Stephane Petit

Acandis GmbH has gained approval from the French national competent authority to initiate the RESOLVE clinical study, which will evaluate the company’s Sirex stent for the treatment of pulsatile tinnitus caused by symptomatic lateral venous sinus stenosis. Emmanuel Houdart Andreas Schuessler Acandis USA https://lnkd.in/eXrb3yPP

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👉 Big regulatory changes are coming to the EU pharmaceutical sector. 🇪🇺 The EU Medicines Regulation 2025–2026 will reshape how variations are classified and managed across Europe. New definitions like Relevant Authority and Reference Authority ✅ Introduction of supergrouping and annual reporting ✅ Annexes restructured from ABCD ➝ EQCM These updates aim to simplify procedures while ensuring greater transparency and patient safety. ☀️ And since it’s August, it might just be the perfect read for a quiet summer break. Insightful, timely, and essential for everyone in the pharmaceutical field. 📖 Read the full article here: 🇪🇸 https://lnkd.in/dU-EpQVn 🇬🇧 https://lnkd.in/dfwnQKym

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Vaccines are specific medicinal products, and as such, their assessment within an EU #HTA Regulation requires a tailored approach. Already at national level, vaccines are generally not assessed by HTA bodies but by specialised advisory groups composed of vaccine experts, called NITAGs. It is therefore crucial to ensure that NITAGs are involved in the joint clinical assessments to be conducted for vaccines.    https://bit.ly/4eRq3V9   #WeWontRest #HTAR 

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🚨 At PrimeVigilance, we’re committed to helping you stay ahead of evolving pharmacovigilance requirements—so you can continue putting patient safety first. What’s New? The European Medicines Agency has published GVP Module XVI Addendum I – Risk minimization measures for medicinal products with embryo-fetal risks, effective 28 August 2025. This guidance provides structured recommendations to: ✔️ Prevent or minimize embryo-fetal exposure to medicines with identified or potential risks ✔️ Apply routine and additional RMM tools, with the possibility of a Pregnancy Prevention Programme (PPP) in exceptional cases ✔️ Evaluate effectiveness of risk minimization measures in line with GVP Module XVI and Addendum II GVP: Introductory cover note, last updated with final Addendum I to Module XVI on minimising embryo-fetal risks of medicines: https://lnkd.in/dUqEAXR2 GVP XVI Addendum I - Risk minimisation measures for medicinal products with embryo-fetal risks: https://lnkd.in/dvjEUkTB #RegulatoryUpdates #Pharmacovigilance #DrugSafety #RiskManagement #PatientSafety

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The EU Commission has published a Stakeholders' Consultation for a revised Chapter 1 of EudraLex Volume 4 - Good Manufacturing Practice Guidelines. The deadline for comments is 3 December 2025. According to the announcement, the update of Chapter 1 "is necessary to establish efficient regulatory frameworks based on good science and risk management". It has been revised by the EMA GMDP-Inspectors Working Group in co-operation with the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The planned changes relate to three areas: - Quality Risk Management (QRM) - Knowledge Management (KM) - Product Quality Review (PQR) 🔗 Read More: https://lnkd.in/er_5DxME

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Jennifer Riter, Vice President, Analytical and Development Services, Kindeva Drug Delivery Contributed an article "Transforming Pharma Analytics Through Innovation" “The goal is always the same, to accelerate development while ensuring the safety, quality, and effectiveness of the product for patients” says Jennifer Riter. Read More : https://lnkd.in/gqi39QjW #PharmaceuticalLeadership #AnalyticalServices #PatientSafety #RegulatoryCompliance #InnovationInPharma #CombinationProducts #CrossFunctionalTeams #DrugDevelopment #QualityScience

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📢EMA's human medicines committee, the #CHMP, recommended 13 new medicines for approval in the 🇪🇺, including: ☑️ 1 medicine for #HIV-1 pre-exposure prophylaxis #PrEP to be taken twice a year ☑️ 1 medicine to treat patients with #Niemann-Pick type C ☑️ 1 medicine to be taken orally to treat hereditary angioedema #HAE Read more in the highlights published today: https://lnkd.in/eb3CBgVC #PublicHealth

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🚨 The European Medicines Agency has validated the marketing application for T-DXd in HER2+ metastatic solid tumors — regardless of tumor type. 🔬 Backed by data from DESTINY trials across breast, lung, colorectal, ovarian & more ✅ Could become the first tumor-agnostic HER2 therapy in the EU 📈 Follows accelerated FDA approval for a similar indication 👉 Read the full article https://lnkd.in/etKBGGZU

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The European Pharmacopoeia (Ph. Eur.) has released a draft monograph for Adalimumab concentrated solution (3147) for public comment — a significant step in harmonizing quality standards for this widely used anti-TNF-α monoclonal antibody. 💡 Adalimumab plays a critical role in treating inflammatory conditions such as rheumatoid arthritis and psoriasis. With numerous biosimilars available across Ph. Eur. member states, this monograph — developed using the multi-source approach (Procedure 1) — aims to ensure applicability across both originator and biosimilar products. This initiative complements existing Ph. Eur. texts on etanercept, infliximab, golimumab, and the general chapter on cell-based potency assays for TNF-α antagonists. 📣 Stakeholder input is essential to ensure the robustness and relevance of the proposed specifications. 📘 Access the draft monograph in Pharmeuropa 37.3: https://lnkd.in/exTzt4C7 🗓️ Deadline for comments: 30 September 2025 📄 More information on how to comment can be found here: Comment on drafts (Pharmeuropa): https://lnkd.in/eKtZmhRG #PharmaceuticalStandards #Biosimilars #PublicComment #Pharmeuropa #EDQM #PhEur

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As pharmacovigilance continues to evolve, so do regulatory expectations. The latest EMA amendment to Regulation (EU) No 520/2012 not only ends the longstanding signal detection pilot in EudraVigilance for MAHs but also redefines the practical application of EV data in safety monitoring. This shift reflects both operational lessons from the pilot and the growing emphasis on integrated, risk-based signal management. AWINSA empowers pharmacovigilance teams with intelligent solutions that streamline EudraVigilance monitoring through real-time safety alerts, enable seamless integration of signals from multiple data sources, and ensure full regulatory compliance with audit-ready documentation. #Pharmacovigilance #RMP #PSMF #EMA #EU #PSMF #Signaldetection #drugsafety #drugdiscovery

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