Posaconazole product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 30 June 2025 - 13:10
Posaconazole product-specific bioequivalence guidance
Infosheet: EMA review of real-world data studies from September 2021 to February 2025
Submitted by Anonymous (not verified) on 30 June 2025 - 13:06
Infosheet: EMA review of real-world data studies from September 2021 to February 2025
Real-world evidence framework to support EU regulatory decision-making: 3rd report on the experience gained with regulator-led studies from February 2024 to February 2025
Submitted by Anonymous (not verified) on 30 June 2025 - 13:05
Real-world evidence framework to support EU regulatory decision-making: 3rd report on the experience gained with regulator-led studies from February 2024 to February 2025
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - September 2025, Online, from 29 September 2025, 09:00 (CEST) to 30 September 2025, 13:30 (CEST)
Submitted by Anonymous (not verified) on 30 June 2025 - 12:13
eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course for sponsors - September 2025, Online, from 29 September 2025, 09:00 (CEST) to 30 September 2025, 13:30 (CEST)
Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects
Submitted by Anonymous (not verified) on 30 June 2025 - 11:52
Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects
EFIM Annual Report 2024 Now Available!
Submitted by Aneta on 30 June 2025 - 11:44
We are pleased to announce the release of the EFIM Annual Report 2024.
The report highlights our key achievements, activities, and collaborations over the past year, reflecting EFIM’s continued commitment to advancing internal medicine across Europe.
Read EFIM Annual Report here!
ICH E20 guideline on adaptive designs for clinical trials - Step 2b
Submitted by Anonymous (not verified) on 30 June 2025 - 11:32
ICH E20 guideline on adaptive designs for clinical trials - Step 2b
Orphan designation: Ramiprilat Treatment of Stargardt's disease, 12/03/2013 Withdrawn
Submitted by Anonymous (not verified) on 30 June 2025 - 11:30
Orphan designation: Ramiprilat Treatment of Stargardt's disease, 12/03/2013 Withdrawn
Orphan designation: Adeno-associated virus serotype C102 containing the human GLA gene Treatment of Fabry disease, 13/04/2022 Withdrawn
Submitted by Anonymous (not verified) on 30 June 2025 - 11:30
Orphan designation: Adeno-associated virus serotype C102 containing the human GLA gene Treatment of Fabry disease, 13/04/2022 Withdrawn
Orphan designation: octreotide hydrochloride Treatment of acromegaly, 12/06/2009 Withdrawn
Submitted by Anonymous (not verified) on 30 June 2025 - 11:30
Orphan designation: octreotide hydrochloride Treatment of acromegaly, 12/06/2009 Withdrawn