Monday Weekly Summary (03.06 - 09.06.2024)

Monday Weekly Summary (03.06 - 09.06.2024)

?? Monday Weekly Summary: Stay informed with the latest regulatory updates!

In the fast-paced world of regulations, staying updated is key to success. We've gathered a comprehensive list of regulatory updates from last week (03.06 - 09.06.2024) to keep you informed about the latest changes in the pharmaceutical industry. Check out the links below for essential insights and ensure compliance with the ever-evolving landscape.

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??? Scientific Articles ?

Key Opinion Leaders’ Interviews to Inform the Future of Benefit–Risk Planning in the Medical Total Product Life Cycle of Global Pharmaceutical and Medical Device Organizations

Capone G, Eriksson B, Al M, van Belkum S, Broich K, Lamas M, Lunzer M, Nolan L, Ester C, Garcia Burgos J, Pioppo L, Zanoletty A, Arlett P. Accelerating?clinical trials?in the EU (ACT EU): transforming the EU?clinical trials?landscape. Nature Reviews Drug Discovery (Nat Rev Drug Discov)?ISSN?1474-1784 (online)?ISSN?1474-1776 (print). doi:?10.1038/d41573-024-00085-5

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??? Recommendations/Regulations/Guidelines/Instructions/FAQs

Recommendations on medication errors

Paediatric medicines: Overview

Paediatric medicines: Research and development

Paediatric medicines: applications and procedures

Class waivers

Paediatric investigation plan (PIP) - Key elements guidance

Paediatric investigation plans: questions and answers

Paediatric investigation plans: Templates and forms

Template for scientific document

Procedural advice on paediatric applications

Guidance for applicants on Simultaneous National Scientific Advice (SNSA) – phase 2 pilot – Optimized process

Removing an orphan designation

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Added in June 2024 5 June NEW - 23-25 April 2024 CMDh minutes NEW - Report from ...

Application form for European Medicines Agency certificates of medicinal products

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?? Reports

2023 annual report of the European Medicines Agency

Annual report on deferrals

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??Trainings/Presentations/Invitations

2024 06 04 European Industry MedDRA User Group Webinar

2024 06 06 What is MedDRA and How is it Used?

Pharmacovigilance: Overview

Joint EMA EORTC follow up workshop on soft tissue and bone sarcoma workshop

185th Meeting of Vaccines and Related Biological Products Advisory Committee

Virtual live hands-on training course for clinical trials sponsors using EudraVigilance system, Online, from 7 October 2024 to 9 October 2024

Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system, Online, from 16 September 2024 to 20 September 2024

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??? News/Press Releases

CTIS newsflash - 31 May 2024

Research projects conducted under the remit of the PRAC impact strategy

Workplan 2023-2025: HMA-EMA joint Big Data Steering Group

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??? Meeting agendas/minutes/summary

Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 14 June 2024, 09:00 (CEST) to 14 June 2024, 16:30 (CEST)

Agenda - Joint HMA/EMA Big Data Steering Group workshop on real-world evidence (RWE) methods

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??Product opinion/decisions/updates

Medicinal products containing oral retinoids (acitretin, alitretinoin, and isotretinoin): Pregnancy Prevention Program - reminder of risk minimization measures - published on PL HA website

List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)

List of medicines currently in PRIME scheme

Referral: Kexxtone 32.4 g continuous-release intraruminal device for cattle, monensin Article 130(4) European Commission final decision, 23/04/2024, 15/05/2024

Shortage of human normal immunoglobulins

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?? Other

Emerging Drug Safety Technology Meeting (EDSTM) Program

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#AIDIFY #RegulatoryUpdates #PharmaIndustry #StayInformed #ComplianceMatters

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