Uitgelicht en gespot op internet (week 1, 2021)

Hierbij een nieuw overzicht van nieuws en andere berichten die de afgelopen weken zijn gespot op het internet.

Biobanking

• GDPR and Biobanking. Individual Rights, Public Interest and Research Regulation across Europe (januari 2021).

Brexit

• What the landmark Brexit deal means for science (5 januari 2021). Nature.
• What’s in the Brexit trade deal for the pharmaceutical and medical device industries? (5 januari 2021). Regulatory Focus.
• Guidance Decentralised and mutual recognition reliance procedure for marketing authorisations (4 januari 2021). Medicines and Healthcare products Regulatory Agency.
• Guidance European Commission (EC) Decision Reliance Procedure (4 januari 2021). Medicines and Healthcare products Regulatory Agency.
• MHRA Launches Accelerated Drug Development Program (4 januari 2021). WCG CenterWatch.
• Building on Covid successes, UK speeds up clinical trial timelines (z.d.). TranspariMED.

COVID-19

• Column ‘Over medicijnen’: Waarom zijn de Britten sneller? (6 januari 2021). College ter Beoordeling van Geneesmiddelen.
  
• Draft landscape of COVID-19 candidate vaccines (6 January 2021). World Health Organization.
• COVID-19-related medical research: a meta-research and critical appraisal (4 januari 2021). BMC Medical Research Methodology.
• UPDATED: UK authorizes Oxford-AstraZeneca COVID-19 vaccine (30 december 2020). Regulatory Focus.

 Ministerie van Infrastructuur en Waterstaat

• Van Nieuwenhuizen versnelt vergunningprocedure gentherapie (23 december 2020).

Europese Commissie

• Reproducibility of scientific results in the EU (01-12-2020).

Research integrity

• SOPs4RI (Standard Operating Procedures for Research Integrity)
  • Research Integrity tools for RPOs
  • SOPs4RI Toolbox
  • Research integrity: nine ways to move from talk to walk (12 oktober 2020). Nature.
• Best Practice Guide for Research Integrity and Ethics (oktober 2020). Austrian Federal Ministry of Education, Science and Research.
• Towards a Responsible Research Climate. Findings from academic researchers in Amsterdam (2021). Tamarinde Haven.

U.S. Food and Drug Administration

• Draft Guidance for Sponsor-Investigators. IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations (January 2021).
  • ‘N of 1’ therapies addressed in draft FDA guidance (5 januari 2021). Regulatory Focus.

Overige berichten

• Towards remote monitoring in pediatric care and clinical trials—Tolerability, repeatability and reference values of candidate digital endpoints derived from physical activity, heart rate and sleep in healthy children (7 januari 2021). PLOS ONE 16(1): e0244877.
• Half of Trials Experienced Slow Enrollment in 2020 (4 januari 2021). WCG CenterWatch.
• EMA Updates Advanced Therapy Guidelines for Developers (4 januari 2021). WCG CenterWatch.
• New EU Trial Regs Closer to Reality with CTIS Launch Date Set (4 januari 2021). WCG CenterWatch.
• Pediatric Trials Burdensome and Disruptive, Parents and Children Say (4 januari 2021). WCG CenterWatch.
• Why an automated tracker finds poor sharing of clinical trial results for an academic sponsor: a bibliometric analysis (4 januari 2021). Scientometrics.
• Citation bias and other determinants of citation in biomedical research: findings from six citation networks (1 december 2020). Journal of Clinical Epidemiology.

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