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Programme

The program for Clinical Trial Supply Southeast will be in development soon. If you have a case study, or key message to deliver to this audience, please contact the Programme Director below with your proposal.

Kathryn.Essery@arena-international.com
Telephone: +44 0207 936 6486

Overview

    • 08:15 - 09:00
      • Registration and Refreshments

      • 09:00 - 09:15
        • Chair's Opening Remarks

        • 09:15 - 09:45
        • Insights into Effective Vendor Management for Clinical Trial Supplies

          • Defining needs and identifying potential vendors early to ensure supply needs are met throughout the trial

          • Timing – At what stage of your clinical trial should the IP group get involved and when should you begin the process of selecting vendors

          • Looking at how you develop RFPs and proposal reviews

          • Creating and maintaining effective open communication with your vendor

          • Considering how to successfully wrap up and close up projects so there are no loose ends when conducting your clinical trials

        • 09:45 - 10:15
          • Speaker

            Leslie W. Holmes – Supervisory Import Specialist, Pharmaceuticals, Health & Chemicals Center of Excellence and Expertise, U.S. Customs and Border Protection

          Regulatory Implementation of the Centers and Account Based Processing

          • The Centers of Excellence & Expertise mission statement, goals of the Centers and why CBP moved to the Center structure

          • The structure of the Centers including integration of additional Center staff

          • The Regulatory implementation of the Centers – Interim Final Rule dated December 20, 2016

          • Center transition to Account Based processing

        • 10:15 - 10:45
          • Speaker

            Tom Heck – President, RxSolutions

          Easing the Burden of Un-blinded Supply Needs of Any Phase Study Through Pharmacy Dispensing

          • Invest in clinical supply simplification

          • Learn to eliminate sourcing hassles For unblinded study supplies

          • Achieve forecasting assistance supported using prescription data

          • Understanding how to eliminate inventory management issues

          • Discover how to jump start the entire supply process completed In 30 days or less

        • 10:45 - 11:30
          • Morning Refreshments and Networking

          • 11:30 - 12:00
          • Overcoming Challenges in Managing Overseas Trials – Steps for Success in China

            • Examining methods to mitigate risks when conducting clinical trials in China • Strategies for reducing fraud and counterfeiting when conducting trials in China • Maintaining and managing your clinical supplies to ensure blinding is not broken • Discover how RFID tracking or ECD can enhance the security of trials done in China • Importance of Green Channel Approval so clinical trials are run on time and saves costs • Approaches to documentation management, to ensure you receive cGMP certification

          • 12:00 - 12:30
            • Speaker

              Amanda Mitchell – Research Scientist and Clinical Trials Supply Specialist, vTv Therapeutics

            Industry Approaches Towards Maintaining QA in Clinical Supplies

            • Assessing the reliability of data control in your clinical supplies to maintain industry standards when conducting clinical trials

            • Assessing the role of automated digital record keeping to ensure supply drugs stay in temperature range

            • Steps in classifying clean rooms in manufacturing suites – managing drug quality during the manufacturing process

            • Utilizing Good Compliance Practice (GCP) to improve standards of QA

          • 12:30 - 12:50
          • Industry Survey Results: Assessing the Current and Future State of Clinical Trial Supplies

          • 12:50 - 14:00
            • Lunch and Networking

            • 14:00 - 14:30
            • Leveraging IRT Systems to Maximize Cost-effectiveness and Minimize Waste

              • Best practices and implementation of IRT – A practical guide for innovation looking at the benefits IRT brings to clinical supply management

              • Leveraging innovations in IRT auto-resupply algorithms – using just-in-time, ‘wait for subject’, and other auto-resupply strategies to reduce unnecessary shipments

              • Overcoming integration challenges in IRT – utilizing bar-code based container-dispensing verification to minimize data duplication, errors and fraud

              • Exploring container count based (virtual) inventory Vs conventional tracking in open label trials – steps for decreasing the issues caused by sites dispensing drug and not recording it in the IRT

            • 14:30 - 15:00
              • Speaker

                Greg Hottell – Director, Supply Chain Group Lead, GSK

              Analysing Approaches Towards Forecasting and Impacts on Supply Chain Efficiency

              • Looking at the impact forecasting has on managing your clinical supplies to ensure you save costs and avoid delays

              • Utilizing agile approaches towards forecasting to respond to changes to demand and lead times

              • Analyzing methods to reduce product wastage and help save cost

              • Looking ahead – How can innovation in technology disrupt and improve forecasting?

            • 15:00 - 15:30
              • Afternoon Refreshments and Networking

              • 15:30 - 16:00
                • Speaker

                  Anil Sharma – President, Envigen Pharmaceuticals

                Bridging Between Clients and CROs: Cost Reduction Strategies in Supply Chain Management

                • Designing clear governance structures - outlining set targets and how you will achieve them

                • Re-negotiation - partnership management to deliver greater value from your existing partnerships with CROs

                • Project managing multiple services across several locations - streamlining to reduce complexity

                • Adding value - practical examples of maximising cost efficiencies and maintaining quality in supply management

              • 16:00 - 16:30
              • Overcoming Challenges Associated with Clinical Trial Study Start Up – A Small Biopharma Perspective

                • Building the foundations for a successful study startup – mapping achievable steps for startup success

                • Evaluating which financial model works for you – ensuring sustainability in your funding streams

                • Exploring common pitfalls unique to biopharma to avoid trial failure

                • Approaches towards risk-based monitoring to enhance patient safety and data quality

              • 16:30 - 16:45
                • Chair’s Summary and Close of Conference Day 1

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