Uitgelicht en gespot op internet (week 40, 2021)
Ook deze week weer een overzicht van actualiteiten en nieuwsberichten de de afgelopen week zijn gespot op het internet.
Heeft u zelf nieuws, een evenement of enquête/consultatie gespot? Geef ze aan mij door via het contact formulier hier op mijn weblog.
En vergeet niet om ook de ‘Events‘ pagina en de ‘Consultations‘-pagina te raadplegen.
Biobanken, Wet zeggenschap lichaamsmateriaal
Centrale Commissie Mensgebonden Onderzoek (CCMO)
Clinical trial lay summaries, Lekensamenvatting onderzoeksresultaten, EU Clinical Trial Regulation (ECTR)
- Good Lay Summary Practice Guidance (4 oktober 2021). Clinical Trials Expert Group, European Commission.
- New guide to clinical trial lay summaries available for EU sponsors (5 oktober 2021). Regulatory Focus.
Clinical trial results reporting
College ter Beoordeling van Geneesmiddelen (CBG)
Conect4children, Paediatric Investigation Plans (PIP)
ELSI Servicedesk
EU Clinical Trial Regulation (ECTR), CTIS
- European Union Clinical Trials Information System CTIS: Go-live Planning. Summary of key areas in preparation of the operation of CTIS (7 oktober 2021).
- EMA readies CTIS go-live plan (8 oktober 2021). Regulatory Focus.
European Clinical Research Infrastructrure Network (ECRIN)
European Commission’s Medical Devices Coordinating Group (MDCG)
- MDCG 2021-24 – Guidance on classification of medical devices (4 oktober 2021).
- New MDCG guidance shows how devices fit into MDR’s classification rules (6 oktober 2021). Regulatory Focus.
Global Alliance for Genomics and Health (GA4GH)
Health-RI
- Grote stappen vooruit in uitwisseling gezondheidsdata (6 oktober 2021). NFU.
- Health-RI trapt miljoenenproject voor landelijke data-infrastructuur af (4 oktober 2021). Skipr.
- Making health data available for research. The next step #2 (4 oktober 2021).
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice, GCP-renovation
- The ICH E8(R1) Guideline reaches Step 4 of the ICH Process (6 oktober 2021).
- ICH announces sign-off on good clinical practices guideline (7 oktober 2021). Regulatory Focus.
- With ICH E6(R3) Draft Due in Early 2022, FDA Official Fields Questions from Impatient Industry (4 oktober 2021). WCG CenterWatch.
International Society for Stem Cell Research (ISSCR)
Koninklijke Nederlandse Akademie van Wetenschappen (KNAW)
- KNAW (2021). Efficiency gains through innovation in medicines development: how can science contribute?, Amsterdam.
- Lancering KNAW-advies over medicijnontwikkeling ‘Meer efficientie door innovatie’ (5 oktober 2021).
- KNAW-advies: start landelijke coördinatie medicijnontwikkeling (6 oktober 2021). Skipr.
Pharma.be
- De Belgische biofarmaceutische sector, een pionier in het competitieve Europese biofarmaceutische landschap.
- Data en digitalisering.
U.S. Food and Drug Administration
- Sponsors Must Repeat Studies Done by Troubled Indian CROs, FDA Cautions (4 oktober 2021). WCG CenterWatch.
- FDA Goes In-Depth on Using EHR and Claims Data in Drug and Biologic Trials (4 oktober 2021). WCG CenterWatch.
- FDA issues draft guidance on RWD sourced from EHRs, claims data (29 september 2021). Regulatory Focus.
- For gene therapies, FDA drafts trial guidance, finalizes “sameness” for orphan exclusivity (30 september 2021). Regulatory Focus.
Vereniging Innovatieve Geneesmiddelen
- Balkenende: ‘Meer investeren in biotechnologie hard nodig’ (7 oktober 2021).
- Schouw omarmt KNAW-pleidooi voor open dialoog medicijnontwikkeling (5 oktober 2021).
- Vier Amerikaanse adviezen voor ‘Boston by the North Sea’ (5 oktober 2021).
- Factsheet Boston aan de Noordzee (4 oktober 2021).
Overige
- Weekend reads: A lawsuit over a cell line; criminal charges for a science agency; nonsense in prestigious journals (9 oktober 2021). Retraction Watch.
- Identification and management of pragmatic clinical trial collateral findings: A current understanding and directions for future research (december 2021). Healthcare.
- Two scientists win chemistry Nobel for discovering a new way to construct molecules, speeding up drug development (6 oktober 2021). STAT.
- Lawyers for Henrietta Lacks estate say more companies to be sued over use of her cells (6 oktober 2021). STAT.
- Systematic review and meta-analyses of studies analysing instructions to authors from 1987 to 2017 (5 oktober 2021). Nature Communications.
- How Should the Precautionary Principle Apply to Pregnant Women in Clinical Research? (oktober 2021). The Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine.
- For the “good of the lab”: Insights from three focus groups concerning the ethics of managing a laboratory or research group (30 september 2021). Accountability in Research.
- Associations With Definitive Outcomes and Clinical Benefit of Cancer Drugs at the Time of Marketing Approval and in the Postmarketing Period (24 september 2021). J Natl Compr Canc Netw.
- A Systematic Review of Retractions in the Field of Cardiothoracic and Vascular Anesthesia (10 september 2021). Journal of Cardiothoracic and Vascular Anesthesia.
- Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study (9 september 2021). BMJ.
- Regulatory considerations for real-world research studies in Europe (28 juli 2021). Regulatory Focus.
- How Life Sciences are steadily becoming Data Sciences (z.d.). Modis.
- Innovation in Drug Research and Development for Prevalent Chronic Diseases: Proceedings of a Workshop (2021). Washington, DC: The National Academies Press.
Meer actueel nieuws, bijeenkomsten en publieke consultaties