Did you miss the insightful LinkedIn live discussion on the therapeutic potential of psychedelics in mental health 🧠 between EMA’s Chief Medical Officer, Steffen Thirstrup, and our press officer, Alessandro Faia? Watch now the recording of this live session: https://lnkd.in/ehHPTKjw Some of the main take-aways: 📌 Developers should get in touch with regulators as early as possible to ensure their development plans align with existing regulatory frameworks; 📌 We must prioritise reliable and valid evidence to address uncertainties in psychedelic research such as optimal dosing and the requirements for “set and setting”; 📌 Collaboration between regulators, researchers, patients, policymakers, healthcare professionals and industry is crucial to advance innovative treatments for mental health conditions. #MentalHealth #Psychedelics #medicineregulation
European Medicines Agency
Overheidsinstanties
Amsterdam, North Holland 306.520 volgers
The mission of EMA is to foster scientific excellence in the evaluation and supervision of medicines in the EU.
Over ons
The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in Amsterdam. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
- Website
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http://www.ema.europa.eu
Externe link voor European Medicines Agency
- Branche
- Overheidsinstanties
- Bedrijfsgrootte
- 501 - 1.000 medewerkers
- Hoofdkantoor
- Amsterdam, North Holland
- Type
- Overheidsinstelling
- Opgericht
- 1995
Locaties
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Primair
Domenico Scarlattilaan 6
Amsterdam, North Holland 1083, NL
Medewerkers van European Medicines Agency
Updates
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On 22 July, we interviewed Bart Van der Schueren, EMA expert and obesity specialist, to discuss some of the common questions around #GLP1 receptor agonists. GLP-1s are: ✍ Prescription medicines 🏥 Indicated for the treatment of type 2 diabetes 🍎 Indicated for weight management in people living with obesity or overweight with weight-related health conditions 🏃♂️ To be used together with a balanced diet and exercise 💊Serious medicines with side effects (like any medicine) GLP-1s are not: 🚫An easy solution for weight loss Didn’t have a chance to catch the full interview? Watch it now: 👉 on YouTube: https://lnkd.in/dHjrTwFv 👉 the Instagram channel @one_healthenv_eu
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📢 Exciting news for medical device manufacturers! EMA has launched a pilot programme to support the development and assessment of orphan #MedicalDevices offering free advice and guidance about their clinical evaluation. Orphan devices are medical devices or accessories used for diseases or conditions affecting only a small number of individuals each year. Find out how you can join this new pilot here 👉 https://lnkd.in/dcsvryJu
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EMA has just published its latest report on real-world evidence studies to support medicine regulation. Some takeaways from the report: 📊 A total of 40 studies were conducted between February 2023 and February 2024. 🌐 The DARWIN EU network expanded from 10 to 20 data partners since 2023, allowing access to data from almost 130 million patients from 13 European countries - in full compliance with data protection legislation. 💉 13 studies informed vaccine safety and effectiveness, supporting the response to health crises like COVID-19 and Mpox. 🧠 One study examined the risk of suicide and self-harm in people using GLP-1 receptor agonists and helped EMA to conclude that the evidence does not support a causal association. 💊 For the first time, two studies looked at the demand and stock levels of critical human medicines, to better understand management and prevention of medicine shortages. Learn more from the infosheet below 👇 👇 👇 Link to the full report 🔗 https://lnkd.in/ddpnHFfg #RealWorldEvidence #BigData #DARWINEU
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EMA has awarded a grant to the African Medicines Regulatory Harmonisation (AMRH) initiative of the African Union Development Agency-NEPAD to support a pilot to test procedures for joint continental evaluation of medicines in Africa. This is an important milestone on the journey towards setting up of the African Medicines Agency. During the pilot, technical committees of scientific experts from African countries will evaluate the quality, safety and efficacy of priority medicines. The learnings will help to develop continental processes and procedures, facilitate national authorisations of recommended medicines and strengthen information sharing and reliance. The two technical committees engaged in the pilot visited EMA in June to share knowledge on regulatory procedures and processes. Read our news: https://lnkd.in/eSqpTfCu #TeamEurope #africa #medicines #africanunion
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📢EMA's human medicines committee, the #CHMP, recommended 1️⃣ 4️⃣ new medicines for approval in the EU. ☑️ 1 medicine for chronic hand #eczema ☑️ 1 medicine for dry eye disease ☑️ 5 medicines to treat #cancer 👉 https://lnkd.in/dJrwY9Qg #PublicHealth
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Public interest around Glucagon-Like Peptide-1 (#GLP1) receptor agonists, mostly around their use for weight-loss, has grown considerably in the last years. From academic and medical discussions to social media, from gossip to celebrity endorsements, GLP-1s are everywhere. 🗨 🎙 Join our Instagram LIVE with Dr. Bart Van der Schueren, EMA expert and obesity specialist. We’ll explore GLP-1s — from what they are and how they work to how they are used in clinical practice. 📅 Tune in on Monday, 22 July at 18:00 on the joint Instagram account @one_healthenv_eu managed with our sister agencies European Food Safety Authority (EFSA), European Environment Agency, European Centre for Disease Prevention and Control (ECDC) and European Chemicals Agency and get your questions answered! #WeightLoss #Obesity #Diabetes #HealthTalk
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Towards better, faster clinical trials in Europe! 🔴 💻 Join the LinkedIn live discussion on #ACTEU, the Accelerating Clinical Trials in the EU initiative, with 🎙 Peter Arlett, Head of Data Analytics and Methods Task Force, 🎙 Marianne Lunzer, chair of the of the Heads of Medicines Agencies (HMA) Clinical Trials Coordination Group (CTCG) and member of the Austrian Agency for Health and Food Safety. Hear more about ACT EU's priority actions and how the initiative aims to strengthen clinical research in Europe. When? 🗓️ Tuesday 16 July at 12:00 CEST We invite you to post the questions for our two speakers via the comment section, either in advance or during the LinkedIn event. #ACTEU #HealthUnion #clinicaltrials
How do we ensure faster and better clinical trials in the EU?
www.linkedin.com
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📢 Call for expression of interest 📢 Are you a manufacturer or medicine developer? Are you an academic working in manufacturing innovation? EMA is calling for case studies on platform technologies for its 4th Listen-and-Learn Focus Group meeting on quality and manufacturing innovation on 19-20 November 2024. ➡️✍️ Submit your case study by 31 July 2024 for a chance to discuss it at the meeting. Key points for discussion will be: 📌 Platforms for medicinal products manufactured using prior knowledge 📌 Platforms for medicinal products against serious health threats like pandemics 📌 Platforms for manufacturing personalised or individualised medicines 🔗 Find out more - https://lnkd.in/djQC9nxj #MedicinesInnovation #QualityInnovation #PlatformTechnologies
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🔎 💊 Our safety committee, the #PRAC, at its July meeting has recommended new measures to minimise the risk of aspiration with GLP-1 medicines during anaesthesia and deep sedation. Patients treated with GLP-1 medicines should inform the doctor involved if they have a planned surgery. The PRAC also agreed a direct healthcare professional communication (DHPC) for glatiramer acetate, a medicine authorised for the treatment of relapsing forms of multiple sclerosis. Following an EU-wide review of all available data, the PRAC concluded that the medicine is associated with anaphylactic reactions which may occur even after months up to years after initiation of treatment. Cases with a fatal outcome have been reported. The DHPC will inform healthcare professionals about this risk and recommend that patients and/or caregivers be advised of the signs and symptoms and to seek emergency care in the event of an anaphylactic reaction. Read more: https://lnkd.in/eKPBbPFf
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