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1. www.ema.europa.eu › en › about-usWebsite outages and upgrades | European Medicines Agency

   www.ema.europa.eu › en › about-us

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   Vor 2 Tagen · During these times, EMA’s corporate website may be intermittently unavailable or not work optimally. When the website is unavailable, a holding page displays EMA’s contact details, including the emergency number for reporting a potentially serious problem with a centrally authorised medicine and the number for notifying EMA of suspected quality defects or product recalls.

2. fmapps.ema.europa.eu › SME › indexSME Search - fmapps.ema.europa.eu

   fmapps.ema.europa.eu › SME › index

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   20. Mai 2024 · For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI

3. www.ema.europa.eu › en › medicinesGiapreza - direct healthcare professional communication (DHPC)

   www.ema.europa.eu › en › medicines

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   23. Mai 2024 · This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine (s). It also includes a communication plan with details of intended recipients and the dissemination date.

4. www.ema.europa.eu › en › eventsPsychedelics and their therapeutic use - Linkedin Live interview...

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   7. Mai 2024 · EMA acknowledges that research into the use of psychedelics for therapeutic purposes looks promising to tackle several mental health conditions. At the same time, the Agency is aware of the challenges developers may face in meeting the scientific and regulatory expectations for getting a marketing authorisation for these products. Regulatory approval must be based on scientifically rigorous ...

5. www.ema.europa.eu › en › reflection-paper-use-real-world-dataReflection paper on use of real-world data in non-interventional...

   www.ema.europa.eu › en › reflection-paper-use-real-world-data

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   3. Mai 2024 · A non-interventional study is a clinical study that does not fulfil any of the conditions defining a clinical trial in Article 2.2(2) of Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use.

6. www.ema.europa.eu › en › eventsPharmacovigilance Risk Assessment Committee (PRAC): 13-16 May...

   www.ema.europa.eu › en › events

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   13. Mai 2024 · PRAC. ): 13-16 May 2024. Event Human Pharmacovigilance. Date. Monday, 13 May 2024 - Thursday, 16 May 2024. Location. European Medicines Agency, Amsterdam, the Netherlands. The Pharmacovigilance Risk Assessment Committee ( PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use.

7. www.ema.europa.eu › en › eventsInformation and Q&A session on updated CAPs in web-based eAF

   www.ema.europa.eu › en › events

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   7. Mai 2024 · Centrally Authorised Products (CAPs) data that is now available in the web-based electronic Application Form (eAF). EMA is hosting this information and Q&A session to explain and showcase the changes in the product data in the web-based Human Variations eAF. Participants will have the opportunity to ask questions in the last part of the session.