Europe Legal and Regulatory AffairsWatchdog UpdateAugust 2022
By:Hind Al Belushi, PhDRoyal HospitalSultanate of Oman
a. Minutes of the meeting (15-17 June 2022)
a. Agenda for the meeting (13-15 July 2022)
b. Agenda for the meeting (15-17 June 2022)
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.
a. EMA open consultation (Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes)
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
Open till 09 September 2022.
© 2021 ISCT. All rights reserved.
Site by eConverse Media