Uitgelicht en gespot op internet (week 22, 2023)

Hierbij een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.

Voor meer nieuws zie ook de nieuwsfeed op de News‘-pagina. Evenementen en symposia zijn te vinden om de Events‘-pagina.

Vergeet niet om ook de Consultations‘-pagina te raadplegen.

Met vriendelijke groet,

Vincent Bontrop

U kunt met mij linken via LinkedIn.

Algemene verordening gegevensbescherming (AVG), Privacy

By reviewing the documents, the DPA noted that the Privacy Policy adequately indicated the legal basis for each processing operation and that the subscription to receive advertising messages and special offers was voluntary. Therefore, it considered that the processing was lawful in accordance with Article 6 GDPR. However, it held that the documents did not offer precise information on the purposes of data processing as it used undefined expressions such as “we can use…”. It emphasized that “language qualifiers such as ‘may’, ‘might’, ‘some’, ‘often’ and ‘possible’ should also be avoided. Where data controllers opt to use indefinite language, they should be able, in accordance with the principle of accountability, to demonstrate why the use of such language could not be avoided and how it does not undermine the fairness of processing” (Article 29 Working Party Guidelines on Transparency under GDPR). In the case at hand, the DPA found that no valid justification was given for the use of generic language and imposed a fine of €5,000 for the violation of Article 13 GDPR.

bron: AEPD (Spain) – PS/00140/2022. GDPRhub.

Clinical trials, Clinical research

Clinical Trials Regulation (CTR), Clinical Trials Information System (CTIS)

DIA Global Forum

European Animal Research Association

European Clinical Research Infrastructure Network (ECRIN)

European Medicines Agency (EMA)

EMA and the Heads of Medicines Agencies (HMA) are running a pilot project to enable clinical-oncology scientists to participate in medicine regulation. The pilot aims to achieve this by providing them with an understanding of basic principles relevant to their field.

The pilot focuses on scientific advice and marketing authorisation assessments for human medicines.

Prospective candidates must have experience in clinical oncology or haemato-oncology.

They do not need to have any prior understanding of regulatory requirements in medicine evaluation.

The pilot consists of live and recorded webinars covering the following areas:

Basic principles of the regulation of human medicines in the EU
Basic regulatory aspects relevant to oncology
Prospective candidates can apply by completing a brief registration form.

Participation is free of charge.

EMA and HMA launched the pilot in May 2023. It will be rolled out over 12 months.

It aims to increase collaboration between regulatory authorities and stakeholders in healthcare and academia, in line with the recommendations of the STARS common strategy.

bron: EMA ‘Academia’

Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) (België)

Findable, Accessible, Interoperable and Reusable (FAIR)

Kunstmatige Intelligentie (KI)

Medicines and Healthcare products Regulatory Agency (MHRA)


Nieuwsbrief voor Goede Onderzoekspraktijken

Towards the European Health Data Space (TEHDAS)

UK Research Integrity Office (UKRIO)

US Food and Drug Administration’s (FDA)

World Health Organization (WHO)


Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties

news.bontrop.com events.bontrop.com consultations.bontrop.co