Webinar Topic
Driving the Modernization of Clinical Trial Monitoring In Europe
Webinar Date & Time
1 June from 04:00 PM to 05:30 PM (CEST)
Webinar Overview
Monitoring is a key component in clinical trials. ICH GCP R(2) defines the purpose of monitoring to verify that: a) The rights and well-being of human subjects are protected. b) The reported trial data are accurate, complete, and verifiable from source documents. c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s).
The COVID pandemic was a catalyst for the deployment of more remote strategies within clinical trials coupled with the need for greater harmonisation and alignment. EMA COVID guidance document flexibilities allow for limited use of remote source data verification and remote source review (rSDV/rSDR) in urgent circumstances, granted that national legislation and derogations permit the use of rSDV/rSDR, and a subsequent recommendations paper for decentralised elements in clinical trial expands the country specific view of acceptance. EUCROF developed a Task Force with a focus on rSDV/rSDR. The Task Force has developed a paper outlining eight propositions around rSDV/rSDR with the intent to look towards how monitoring processes can be less limited, and more modernised and harmonised in Europe.
This webinar will provide an overview of clinical trial monitoring and rSDV/rSDR which will be followed by an expert panel discussion. The agenda and speakers are below.
Presenters
Fiona Maini
Senior Director - Global Compliance and Strategy
Medidata Solutions a Dassault Systèmes Company
Fiona has worked within the Life Sciences and Healthcare domain for over 22 years working across Her focus at Medidata includes strategy and advocacy pertaining to the interface of technological advances and regulatory evolution in clinical research.In this role Fiona regularly interacts with authorities and industry bodies on modern technology strategies in particular patient centric technologies. For the past two years Fiona has been co-chair of the EUCROF rSDV/rSDR. She is also the ACRO DCT working party chair
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 of Deloitte services to the European Medicines Agency and their programmes. Fiona has a BSc and Msc in Chemistry
Silke Wendler
Associate Director Clinical Delivery
Labcorp Drug Development
Working in Clinical Research for 27 years. Started as CRA with IFNS (Germany, Cologne area - thereafter IBAH, Omnicare, Theorem via mergers, acquisitions and Spin off) in 1995 and has been a CRA and CTL until 2010 when stepping into Clinical Operations Line Management tasks. Management of CTAs, IHCRAs, CRAs and CTLs in 9 European countries. Moving into German CRA Line management tasks at the time point of acquisition by Chiltern in 2015 (with subsequent acquisition by Covance in 2017). As of 2018 taking on more responsibilities and being the ClinOps Lead for the DACH Region. In 2021 the company name changed to Labcorp Drug Development. As of October 2022 being Associate Director Clinical Delivery and being responsible for delivery, performance and quality of several EMEA countries. I am driven by quality and delivery.
Valeria Orlova
Regulatory Strategy Analyst - Global Compliance and Strategy
Medidata Solutions a Dassault Systèmes Company
Valeria helped coordinate the rSDV/rSDR EUCROF taskforce leading the development of the propositions paper. Valeria has a background in Biomedical Sciences from Imperial College London and is a Global Compliance and Strategy Analyst at Medidata, working towards a mission of driving global regulatory progress within the clinical trial domain. Valeria’s work lies within decentralised clinical trial regulatory enablement. She currently leads internal Medidata and external industry groups focusing on several DCT areas. Valeria monitors the evolving regulatory landscape and directly engages in dialogue with global health authorities and Ethics Committees. Valeria has presented on the topic of DCTs to global regulators, and industry stakeholders in DCT specific meetings and listening sessions, as well as at industry conferences, like RQA, SCDM, DiMe, eClinical Forum and EUCROF. In her regulatory strategy mission, Valeria strives to align technology innovation for clinical research and regulatory acceptance, with the goal of powering smarter treatments and healthier people.
Antoinette van Dijk
Clinical & Medical Affairs Director
D.O.Research
In 2016 she founded her own company D.O. Research, an Associate Member of EUCROF, providing consultancy in the clinical research and development for pharmaceuticals and medical devices. In the role of Clinical and Medical Affairs Director she has sound understanding of the complexity of global clinical development with a specific focus on methodological and ethical aspects of development and has more than 20 years of experience of both pharma and CRO industry and in the organisational set up of clinical trial centres. Antoinette is currently covering the role of Director Growth & Operations Europe at the Decentralised Research Organisation Care Access. She is a registered Physician. She is also a founding member of the Italian Association of CRO's, AICRO, in which she covered the role in the Board as Scientific Director for 15 years and is now still active as Chair of the Working Group Clinical Trial Centres. Through this role often involved in program committees and as speaker or chair at seminars and events. Within the European CRO Federation (EUCROF) she has been Chair of the working group for Education & Training and created the Working Group Clinical Trial Centres within EUCROF.
In March 2020 she was recognised as Global Fellow in Medicines Development, an award received from the IFAPP academy and in January 2022 she has been nominated as honorary member of the Italian Association of CRO’s (AICRO).
Yoani Matsakis
CEO
Telemedicine Technologies
Yoani Th. MATSAKIS is the CEO of Telemedicine Technologies, a company specialized in e-health systems and delivering EDC and ePRO solutions for clinical trials. He is also member of the executive board and treasurer of EUCROF (the European CRO Federation), co-chairman the working group on new technologies and member of the board of directors of AFCRO (French CRO association). He graduated as space and aeronautics engineer at the National High School for Aeronautics and Space (ENSAE) in France. He then joined the French National Center for Scientific Research (CNRS) as scientist where he was in charge of an experiment onboard the MIR Space Station. He then joined CNES – Centre National d’Etudes Spatiales – as payload manager and participated to several scientific programmes in the field of space physiology and medicine.
In 1997 he founded the telematics department of the Institute of space medicine and physiology and conducted an R&D programme in the field of telemedicine that resulted in the creation of Telemedicine Technologies in March 2000
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
31 May 2023 at 6 p.m.
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