Lessons learned implementing the new EMA guideline
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 authorisation in the European Union (EU). Effective on 9 September 2023, the guideline sets forth consolidated requirements on the use of computerised 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. This ICON webinar will provide you with the knowledge now required to achieve compliance with the new regulatory regime, with a strong focus on data accuracy, security and operational efficiency of your trial.
The participants will learn the following:
- Deep dive into the new framework of standards
- Scope of impact to electronic data and computerised systems in clinical trials
- Distinguishing between technology and usage (interfaces and application)
- Lessons learned and inspection readiness.
Audience summary
Professionals from pharma / biotech companies, investigative sites and service providers in the following areas:
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Speakers
Vesta Marciulioniene
Director, Global Regulatory Clinical Services, ICON Biotech
Vesta Marciulioniene has 21 years’ 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 centralisation and organisational change management.
Within ICON, Vesta has been at the forefront of the implementation of the EMA Guideline on computerised systems and electronic data in clinical trials across multiple functions in the organisation.
Cooper Brown
Senior Project Manager, DCT Solution Enablement, ICON
Cooper Brown has been with ICON for 8 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 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 places a strong emphasis on maintaining data integrity and safeguarding quality & compliance within the pharmaceutical industry. George has extensive knowledge of auditing, cloud computing, computerised systems validation, and artificial intelligence. He holds a CISA certification in Information Systems auditing and is actively involved as a privacy and security champion.