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Date(s) - 30/06/2020
10:00 am - 11:30 am

Webinar Overview:

The patient centric benefits of electronic informed consenting (eConsent) technologies have been well documented, from the provision of better educational mechanisms of informing patients and overall improved comprehension of the study.

There is variability in permissible laws around the European region and globally to be aware of.

This presentation provides an introduction and overview of the:

 History of eConsent and established practices globally.

 The eConsent processes for patient, site and sponsors:

o use of multimedia tools for informing and educating a trial participant

o use of electronic and wet ink signatures.

 Common EU regulatory considerations including GCP, GDPR, eIDAS and

other national considerations.

 Overview of eConsent case studies



Fiona Maini BSc. MSc.

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.

Organiser: EUCROF

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