Uitgelicht en gespot op internet (week 51, 2020)

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

Biobanking

• Organoids for personalized treatment of Cystic Fibrosis: Professional perspectives on the ethics and governance of organoid biobanking (7 december 2020). Journal of Cystic Fibrosis.

Brexit

• End of Brexit transition period: Exhaustion of Intellectual Property Rights and Parallel Trade in the UK and EU (17 december 2020). BioSlice Blog, Arnold & Porter.
• Geneesmiddelensector bereidt zich voor op no-deal Brexit (16 december 2020). Vereniging Innovatieve Geneesmiddelen.

Centrale Commissie Mensgebonden Onderzoek (CCMO)

• Risico-inventarisatie van belang voor uitvoering klinisch onderzoek (15 december 2020).
  • Informatie CCMO naar aanleiding van uitbraak coronavirus
• Nieuwe versie model Investigational Medical Device Dossier (IMDD) beschikbaar (15 december 2020).
  • D2. Investigational Medical Device Dossier (IMDD)

COVID-19

• How to Expand Access to COVID Vaccines without Compromising the Science. Emergency use authorizations by the FDA are not ideal (17 december 2020). Scientific American.
• EXCLUSIVE: AstraZeneca makes tough unblinding call, grappling with a vaccine rollout that threatens to impair their embattled PhIII (16 december 2020). Endpoints News.
• The rapid, massive infection of the scientific literature and authors by COVID-19 (16 december 2020). bioRxiv.
• Waivers and Alterations of Research Informed Consent During the COVID-19 Pandemic (15 december 2020). Annals of Internal Medicine.
• Terugkijken, presentaties: Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU (11 december 2020). European Medicines Agency.
• Decision Regulatory approval of Pfizer / BioNTech vaccine for COVID-19 (Updated 16 december 2020). Medicines and Healthcare products Regulatory Agency.
• FDA authorizes Pfizer-BioNTech vaccine for emergency use (11 december 2020). Regulatory Focus.
• MHRA authorizes Pfizer-BioNTech COVID vaccine as FDA, EMA set more conservative timeline (2 december 2020). Regulatory Focus.
• Zo werkt de beoordeling van een vaccin. College ter Beoordeling van Geneesmiddelen.
• Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project (5 november 2020). BMJ Open.

 

Dierexperimenteel onderzoek

• Norecopa Newsletter no. 8-2020 (17 december 2020).
• Bringing animal research into the open (14 december 2020). League of European Research Universities.

Dutch Oncology Research Platform (DORP)

• DORP Monitoring Toolkit (17 december 2020).
• Terugkijken en presentaties: Succesvol DORP webinar ‘Monitoring, van last naar lust’ (17 december 2020).

EudraCT Public website

The EMA will be closed from 23/12/2020 to 03/01/2021. Please note: Requests sent after 21/12/2020 for assignment as a primary user to post results and for EudraCT/EU CTR related queries will be processed after the 03/01/2021.

-Bron: EudraCT Public website d.d. 17 december 2020

European Clinical Research Infrastructure Network (ECRIN)

• Proposed categorisation system published for resources in the toolbox for sharing sensitive data (11 December 2020).
  • EOSC-Life WP4 Toolbox: Categorisation system for resources to be referenced in the toolbox for sharing of sensitive data (8 december 2020). Zenodo.
• Two chapters published in Principles and Practice of Clinical Trials (11 December 2020).
  • Long-Term Management of Data and Secondary Use. In: Piantadosi S., Meinert C.L. (eds) (4 december 2020). Principles and Practice of Clinical Trials.
  • Design and Development of the Study Data System. In: Piantadosi S., Meinert C. (eds) (27 juli 2020). Principles and Practice of Clinical Trials.
• PERMIT project holds Gap Analysis Workshop (11 December 2020).
• EMA providing support for developing orphan medicines by academics (7 December 2020).
• ECRIN Newsletter – December 2020 (15 december 2020).

European Commission’s Medical Device Coordination Group (MDCG)

• MDCG clarifies remote audit expectations for notified bodies (4 december 2020). Regulatory Focus.

European Medicines Agency (EMA), Clinical Trial Information System (CTIS)

• EMA Management Board: highlights of December 2020 meeting (18 december 2020).
• Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (3 november 2020).
  • EMA updates advanced therapy guidelines for developers (18 december 2020). Regulatory Focus.

Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten (FAGG) (België)

• Update van de aanbevelingen om sponsors van klinische proeven te begeleiden binnen het pilootproject van het FAGG (17 december 2020).
  • Guidance document for clinical trials sponsors, version 9.0, d.d. 17.12.2020.
  • Addendum to the CTR pilot project guidance for sponsors, version 2.0, d.d. 17 december 2020.

International Council for Harmonisation (ICH)

• ICH updates focus on patient-focused drug development, nitrosamines (11 december 2020). Regulatory Focus.

Netherlands Research Integrity Network (NRIN)

• Terugkijken: NRIN symposium 2020 (3 december 2020).

Representativiteit

• Man-vrouwverschillen onderbelicht in onderzoek coronamedicijnen (12 december 2020). NOS.
• The “sex gap” in COVID-19 trials: a scoping review (30 november 2020). EClinicalMedicine.

Inspectie Gezondheidszorg en Jeugd (IGJ)

• Medisch wetenschappelijk onderzoek kan op sommige punten beter (16 december 2020).
  • Factsheet klinisch onderzoek UMC’s 2018-2019

UK Research Integrity Office

• UK Research Integrity Office – December Newsletter (18 december 2020).

U.S. Food and Drug Administration (FDA)

• Controlled Correspondence Related to Generic Drug Development Guidance for Industry (December 2020).
• Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. Guidance for Industry (december 2020).

ZonMw

• Kijk terug: Webinar Placebo of no-cebo (8 december 2020).

Overige berichten

• ‘Over tien jaar moet Nederland dé medicijnhub van Europa zijn’ (15 december 2020). Vereniging Innovatieve Geneesmiddelen.
• What do trialists do about participants who are ‘lost to follow-up’? (15 december 2020). Students 4 Best Evidence.
• FDA finalizes guidance on complex innovative trials designs (16 december 2020). Regulatory Focus.
• FDA’s proprietary name guidance seeks to avoid medication errors (9 december 2020). Regulatory Focus.
• Is There an Ethical Upper Limit on Risks to Study Participants? (3 november 2020). Public Health Ethics.

---

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

Nieuwsfeed
> news.bontrop.com <

Consultaties
> consultations.bontrop.com <

Events
> events.bontrop.com <