Global Clinical Trials Connect Conference 2023 ( London, United Kingdom - May 10-11, 2023)
Dublin, April 06, 2023 (GLOBE NEWSWIRE) -- The "Global Clinical Trials Connect 2023" conference has been added to * ResearchAndMarkets.com's* offering.
The Global Clinical Trials Connect 2023 will provide a platform to discuss on futuristic advancements in clinical trials and clinical research.
This multidisciplinary program involves the broad participation of people from the clinical trials community from around the globe who are focused on learning more about clinical research, clinical trials planning and management.
The Pharma and Bio-Tech companies are consistently evolving and new clinical studies, technologies and advancements in care and treatments have augmented the efficiency at the same time, the complexity of clinical trials has increased, with tests being carried out in a highly structured and closely coordinated manner. It is high time that we look into innovative strategies, new technologies, effective and quality collaborations to address these issues, which can cater to the needs of the patient and the industry.
This conference intends to focus on global health and clinical trials around the world. Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based monitoring, clinical auditing & financial planning and other significant topics that play a key role in clinical trials will be addressed along with innovative sessions on new technologies, effective and quality collaborations.
This program will certainly educate healthcare scientists on trial design, operations, organizing trials, research computing, regulatory aspects, report on clinical trials and gain a better knowledge of the implications of clinical trials in prevention, diagnosis, clinical trial-related ethics and disease treatments.
The summit will facilitate an invaluable networking opportunities with decision makers and focus on real case studies, insightful presentations and round tables.
It gives us great pleasure in welcoming you to the Global Clinical Trials Connect 2023.
*Key Highlights*
· Patient Recruitment and Site Selection
· Innovative trial designs
· Partnership & Collaboration - Sponsors, CROs, Sites and External Vendors
· Patient-centric clinical trials
· Making Patient Engagement a Reality
· New innovations in Patient Recruitment planning and execution on a clinical trial
· Outsourcing strategies and models
· Electronic Clinical Outcome Assessment and Electronic Patient Reported Outcome
· Streamlined IRT development process
· Pharmacovigilance & Clinical Trials
· Post-Clinical Trial closed communities
· How to future proof your clinical operations
· Diversity and Inclusion in Clinical Trials
· Implementing Risk-Based Monitoring
· Streamlining R&D and lower costs in clinical Trials
· Adaptive Trial Model
· Clinical Trial Auditing
· Real-World Clinical Trial Strategies
· Data Quality & Technology
· Clinical Data Strategy & Analytics
· Electronic Data Capture (EDC) Systems
· Decentralised Clinical Trials
· Clinical Technology and Driving Innovation
· M-Health, Wearable and Consumer Technology
· Big Data, IoT and Artificial Intelligence in Clinical Trials
· Blockchain technology for improving clinical research quality*Who Should Attend:*
This event is designed for senior-level attendees from various companies including Pharmaceutical, Bio-Tech, Bio-Pharma, CROs, Investigative Sites, Solution providers and Government institutions.
*Attendees include VPs, GMs, Directors, Heads and Managers of*
· Clinical Trials
· Clinical Study Management
· Clinical Operations
· Clinical Research
· Patient Organizations
· Patient Recruitment
· Outsourcing
· Vendor Management
· Site Management
· Site Monitoring
· Clinical Pharmacology
· Clinical Data Management
· Risk Monitoring
· EDC
· Clinical/Digital Innovation
· Clinical Design/Protocol design/ Strategy makers
· Clinical Research Sites
· CROs and CMOs
· Hospitals/ Associations
· Regulatory affairs
*Agenda:*
*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
*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, 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 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?
*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 the 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*
Natalie Wilson Natalie Wilson 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 the 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*
*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
*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 the 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 patient centric 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*
*Speakers*
*Sarah Tremethick*
Global Consortia Program Lead - TransCelerate BioPharma Inc
Roche
*Michael Zaiac*
Head of Medical Affairs Oncology Region Europe
Novartis
*Faidra Van Der Wal*
Associate Director Global Development Operations Trial Lead
Janssen Pharmaceutical
*Francis Crawley*
Executive Director
Good Clinical Practice Alliance - Europe (GCPA)
*Maria Palombini*
Leader, Healthcare Life Sciences Practice
IEEE Standards Association
*Nancy Meyerson-Hess*
Chief Compliance and Regulatory Officer
eMQT
*Mohamed Sharaf*
EMEA Senior Medical Advisor
Janssen Europe, Middle East & Africa
*Diane Driver*
Head Program Delivery
UCB
*Siddharth Chachad*
Founder & Chief Strategist
Reguclin Consulting
*Richard Evans*
Head Of Business Development and Innovation
Leeds Teaching Hospitals NHS Trust
*Kate Chapman*
Director
Clinical Technology Consultants Ltd
*Joanne Stevens*
Global Head of R&D Operations
GE Healthcare
*Domenico Merante*
Clinical Research Lead TA Orphan-Nephrology
CSL Vifor
*Gayna B. Whitaker*
President and Founder
Genesis Medical Research Group
*Nadir Ammour*
Global Lead, Clinical Innovation & External Partnership
Sanofi
*Alpana Gandhi*
Senior Process & Vendor Manager
Boehringer Ingelheim
*Viraj Rajadhyaksha*
Area Medical Director
AstraZeneca
*Tina Barton*
Chief Operating Officer
eMQT
*Shalom Lloyd*
Co-Founder & Chief Strategy Officer
eMQT
*Vladimir Anisimov*
Principal Data Scientist, Center for Design & Analysis
Amgen
*Rebecca Jackson*
Sr. Mgr. Clinical R&D Innovation & Novel Modalities IT
The Janssen Pharmaceutical Companies of Johnson & Johnson
*Andrew Gray*
Global Regulatory and R&D Policy
Amgen
*Anthony Mikulaschek*
Vice President, eCOA
IQVIA
*Natalie Wilson*
Business Development Manager
NIHR Clinical Research NetworkFor more information about this conference visit https://www.researchandmarkets.com/r/f18frs
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