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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
        • 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

      • 09:00 - 09:30
        • Speaker

          Kirsten Welz – Principal Medical Research Manager, Namsa

        Forward Together – a Joint Venture: CRO Perspective on Sponsor Cooperation and Study Management

        • Assessing the necessity of outsourcing – why do we need to outsource?

        • CRO selection and bid-process: the importance of transparency on both ends

        • Sponsor oversight & responsibilities and interaction with the CRO

        • Identifying ways for a successful study conduct for medical device companies

      • 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
        • Speaker

          Megan Critser – Regulatory/ Quality Acquisition Integration Manager EMEA EMEA, Cardinal Health

        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

          • Exploring examples of randomised registries in real-world

          • Investigating challenges of Randomised Registry Trial to build your risk management strategies

        • 11:30 - 12:00
          • Speaker

            Janet Kube – Project Director, Premier Research
          • Speaker

            Joanne Emmett – Vice President, Medical Device & Diagnostics, Premier Research

          The New MDR Requirements: Study Impacts You Need to Consider

          • New opportunities for advanced planning and operational application

          • Investigating key elements to consider during study planning

          • Applying the MDR with a global program and study environment in mind

          • Establishing strategies to keep your study on track

        • 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

            Jens 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

            Evidence-based Forecasting of Medical Device Development Timelines

            • Development of a forecasting methodology for development and launch of pipeline medical devices

            • Highlighting differences in product development for US market compared to EU and Japan

            • Application of forecasting methodology to an existing pipeline product database

          • 14:30 - 15:00
            • Speaker

              Drew Matheson – Sr Director, Clinical Development, Syneos Health

            Expanding Horizons: Accessing Global Opportunities in Medical Devices and Diagnostics

            • Exploring future trends in the global MD&D market

            • How to adapt to changing approaches to global markets

            • How are the FDA implementing initiatives for faster approvals in the US

            • Understanding the requirements of evolving global markets such as China

          • 15:00 - 15:30
          • 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

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

            • 16:00 - 16:30
            • 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

            • 16:30 - 17:00
              • Speaker

                Sarah Cooper – Business Development Manager, NIHR(National Institute for Health Research)

              How to conduct more clinical trials - the network approach

              • Understanding the clinical research delivery infrastructure in the UK ?

              • Enhancing your marketing strategy by bringing your product to clinical trial in the NHS (National Health Service)

              • The network approach - accurate study feasibility, streamlined costing and contracts, rapid site identification, coordinated study set-up, and proactive performance management

              • Demonstrating the power of the network approach - real life case studies

            • 17:00 - 17:30
              • 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?

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

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