Planned for October 2024

If you are involved in Clinical Trials or in Regulatory Affairs… Here a list of events or documents expected in?October 2024?that may be of interest to you:?

I should start by highlighting the 3 key events for this month:

• ICH: Steps 3 and 4 for the E6(R3) Principles and Annex 1 are expected this month, and we are also waiting for Steps 1 and 2a/b for the E6(R3) Annex 2 draft Technical Document
• 16-19Oct24?: WMA General Assembly with the 2024 revision of the Declaration of Helsinki
• 16Oct24: The window for expedited transition of clinical trials from EU CT Directive to EU CT Regulation will close. A Clinical Trials Information System (CTIS) bitesize talk: End of transition period and notifications including serious breach will be organized this day

EMA:

04-14Oct24?: Several EMA SPOR and xEVMPD Stakeholder Engagement Webinars:

• 04Oct24?: SPOR Data Governance
• 07Oct24?: Referentials Management Service (RMS)
• 08Oct24?: Substance Management Service (SMS)
• 09Oct24?: Organisation Management Service (OMS)
• 10Oct24?: Product Management Service (XEVMPD) for MAH
• 11Oct24?: Product Management Service (XEVMPD) for Sponsors
• 14Oct24?: Substance, product, organisation and referential (SPOR) application programming interface (API) - SPOR API

and in addition at EMA:

10Oct24?: Scientific Symposium on Advanced Therapy Medicinal Products - ‘Contribution, evolution, revolution’

16Oct24?: Clinical Trials Information System (CTIS) bitesize talk: End of transition period and notifications including serious breach

16Oct24?: Training webinar on Product Management Service (PMS) Product User Interface (PUI)

18Oct24?: Small and medium-sized enterprises info day

22Oct24: ACT EU multi-stakeholder platform annual meeting

22Oct24 & 29Oct24?: Q&A clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API)

EMA Scientific Committees:

08-10Oct24:?COMP?meeting?& CVMP?meeting

09-11Oct24:?CAT?meeting

14-17Oct24:?CHMP?meeting

15-18Oct24:?PDCO?meeting

30Sep-03Oct24:?PRAC?meeting

and

03Oct24: EMA Management Board meeting

22Oct24: Multi-stakeholder platform annual meeting (MSP)

End of Consultation:

31Oct24?: EMA for Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals

31Oct24?: EMA for the Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products????? ?

EU Commission:

09Oct24?: Deadline for the call for applications to join the Health Technology Assessment Stakeholder Network

10Oct24?: Deadline for the EU4Health call for tenders: single framework contract for joint clinical assessments and joint scientific consultations on health technology assessment

16Oct24?: EUHPP Webinar: 25 years of breast cancer research: Past, present and future

FDA:

08Oct24: Webinar - The Voluntary Improvement Program: How to Enroll, Opportunities, and Best Practices

09Oct24: ICH M12 Drug-Drug Interaction Studies Final Guidance

10Oct24: FDA Grand Rounds - Acute Pain Management/Patient Experience Study in Diverse Populations

15Oct24: Webinar - Draft Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

15Oct24: 2024 FDA Oncology Center of Excellence Pediatric Advocacy Forum

16Oct24: Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub

16Oct24: Benchmarks for Diversity in Oncology Clinical Trials: An FDA - ACS Hybrid Workshop

16Oct24: Global IDMP Implementation - Getting Closer to the Goal Webinar

30Oct24: Finding Your Support Team While Participating in a Clinical Trial

Selected Key points for November:

05Nov24?: HMA/EMA multi-stakeholder workshop on Artificial Intelligence

05Nov24?: European Commission ??From Theory to Practice: Implementing the EU Health Technology Assessment Regulation” stakeholder event

05-06Nov24?: The Assembly of the International Council for Harmonisation (ICH) will meet in Montréal, Canada and will be preceded by meetings of the ICH Management Committee and the MedDRA Management Committee

20-21Nov24?: FDA Inaugural Digital Health Advisory Committee meeting

And hopefully before end of the year:

• The legislative text of the European Health Data Space (EHDS) was adopted by the European Parliament (EP) on 24 April 2024, and the final publication is expected at the end of 2024, marking the entry into force.
• FDA plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to support drug development.?

"Disease" Day:

01Oct24:?Urticaria?day

03Oct24:?Virus Appreciation?Day

06Oct24:?World Cerebral Palsy?Day

05Oct24:?European (organ, tissue and cell)?Donation?Day

06Oct24: European?Depression?Day

08Oct24: International?Podiatry?Day

09Oct24:?US National?Nanotechnology?Day

10Oct24: World?Mental Health?Day (This year’s theme is?workplace mental health)

10Oct24:?World?Sight?Day

12Oct24:?World Arthritis?Day

14Oct24:?World Standards?Day

15Oct24:?Global Handwashing?Day

16Oct24:?Sudden Unexpected Death in Epilepsy (SUDEP)?Action Day

18Oct24:?World?Menopause?Day

18Oct24:?Developmental Language Disorder?Awareness Day

20Oct24:?Osteoporosis?World Day (LOVE YOUR BONES: Protect your future)

24Oct24: World?Polio?Day

29Oct24: World?Stroke?Day

29Oct24: World?Psoriasis?Day

31Oct24:?My Birthday…

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

October is also:

·?????? Breast Cancer Awareness Month

·?????? US Mental Health Month

·?????? US ADHD?Awareness Month

·?????? Cybersecurity Month?(in EU: = European Cyber Security Month; in US: = National Cyber Security Awareness Month).?