Uitgelicht en gespot op internet (week 3, 2021)

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

Ook de ‘Events‘ pagina en de ‘Consultations‘ pagina zijn weer bijgewerkt en voorzien van nieuwe evenementen en publieke consultaties.

Biobanking

• Big data in de biobank (21 januari 2021). C2W.

AVG, Persoonsgegevens

• Datalekken
  • Guidelines 01/2021 on Examples regarding Data Breach Notification (19 januari 2021). Einddatum consulatie 2 maart 2021. EDPB.
  • EDPB Publishes Guidelines on Examples regarding Data Breach Notification (19 januari 2021). LexBlog.
• Standard Contractual Clauses
  • EDPB-EDPS Joint Opinion 2/2021 on standard contractual clauses for the transfer of personal data to third countries (14 januari 2021). EDPB.
  • EDPB and EDPS Release Joint Opinion on Draft EU Standard Contractual Clauses(21 januari 2021). LexBlog.
  • EDPB and EDPS Adopt Joint Opinions on Draft SCCs (15 januari 2021). LexBlog.
• Presentatie ‘De verwerkersovereenkomst. De lastige vragen’ (do’s and don’ts en bestaande template verwerkersovereenkomsten op een rij). Vonne Laan, via LinkedIn.

Clinical Trials Results Reporting

• SME and academia Clinical Trials Information System (CTIS) two-part training webinar.
  Express your initial interest by completing the expression of interest questions by 29 January 2021.
• Training course: Using the new post-2021 European clinical trial registry CTIS (z.d.). TranspariMED.

COmmissie REgelgeving ONderzoek (COREON)

• Federa en COREON gaan verder als Stichting COREON (21 januari 2021).

COVID-19

• WHO platform for pharmaceutical firms unused since pandemic began (22 januari 2021). The Guardian.
• Elderly begin to drop out of Novavax vaccine trial to get Pfizer and Moderna shots (19 januari 2021). The Washington Post.
• Israel sharing COVID-19 data with Pfizer to help fine-tune vaccine rollout (18 januari 2021). Reuters.
• Scientists tackle vaccine safety, efficacy and access at global R&D forum (16 januari 2021). World Health Organization.
• The need for inclusion of pregnant women in COVID-19 vaccine trials (11 januari 2021). Vaccine.
• January 15, 2021: How CTTI & the Clinical Trials Community Have Risen to Meet the Challenge of the COVID-19 Pandemic.
• Over 40% of trials for potential Covid drugs are missing results (z.d.). TranspariMED.

Covidus Interruptus, Evidence based

• Corona-vaccinatie: sneller meer mensen beschermen (20 januari 2021). Ministerie VWS.
• Revisiting the UK’s strategy for delaying the second dose of the Pfizer covid-19 vaccine  (20 januari 2021). The BMJ Opinion.
• VIG: houd bij vaccinatiedosering vast aan wetenschappelijk bewijs (19 januari 2021). Vereniging Innovatieve Geneesmiddelen.
• WHO: 2nd dose of BioNTech/Pfizer vaccine can be delayed. It can be given up to six weeks after the first, the health body says (5 januari 2021). POLITICO.
  • Extraordinary meeting of the Strategic Advisory Group of Experts on Immunization (SAGE) (5 January 2021). WHO.
• FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines (4 januari 2021). FDA.
• Britain takes a gamble with Covid-19 vaccines, upping the stakes for the rest of us (4 januari 2021). STAT.
• Of Weighting and Waiting (1 januari 2021). Stephen Senn, via LinkedIn.

European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)

• Assent / Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe (18 januari 2021).
  Developed by Enpr-EMA’s Working Group on EthicsThis document is intended to be used as an overview tool of the contents for assent/informed consent forms for all stakeholders (such as patients, sponsors and investigators) to support the conduct of high-quality paediatric clinical trialsin Europe across all paediatric age groups, from birth to less than 18 years of age.

Gene editing

• “Prevention” and Human Gene Editing Governance (januari 2021). AMA Journal of Ethics.

Publiceren, Reporting guidelines

• Onderzoekers krijgen toegang tot wereldwijd platform voor open access publiceren. NWO en ZonMw worden lid van Europe PMC (19 januari 2021). ZonMw.
• Universiteitsuitgeverij gaat in september van start (18 januari 2021). Vox magazine.
• The IDEAL Reporting Guidelines. A Delphi Consensus Statement Stage Specific Recommendations for Reporting the Evaluation of Surgical Innovation (januari 2021). Annals of Surgery.
• Reporting guidelines should be free to publish, read, and use (december 2021). Journal of Global Health.

Overige berichten

• Exempting low-risk health and medical research from ethics reviews: comparing Australia, the United Kingdom, the United States and the Netherlands (28 januari 2021). Health Research Policy and Systems.
• Best practices for artificial intelligence in life sciences research (22 januari 2021). Drug Discovery Today.
• Clinical trials disrupted by slow recruitment still growing (20 januari 2021). Clinical Trials Arena.
• FDA’s 2021 Clinical Trial Regulatory Plan Focuses on Diversity, Complex Design (18 januari 2021). WCG CenterWatch.
• What Factors Predict Willingness to Join Low‐Risk Pragmatic Clinical Trials? (19 januari 2021). Ethics & Human Research.
• Informed Consent: What Must Be Disclosed and What Must Be Understood? (18 januari 2021). The American Journal of Bioethics.
• Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources (18 januari 2021). WCG CenterWatch.
• Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites (18 januari 2021). WCG CenterWatch.
• Scientific and Ethical Uncertainties in Brain Organoid Research (29 december 2020). The American Journal of Bioethics.
• The science behind diversity: Why we need to act now to demand diversity and inclusion (18 november 2020). Demand Diversity.

Raadpleeg het weblog voor een overzicht van het laatste nieuws, bijeenkomsten en publieke consultaties.

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