Call for Abstract
Scientific Program
8th World congress on Clinical Trials & Regulatory Affairs, will be organized around the theme “Current challenges in Clinical Trials: From Trials Design to Regulatory Framework
Venue : Holiday Inn Paris – Marne La Vallée
WCT-2018 is comprised of 20 tracks and 132 sessions designed to offer comprehensive sessions that address current issues in WCT-2018.
Submit your abstract to any of the mentioned tracks. All related abstracts are accepted.
Register now for the conference by choosing an appropriate package suitable to you.
- Track 1-1Endpoint design of Clinical Trials
- Track 1-2Trial design: formulation development, manufacturing and analytical testing
- Track 1-3Non-randomized controlled and randomized clinical trial designs
- Track 1-4Clinical Study designs: Observational studies and experimental studies
- Track 1-5Experimental & observational Clinical studies
- Track 1-6Statistical Considerations for Trial Designs and Methodologies
- Track 2-1Pre-clinical studies
- Track 2-2Clinical Phases: Phase I, Phase II, Phase III, & Phase IV
- Track 2-3Study designs in various Phases of trials
- Track 2-4Patient recruitment in various phases of clinical research
- Track 2-5Data management, access, and sharing
- Track 2-6New drug application (NDA) application procedure for FDA approval
- Track 3-1Operational strategies for early clinical development
- Track 3-2Process to Streamline R&D in clinical trials operations
- Track 3-3Translation of clinical trial documents: Current challenges, options and solution for future
- Track 3-4Clinical trial project management
- Track 3-5Setting & managing priorities in a clinical project schedule
- Track 3-6Managing risk with contracts: Informed consent, Subject injury, Insurance & Indemnification
- Track 3-7Misconduct and fraud management in in clinical trials
- Track 3-8Misconduct and fraud management in in clinical trials
- Track 3-9Misconduct and fraud management in in clinical trials
- Track 3-10Good clinical practice (GCP) for Clinical Trials & inspection
- Track 4-1Methodologies to track and management of clinical supplies via various channels
- Track 4-2Direct-to-Patient distribution: Meeting the patient’s needs
- Track 4-3Patient oriented clinical trial material design and delivery
- Track 4-4Global Clinical trials supply chain management
- Track 4-5Streamlining information management in clinical supply
- Track 4-6Major Clinical Trial Supply Chain Challenges and methods to overcome it
- Track 4-7Clinical trials product supply & distribution management
- Track 5-1Challenges facing by Clinical Trials Sponsors
- Track 5-2Global and local clinical outsourcing and operations strategies
- Track 5-3Clinical trials outsourcing trends
- Track 5-4Advanced outsourcing models in Clinical Trials
- Track 5-5Transactional and partnership based Clinical Trials outsourcing
- Track 5-6Evaluating trials sponsors and selection of third party vendors
- Track 6-1Paperless Clinical Trials
- Track 6-2Future technologies in Clinical trials ranging from trials designs to data management
- Track 6-3Cloud technology in clinical trials data management, data sharing
- Track 6-4Future innovation and technology driven Clinical trials
- Track 6-5Roles of mobile technology in Clinical Trials
- Track 7-1Cost management in Clinical Trials
- Track 7-2Patients recruitment for a timely Clinical Trial
- Track 7-3Patients segregation for Clinical trials
- Track 7-4Challenge sin data mining for Clinical trials
- Track 7-5Data Collection & sharing
- Track 7-6Standardization of protocols
- Track 8-1Types of imaging Clinical Trials: Screening imaging clinical trials, Diagnostic imaging clinical trials, and Image-guided interventional clinical trials
- Track 8-2Imaging as Biomarker in Clinical Trials
- Track 8-3Limiting factors affecting Imaging in Clinical Trials
- Track 8-4Standardization of imaging protocol, image review & assessment
- Track 8-5Role of imaging in meta data collection and integration into Clinical trials databases
- Track 8-6Role of Clinical Trials imaging analysis software
- Track 9-1Strategies to optimize Clinical Trials resource allocation, outsourcing strategy and scheduling of clinical trials under limited manpower and budget
- Track 9-2Cost saving measures in Clinical Trials
- Track 9-3Efficient budget development for investigator grants
- Track 9-4Extraction of comparable data throughout the Clinical trials
- Track 9-5Budget forecasting for human trials and drug supply
- Track 10-1GCP, risk management principles and procedures
- Track 10-2Guidelines on Risk Management in Clinical Trials
- Track 10-3Risk-based quality management in Clinical trials
- Track 10-4Risk Assessment - Clinical Trials Toolkits
- Track 11-1Patient Recruitment Strategies for resource limited trials
- Track 11-2Smart data analytics driven patient recruitment strategies
- Track 11-3Data Analytics and Patient Recruitment
- Track 11-4Future of clinical trial information exchange
- Track 11-5Clinical Trial Site Selection: Challenges, Opportunities and Solutions
- Track 11-6Regulatory requirements in patient & sites selection
- Track 11-7Clinical trials site selection: cost optimization and data mining
- Track 11-8Databases or sources to identify Clinical trials investigators
- Track 11-9Patient recruitment techniques to overcome study participation barriers
- Track 11-10Factors influencing clinical trial site selection in Europe, USA and other countries
- Track 11-11Site selection in community-based clinical trials
- Track 12-1Methodology, challenges and prospect of adaptive design
- Track 12-2Adaptive Trial Design Guidance
- Track 12-3Adaptive Bayesian Clinical trials
- Track 12-4Adaptive Trial designs for various diseases
- Track 12-5Adaptive Clinical Trials for Biologic & Drugs: Case studies
- Track 12-6Adaptive Trial designs: Barriers & opportunities
- Track 13-1Strategies to anonymize & release patient level data
- Track 13-2Compliance issues and challenges with clinical data disclosure and transparency requirements
- Track 13-3Title VIII of FDAAA Final Rule and complimentary NIH policy, EMA Policy 0070, ICMJE requirements
- Track 13-4Regulations to share patient-level data and international registries
- Track 13-5Anonymize data sharing standards at the local and global level
- Track 13-6Patient engagement via lay summary documents in clinical trials
- Track 13-7New anticipated USA & EU regulatory reforms
- Track 13-8Protect patient level data privacy and preservation of regulatory integrity while sharing patient-level data
- Track 14-1Advanced Clinical Trials: Use of data analytics and innovative tools
- Track 14-2Patient centric approaches to incorporate technologies in Clinical Trials
- Track 14-3Digital health innovations in Clinical Trials
- Track 14-4Wearable in Clinical Trials
- Track 14-5Role of Artificial Intelligence (AI) & Internet of Things (IoT) in Clinical Trials
- Track 14-6Big Data Analytics & Machine Learning approaches in Clinical Trials
- Track 15-1IRT system to Optimize the Clinical trials process & improve supply chain planning
- Track 15-2Regulatory Compliance for IRT
- Track 15-3Novel approaches to integrate e-Source and IRT and role in simplifying the Clinical site experience
- Track 15-4IRT and its role in patient randomization
- Track 15-5Web based tools to improve IRT and to avoid duplicate enrollments of patients
- Track 15-6Role of IRT in Logistics management (both clinical supplies and samples)
- Track 16-1New Clinical trials regulatory frameworks worldwide
- Track 16-2New Clinical trials regulatory frameworks worldwide
- Track 16-3Europe (EU ) Clinical Trials portals & Databases
- Track 16-4Worldwide Clinical Trials Regulations (CTR), Medical Device Regulations (MDR) and General Data Protection regulations (GDPR)
- Track 16-5Considerations to establish the process to support Clinical trials Regulations
- Track 16-6Best Practices to establish a Successful Lay Summary Process
- Track 16-7Frameworks for adverse events reporting and regulation
- Track 16-8New Eu regulatory system and its impact on Clinical trials regulatory landscape
- Track 16-9Clinical Trial Data Transparency and the legal principles
- Track 16-10The future of Clinical trials regulation
- Track 16-11Regulatory challenges in clinical trials data management
- Track 17-1Ethics & Human Subject Protection
- Track 17-2Moral, Ethical and regulatory issues in Clinical trials
- Track 17-3Compliance and regulatory requirements in clinical research: Globally
- Track 17-4Regulatory Inspections of Clinical Trials & Research Sites
- Track 17-5Documentation Techniques and designing case report in clinical research
- Track 18-1Clinical trials for disease: Cancer, cardiovascular diseases, Diabetes, Alzheimer’s, Bacterial, Viral & Fungal diseases and more.
- Track 18-2Clinical trials for rare diseases: Challenges and opportunities
- Track 18-3Understanding the complexities of Oncology Clinical Trials
- Track 18-4Use of controls in clinical trial for various diseases
- Track 18-5Selection of Primary & Secondary endpoints for diseases
- Track 19-1Importance of Pharmacovigillance: Safety Monitoring of Medicinal Products
- Track 19-2Pharmacovigillance in Drug Regulation
- Track 19-3Monitoring Safety in Clinical Trials and Drug Development
- Track 19-4Role of Pharmacovigillance in drug development
- Track 19-5Post-marketing safety monitoring
- Track 19-6Adverse events reporting: Individual Case Safety Report (ICSR), Expedited reporting, Spontaneous & Aggregate reporting, Coding of adverse events etc.
- Track 19-7Risk management: Causality assessment, Risk management plans, Risk to benefit profile of drugs
- Track 19-8Pharmacoepidemiology, Pharmacogenetics and pharmacogenomics
- Track 19-9REMS/RMP design, Clinical Trials Registries
- Track 20-1Regulatory approval process for medical devices
- Track 20-2Clinical trials for medical devices: FDA and the IDE process
- Track 20-3Premarket approval & notification
- Track 20-4Clinical trials procedures for medical devices