Planned for January 2025

If you are involved in Clinical Trials or in Regulatory Affairs… Here a list of selected events or documents expected in?January or early 2025?that may be of interest to you:

Before going into the details, here a few key elements from my point of view:

1)????? 30Jan25 is the last day of the EU Clinical Trials Directive 2021/20/EC;

2)????? 12Jan25: The Regulation (EU) 2021/2282 on health technology assessment (HTA) and amending Directive 2011/24/EU shall apply;

3)????? From 01Jan25, Poland will hold the Presidency of the Council of the European Union (the "Council") for 6 months.

4)????? From January 2025,?post-authorisation procedures submitted to the EMA?on or after 20 December 2024 will be managed in IRIS.?

5)????? Hopefully in January, we may hear about the newly created Health Committee at EU Parliament (separated from the ENVI Committee).

6)????? Hopefully beg of January, CDER & CBER will publish their Guidance agendas for Publication in Calendar Year 2025.

7)????? February will be a key month for ICH E6(R3) with the End of consultation for Annex 2, the Joint US FDA – Health Canada ICH Public Meeting and the ACT EU workshop on ICH E6 R3 (principles and Annex 1) but I will come back on this next month. Regarding ACT EU, an upcoming revision of the workplan is also expected probably during 1Q25.

?EMA:

08Jan25: End of the Winter Clock Stop for CTIS

08Jan25: Q&A Clinic on post-authorisation procedure management in IRIS

14Jan25: Conversations on cancer - cervical cancer treatment innovation: a collaborative discussion (in collaboration with the FDA Oncology of Excellence (OCE))

17Jan25: Q&A Clinic on post-authorisation procedure management in IRIS

22Jan25: SPOR Status Update public webinar

25Jan25: Date for coming into effect of the ICH E11A Guideline on pediatric extrapolation (Step 5)

25Jan25: End of Public consultation on draft qualification opinion of AI model (DRAFT Qualification opinion for Artificial Intelligence-Based Measurement of Non-alcoholic Steatohepatitis Histology in Liver Biopsies to Determine Disease Activity in NASH/MASH Clinical Trials)

29Jan25: Clinical Trials Information System (CTIS): Walk-in clinic

31Jan25: End of Public consultation for the Draft Guideline on the chemistry of active substances

31Jan25: End of Public consultation for the Draft Data Quality Framework for EU medicines regulation: application to Real-World Data

Also Hopefully in January:

• The first meeting of the new EU Network Data Steering Group (NDSG) will take place.
• The final 0044 policy, as well as a high-level overview of the contributions received during the consultation and how comments have been addressed by EMA, will be published on the EMA website with a news announcement in January 2025.?

EU Commission:

15Jan25: End of Public consultation on the Performance of pharmacovigilance activities for human medicines (update of Implementing Regulation (EU) 520/2012)

24Jan25: The EU HTA Regulation: Webinar for health technology developers of medicinal products

30Jan25: Meeting of the Public Health Expert Group

Sometimes in January, the EU Commission may issue guidance on specific points prior to the entry into force on 2 February 2025 of the Chapter I & II of the AI ACT.

?HMA:

08-09Jan25: HMA CTCG Meeting

European Data Protection Board (EDPB):

27Jan25: End of Public consultation on the Guidelines 02/2024 on Article 48 GDPR (EDPB clarified rules for data sharing with third country authorities)

FDA:

14Jan25: Webinar – Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

21Jan25: Optimizing the Assessment of Cancer Treatment Tolerability: Examination of Patient-Reported Symptoms & Physical Function

28-29Jan25: Knowledge Management and Modernization of Regulatory Quality Assessment and Submissions at FDA

EMA Committees:

13-16Jan25:?PRAC?meeting

14-16Jan25:?CVMP?meeting

20-22Jan25:?HMPC?meeting

21-23Jan25:?COMP?meeting

22-24Jan25:?CAT?meeting

27-30Jan25:?CHMP?meeting

28-31Jan25:?PDCO?meeting

??Disease DAY??:

01Jan25: Commitment Day ;-)

03Jan25: International Mind-Body Wellness Day

04Jan25: World Braille Day

11Jan25: Paget’s Awareness Day

13Jan25: Clean Off Your Desk Day

28Jan25: Data Protection Day (EU) & Data Privacy Day (USA, CAN, IND)

26Jan25: World Leprosy Day

30Jan25: (WHO) World Neglected Tropical Diseases Day

?January is also Thyroid Awareness Month & Cervical Cancer Awareness Month.

?You can take advantage of these "disease" day to generate a newsletter for your corresponding clinical trials.