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Did you know that pharma companies may face much stricter requirements in terms of #Environmentalriskassessments (ERAs) for their #Medicines as part of revisions to the #EUpharmarevision? Marketing authorization applications could be rejected if their ERAs do not pass muster, the European Commission has proposed, while regulators could impose post-marketing conditions of use relating to environmental considerations, such as prescription-only status. In this exclusive interview with Citeline Commercial's HBW Insight, A&O Shearman regulatory law experts Tine Carmeliet and Eline D'Joos outline what ERAs are, what is new in the pharma revision proposals and what might happen to companies that don’t comply with the new rules. Link in the comments Free to access for a short time Image: Shutterstock #Environment #ESG #Pharma #Manufacturing #GreenDeal
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Director Marketing & Sales, Digital & Purpose driven, Networker, Passionate about new work & sustainability
📣 Agenda update for the Expo '24 by Chemical Watch news & events by Enhesa ❗ Five knoell experts will join the stage and present latest updates on regulatory #compliance and #sustainability across the continents🌍 . ▶ Update on selected #ASEAN regulations ▶ Updates on #China regulations for new and hazardous #Chemicals ▶ Regulatory developments in delected countries in #LATAM ▶ Product #sustainability assessment for SMEs 🌿 ▶ Future-proofing your data: Navigating regulatory challenges with sustainable master data management Cristina Garcia, Piyatida (Tung) Pukclai, Oliver Spaniol, Hui Wang; John Adams knoell - your go-to-partner for global registration and compliance
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🌏🧪🦠 Drugs that help patients and the planet? The most life saving drugs may have a negative impact on the environment through their manufacturing process. Pharma companies may face stricter requirements in terms of their ERA for their drugs with marketing authorization applications being rejected if their ERA do not suffice. Thanks @DavidRidley for the opportunity to discuss one of the more trickiers proposals in the EU pharma package! With Eline D'Joos #environmentalriskassessment #EUpharmapackage
Did you know that pharma companies may face much stricter requirements in terms of #Environmentalriskassessments (ERAs) for their #Medicines as part of revisions to the #EUpharmarevision? Marketing authorization applications could be rejected if their ERAs do not pass muster, the European Commission has proposed, while regulators could impose post-marketing conditions of use relating to environmental considerations, such as prescription-only status. In this exclusive interview with Citeline Commercial's HBW Insight, A&O Shearman regulatory law experts Tine Carmeliet and Eline D'Joos outline what ERAs are, what is new in the pharma revision proposals and what might happen to companies that don’t comply with the new rules. Link in the comments Free to access for a short time Image: Shutterstock #Environment #ESG #Pharma #Manufacturing #GreenDeal
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I had the privilege of attending an outstanding talk, expertly introduced by Paul Sheppard, a compliance manger of the OIL & COLOUR CHEMISTS' ASSOCIATION at HMG Paints Ltd. The discussion started on history regarding the fall of the Berlin Wall in 1989 to recent trend in pharmaceutical science and regulatory frameworks. It focused on looking into the EU's fundamental principles, including the "Four Freedoms" and the Euro's introduction in 1999, the talk highlighted critical moments like Croatia's accession to the EU in 2013 and the UK's Brexit referendum in 2016, which personally was very new information to me, quite fascinating. The presentation emphasises environmental advancements, particularly the development of eco-friendly solvents like Cyrene™ derived from waste materials. It looks into the legal such as EU regulations and legislative procedures, focusing on the implications of chemical management. Paul explained how chemicals have great properties such as being environmentally friendly which contributes to sustainability which I am very passionate about and really keen in exploring as a future career path. Of particular interest was the introduction of the Globally Harmonized System (GHS) for chemical classification and labeling, emphasising its essential role in enhancing international safety standards. And it serves as a vital guideline for harmonising chemical regulations worldwide. I extend my sincere gratitude to Joshua Lehr and the industry speakers for providing such valuable insights, which have encouraged me to reflect on the relevance of this field to my future career path. #pharmaceuticals #pharmaceuticalindustry #pharmaceuticalscience
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Are you interested in detecting more than 500 compounds in waters with HRAM technique? 💡 Join this webinar and learn from Janine Elliott from SEPA how to do it with a cost effective and sensitive approach. 👇🏻
Scientist and marketing manager 👩🔬🧪Environmental analytical chemistry 💦Ion Chromatography ❄️shares tales of Antarctic fieldwork adventures 🐧
The chemical cocktail in our natural waters comes from many sources and pathways. There are quantitative and sensitive high resolution accurate mass spectrometry (HRAM) approaches that enables laboratories to monitor a broad range of these substances from one sample injection. Join our webinar to hear Janine Elliott, senior scientist from the Scottish Environmental Protection Agency (SEPA), detail her flexible and cost-effective HRAM approach to detect over 500 compounds in Scottish waters, including plant protection products, pharmaceuticals, personal care products (PPCPs) in our webinar. When? November 16, 10:00 London, 11:00 Berlin, 14:00 Dubai Register for free 👇 https://lnkd.in/e-nRhhnS Discover: 💧 A fast, sensitive HRAM method for environmental monitoring ℹ How to get more data from a single water sample 💧 A cost-effective solution for emerging contaminant analysis #womeninscience #massspectrometry #science #waterindustry #analyticalchemistry #environmentalmonitoring
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Scientist and marketing manager 👩🔬🧪Environmental analytical chemistry 💦Ion Chromatography ❄️shares tales of Antarctic fieldwork adventures 🐧
The chemical cocktail in our natural waters comes from many sources and pathways. Join our webinar as we hear from Janine Elliott, senior scientist from the Scottish Environmental Protection Agency (SEPA), who will detail her high-resolution accurate mass spectrometry (HRAM) approach to detect over 500 compounds in Scottish waters, including plant protection products, pharmaceuticals, personal care products (PPCPs). November 16, 10:00 London, 11:00 Berlin, 14:00 Dubai Register for free 👇 https://lnkd.in/gP4fKcra Discover: 💧 A fast, sensitive HRAM method for environmental monitoring ℹ How to get more data from a single water sample 💧 A cost-effective solution for emerging contaminant analysis #womeninscience #massspectrometry #science #waterindustry #analyticalchemistry #environmentalmonitoring
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🔔 #EU_CLP - The European Commission has updated 🔄 the list of harmonised classification and labelling, adding 28 new substances and revising 24 existing entries. 🔎 Check the list to see if your business is affected 👇🏽 #chemicals #substances #CLP #hazards #SaferChemicals #REACH #EU_REACH #environment #health #regulatory https://lnkd.in/dK5Yz4JT
Choose the experimental features you want to try
eur-lex.europa.eu
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If you're looking to market biocidal products in different regions, scoping assessment reports are a great way to evaluate your company's obligations and determine the best compliance strategy. It's a cost-effective and low-risk way to determine whether marketing your products in different regions is right for your business and what is the best strategy to comply. Reach out to learn more about how scoping assessments can benefit your business and how we can help ensure that you meet your regulatory requirements: https://lnkd.in/graWdZaN #BiocidalProducts #ComplianceStrategy #BiocideServices #ScopingAssessment #DataGapAssessments #RegulatoryObligations
Comprehensive Biocide Services: From Strategy to Compliance - We've Got You Covered! — Yordas Group
yordasgroup.com
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In a mandate from the European Commission, dated 27 September 2023, European Chemicals Agency (ECHA) has been asked to prepare an Annex XV restriction dossier on certain chromium (VI) substances. ECHA published the request on 11 October 2023 in a new release (see link). Since 2013, chromium substances are required to have a time limited authorisation to be used by industries. As time limited #authorisations are coming to an end, ECHA has received a more reauthorisation requests than expected and have limited capacity. In a statement released on 11 October ECHA said “evaluating the applications and concluding opinions on them would go beyond the available resources of the committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) and would affect their work in regulating other hazardous chemicals.” In response to the extensive number of applications received, the European Commission have now proposed a change in the regulatory REACH Regulation approach for Cr(VI) compounds. This would see the removal of Cr(VI) from Annex XIV Authorisation list and move the substances to Annex XVII, placing a #restriction on the manufacture, use and import within the EU. Under a restriction the use of Cr(VI) compounds across Europe would be banned unless specific derogations are included in the restriction. ECHA have stated the restriction process will follow the normal procedure, including two consultation periods in which interested parties may submit evidence to inform the scope and derogations of the restriction. In a Q&A document published, the Commission expects that a restriction, in best case could be adopted approximately 3 years from the receipt of the mandate by ECHA. Risk & Policy Analysts Ltd (RPA) has long experience with Chromium substances, and can always be contacted for specific questions. post@rpaltd.co.uk https://lnkd.in/e6yqMvnd
Chromium (VI) restriction announcement
echa.europa.eu
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Quality Compliance|Training Management|USFDA Remediation|Green Field&Brown Field Establishment|Facility Design for SVP, LVP, Biologics and OSD|Quality Audits for vendors,CMO,CDMO and CTL|Worked with ex-USFDA auditors.
The good session by USFDA experts on Regulatory Affairs; ANDA submission and its approval lifecycles. Thanks to Dr. Yang Wang and Dr. Eleftheria Tsakalozou for the distinguished presentation.
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