Hierbij weer een nieuwe uitgave van ‘Uitgelicht en gespot op internet‘, met een overzicht van nieuws en andere berichten die zijn gespot op het internet.
‘Uitgelicht en gespot op internet‘ is een supplement van de ‘Nieuwsbrief voor Goede Onderzoekspraktijken‘.
Clinical Trials Regulation (CTR), Verordening (EU) Nr. 536/2014 betreffende klinische proeven met geneesmiddelen
- Updated: Questions and Answers Document – Regulation (EU) 536/2014 – Version 6.2 (September 2022)
- Nieuw: 1.24 (Question: How are patient facing documents expected to be submitted ?)
- Updated Q&A 2.6 No. 94
- Updated Q&A 3.8. No. 171
- Updated Chapter 11 (Arragements for the transitional period)
- Annex II: Language requirements for part I documents : DK, EL, LV, HU, SE
EuropaBio
- EuropaBio response to the public consultation on the proposal for a Regulation on substances of human origin (SoHO) (07-09-2022).
- Factsheet – Increased regulatory efficiency; what we need for the next generation of medicine (07-09-2022).
European CRO Federation (EUCROF), Decentralized Clinical Trials
Dutch Clinical Research Foundation (DCRF)
European Clinical Research Infrastructure Network (ECRIN)
- IRDiRC Announces The Creation of Regulatory Science Committee to Tackle Regulatory Challenges in Rare Disease Research (22-09-2022).
- Kick off of new EU cluster project, canSERV, to provide cancer research services to EU (19-09-2022).
European Medicines Agency (EMA)
- EMA proposes quality guidelines for synthetic peptides and oligonucleotides (22-09-2022). Regulatory Focus.
- Establishment of a guideline on the development and manufacture of synthetic peptides (20-09-2022).
- Establishment of a guideline on the development and manufacture of synthetic oligonucleotides (20-09-2022).
International Rare Diseases Research Consortium (IRDiRC)
Reporting guidelines, SPIRIT, CONSORT
- An update to SPIRIT and CONSORT reporting guidelines to enhance transparency in randomized trials (15-09-2022). Nature Medicine.
- Would you like to contribute to updating the SPIRIT (2013) and CONSORT (2010) reporting guidelines?
Research integrity, Lex Bouter
- Terugkijken: Voorsymposium Lex Bouter 23 sept. 2022
- Terugkijken: Afcheidsrede Lex Bouter 23 sept. 2022
U.S. Food and Drug Administration (FDA), Verenigde Staten
- New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials (23-09-2022).
- Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs (draft 23-09-2022).
- CDER official reflects on a decade of patient-focused drug development (19-09-2022). Regulatory Focus.
- Good Clinical Practice Inquiries
Wet zeggenschap lichaamsmateriaal (Wzl)
Overig
- Weekend reads: ‘Papermill alarm’ software; questions about a study of prosthetics; what do publishers stand for? (24-09-2022). Retraction Watch.
- A new study asks: Are we harming blood donors by taking blood from them? (20-09-2022). STAT.
- ZonMw: meer aandacht nodig voor gender en sekse in gezondheidsonderzoek (16-09-2022). Skipr.
Op de hoogte blijven van actueel nieuws, bijeenkomsten en publieke consultaties