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
  • DCT Case Studies – Real World Learnings from DCTs in Europe and the US

      Presentation
    Rebecca Jackson

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

  • 09:30
  • Clinical Trial Decentralisation: Why Implementation Matters?

    • The DCT framework
    • How to ensure appropriate standards and protocols in a decentralised clinical trial environment
    • Potential barriers to the adoption of decentralised clinical trials and how to overcome them
      Presentation
    Nikita Sharma

    Nikita Sharma Global Clinical Sciences & Operations Innovation Manager
    UCB

  • 10:00
  • Decentralized clinical Trials- An opportunity for Patients, Regulators, Payors and Industry alike

      Presentation
    Michael Zaiac

    Michael Zaiac Head of Medical Affairs Oncology Region Europe
    Novartis

  • 10:30
  • Business Card Exchange with Morning Coffee/Tea & Discussion

     

         

  • 10:50
  • Implementing the right COAs, the right way, to support the patient experience in trials


    Anthony Mikulaschek

    Anthony Mikulaschek Vice President, eCOA
    IQVIA Technologies

    Elan Josielewski

    Elan Josielewski Senior Principal and head of Operations of Patient Centered Solutions
    IQVIA Technologies

  • 11:20
  • The complementary roles of RWE and trials to determine treatment effects

      Presentation
    Nawab Qizilbash

    Nawab Qizilbash Clinical Epidemiologist & Head of OXON
    OXON Epidemiology

  • 11:50
  • Noala Clinical Research Study Presentation

     

    The Noala DLD Program is effective in increasing receptive and expressive language skills in children aged 1-7 with delayed language skills

      Presentation
    Sarah Lyons

    Sarah Lyons Clinical Director
    Noala

Patient Recruitment & Site Selection

  • 12:15
  • Pioneering AI for community engagement, operations, and diversity in research

    • Digital transformation in patient/community engagement and recruitment.
    • Role of AI technology in engagement in DE&I.
    • Using data automation to scale operations and resourcing
      Presentation
    Amber Hill

    Amber Hill Founder and CEO
    Research Grid

  • 12:40
  • Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge

     

                

  • 13:20
  • Medical Affairs and Clinical Operations collaborating on Clinical Trial Optimization


    Viraj Rajadhyaksha

    Viraj Rajadhyaksha Area Medical Director
    AstraZeneca

  • 13:50
  • 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
      Presentation
    Vladimir Anisimov

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

  • 14:20
  • 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
       
      Presentation
    Tina Barton

    Tina Barton Chief Operating Officer
    eMQT

    Shalom Lloyd

    Shalom Lloyd Co-Founder & Chief Strategy Officer
    eMQT

  • 14:50
  • 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

    Carole Scrafton

    Carole Scrafton Patient & Health Advocate
    FibroFlutters

    Amelia Hursey

    Amelia Hursey Research Manager
    Parkinson's Europe

  • 15:20
  • Grab your Tea/Coffee - Visit our Exhibitor Booths & Network with your colleagues

     

         

Patient Centricity & Patient Engagement

  • 15:40
  • Play the long game: Plan for clinical trial success.

      Presentation
    Natalie Wilson

    Natalie Wilson Business Development Manager
    NIHR Clinical Research Network

  • 16:10
  • EU-PEARL: An EU patient-centric clinical trial platform


    Nadir Ammour

    Nadir Ammour Global Lead, Clinical Innovation & External Partnership
    Sanofi

  • 16:40
  • Patient partnering strategies in clinical research

    • How can current systems assist researchers assess which method of engagement could work best
    • How users can have an active role in setting your research priorities
    • Working in partnership with Patient organisations - shared learning and insights
      Presentation
    Amelia Hursey

    Amelia Hursey Research Manager
    Parkinson's Europe

  • 17:10
  • The importance of patient advocacy for clinical research.

      Presentation
    Carole Scrafton

    Carole Scrafton Patient & Health Advocate
    FibroFlutters

  • 17:40
  • Chairperson’s closing remarks


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

  • 17:50
  • 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
  • Remote Inspection and Audit

      Presentation
    Seif Eddine Amara Madi

    Seif Eddine Amara Madi Senior Manager Clinical Labs Quality
    GSK

  • 09:30
  • Empathy: a crucial ingredient to improve (diverse) patient recruitment and retention in clinical trials

      Presentation
    Roger Legtenberg

    Roger Legtenberg Senior Partner & Co-Owner
    Admedicum

  • 10:00
  • How Real-World Evidence and Real World Data Can Help Regulatory Agencies Make More Informed Decisions

      Presentation
    Andrew Gray

    Andrew Gray Global Regulatory and R&D Policy
    Amgen

  • 10:30
  • Business Card Exchange with Morning Coffee/Tea & Discussion

     

         

Clinical Data & Tech Driven Clinical Trials

  • 10:50
  • Interpretation and Impact of Real-World Clinical Data

      Presentation
    Mohamed Sharaf

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

  • 11:20
  • Standardisation and deployment of novel digital biomarkers in decentralised clinical trials and recent developments in AI (ChatGPT)

      Presentation
    Meelis Lootus

    Meelis Lootus Member of IEEE Novel Biomarkers for Decentralised Clinical Trials Working Group
    IEEE

  • 11:50
  • Interactive Response Technologies - Best Practices for Remote User Acceptance Testing.

    • IRT in a post-covid era
    • Modern challenges for UAT
    • Best practices for an efficient and successful Remote UAT
      Presentation
    Kate Chapman

    Kate Chapman Director
    Clinical Technology Consultants Ltd

  • 12:20
  • 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)

  • 12:50
  • Luncheon & Networking - Visit Exhibitor Booths & Network with your peers in our Lounge

     

                

  • 13:30
  • RBQM: Align Monitoring Strategy to Quality Risk Assessment


    Shawntel Swannack

    Shawntel Swannack Director, Central Monitoring and Data Analytics
    GSK

  • 14:00
  • Global Clinical Development – Complex Generics

      Presentation
    Siddharth Chachad

    Siddharth Chachad Founder & Chief Strategist
    Reguclin Consulting

  • 14:30
  • From Insight to Action: Leveraging Enterprise Data for Strategic Decision-Making

      Presentation
    Jana Glogowski

    Jana Glogowski Insights Partner & Product Manager
    Roche

Outsourcing & Clinical Trials

  • 15:00
  • Feasibility in clinical trials

      Presentation
    Rali Vaskova

    Rali Vaskova Strategic Partnerships & Solutions
    FindMeCure

  • 15:30
  • Grab your Tea/Coffee - Visit our Exhibitor Booths & Network with your colleagues

     

         

  • 15:50
  • 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

    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT

    Diane Driver

    Diane Driver Head Program Delivery
    UCB

    Kate Chapman

    Kate Chapman Director
    Clinical Technology Consultants Ltd

    Roger Legtenberg

    Roger Legtenberg Senior Partner & Co-Owner
    Admedicum

  • 16:20
  • Analysis of Real-World Data for clinical research and drug development

    • INC & EXC Criteria: Consensus resulted from a political game
    • INC & EXC Criteria: Universality and reproducibility in RWD?
    • RWD challenges for the ClinOps’s team:
    • From where the RWD datasets will come from?
    • Can they be audited?
    • How will it match the CT protocol IN & EXC?
      Presentation
    Aldir Medeiros Filho

    Aldir Medeiros Filho Former Senior Project Manager - Data Sciences Department
    Mitsubishi Tanabe Pharma Europe Ltd

  • 16:50
  • Chairperson’s closing remarks


    Nancy Meyerson-Hess

    Nancy Meyerson-Hess Chief Compliance and Regulatory Officer
    eMQT


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