The new framework of globally applicable standards for clinical trial data, effective from September 9, 2023.
All companies now need to implement the EMA guideline on computerised systems and electronic data in clinical trials if the data will be used to support a marketing authorization in the European Union (EU). Effective on September 9, 2023, the guideline sets forth consolidated requirements on the use of computerized systems, the collection and use of electronic data and introduces a new framework of standards to be upheld by sponsors, investigators and their service providers globally.
The new guideline impacts sponsors, investigators and service providers involved in running clinical trials. Join this ICON webinar to gain the knowledge required to achieve compliance with the new regulatory regime, with a strong focus on data accuracy, security and operational efficiency of the trial.
Vesta Marciulioniene, Director, Global Regulatory Clinical Services, ICON Biotech
Vesta Marciulioniene has 21 years of experience in the clinical research industry. She has led multifunctional teams regionally and globally, including start-up operations, clinical operations, clinical delivery, flexible solutions, document review, site ID and regulatory. Vesta brings significant start-up and regulatory experience, in addition to having versatile proficiency in global initiatives, clinical trial service centralization and organizational change management.
Within ICON, Vesta has been at the forefront of the implementation of the EMA Guideline on computerized systems and electronic data in clinical trials across multiple functions in the organization.
Cooper Brown, Senior Project Manager, DCT Solution Enablement, ICON
Cooper Brown has been with ICON for eight years supporting clinical trial delivery and project management. He works within the Solutions Enablement team in the decentralised clinical trials (DCT) group. The focus of this team is to further ICON’s DCT capabilities by integrating innovative clinical trial products into daily activities to enhance the overall experience for patients, sites, operations and sponsors. Cooper and his team partner with stakeholders in IT, product development and operations to develop and implement technology and processes supporting the delivery of DCTs.
Berit Gorsøe Kjeldsen, Director, Project Management, ICON Biotech
Berit Gorsøe Kjeldsen is an experienced clinical research management professional with more than 20 years of experience in the pharmaceutical Industry/clinical research organization. She has experience in managing clinical trials from various roles and has a strong focus on building and maintaining relationships between sponsors and CROs as well as finding new and efficient ways of working. Through her involvement in audits and inspections has gained experience with the New EMA guideline on computerised systems and electronic data in clinical trials.
George Evgrafov, Senior Manager, Technology Quality Assurance, ICON
George Evgrafov has over 25 years of experience in information technology. He is an accomplished quality assurance professional and has dedicated more than a decade to working in the pharmaceutical sector. He strongly emphasizes maintaining data integrity and safeguarding quality & compliance within the pharmaceutical industry.
George has extensive knowledge of auditing, cloud computing, computerized systems validation and artificial intelligence. He holds a CISA certification in information systems auditing and is actively involved as a privacy and security champion.
Who Should Attend?
This webinar will appeal to professionals from Pharma/Biotech companies, investigative sites and service providers in the following areas:
- Site feasibility and identification
- Contract management
- Study start-up
- Regulatory affairs
- Clinical delivery
- Project delivery
- Data management
- Systems management
- Information technology
- Vendor management
- Statistical programming
- Decentralised clinical trials
- Lab and imaging services
- Medical writing
- IRT services
- Innovation and transformation
What You Will Learn
The participants will learn the following:
- Deep dive into the new framework of standards
- Scope of impact on electronic data and computerized systems in clinical trials
- Distinguishing between technology and usage (interfaces and applications)
- Lessons learned and inspection readiness
ICON is the world’s leading clinical research organisation, powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing a comprehensive suite of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. Our outsourcing models can be adapted to suit small local trials to large global programs, including full service, standalone services, FSP and full asset development.
With headquarters in Dublin, Ireland, ICON employs approximately 41,150 employees in 113 locations in 53 countries.