Cécile van der Heijden Axon Lawyers
Cécile is an Amsterdam-based attorney with a background in data protection and healthcare law. She regularly advises sponsors and CROs on the legal aspects of clinical research. Cécile has a special interest in the confluence of the GDPR with clinical research and the impact of data protection legislation on the obligations of manufacturers of medicinal products and medical devices.
Catherine Jervis MRN
Catherine has 26 years of experience working in a global environment across the pharmaceutical and CRO industry. Through her experience she’s gained deep knowledge and expertise across research, clinical development, decentralized trials, outsourcing and external alliance management. She is an accomplished leader, passionate about leveraging new ways to bring medicines to the patient with a sense of urgency.
Cathelijne de Gram obtained her PharmD degree in 2000 from Groningen University, The Netherlands and since then she has been working in regulatory affairs both in the EU as well as USA. Cathelijne joined the global regulatory affairs department at Johnson & Johnson Innovative Medicine in 2012. Currently she is an EU regulatory policy leader in the Global Regulatory Policy and Intelligence department at Johnson & Johnson Innovative Medicine.
Begonya Nafria Escalera Sant Joan de Déu Research Foundation
She is Patient Engagement in Research Head of Department at Sant Joan de Déu Chidren’s Hospital (Spain). She has long experience in the field of the involvement of patients and families in research initiatives. She has also a personal story as a caregiver and patient advocate because is the sister of a young adult with cerebral palsy.
Her areas of expertise are focused in paediatric patients involvement in research and specifically in the field of clinical trials. She is currently a PhD student in the patient involvement in paediatrics field.
Other relevant background of her profile is: Fellow of EUPATI (first cohort), Coordinator of eYPAGnet (European Young Patients Advisory Group Network – www.eypagnet.eu), Coordinator of Kids Barcelona (www.kidsbarcelona.org), member of Children’s Medicines Working Party of EFPGCP, chair of the working the working group of cross-border access to clinical trials at EmprEMA and member of the EUPATI Board.
Coordinator of the cross-cutting theme of patients involvement in Conect4Children project (pan-European paediatric clinical trials network).
The main aim of all the activities leaded or participated by Begonya is to achieve a better quality of life for the paediatric patients thanks to research and new therapies.
Audrey Van Scharen Belgian Association of Research Ethics Committees - Vrije Universiteit Brussel - UZ Brussel
Audrey Van Scharen graduated with a Master in Political Sciences from the Vrije Universiteit Brussel (VUB) in 2008. While working at the Science Communication Department of the Research Department (RD) at VUB from 2010 to 2018, she obtained her Master in Laws. During her law studies, she had the opportunity to establish the Ethics in Research Department at VUB. She followed the growth and importance that Belgian, European, and international funding organizations and publishers placed on responsible research, including legal compliance, ethical principles, scientific integrity, and transparency.
While working at the Research Department of VUB, Audrey noticed that researchers had many questions regarding the use of data. This led her to obtain a Data Protection Officer (DPO) certificate. Awareness of privacy legislation in research was low at that time, but she observed the significant changes brought about by the GDPR since its creation in 2016. Given her experience in data protection, she initiated the GDPR implementation process at VUB. Currently, she is a DPO for the National Belgian Council of Doctors and the National Belgian Council of Pharmacists in Belgium, advising on the use of health data in both professional orders.
At the University Hospital Brussels, Audrey is the Manager in Ethics and Research. She assumed this role after several years as a member of the Medical Ethics Committee of UZ Brussels (2015 – present). Currently, she is the vice-president of the Medical Ethics Committee of the University Hospital/VUB and the vice-chair of the Health Ethics Committee of the University Hospital Brussels. She remains closely involved with the essential questions that researchers and healthcare professionals have regarding legal and ethical compliance in their professional activities. In recent years, she has observed new challenges in ethics and legal compliance in healthcare due to the rapid advancements in medical devices and data-driven solutions. She chairs the Medical Device Framework Board of the University Hospital, advising on the implementation of the Medical Device Regulation, the In-Vitro Diagnostics Regulation, and the AI Act.
As an affiliated Professor in the Faculty of Health and Pharmacy at VUB, Audrey teaches Bioethics, Ethics in Research, and Ethics in Health Management and Policy. She aims to impart the knowledge she gathers in daily practice to her students.
Drawing on her practical experience in ethics evaluations and the application of the CTR, GDPR, MDR, and IVDR, Audrey started a PhD on the topic: “The Sense and Nonsense of the Role Attributed to Medical Research Ethics Committees.” On one side, she will examine the focus of Belgian research ethics committees in the ethics review of innovative (bio)medical research. On the other side, she will propose best practices for the creation of ethics consultancy in healthcare at the University Hospital. She conducts her PhD research under the supervision of Prof. Dr. Pieter Cornu, Prof. Dr. Maarten Moens, and Prof. Dr. Michel Deneyer at the Faculty of Health of VUB.
Atiye Nazari Nestle Research
After completing my Master’s degree in Biostatistics, I began my career as a Biostatistician in a pharmaceutical company in Iran. In this role, I focused on clinical trial studies related to Biosimilar drugs.
In March 2022, I transitioned to Nestle and joined their clinical research unit. Here, I am currently involved in conducting clinical trials for infant formula. This role allows me to apply my expertise in biostatistics to contribute to the development and improvement of safe and effective products for infants.
Annika Baan CTU oncology Sahlgrenska Comprehensive Cancer Center Sweden
I work as head of the oncology clinical trial unit with early trials, FIH – Phase 3. I am also a development manager within Sahlgrenska Comprehensive cancer center. My primary education is nursing (SRN) and I have completed my academic degree in genetic counselling
Anna Titkova Pratia
I graduated from Kharkiv National Medical University, Ukraine. I obtained the qualification of MD, PhD and gained the Assoc. Professor title. I have MBA certification, Master of Science degree in Medicine and Education. I am the author of more than 100 scientific articles, 5 patents on inventions, and a medical monograph published in Germany. In 2020 I organised the SMO company Pratia Ukraine as a part of international site network and opened the first in the country clinical research site. During the period of war I combine the management of the operations in Ukraine and the international activities within the network of our 7 European countries in Pratia.
