Wednesday - 10th May 2023

  • 08:00
  • Registration & Refreshments

  • 08:50
  • Chairperson’s opening remarks


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 09:00
  • Strategies for globalization in clinical trials

    • Connecting the developed and the developing nations
    • Dealing with differences owing to culture and ethnicity
    • Role of CROs and third party stakeholders

    Francis Crawley

    Francis Crawley Executive Director
    Good Clinical Practice Alliance - Europe (GCPA)

  • 09:30
  • Stepping up the decentralization of clinical trials


    Michael Zaiac

    Michael Zaiac Head of Medical Affairs Oncology Region Europe
    Novartis

  • 10:00
  • Innovative trial designs to save time and cost without compromising on the efficiency

    • Strategies & Methods for flexible design trials
    • The Adoption and Impact of Adaptive Trial Designs
    • Preclinical environment and trial designs Opportunities and Limitations

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

  • 10:30
  • Morning Coffee/Tea & Networking

  • 10:50
  • Medical Affairs and Clinical Operations collaborating on Clinical Trial Optimization


    Viraj Rajadhyaksha

    Viraj Rajadhyaksha Area Medical Director
    AstraZeneca

Patient Recruitment & Site Selection

  • 11:20
  • The National Institute for Health Research (NIHR) Patient Recruitment Centres: Optimising patient recruitment to ensure trial success


    Richard Evans

    Richard Evans Head Of Business Development and Innovation
    Leeds Teaching Hospitals NHS Trust

  • 11:40
  • Innovative analytic technologies for predictive modelling, forecasting and optimal designing patient recruitment in clinical trials

    • Advanced technologies to maximize patient recruitment predictability at different stages
    • Optimal time-cost efficient recruitment design, sites/countries selection
    • Data-driven re-projection and optimal adjustment of recruitment
    • Centralized statistical monitoring and detecting unusual data patterns
    • Predicting event counts in event-driven trials

    Vladimir Anisimov

    Vladimir Anisimov Principal Data Scientist, Data Science, Center for Design & Analysis
    Amgen

  • 12:00
  • Monitoring and Quality Assurance in site selection and patient recruitment to optimize clinical trials

    • Site pre-assessment and selection
    • Ensure patient protection and to deliver high quality data
    • Quality assurance can at times be difficult as regulatory requirements, standards and access to care differ globally – How are we going to handle this?

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

  • 12:20
  • Networking luncheons

  • 13:10
  • The Impact of Diversity Plans on Increasing Overall Enrollment in Clinical Trials


    Gayna B. Whitaker

    Gayna B. Whitaker President and Founder
    Genesis Medical Research Group

  • 13:40
  • Enrolment and retention in clinical studies before and during Covid-19 pandemic: clinical challenges and new opportunities. A case report from a phase 3 clinical program in fibromyalgia

    • What will persuade and impact the patient?
    • Is there anything pharma can provide for a trial member that will increase the value of participation?
    • The aim of patient-driven clinical trials is to diminish the burden of participation by making the participant journey as convenient and pleasant as possible
    • Utilize fitting procedures and techniques to limit dropouts without, in any capacity, constraining a patient to remain in the study

    Domenico Merante

    Domenico Merante Clinical Research Lead TA Orphan-Nephrology
    CSL Vifor

  • 14:10
  • Panel discussion: Critical Success Factors while Planning for Site Selection and Patient Recruitment

    • Discover sites with a demonstrated track record of good execution in trials
    • Study and site staff with solid certifications to expand the likelihood of powerful enrolment and an effective trial.
    • Factors such as disease prevalence rates, treatment practices, regulatory requirements and statistical considerations must be considered.
    • Access to subject population with the required eligibility criteria
    • Network within industries

    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

    Diane Driver

    Diane Driver Head Program Delivery
    UCB

    Joanne Stevens

    Joanne Stevens Global Head of R&D Operations
    GE Healthcare

  • 14:40
  • How Can African Sites be routinely included? Addressing diversity at its core

    • Addressing and overcoming the fears
    • Understanding and removing the challenges
    • Providing robust tools to gather evidence
       

    Tina Barton

    Tina Barton Chief Operating Officer
    eMQT

    Shalom Lloyd

    Shalom Lloyd Co-Founder & Chief Strategy Officer
    eMQT

  • 15:10
  • Afternoon Tea/Coffee

Patient Centricity & Patient Engagement

  • 15:30
  • Patient Engagement in Clinical Development - A look at what the UK are doing to bring patients to the forefront of study design


    Alex Hammond

    Alex Hammond Business Development Manager
    NIHR Clinical Research Network

  • 16:00
  • EU-PEARL: An EU patient-centric clinical trial platform


    Nadir Ammour

    Nadir Ammour Global Lead, Clinical Innovation & External Partnership
    Sanofi

  • 16:30
  • Panel Discussion: Putting the patient first - Embedding a patient-centric approach to clinical trial design


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 17:00
  • Interactive Breakout Discussions

     

    All the participants will have a great opportunity to discuss and explore a selection of most interesting topics discussed during the conference in small groups with their industry colleagues in an informal setting.

    Round Table 1: Innovation in Clinical Trials - Digital Approaches

    Round Table 2: Patient Centricity

    Round Table 3: Globalization and Country Specifics

    Round Table 4: Recruitment Challenges - Patients and Sites

    Round Table 5: Changing Clinical Trials - What needs to be addressed

    Round Table 6: Patient Retention

  • 17:50
  • Chairperson’s closing remarks


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 18:00
  • Networking Drinks Session


Thursday - 11th May 2023

  • 08:30
  • Registration & Refreshments

  • 08:50
  • Chairperson’s opening remarks


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 09:00
  • EHR Case Study: NHS health records in pandemic vaccination programs


    Rebecca Jackson

    Rebecca Jackson Sr. Mgr. Clinical R&D Innovation & Novel Modalities IT
    The Janssen Pharmaceutical Companies of Johnson & Johnson

  • 09:30
  • Global Clinical Development – Complex Generics


    Siddharth Chachad

    Siddharth Chachad Founder & Chief Strategist
    Reguclin Consulting

  • 09:50
  • Setting up Your Decentralised Trial for Success

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

Clinical Data & Tech Driven Clinical Trials

  • 10:10
  • How Real-World Evidence and Real World Data Can Help Regulatory Agencies Make More Informed Decisions


    Andrew Gray

    Andrew Gray Global Regulatory and R&D Policy
    Amgen

  • 10:30
  • Morning Coffee/Tea & Discussion

  • 10:50
  • Improving clinical data management (CDM) and statistics to meet new regulatory requirements

    • Integrating end-to-end clinical data management to manage data disruption
    • Centralized Statistical Monitoring to Improve the Quality of Clinical Data
    • Analysing the data constantly to evaluate and adjust the monitoring strategy as required

     

    For sponsorship opportunities please contact: sponsor@corvusglobalevents.com or call +44 (0) 207 096 0786

  • 11:10
  • Interpretation and Impact of Real-World Clinical Data

    • Strategies for better decision-making
    • High-level models and simulations compelled by data will allow elimination of risky trials
    • The potential of real world data in clinical research goes past patient identification and patient recruitment
       

    Mohamed Sharaf

    Mohamed Sharaf EMEA Senior Medical Advisor
    Janssen Europe, Middle East & Africa

  • 11:30
  • Trusting Digital Health Technologies: Why Global Standards Are A Must


    Maria Palombini

    Maria Palombini Leader, Healthcare Life Sciences Practice
    IEEE Standards Association

  • 12:00
  • Panel Discussion: The Evolution Of Tech- Enabled Clinical Trials and what to expect from the next decade of drug development

    • The use of artificial intelligence and machine learning
    • Effectively using Technology is enabling patient centricity
    • How to implement mobile technology and make it work in clinical trials
    • Does consumer technology devices used in clinical trials?
    • IoT in digital transformation of clinical trials
    • Technology partnerships

    Maria Palombini

    Maria Palombini Leader, Healthcare Life Sciences Practice
    IEEE Standards Association

    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 12:30
  • Networking luncheon

  • 13:10
  • Achieving a streamlined IRT development process

     

    IRT systems are critical to both randomisation and efficient drug supply management, but too often they are an afterthought for a study team juggling many conflicting priorities. With an efficient internal process, preferred IRT vendors and standardised IRT modules, processes and documentation, IRT development can be achieved in a streamlined fashion delivering an optimum IRT system with a fraction of the customary frustration and duplication of effort


    Kate Chapman

    Kate Chapman Director
    Clinical Technology Consultants Ltd

Outsourcing & Clinical Trials

  • 13:30
  • Non enrolling sites: How to early detect them and what to do?


    Faidra Van Der Wal

    Faidra Van Der Wal Associate Director Global Development Operations Trial Lead
    Janssen Pharmaceutical

  • 14:00
  • Key Considerations for Effective Clinical Trial Vendor Selection

    • Monitoring outsourced clinical trials
    • Managing Continuous & Real-Time Collaboration
    • Both sponsor and CRO must invest time in defining goals, anticipating issues and measuring results.

    Alpana Gandhi

    Alpana Gandhi Senior Process & Vendor Manager
    Boehringer Ingelheim

  • 14:20
  • How Industry Collaboration is Transforming Clinical Trials


    Sarah Tremethick

    Sarah Tremethick Global Consortia Program Lead - TransCelerate BioPharma Inc
    Roche

  • 14:50
  • A key factor in vendor Selection - The role of the CRO in advancing patientcentric clinical trial approaches

  • 15:20
  • Afternoon Tea/Coffee

Quality, Compliance & Risk Management

  • 15:40
  • Implementing risk proportionate approaches in clinical trials -moving towards risk-based monitoring

    • Observing exercises and methodologies ought to be chosen to be proportionate to the risks identified within a trial.
    • Risk-based monitoring needs an effective and adaptable technology platform with analytics, which are combined with monitoring to assess, manage and mitigate risk.

  • 16:00
  • Are we obsessed with Quality Tolerance Limits?

    • Choosing QTL Parameters wisely
    • Are you asking the right questions when considering the application of Quality Tolerance Limits (QTL)?
    • Controlling risk within diagnostic clinical studies

  • 16:30
  • Implementation of Quality by Design (QbD) Principles

  • 17:00
  • Panel Discussion – Partnering for progress - How Collaborative partnerships are transforming clinical trials?

    • Managing continuous & real-time collaboration
    • How transparency will lead to industrywide collaboration
    • Both sponsor and CRO must invest time in defining goals, anticipating issues and measuring results
    • Considering what patient centricity factors your CRO brings in

    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

    Diane Driver

    Diane Driver Head Program Delivery
    UCB

  • 17:40
  • Chairperson’s closing remarks


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