Uitgelicht en gespot op internet (week 25, 2021)
Hierbij een nieuw overzicht van actualiteiten en andere nieuwsberichten die de afgelopen weken zijn gespot op het internet.
Vergeet niet om ook de ‘Consultations‘ en ‘Events‘ pagina te raadplegen.
Associatie van Contract Research Organisaties in Nederland (ACRON)
Biobanking
Centrale Commissie Mensgebonden Onderzoek (CCMO)
- Aanbevelingen doorgifte gegevens proefpersonen naar landen buiten de EER (25 juni 2021).
- Nieuwe documenten:
- P1a. Model primair besluit MDR-onderzoek artikel 82 positief (d.d. 21 juni 2021).
- P1a. Model primair besluit MDR-onderzoek artikel 82 negatief (d.d. 21 juni 2021).
- P1a. Model primair besluit MDR-onderzoek artikel 74.1 positief (d.d. 21 juni 2021).
- P1a. Model primair besluit MDR-onderzoek artikel 74.1 negatief (d.d. 21 juni 2021).
- P1a. Model primair besluit MDR-onderzoek artikelen 62.1 en 74.2 positief (d.d. 21 juni 2021).
- P1a. Model primair besluit MDR-onderzoek artikelen 62.1 en 74.2 negatief (d.d. 21 juni 2021).
Cochrane
COmmissie REgelgeving ONderzoek (COREON)
European Clinical Research Infrastructure Network (ECRIN)
European Clinical Trial Regulation (ECTR)
- Blog: Introduction to the Clinical Trial Regulation (536/2014) (z.d.). Deloitte.
- Article: Legal representation set out in the EU Clinical Trial Regulation (z.d.). Deloitte.
- Article: User management in the Clinical Trial Information System (z.d.). Deloitte.
- Article: Application procedures and Timelines under the EU Clinical Trial Regulation (z.d.). Deloitte.
European Medicines Agency (EMA)
- Newsletter #3: Clinical Trials Information System (CTIS) highlights – June 2021
- Clinical Trials Information System (CTIS): training programme (updated)
- EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper (24 juni 2021). Regulatory Focus.
- ICH reflection paper – proposed ICH guideline work to advance Patient Focused Drug Development (PFDD) (24 juni 2021). EMA.
- Outcome of public consultation on ICH Reflection Paper on Patient-Focused Drug Development (PFDD) Summary report of comments received during the public consultation (24 juni 2021). EMA.
- ICH guideline E6 on good clinical practice – Draft ICH E6 principles d.d. 19 april 2021 (24 juni 2021). EMA.
- EMA management board report: COVID coping, CTIS updates and more (21 juni 2021). Regulatory Focus.
EU Medical Device Regulation (MDR)
- Terugkijken MDR webinars FMS, NFU, NVZ, ZKN via Vimeo
NHS Health Research Authority
Publishing, Open Access
U.S. Food and Drug Administration (FDA)
- Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies. Guidance for Industry (draft) (25 juni 2021).
- FDA releases new draft guidance on sponsor role for safety reporting requirements (25 juni 2021). Regulatory Focus.
- FDA calls for inclusion of patients with incurable cancers in oncology trials (24 juni 2021). Regulatory Focus.
- What’s a Sponsor to Do?: The Curious Case of “Disputes” Over Phase 3 Study Design (22 juni 2021). FDA Law Blog, Human, Phelps & McNamara PLC.
- FDA Disease Specific Workshops: Clinical Trial Designs for Progressive Multifocal Leukoencephalopathy (21 juni 2021). FDA Law Blog, Human, Phelps & McNamara PLC.
U.S. National Institutes of Health (NIH)
- Affirming NIH’s commitment to addressing structural racism in the biomedical research enterprise (10 juni 2021). Cell.
- NIH Commits to Combating Structural Racism in Biomedical Science (21 juni 2021). WCG CenterWatch.
Overige
- Weekend reads: ‘The obesity wars and the education of a researcher’; zombie research; hijacked journals (26 juni 2021). Retraction Watch.
- Impact factor abandoned by Dutch university in hiring and promotion decisions (25 juni 2021). Nature.
- A study protocol of qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance (22 juni 2021). HRB Open Research.
- Where Did the Coronavirus Come From? What We Already Know Is Troubling (25 juni 2021). The New York Times.
- Deleted coronavirus genome sequences trigger scientific intrigue (24 juni 2021). Nature.
- Oxford University explores anti-parasitic drug ivermectin as COVID-19 treatment (23 juni 2021). Reuters.
- Anticipating the ethical, legal, and social implications of human genome research: An ongoing experiment (22 juni 2021). American Journal of Medical Genetics Part A.
- Despite Pandemic Positives, Crisis Highlights Issues with Growing Use of Service Providers (21 juni 2021). WCG CenterWatch.
- ‘Snapback’ to Pre-Pandemic Trial Approaches Unlikely, Focus Is on Innovation (21 juni 2021). WCG CenterWatch.
- Embryoid research calls for reassessment of legal regulations (19 juni 2021). Stem Cell Research & Therapy.
- Washington State University to review claims of research misconduct (18 juni 2021). PR Newswire.
- Do the Potential Medical Benefits of Phase 1 Pediatric Oncology Trials Justify the Risks? Views of the US Public (15 juni 2021). The Journal of Pediatrics.
- Editors-in-chief perceptions of patients as (co) authors on publications and the acceptability of ICMJE authorship criteria: a cross-sectional survey (14 juni 2021). Research Involvement and Engagement.
- “Natural Experiments” in Health Care Research (11 juni 2021). JAMA Health Network.
Raadpleeg het weblog voor een overzicht van het laatste nieuws, bijeenkomsten en publieke consultaties.
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