Uitgelicht en gespot op internet (week 47, 2020)

Een verzameling van nieuwsberichten die de afgelopen weken zijn gespot op het internet:

Advanced Therapy Medicinal Products (ATMP)

• Call for more effective EU regulation of clinical trials of Advanced Therapy Medicinal Products (13 november 2020). Alliance for Regenerative Medicine (ARM), European Federation of Pharmaceutical Industries and Associations (EFPIA) & European Association for Bioindustries (EuropeBio).
• Call for more effective EU regulation of clinical trials of Advanced Therapy Medicinal Products. EuropeBio.

COVID-19

• Self-interest nudged me to join Moderna’s Covid-19 vaccine trial. Here’s how it’s going (19 november 2020). STAT.
• Coronavirus disease (COVID-19): SARS-CoV-2 Evolution (18 november 2020). World Health Organization.
• Episode #13 – COVID-19 – Vaccine trials (13 november 2020). World Health Organization.
• COVID-19: Serology, antibodies and immunity (13 november 2020). World Health Organization.

Drug Information Association – (DIA Global)

• DIA Global Forum – issue November 2020.

European Clinical Research Infrastructrure Network (ECRIN)

• ECRIN to support the coordination of European Adaptive Platform Trials on COVID-19 (10 november 2020).

European Data Protection Supervisor

• Preliminary Opinion 8/2020 on the European Health Data Space (17 november 2020).

EU-US Privacy Shield, Shrems II

• Overzicht: EU-US Privacy Shield, Shrems II (bijgewerkt 22 oktober 2020). Vincent Bontrop [blog].

Examenbureau Medisch-Wetenschappelijk Onderzoeker (EMWO)

• Nieuw examenreglement GCP-WMO (19 november 2020).

Federalwide Assurance (FWA)

• Surprise! “Checking the Box” Is Still an Option on the Federalwide Assurance (FWA) (18 november 2020). Advarra.

Nederlandse Voedsel- en Warenautoriteit (NVWA)

• NVWA publiceert handboek Nieuwe voedingsmiddelen (18 november 2020).

Norecopa

• Newsletter no. 7-2020 from Norecopa (18 november 2020).

Pharmaceutical Research and Manufacturers of America (PhRMA) 

• Principles on Conduct of Clinical Trials Communication of Clinical Trial Results (2020).
  • Just released: PhRMA members’ new clinical trial diversity principles (18 november 2020). PhRMA.

Research Quality Association (RQA)

• Newsletter 107, 18th November 2020.

Regulatory Science Network Netherlands (RSNN)

• Looking back at an inspiring online RSNN workshop “Leveraging the value of collaboration – from regulatory science to regulatory innovation” (20 november 2020).

Universiteit Utrecht

• Integrity Thursdays

U.S. Food and Drug Administration

• Investigational COVID-19 Convalescent Plasma Guidance for Industry (November 2020).
• Clinical Drug Interaction Studies With Combined Oral Contraceptives Guidance for Industry – Draft Guidance for Industry (November 2020)

Wet zeggenschap lichaamsmateriaal (Wzl)

• Korte update over de Wet zeggenschap lichaamsmateriaal, uit de Stand van zakenbrief COVID-19 van de regering d.d. 18 november 2020. Nieuwsbrief voor Goede Onderzoekspraktijken.

Overige berichten

• Messaging in Biological Psychiatry: Misrepresentations, Their Causes, and Potential Consequences. Harvard Review of Psychiatry.
• The failure of success – Careers, cultures, and integrity in science (2020). NRIN Theses page.
• A Crisis Year Brings Clinical Trials Face to Face with the Underserved. A Path Forward: Crisis as Catalyst for Change (Novermber 2020). DIA Global Forum.
• Simple Changes Can Make Trials More Patient Friendly (16 november 2020). WCG CenterWatch.
• Two-Thirds of Trial Subjects for Drug Approvals Are Outside the U.S. (16 november 2020). WCG CenterWatch.
• FDA Guidance Signals Clear Support for Efforts to Increase Trial Diversity (16 november 2020). WCG CenterWatch.
• CDER Suggests Schizophrenia Trials Can be Shorter, Simpler (16 november 2020). WCG CenterWatch.

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