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Programme

If you have any unique case studies or topics you would like to see covered on the agenda please contact the program director below if you have any questions or queries.

Jisong.seo@arena-international.com
Telephone: +44 0207 936 6607

Overview

    • 07:30 - 08:20
      • Registration and Refreshments

      • 08:20 - 08:30
      • Chair’s opening remarks

      • 08:30 - 09:00
      • Reassessing why you should outsource vs building up in-house process to speed up your trial

        • Inspecting potential weaknesses in your in-house resources and the impact this would have on trial progression

        • Exploring the benefits of controlling your study internally to keep quality management and knowledge in-house

        • Identifying the time and labour resource required for in-house trial management to assess internal capabilities

        • Reviewing economic & time benefit when you get support from partners and keep your team lean

      • 09:00 - 09:30
        • Reserved for Namsa

        • 09:30 - 10:00
          • Speaker

            Bassil Akra – Vice President - Global Focus Teams, TUV SUD

          Analysing the challenges of having clinical evidence fulfilling the requirements of the MDR

          • Outlining changes on the expectations on clinical data requirements for CE Marking Process

          • Presenting the most effective methods of collecting a sufficient amount of clinical data towards CE Marking

          • Identifying a suitable active and systematic post-market surveillance method

        • 10:00 - 10:30
        • Investigating usage of European database EUDAMED for successful product registry/ studies

          • Outlining the significance of public access to EUDAMED and how this data is utilised

          • Discussing effective ways to compile clinical data for being uploaded in Eudamed

          • Level of access and type of information that will change the current landscape

          • New documents and reports into Eudamed – Importance on preparation and alignment of manufacturers documentation

        • 10:30 - 11:00
          • Morning refreshments and networking

          • 11:00 - 11:30
          • Discussing clinical trial innovation to obtain useful real-world data for your study – pros/cons of the Randomised Registry Trial

            • Discussing Pros & Cons of Registries and Randomised Clinical Trials

            • Establishing innovative study design - Randomised Registry Trial

            • Examples of randomised registries in real-world

            • Investigating challenges of Randomised Registry Trial

          • 11:30 - 12:00
            • Reserved for Premier Research

            • 12:00 - 12:30
              • Speaker

                Gudrun Denke – Head of Clinical Science Support, Geistlich Pharma

              A SME perspective – establishing strategies to find the perfect CRO for your trial needs

              • Evaluating which functions to outsource in order to identify your vendor pool

              • Considering staff recruitment to find CROs specialised in medical devices

              • Engaging your CROs in smaller scale trials – how to collaborate to effectively manage trial progress

              • Designing governing procedures for clinical trials prior to assigning your CROs to create robust management structures

            • 12:30 - 13:00
              • Speaker

                Jen Giese – Clinical Trial Manager, CR Bard

              Ensuring flexible communication with your CRO during the start phase to set clinical trial expectations early

              • Underlining the tailored clinical trial procedure for your study to ensure your CRO understand the goals of your trial

              • Determining the importance of clear communication with CROs during the start phase to avoid misunderstandings in later phases

              • How to make changes collaboratively with CROs to trial protocols and set well-structured milestones for trial progress

              • Steps for better engagement with your CRO throughout the trial life-cycle

            • 13:00 - 14:00
              • Lunch and Networking

              • 14:00 - 14:30
                • Speaker

                  Andrew Thompson – Director of Therapy Research and Analysis, Medical Devices, GlobalData
                • Speaker

                  Tyler Fletcher – Head of Medical Devices, GlobalData

                Establishing responses to the MDR regulatory changes – are you ready?

                • Analysing manage assessments current processes and documentation to meet future requirements

                • Understanding the director of regulatory changes within the EU and the drive towards worldwide uniformity

                • Deconstructing compliance with data acquisition to avoid changes to your clinical study plan

                • Creating closer connections between Post Market Surveillance and your clinical study team to maximise safety

              • 14:30 - 15:00
                • Speaker

                  Angela Stokes – Sr. Director Regulatory Consulting/ MD&D, INC Research/inVentiv Health

                Have the enabling acts smoothed the way to MDR compliance? - One year on from the MDR publication:

                &Bull; Have the enabling acts clarified the outstanding points?

                &Bull; What does it all mean for medical device companies?

                &Bull; Has the role of the Authorised Representative become clearer?

                &Bull; Are the clinical evidence requirements any clearer?

                &Bull; The clock is ticking….have you started planning? Do you know where to start?

              • 15:00 - 15:30
              • Case Study: Exploring strategies to find & manage CRO for SME companies

                • Evaluating which functions to outsource in order to identify your vendor pool

                • Considering staff recruitment to find CROs specialised in medical devices

                • Engaging your CROs in smaller scale trials – how to collaborate to effectively manage trial progress

                • Designing governing procedures for clinical trials prior to assigning your CROs to create robust management structures

              • 15:30 - 16:00
                • Afternoon refreshments and networking

                • 16:00 - 16:30
                  • Speaker

                    Frank Van Leeuwen – Senior Director Clinical Affairs, Elixir Medical Corporation

                  Case Study: How we managed a trial in-house

                  • Outlining the critical criteria needed for successful in-house trial operations

                  • Exploring disruptive innovations for trial management – the potential for automation to save time and costs

                  • Determining which positions you need in your team to strengthen internal capabilities

                  • Maintaining quality, keeping knowledge and better control - can this only be achieved through in-house trial management?

                • 16:30 - 17:00
                  • Reserved for NIHR

                  • 17:00 - 17:30
                    • Speaker

                      Torsten Kayser – Senior Clinical Research Fellow, Boston Scientific

                    Uncovering strategies to maintain project timelines and reduce unexpected added costs

                    • Underlining options for risk management to maintain trial budgets even in case of project delay

                    • Presenting strategies for CRO contract management – how can you incentivise your vendors to work to your timelines?

                    • Investigating strategies to persuade your Notified Bodies to validate your Post Market Surveillance data

                  • 17:30 - 17:40
                  • Chair’s summary and close of conference

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