Webinar Topic
Electronic Informed Consent ... bringing the clinical trial home
Webinar Date & Time
30 November 2020 from 2:00 pm to 3:30 pm (CET)
Webinar Overview
This webinar on electronic informed consent (eConsent) addresses the practical considerations when implementing eConsent.
It introduces the EUCROF Implementation Practical Guide to eConsent which addresses key themes and hot topics, and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic.
Some of the topics addressed in the presentation include:
- Introduction and recap on eConsent
- Decoding the ‘electronic’ in eConsent
- COVID-19 - the eConsent catalyst
- Stakeholder perspectives: patient, site, sponsor
- Implementation Considerations such as:
- Process: what will you do differently with eConsent?
- Practical implementation considerations
- Financial considerations
- Regulatory landscape updates
The webinar will also address questions and discussions highlighted after the previous webinar that was held on June 30 this year, which addressed the basics and the global perspective on eConsent. It highlighted the process of informing the patient and obtaining their consent for clinical trial participation using multimedia training tools and eSignature capabilities, which created a very stimulated discussion in the field. The previous webinar is still accessible on the EUCROF Moodle eLearnIN Platform.
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
29 November 2020
How to register?
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Confirmation
You will receive 2 confirmation emails:
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