Webinar – June 28, 2023

After several years of work, the European Federation of CROs (EUCROF) is close to the finalisation of a GDPR Code of Conduct for clinical vendors. This Code sets out the practical terms of compliance with the GDPR, in the specific field of clinical research and particularly Clinical Research Service Providers. Highly anticipated by all players in the field, it is a transnational Code, which will be applicable in all States of the European Union.

The Code has now passed through different review phases by all the Data Protection Authorities of the 27 Member States. Its finalisation is imminent.

The Public Register of member CROs is already open, as part of a first pre-registration phase. The site has nearly 30 pre-registered companies.

The webinar will aim to briefly recall the objectives of the Code, will illustrate its added value for all actors in clinical research, the functioning of the governance body and verification of the maintenance of the conditions of adherence, complaints management and sanctions etc.

Next, a panel of experts will provide more practical answers to the most common questions around the Code.

 

Presenters

Anastassia Negrouk – COO – MyData-Trust

Anastassia Negrouk is holding master’s degree in biology and spent most of her carrier in regulatory affairs, policy & data protection. Today she is a certified DPO (@Solvay), COO at MyData-Trust, specialised in GDPR compliance in life sciences.

Cumulating over 20 years of regulatory experience in clinical research (public and private sectors), from which almost 8 years as DPO. She is regularly monitoring, analysing and publishing on potential impact of data protection regulation, but also other EU directives and regulations relevant to clinical research, such as clinical trials regulation, in vitro medical device regulation regulations on life science sector, with a specific interest in international clinical research and global privacy frameworks. Excellent speaker, Anastassia is frequently taking part in international meetings and conferences in the domain.

Anastassia also contributed through the AFCROs and its CNIL-RGPD working group, in the development of this Code.

Panelists

Yoani Matsakis – CEO – Telemedicine Technologies

Yoani Th. MATSAKIS is the CEO of Telemedicine Technologies, a company specialised 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.

Ekaterina (Kate) Smirnova – DPO – PSI CRO

Ekaterina (Kate) Smirnova is a Data Protection Officer (DPO) at a global mid-sised contract research organisation headquartered in Switserland.
Ekaterina is a co-chair of the task force of the EUCROF Code of Conduct for service providers regarding the application of the General Data Protection Regulation to clinical research.
A speaker at professional events and an active member of the International Association of Privacy Professionals (IAPP), Ekaterina has an over 15-year experience of working in the domain of clinical trials.
Kate holds IAPP certifications as a Certified Information Privacy Professional for Europe (CIPP/E), the United States (CIPP/US), Asia (CIPP/A), and the Certified Information Privacy Technologist (CIPT).

Victoria Watts – Vice President, Privacy and Global Data Protection Officer – Premier Research

Victoria Watts is the Vice President, Privacy and Global Data Protection Officer at Premier Research. Ms. Watts has extensive experience formulating, operationalising, and implementing data protection compliance programs and is an expert in
interpreting the General Data Protection Regulation (GDPR) as it relates to clinical research. Prior to joining Premier Research, she held positions of increasing responsibility in the fields of data protection and legal compliance.

Ms. Watts has a Master of Studies from the University of Oxford and both a Bachelor of Laws degree from the University of Law in the United Kingdom and a Bachelor of Arts degree from Royal Holloway, University of London. In the field of data protection, she is a Certified Information Privacy Technologist (CIPT) and Certified Information Privacy Professional with an emphasis in Europe (CIPP/E). Ms. Watts is a key contributor to the European CRO Federation (EUCROF) initiative to draft a GDPR Code of Conduct for the CRO industry and also works with the International Association of Privacy Professionals (IAPP) as a consultant to produce training content and examination questions.

Anne Vidal – Counsel – CNIL – French Data Protection Authority

Anne Vidal is legal Counsel at the CNIL, the French Data Protection Authority. She works in the DPO and support department, helping controllers and processors to be compliant with GDPR. She has a specialisation in health research and worked previously at the health department at the CNIL.
Anne has been involved in the review of the EUCROF draft Code of conduct since the beginning and exchanges regularly with EUCROF to discuss the main GDPR issues, in collaboration with the other agents of the team dedicated to the code at the CNIL.

 

Attendance Fee

€ 90,- for non-EUCROF members

€ 60,- for EUCROF members

Deadline for registration

27 June 2023 at 6 p.m.

How to register?

1) Go on the REGISTRATION PAGE and click on the red button “RESERVE A SPOT”

2) Check your order and click on the green “CHECKOUT” button

3) Fill in all the necessary information and validate your order

Confirmation

You will receive 2 confirmation emails:

A) One from Eventbrite with your invoice

B) One from “GoToWebinar” with all the necessary information to connect the D-Day!