Europe Legal and Regulatory AffairsWatchdog UpdateAugust 2022
By:Hind Al Belushi, PhDRoyal HospitalSultanate of Oman
a. Minutes of the meeting (15-17 June 2022)
https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-11-13-may-2022_en.pdf
a. Agenda for the meeting (13-15 July 2022)
https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-13-15-july-2022-meeting_en.pdf
b. Agenda for the meeting (15-17 June 2022)
https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-15-17-june-2022-meeting_en.pdf
https://www.ema.europa.eu/en/documents/report/cat-quarterly-highlights-approved-atmps-april-2022_en.pdf
Step 4 Training presentation for E8(R1). The ICH E8(R1) General Considerations for Clinical Studies was finalised in October 2021 and sets out general principles on the conduct of clinical studies.
https://database.ich.org/sites/default/files/ICHE8%28R1%29_Step4Presentation_2022_0408.pdf
a. EMA open consultation (Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes)
https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-required-confirmatory-studies-medicinal-products-treatment-type-2-diabetes_en.pdf
Open till 31 August 2022.
b.Call for Comments on the “WHO approach towards the development of a global regulatory framework for cell and gene therapy products
https://cdn.who.int/media/docs/default-source/biologicals/bs2424_cgtp-document-for-2nd-public-consultation.pdf?sfvrsn=11a0c885_1
Open till 09 September 2022.
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