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May 2024
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Human Medicines Highlights
The newsletter for patients, consumers and
healthcare professionals
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Foreword
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Welcome to the first issue of our revamped Human Medicines Highlights newsletter. This is the only newsletter published by the European Medicines Agency specifically for patients, consumers, healthcare professionals and their representative organisations. I would like to thank all those who have taken the time to share their feedback over the past year, helping us to improve this newsletter.
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We have improved the visibility of this newsletter, with a more modern look and multilingual content
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As we launch the new Human Medicines Highlights, here are a few things you will notice:
- The newsletter arrives directly in your inbox, with a summary of each item that can be clicked to access the full content online;
- The online version of the newsletter is now available in all EU languages, which we hope will help bring the content to more readers;
- The content is grouped in dedicated sections, making it easier to find information on topics of interest, such as upcoming events, calls for interest and open consultations.
The newsletter will also include featured articles on topics of interest that we want to share with you from time to time. As we celebrate European Mental Health Week during 13-19 May, it is timely to include an update from a recent multistakeholder workshop on psychedelics.
I hope you enjoy reading the new Human Medicines Highlights. Please feel free to circulate it to your members and networks. We welcome your feedback and suggestions for future issues. Please share this with us by email: public-engagement@ema.europa.eu.
Juan Garcia Burgos
Head of Public and Stakeholder Engagement
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EMA news
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Information on medicines
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Upcoming events
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Follow-up meeting on soft tissue and bone sarcoma
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This meeting is organised as a follow-up on the EMA and EORTC workshop on soft tissue and bone sarcoma, held on 12 January 2024. Registration is open until 20 May.
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24/05/2024
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EMA and online
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Joint HMA/EMA Big Data Steering Group workshop on RWE methods
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This workshop aims to gather views of stakeholders on the EMA's draft reflection paper on real-world evidence, including priorities for further regulatory guidance development and on future collaboration beyond the reflection paper.
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14/06/2024
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EMA and online
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EMA workshop on the challenges in drug development, regulation and clinical practice in haemoglobinopathies
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This workshop will gather stakeholders' perspectives on sickle cell disease and thalassaemia before initiating the drafting of new guidelines for both diseases, in line with the Agency's haematology work plan 2024.
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01/07/2024
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Online
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Recent events
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Cancer Medicines Forum, February 2024: minutes and presentations
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Minutes and presentations from the Cancer Medicines Forum meeting held on 24 February are now available. The Forum explores how EMA can contribute towards addressing remaining uncertainties about the use of cancer medicines in clinical practice.
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Multistakeholder workshop on psychedelics: presentations available
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On 16 April 2024 EMA held a workshop on the development of safe and effective psychedelic medicines, where stakeholders discussed their therapeutic potential and regulatory challenges associated with their development. Presentations from the workshop are now available.
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Open consultations
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- Revised HMA/EMA guidance on identification of commercially confidential information and personal data in the structure of marketing authorisation application dossiers
Deadline for comments: 28 June 2024
- Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence
Deadline for comments: 31 August 2024
- Guideline on requirements for demonstrating therapeutic equivalence between orally inhaled products for asthma and COPD
Deadline for comments: 30 October 2024
- Guideline on pharmaceutical quality of inhalation and nasal medicinal products
Deadline for comments: 31 October 2024
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Scientific committee and working party activities
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- Medicinal products for human use: monthly figures - March 2024
- CAT - agendas, minutes and reports
- CHMP - agendas, minutes and highlights
- CHMP - applications for new human medicines: May 2024
- COMP - agendas, minutes and meetings reports
- HMPC - agendas, minutes and meetings reports
- PDCO - agendas, minutes and meeting reports
- PRAC - agendas, minutes and highlights
- PRAC statistics: April 2024
- PRAC recommendations on safety signals
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EMA publications
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How EMA involves stakeholders
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Contact us: public-engagement@ema.europa.eu
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ISSN: 2811-9649
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Catalogue Number: TC-AN-24-001-EN-Q
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