Webinar Topic
Electronic Informed Consent ... bringing the clinical trial home
Webinar Date & Time
21 June 2021 from 10:00 AM to 11:30 AM (CEST)
Webinar Overview
This webinar on electronic Informed Consent (eConsent) addresses the practical considerations when implementing eConsent. This topic has become an ever increasingly important topic as remote strategies and decentralised clinical trials are being deployed.
The session starts with an introduction to the eConsent Implementation Practical Guide, which was published earlier this year. The Guide was developed by EUCROF and eClinical Forum members and addresses key themes and hot topics and provides a view on the modernisation of the clinical trials informed consenting process, including the current perception and shift of eConsent adoption in light of the COVID-19 pandemic.
Some of the topics addressed in the presentation include:
- eCF and EUCROF eConsent task force activities
- eConsent fundamentals
- eConsent Implementation Guide
- Introduction to the eConsent Implementation Guide
- Stakeholder Perspectives
- Implementation steps and considerations
- Regulatory landscape
Overview of draft ICH E6 (R3) relating to informed consent.
The session will end with questions and answers.
Presenters
Fiona Maini BSc. MSc.
Principal Global Compliance and Strategy
Medidata Solutions a Dassault Systèmes Company
As a Medidata Global Compliance and Strategy Principal, Fiona’s focus includes evaluation of GxP relevant regulatory changes coupled with the regulatory aspects of technological advancements impacting the Life Sciences and Healthcare industries, specifically within in the clinical research domain. In this role Fiona regularly interacts with authorities and industry bodies on modern tech strategies such as emerging patient centric and clinical platform technologies. Fiona has been leading a study on the variability of the adoption of eConsent internationally engaging with authorities and Ethics Committees.
Fiona is also currently the Chair of the ACRO Decentralised Clinical Trials Working Party in the EU, focused on the development of the end to end process framework, quality by design guidance and risk assessment criteria for decentralised clinical trials. Fiona is also a member of the EU Alliance on Artificial Intelligence.
Prior to Medidata Fiona was a Director at Deloitte, where she led the Deloitte Global Centre for Regulatory Excellence for Life Sciences and provided governance and oversight of Deloitte services to the European Medicines Agency. Prior to Deloitte Fiona also has 4 years’ experience as a research chemist working within R&D. Fiona has an MSc in Chemistry, a BSc in Chemistry, Management Science with French, which included an Erasmus year at the University of Liège, Belgium.
Mika Lindroos
Signant Health - Director, Product Management, eConsent
Mika Lindroos is the Director of Product Management and an eConsent expert at Signant Health, and he says he is most at home where technology meets humanity. With over 25 years of experience in software product management in the global environment, Mika’s breadth of experience spans from product and portfolio management, strategy and business development, and heading a product line at Nokia to revenue and business relationship development at Digia Plc. Mika is a specialist in developing and managing relationships both internal and external to his organization, as evidenced by his varied roles in team motivation, change management, as well as customer relationship development.
Valeria Orlova
eConsent Guide Co-ordination
Medidata Solutions a Dassault Systèmes Company
Valeria is a final year Biomedical Sciences student at Imperial College London with an interest in the Healthcare & Life Sciences regulatory environment. She is undertaking a project placement at Medidata and the main focus of her work is decentralised clinical trials and in particular eConsent. Over the past couple of months Valeria has been responsible for the coordination of the eConsent Implementation Guide and other related activities.
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
20 June 2021
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