Uitgelicht en gespot op internet (week 41, 2021)

Hierbij een overzicht van actualiteiten en nieuwsberichten die de afgelopen week zijn gespot op het internet.

Ook de ‘Events‘ pagina en de ‘Consultations‘-pagina zijn recentelijk weer bijgewerkt.

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Biobanken, Wet zeggenschap lichaamsmateriaal

• Verslag inzake Regels voor handelingen met lichaamsmateriaal, welke worden verricht voor andere doeleinden dan geneeskundige behandeling of diagnostiek van de donor (Wet zeggenschap lichaamsmateriaal) (15 oktober 2021). Vaste commissie voor Volksgezondheid, Welzijn en Sport.

Biosafety

• Reporting all biosafety errors could improve labs worldwide – and increase public trust in biological research (12 oktober 2021). The Conversation.

Clinical trials

• Disrupted clinical trials due to slow recruitment continue to rise (14 oktober 2021). Biotechnology community.
• The Future of Decentralized Clinical Trials Demands New CRA Skillsets (12 oktober 2021). ACRP.
• Estimating Power for Clinical Trials with Patient Reported Outcomes – using Item Response Theory (11 oktober 2021). Journal of Clinical Epidemiology.
• Modernized CT.Gov Site’s Beta Will Be Ready by Year’s End (11 oktober 2021). WCG CenterWatch.
• Ask the Experts: GCP Training Requirements Dependent on Sponsor, Protocol (11 oktober 2021). WCG CenterWatch.
• EC Walks Sponsors Through Trial Lay Summaries (11 oktober 2021). WCG CenterWatch.
• As Need for Sites Grows, ‘Site Tiering’ Could Become a Viable Approach to Help New Sites (11 oktober 2021). WCG CenterWatch.
• Covid-19, children, clinical trials and compassion: the ethical case for using innovative or compassionate treatments (9 oktober 2021). Acta Paediatrica.
• The Ethics of Human Challenge Trials Using Emerging SARS-CoV-2 Virus Variants (8 oktober 2021). The Journal of Infectious Diseases.
• Interim Analyses During Group Sequential Clinical Trials (1 oktober 2021). JAMA.
• Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics (30 augustus 2021). Therapeutic Innovation & Regulatory Science.

College ter Beoordeling van Geneesmiddelen (CBG)

• Nieuwste editie Regulatory Science Magazine (12 oktober 2021).

Data Archiving and Networked Services (DANS)

• Now in E-data: “Step by step towards a national data infrastructure”

Dutch Oncology Research Platform (DORP)

• Laagdrempelige PIF – interview met twee betrokkenen vanuit DORP (14 oktober 2021).
• Platform Onderzoekersnetwerken – samen voor klinisch onderzoekers (13 oktober 2021).

EU Clinical Trials Regulation (CTR)

• Clinical Trials Regulation (EU) No 536/2014 Draft Questions & Answers, Version 4.1, September 2021 (14 oktober 2021).

European Medicines Agency (EMA), CTIS

• Clinical Trials Information System: training and support
  • Principles for Sponsor organisation modelling for CTIS (13 oktober 2021).
  • Clinical Trial Information System (CTIS) – Sponsor user personas (updated 11 oktober 2021).

EMA CHMP heeft op 14 oktober 2021 ICH guideline E8 (R1) on general considerations for clinical studies aangenomen (Step 5). De gereviseerde guideline treedt in werking op 14 april 2022.

• ICH guideline E8 (R1) on general considerations for clinical studies aangenomen (Step 5)

In Vitro Diagnostic Regulation (IVDR)

• Proposal to manage IVDR (15 oktober 2021). Medicaldeviceslegal.
• European Commission proposal to delay application of In Vitro Diagnostics Regulation (15 oktober 2021). BioSlice Blog, Arnold & Porter.

International Agency for Research on Cancer (IARC)

• Research Leadership Training Programme (5 oktober 2021).

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice, GCP-renovation

• ICH E6(R3) EWG Update on Progress Public Web Conference Report and Video Presentation Online (15 oktober 2021).
  • ICH E6(R3) EWG – Public Web Conference Report – May, 2021
  • Terugkijken: ICH E6(R3) EWG – Public Web Conference – May, 2021, via YouTube.
• ICH’s E8 Revisions Now Ready for Regulatory Approval (11 oktober 2021). WCG CenterWatch.

International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP)

• IFAPP TODAY newsletter (oktober 2021).

Nieuwsbrief voor Goede Onderzoekspraktijken

• Nieuwsbrief voor Goede Onderzoekspraktijken nr. 138 (14 oktober 2021).

Medicines and Healthcare products Regulatory Agency

• Transparency data – Clinical trials for medicines: authorisation assessment performance(updated 11 oktober 2021).

NHS Health Research Authority

• Make it Public annual conference (11 oktober 2021).

Stichting Code Geneesmiddelen Reclame (CGR)

• CGR Nieuwsbrief nummer 3 (15 oktober 2021).

ZonMw

• FAIR metadata over de COVID-19-projecten beschikbaar op de COVID-19 Data Portal van Health-RI (6 oktober 2021).
• FAIRification

Overige

• Weekend reads: Attacks on scientists; NAS ousts researcher; how much it costs to publish (16 oktober 2021). Retraction Watch.
• Integrating heterogeneous data to facilitate COVID-19 drug repurposing (16 oktober 2021). Drug Discovery Today.
• Steun gevraagd voor Groeifondsvoorstel Biotech Booster (12 oktober 2021). HollandBIO.
• Early experience with the FDA’s regulatory review of novel gene therapies (11 oktober 2021). BMJ Evidence-Based Medicine.
• As Need for Sites Grows, ‘Site Tiering’ Could Become a Viable Approach to Help New Sites (11 oktober 2021). WCG CenterWatch.
• Indigenous knowledge around the ethics of human research from the Oceania region: A scoping literature review (9 oktober 2021). Philosophy, Ethics, and Humanities in Medicine.
• Pregnant Individuals’ Views on Fetal Tissue Research in the United States (7 oktober 2021). Obstetrics & Gynecology.
• What the Aducanumab Approval Reveals About Alzheimer Disease Research (4 oktober 2021). JAMA Neurology.
• Ethics of genetic research on same-sex sexual behaviour (23 augustus 2021). Nature Human Behavior.

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