraine this year
      • Crisis management: key takeaways in keeping supply chains running smoothly during times of crisis
      • Learnings from disruption to European supply chains as a fallout of the Russia-Ukraine conflict

      Speakers

      1:30 PM

      Lunch and networking

      2:30 PM

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      During the roundtable discussion session, the conference hall will be divided into two ‘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 clinical trial supply. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.
      ROUNDTABLE 1: Selecting vendors and partners for your supply chain: key considerations

      Ilaria Rondinone, Senior Clinical Supply Lead, Chiesi Group
      ROUNDTABLE 2: Usage of internal systems for outsourced manufacturing steps

      Chiranth Hulgur, Senior Manager Clinical Supply Chain Data and Analytics, CSL Behring
      ROUNDTABLE 3: Forecasting the unexpected: how to handle unforeseen circumstances to reduce impact to clinical supply chains

      Ruth Barbero, Associate Director Global Clinical Supply Chain, Incyte
      ROUNDTABLE 4: The pros and cons of just in time labelling: what to consider when adopting this as a strategy

      Dr Kamal Amin, Head of Clinical Supplies Management, Galderma
      ROUNDTABLE 5: End2End visibility in clinical trial supply

      Ulrich Mengel, Associate Director, CTS Business Operations, CSL Behring
      ROUNDTABLE 6: Q&A Session with U.S. Customs and Border Protection: here to help with any questions you may have about how to import or export biological materials to or from the U.S.

      Sean Smith, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

      George Amerson, Biological Threat Exclusion Coordinator (BTEC), U.S. Customs and Border Protection

      Speakers

      4 PM

      Chairperson’s closing remarks

      Speakers

      2023 Speakers

      Select a speaker to learn more

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      Edo Madussi
      Managing Director, Euromed Pharma

      Edo Madussi is the Managing Director, of Euromed Pharma US and Business Unit head of the Clinical Trial Division at the Petrone Group.

      His business experience combined with his academic background and four spoken languages - English, German, French, and Italian - brought him to develop an extensive network within the global clinical supply chain space.  He is currently developing one of the latest ventures of the Petrone Group: a US-based integrated platform to support Clinical Trial Sponsors and other industry players around the world with a wide range of services in the R&D space.

      Session Details:

      Reserved for Edo Madussi

      2023-03-15, 10:00 AM

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      Ruth Barbero
      Director Global Clinical Supply Chain, Incyte

      BSc in Pharmacy, MSc in Pharmaceutical Industry and Technology, MSc in Pharmaceutical Biotechnology. Currently studying an Executive MBA. After exploring opportunities in the academia and as community pharmacist I developed my career in the pharmaceutical industry were I have been working for about 12 years, initially in formulation and manufacturing within pharmaceutical development, and during the last 7 years in Clinical Supplies. I have worked for Almirall and AstraZeneca in Spain and for Galderma, Debiopharm and Incyte in Switzerland. I have recently moved back to Spain were I am still working for Incyte within the Global Clinical Supplies group.

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-03-16, 2:30 PM

      Session Details:

      Forecasting and demand planning in the supply chain: preparing for uncertainty

      2023-03-15, 12:15 PM

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      Amaury Jeandrain
      Vice President of Strategy, N-SIDE

      Amaury Jeandrain has a Master’s Degree in Business Engineering with a specialization in supply chain management. After working for a CRO, he joined N-SIDE where he supported the optimization of hundreds of trials from different indications and pharmaceutical companies, providing services ranging from risk-based optimization to clinical trial design and solving drug supply shortage problems. Amaury now leads a group of consultants, focusing on the extension of N-SIDE’s solutions.

      Session Details:

      How best-in-class biopharma companies reduced their drug waste by 50%.

      2023-03-15, 11:45 AM

      Session Details:

      PANEL DISCUSSION: Uncovering new trends and technological advancements for the European clinical supply chain: what’s new for 2023?

      2023-03-15, 11:15 AM

      Session Details:

      FIRESIDE CHAT: The clinical to commercial transition in packaging: managing and aligning different prime directives

      2023-03-16, 10:00 AM

      Session Details:

      PANEL DISCUSSION: Automation in clinical supply chains: what level of automation can you incorporate?

      2023-03-16, 9:00 AM

      Session Details:

      PANEL DISCUSSION: Making a success of direct-to-patient for your clinical trials

      2023-03-15, 2:30 PM

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      Vanessa Dekou
      Managing Director, CSI

      Vanessa is the MD of Clinical Services International (CSI) a leading provider of Clinical Trial Supplies to the Biopharmaceutical Industry. Vanessa started her career as a research associate at Scotland Yard. Subsequently she worked for leading CROs and with some of the largest biopharmaceutical and Biotechscompanies to provide innovative solutions. She has extensive experience in drug development from Preclinical to registration and commercialization strategies and has secured product registration for several orphans and first in class drugs. She has a PhD in Cardiovascular Genetics from UCL, an MBA from Cambridge and Masters in Market Access from University m University of Lyon.

      Session Details:

      Chairperson’s opening remarks

      2023-03-15, 8:20 AM

      Session Details:

      Chairperson’s closing remarks

      2023-03-15, 6:00 PM

      Session Details:

      Holistic approach to effective clinical trial supply strategies: beyond comparator sourcing

      2023-03-15, 3:00 PM

      Session Details:

      PANEL DISCUSSION: Running your clinical trial internationally: overcoming logistical challenges to maximise supply chain efficiency

      2023-03-15, 3:30 PM

      Session Details:

      Chairperson’s closing remarks

      2023-03-16, 4:00 PM

      Session Details:

      Chairperson’s opening remarks

      2023-03-16, 8:50 AM

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      Arnaud Dourlens
      Head of Clinical Trial Supply, Sanofi

      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.

      Session Details:

      PANEL DISCUSSION: Uncovering new trends and technological advancements for the European clinical supply chain: what’s new for 2023?

      2023-03-15, 11:15 AM

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      Sean Smith
      Biological Threat Exclusion Coordinator, US Customs And Border Protection

      Sean Smith is a Biological Threat Exclusion Coordinator (BTEC) for CBP in the Office of Field Operations/ Agriculture Programs and Trade Liaison/ Agro/Bio-Terrorism Countermeasures. As a BTEC, Mr. Smith is charged with supporting and developing U.S. Customs and Border Protection (CBP) operational capacity and capability in preventing tools of agro/bio-terrorism from entering the U.S.

      Mr. Smith joined CBP in 2005 as an Agriculture Specialist (CBPAS) and was promoted to Supervisory CBPAS in 2008. He has served CBP in the following ports of entry: San Diego, San Ysidro, Otay Mesa and Boston Logan Airport. From 2011- 2018, Mr. Smith served as the primary Public Affairs Liaison and Border Community Liaison, respectively, for CBP in New England. He has also volunteered to assist in past domestic and international CBP disaster recovery operations, including: Hurricane Ike (2008), 'Operation Safe Return' (Haitian Relief Effort- 2010), and Hurricane Harvey, DHS Surge Capacity Force (2017).

      Prior to CBP, Mr. Smith contributed to wildlife conservation for nearly a decade, completing field work on rare endemic Hawaiian birds on the Big Island of Hawaii, and raising rare and endangered birds (in some cases, extinct in the wild) at the San Diego Zoo's Avian Propagation Center. Also, Mr. Smith is a former reserve firefighter and EMT for the City of Borrego Springs in California. He holds a Bachelor of Science degree in Ecology and Systematic Biology from Cal Poly San Luis Obispo, California.

      Mr. Smith, his wife, two children, one dog, and one chicken live in an old farmhouse in Massachusetts.

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      Révérien Uwacu
      Clinical Trial Supply Manager, UCB

      Originally from Rwanda but studied and living in Belgium, Reverien has an IT and Supply Chain academic background. Professionally, he is a pharma Supply Chain Consultant with 12+years’ experience. Reverien’s experience includes companies such as Johnson and Johnson, UCB, Baxter, and Thermofisher.

      Session Details:

      CASE STUDY: Designing a direct-to-patient distribution model for your clinical supply chain

      2023-03-15, 12:15 PM

      Session Details:

      PANEL DISCUSSION: Making a success of direct-to-patient for your clinical trials

      2023-03-15, 2:30 PM

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      Thomas Thoma
      Head Managed Access Programs, CTS/GHT/SR, Teva Pharmaceuticals

      Three University degrees at the University of Augsburg 5 years of Supply Chain Management responsibilities in automotive electronics industry 12 years of Management responsibilities in multiple roles (SCM, IT, Sales) in the pharma industry Since 2014 Head of Clinical Trial Supply (Sales) of Teva Europe. Offering Teva widest pipeline of pharmaceuticals, placebos and manufacturing for clinical trial purposes. Since 2017 Head of Global Health Tendering of Teva Global. Offering Teva widest pipeline to NGOs, GOs and UN related organizations. Married and father of three beautiful kids

      Session Details:

      FIRESIDE CHAT: The clinical to commercial transition in packaging: managing and aligning different prime directives

      2023-03-16, 10:00 AM

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      Roel van der Heijde
      Facilitator & Trainer, Rotterdam And Patient Experience Association

      Roels inspiration: “Be the change you wish to see in the world” - Ghandi Roel van der Heijde lives in Rotterdam, The Netherlands. He has a MA in International Business, is an international acknowledged NLP trainer, executive team coach and a certified death and grief counsellor. He is a driven and experienced trainer and facilitator in: - Patient Fear Reduction (for all caregivers); - Team Collaboration; - Vulnerability & Leadership; - Discrimination & Inclusion. Roels motivation: “Acknowledgement and recognition of the fears and emotions of our patients are the basis for excellent patient experience and patient safety”. “Working with Groups I experience as thoroughly fascinating and inspiring. In interaction with groups I am every time amazed by the enormous potential of practical knowledge and direct experience that lies hidden in groups and that is so easily overlooked. Herein lies the basis for excellent vulnerable leadership.

      Session Details:

      How clinical trial supply managers can reduce the patient burden from a fear reduction perspective

      2023-03-15, 3:30 PM

      Session Details:

      PANEL DISCUSSION: Uncovering new trends and technological advancements for the European clinical supply chain: what’s new for 2023?

      2023-03-15, 11:15 AM

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      Diana Cocora
      Senior Supply Chain Manager, Akamis Bio

      Session Details:

      Choosing a manufacturing partner: what to consider when selecting a CMO

      2023-03-16, 9:00 AM

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      Niklas Mattsson
      Director, Comparator Management, MSD

      At MSD from 2012 and before worked with comparator sourcing since 2004 at a few wholesalers and a CMO. Started career in product management of medical devices and OTC products. M.Sc. in Engineering in 1995 and proficient in English, German, Italian and Swedish.

      Session Details:

      PANEL DISCUSSION: Operational agility: the importance of maintaining flexibility in your clinical supply chain

      2023-03-16, 11:30 AM

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      Dan Fitzgerald
      Director, Clinical Supplies, Galecto Inc

      Dan is the Director of Clinical Supplies for Galecto Biotech, a clinical-stage biotech developing novel therapeutics in fibrosis, cancer and inflammation. Prior to joining Galecto, Dan worked in clinical supply management for large CMOs and CROs for a number of years. In this time he has managed supplies for a wide range of trials, from small FIH single-country trials, to large global Phase III trials, in a number of different therapeutic areas. Dan is based in the United Kingdom, and has a Master’s degree in Clinical Research from Cardiff University.

      Session Details:

      PANEL DISCUSSION: Making a success of direct-to-patient for your clinical trials

      2023-03-15, 2:30 PM

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      Dr Kamal Amin
      Head Of Clinical Supplies Management, Galderma

      Kamal is a trained Chemist who decided to pursue a career in supply chain management and quality. In this role, he was tasked to supervise commercial and clinical trial products. Kamal has worked in the pharmaceutical and device industries for over 15 years in different size organisations ranging from large multinational to small virtual companies. He is currently leading a global team at Galderma to develop an integrated clinical supply chain organisation within the company.

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-03-16, 2:30 PM

      Session Details:

      PANEL DISCUSSION: Automation in clinical supply chains: what level of automation can you incorporate?

      2023-03-16, 9:00 AM

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      Paula Figueiredo
      Clinical Supplies Leader, Galapagos

      Paula was born in Portugal in the early 80’s.

      She grew up in a small village of the Bairrada winegrowing region and wanted to study History of Art or Archeology.

      Twist of Fate, she became a Clinical Psychologist and practiced individual psychotherapy until she moved to Belgium, in 2008.

      Pharma entered Paula’s professional life more out of chance than by choice and, twist of Fate again?, she has been working in this business for the past 14 years.

      She started as a Clinical Study Supply Manager in 2017 at GSK Vaccines, joined UCB as a Clinical Set-up Manager and left the company as a Global Development Supply Lead. Paula is since 2020 “making it happen” as a Clinical Supply Leader at Galapagos.

      Session Details:

      IMP during the Ukrainian conflict: an inspiring story of humanity

      2023-03-16, 12:30 PM

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      Camillo Rossi
      Associate Director, Clinical Trial Material Logistics, Eli Lilly And Company

      Session Details:

      PANEL DISCUSSION: Running your clinical trial internationally: overcoming logistical challenges to maximise supply chain efficiency

      2023-03-15, 3:30 PM

      Session Details:

      PANEL DISCUSSION: Automation in clinical supply chains: what level of automation can you incorporate?

      2023-03-16, 9:00 AM

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      Chiranth Hulgur
      Senior Manager Clinical Supply Chain Data And Analytics, CSL Behring

      Chiranth Hulgur is a senior manager in clinical supply chain data and analytics team at CSL Behring. He holds a background in supply chain engineering, with 9 years experience in the field. In his role at CSL Behring, he leverages his knowledge and expertise to lead initiatives aimed at improving the clinical supply chain through data-driven decision making and advanced analytics. A digital champion and bridge between business users and IT engineers. Chiranth is known for his ability to drive cross-functional collaboration and his commitment to delivering innovative solutions that drive operational efficiency and ensure the highest level of patient care. Chiranth Hulgur has also been a power user for clinical supply chain systems and played a pivotal role in implementation of KPIs in Clinical Supply Chain.

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-03-16, 2:30 PM

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      Ilaria Rondinone
      Clinical Trial Supply Coordinator, Chiesi Group

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-03-16, 2:30 PM

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      Philip Oyewale Babatunde Olabode
      Senior Manager, Supply Chain And Logistics, Bristol Myers Squibb

      Session Details:

      Incorporating technology to increase clinical supply chain efficiency

      2023-03-15, 4:30 PM

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      Gary Cunnington
      Global Leader Clinical Trial Supplies Business Consultancy, Boehringer Ingelheim

      Gary Cunnington is a Global Development Manager at Boehringer Ingelheim with over 30 years Pharma experience, he prefers however, to describe himself as an innovation coach, helping staff, vendors and Business Partners to deliver the future business needs in the heavily regulated healthcare world where risk is usually to be avoided.  More recently his efforts have focused on patient centric technology solutions that deliver improvements in recruitment, retention and adherence in global clinical studies.

      Session Details:

      Harnessing the benefits of e-labelling: accelerating packaging and labelling processes through technological innovation

      2023-03-16, 10:00 AM

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      Alexandru Marineac
      International Logistics Manager, Audubon Biosciences

      Alexandru has 8 years of experience in clinical trials and biobanking logistics. His educational background builds upon an M.A. in Entrepreneurship & Business Management and multiple training courses in GCP, GCLP, and IATA regulations. Alexandru enjoys working in a multicultural environment, and he joined Audubon Bioscience in January 2021 as part of the Operation system, handling collection kits and specimens from the collection stage to their delivery. Along the way, Alex had main roles in specimen shipping SOP and Policy writing and QC performing.

      Session Details:

      PANEL DISCUSSION: Running your clinical trial internationally: overcoming logistical challenges to maximise supply chain efficiency

      2023-03-15, 3:30 PM

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      Laura Gibbons
      Director of Business Strategy and Portfolio Management, AstraZeneca

      Laura Gibbons is the Senior Director for Strategy & Transformation within Clinical Manufacturing & Supply at AstraZeneca.

      Having held numerous roles spanning across Operations and Supply Chain over the last 17 years, Laura brought her broad supply chain experience to Clinical Supply Chain two years ago. As a leader that has a passion for driving sustained change and developing people, Laura has led the strategic transformation with the Clinical Manufacturing & Supply Leadership Team.

      Session Details:

      Transforming our supply chain by investing in key capabilities: processes, people and digital

      2023-03-15, 11:15 AM

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      Sam Mulligan
      Digital Lead, Clinical Manufacturing And Supply, AstraZeneca

      Session Details:

      Transforming our supply chain by investing in key capabilities: processes, people and digital

      2023-03-15, 11:15 AM

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      Hadar Shaked
      Clinical Supply Project Manager, Teva Pharmaceuticals

      Session Details:

      CASE STUDY: Incorporating e-labelling into your clinical trial supply processes

      2023-03-16, 11:30 AM

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      Brendan Krause
      Head of International, Uber Health

      Brendan has over 20 years of policy, strategy and business development experience in health
      care. He began his career at the National Governors Association in Washington, DC, working
      on health reform between the US Federal Government and states. Following NGA, Brendan
      attended the London School of Economics as a Fulbright Scholar, where he studied the impact
      of the Blair Government's choice and competition reforms in the NHS and earned an MSc in
      International Health Policy and Economics. He then spent 12 years working for Optum in the
      UK in a number of UK and global strategy roles, with a focus on use of data to improve
      population health. Recently, Brendan joined Uber as Head of International for Health, where he
      is building a global strategy to remove transportation and logistics as a barrier to care.

      Session Details:

      Removing transportation as a barrier to health: improving equity, increasing retention, achieving decentralised trials

      2023-03-15, 8:30 AM

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      Henk Dieteren
      Clinical Supply Chain Solutions Consultant, Suvoda

      As Clinical Supply Chain Solutions Consultant, Henk has been assisting Suvoda with his knowledge in various areas of clinical trial supply management since October 2020. Prior to joining Suvoda, Henk co-founded the clinical supply chain department at Grünenthal GmbH (Aachen - Germany) and served as Associate Director of this department for 10 years. At Grünenthal, Henk developed operational processes and promoted risk management procedures to establish the company as a clear market leader in the area of the clinical trial supply chain.

      Following his time at Grünenthal, Henk moved to BioNTech S.E. (Mainz - Germany) where he assumed the role of Senior Investigational Medicinal Product Manager. At BioNTech, he streamlined data processing in the clinical supply chain for personalized oncology therapies.

      Henk is an innovative expert in IRT, temperature excursion management and direct-to-patient logistics and a member of the DtP sub-team of the GCSG Regulatory e-Team.

      Session Details:

      PANEL DISCUSSION: Operational agility: the importance of maintaining flexibility in your clinical supply chain

      2023-03-16, 11:30 AM

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      Landry Giardina
      Global Head of Clinical Supply Chain Operations Innovation and Technology, Sanofi

      20y experience within pharmaceutical industry and specially within clinical supply chain & digital development.

      Knowledge acquired via several jobs such as vaccine supply manager, unit head of alignment supply (Drug product/marketed product) and more recently as Digital supply chain leader.

      Technology, innovation and data & team management are the main drivers of Landry’s career.

      Session Details:

      Clinical supply performance and resilience

      2023-03-15, 9:30 AM

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      Jasmin Hellwig
      Associate Director Vendor Relationship Management, MSD

      Session Details:

      Strategic partnerships: the importance of aligning strategic partners and sponsors under one shared goal to deliver to our trial

      2023-03-16, 12:30 PM

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      Urtė Fultinavičiūtė
      Healthcare Reporter, Clinical Trials Arena, GlobalData Healthcare
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      Ulrich Mengel
      Associate Director, CTS Business Operations, CSL Behring

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-03-16, 2:30 PM

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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:

      Reducing the impact of emerging macroeconomic pressures on trial supply

      2023-03-15, 5:00 PM

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      Marcel Walraven
      Clinical Trial Supply Chain Specialist, Biocair

      Delivering supply chain solutions that perfectly solve a customer's problem is something I greatly enjoy. I have over 20 years of experience creating solutions for customers in the Biotech and life sciences industry, having worked for leading logistics providers in a variety of roles within Operations, Product Management and Customer Services.

      Recently I managed the set up of a new pharmaceutical, fully GDP-compliant warehouse for a large NGO. I am now active for Biocair, a specialist courier dedicated to the life sciences industry, with a proven track record of delivering highly complex and fully compliant supply chain solutions.

      Session Details:

      Bringing innovation to clinical trial supply chains

      2023-03-16, 9:30 AM

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      Marcus Wajngarten
      Senior Director, Home Supply, AstraZeneca

      Marcus has been realizing innovative solutions and clinical science in the Pharma space for almost 20 years.

      Passionate in driving operational value with technology, the science and the patient is always in focus.

      As part of AstraZeneca’s Digital Health transformation, he is aiming to bring greater value to patients faster though technology.

      Marcus is gearing up AstraZeneca’s capabilities to take on De-centralized trials, with patient centricity at heart.

      Session Details:

      PANEL DISCUSSION: Making a success of direct-to-patient for your clinical trials

      2023-03-15, 2:30 PM

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      Margaret Radford
      Unlicensed Medicine Services Manager, Almac

      As the Unlicensed Medicine Services Manager at Almac Clinical Services, Margaret leads a team of experienced personnel who are responsible for the onboarding and delivery of Managed Access Programmes at all Almac sites globally.

      Margaret has 20 years of professional experience within Project Management, Business Development, GMP Operations, and People Management.

      Session Details:

      Managed Access Programmes: how to get unlicensed medicine to those in need, no matter where they are in the world

      2023-03-15, 12:45 PM

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      Marc Kaufman
      Senior Director, RTSM Product, Medidata

      Marc Kaufman has been in the Life Sciences Industry for more than 20 years, specializing in IRT/RTSM technology for the past 15 years. Marc is the Senior Product Director - RTSM at Medidata Solutions. Marc has been at Medidata for more than 5 years. Marc is a thought leader on clinical trials with extensive expertise on supply management strategies, decentralized and adaptive trials. Marc has presented at many industry conferences and is an expert on clinical supply management..

      Session Details:

      How your RTSM experienced team can help with the strategy and execution of a successful trial

      2023-03-15, 12:45 PM

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      Chris Mogg
      Solutions Specialist, RTSM, Medidata

      Chris is a RTSM Solutions Specialist at Medidata with over 23 years of experience in Clinical Research specialising in Randomisation and Trial Supply Management (RTSM). He began his career at Clinphone working as a programmer and has held various Technical and Project related roles at Technology Vendors and CROs. With his vast experience and knowledge, he has a great understanding of what it takes to efficiently work with Sponsors and to help them select and develop systems. Chris is a graduate of Nottingham Trent University and holds a Bachelors of Science degree in Physics and Computer Science.

      Session Details:

      PANEL DISCUSSION: Operational agility: the importance of maintaining flexibility in your clinical supply chain

      2023-03-16, 11:30 AM

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      Hanna Söderström
      Global Key Account Manager, TSS

      Hanna Söderström is a global Key Account Manager at TSS. Ever since joining the Life Science Industry in 2004, Hanna has been dedicated to help life science companies protect product integrity by refining existing IT-solutions. Hanna’s expertise in Customer Relationship Management originates from managing global projects, delivering time and cost benefits to the clinical trials ecosystem. Hanna represents TSS in their cooperation with pharmaceutical companies in digitizing the supply chain to ensure effective and sustainable delivery of safe drugs to patients around the world.

      Session Details:

      3 steps to accelerate decentralized trials and release to patients faster

      2023-03-16, 10:30 AM

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