Regulatory Rapporteur June 2021
Focus: Data Transparency - The challenges of disclosing adequate clinical trial information in a comprehensible format Plus: • ATMPs - How to obtain positive HTA recommendations • ICH Q12 - Flexible management of post-approval changes • Veterinary Medicines - EMA's veterinary data strategy explained
Regulatory Rapporteur - June 2021 - Full IssueMEMBERS
Advanced therapies in the EU: challenges with HTA and real-world evidenceMEMBERS
ICH Q12 – adopting greater flexibility in product lifecycle managementMEMBERS
Preparing for data transparency requirements of the new EU CTRMEMBERS
Opinion: Concerns about a new transparency approach on submitted data to EFSAMEMBERS
From collection to connection – the EMA veterinary data strategyMEMBERS
Using plain language summaries for clinical trial results summariesMEMBERS
Editorial: Clinical data transparency in the digital era PUBLIC