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 Network
For more information about this conference visit https://www.researchandmarkets.com/r/f18frs
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