>> Webinar Topic:

GDPR and Clinical Trials: Compliance and Harmonization

>> Webinar Date & Time:

25 May 2021 from 10:00 AM to 11:30 AM (CEST)

>> Webinar Overview:

The GDPR (General Data Protection Regulation) has been with us for three years now. Yet, the industry continues to struggle through the multiple legal interpretations of how the GDPR requirements apply to the clinical research.

Ethics committees, data protection officers of the clinical sites and of study funding sponsors, as well as the other stakeholders, defend their approaches. This altogether expands the gap in how a CRO and therefore, a Sponsor should process personal data to state with confidence, “We are GDPR compliant”.

To enable mutual agreement on the rules of applying the GDPR requirements to clinical research and help CROs demonstrate compliance with the GDPR, the EUCROF task force developed and is proud to introduce the first clinical trial Code of Conduct.

The Code is aimed at explaining the application of the GDPR to the services delivered by the CROs.

If you are a data protection officer, you work in a regulatory or legal department, if you are a healthcare professional wishing to boost your awareness about protection of personal data in the trial-related domain and get some insightful tips, you are welcomed to join us on this webinar!

25 May 2021, on the day of the 3rd anniversary of the GDPR, we will guide you through the first clinical trial Code of Conduct. You will have the opportunity to ask questions about the Code and our reasons to trust in its value, as well as receive practical advice on adherence.

>> Presenters:

​Kate Smirnova

Data Protection Officer (DPO)

PSI CRO

Ekaterina (Kate) Smirnova is a Data Protection Officer (DPO) at a global mid-sized contract research organization headquartered in Switzerland. Kate has been with the company since 2006. In the present role of a DPO she consults

the company on data protection matters; developed and maintains data protection program at PSI CRO. The focus of her particular professional interest dwells with seeking for the methods of establishing an effective data protection program for an SME. An active member of the International Association of Privacy Professionals (IAPP), Ekaterina holds IAPP certifications as a Certified Information Privacy Professional for Europe, the United States and Asia. Kate is a speaker at data protection events, a contributor and co-chair of the task force engaged into the development of the Code of Conduct for service providers regarding the application of the General Data Protection Regulation to clinical research. The initiative is supported and budgeted by the European CRO Federation (EUCROF).

Vicotoria 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, operationalizing, 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 currently a member of the Training Advisory Board of the International Association of Privacy Professionals (IAPP) as well as a key contributor to the European CRO Federation (EUCROF) initiative to draft a GDPR Code of Conduct for the CRO industry.

Thierry Lepoutre

Manager Clinical Operations

Telemedicine Technologies

Thierry LEPOUTRE is the Managing Director of Telemedicine Technologies Belgium. He has the overall responsibilities of operations and data intelligence. He has more than 20 years of experience in clinical research in various domains such as eClinical, drug supply management and quality and security.

Thierry has been graduated with a Master in Computer Sciences from the University of Namur in 1990. He then successfully graduated with a Certificate in Management of Information Security (InfoSafe) from the University of Namur and ICHEC (Brussels) in 2010. He finally successfully graduated with a formal certification in data privacy management (DataSafe) from the University of Namur and ICHEC (Brussels) in 2019.

>> Attendance Fee:

€ 90 for EUCROF non-members

€ 60 for EUCROF members

>> Deadline for registration:

24 May 2021

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>> How to register?

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>> Confirmation

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>> Questions?

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