The pharmaceutical industry faces challenges in standardizing and reporting progress on environmental sustainability. Discrepancies exist between companies with strong climate-focused sustainability strategies and those lagging behind. However, regulatory developments in Europe and the U.S. are rapidly reshaping the industry's mindset by shifting from a duty of reporting to a duty of effort and progress. Strong legal strategies are now critical for pharma companies to navigate evolving environmental regulations and emerging business incentives. As more countries implement regulations requiring climate-related risk disclosure, a robust legal framework is essential for pharma companies to adapt and thrive in this changing landscape. At OLIVARES, we boast a team of specialists ready to advise companies aiming to seize opportunities in the evolving pharma landscape. Our team is highly specialized in assisting companies in the Life Sciences industry, and we are prepared to help organizations maximize their potential in the face of environmental regulatory changes and emerging business incentives. Visit our website to learn more about how we can assist you: https://lnkd.in/ekKAHhP #OLIVARES #OLIVARESLaw #Mexico #PharmaSustainability #EnvironmentalRegulations #LegalSupport #Regulatory #Pharma #LifeSciences
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As a pharmaceutical manufacturer, safeguarding the environment and ensuring the well-being of your customers and employees are fundamental responsibilities. The pharmaceutical industry operates in a highly regulated environment, where environmental stewardship and social accountability are critical to long-term success. Conducting environmental risk assessments and ensuring strict compliance with regulations are not just about meeting legal requirements. They also: ✅Reduce Operational Costs: Identifying and mitigating environmental risks early can lower waste management expenses and energy consumption. ✅Avoid Penalties and Legal Issues: Proactive compliance prevents costly fines and interruptions to operations. ✅Enhance Brand Reputation: Demonstrating environmental responsibility builds trust among consumers, investors, and stakeholders, strengthening your position in the market. ✅Promote Employee Well-Being: A safe, eco-conscious workplace fosters a healthier environment for employees and boosts morale. ✅Support Sustainability Goals: Implementing green practices contributes to global sustainability efforts, aligning your operations with broader environmental objectives. By integrating environmental risk management into your operations, you not only protect your business from potential risks but also contribute positively to the health of the planet and the communities you serve. Remember, sustainable practices are not just good ethics—they are good business. #EnvironmentalCompliance #Sustainability #PharmaceuticalIndustry
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🔍 Key Insights from CHEMUK 2024 After visiting the show last week, I managed to not only get to meet some important actors in the industry, but also catch a few talks around the ever evolving Chem landscape when it comes to regulations It seems the impact of regulatory divergence between the UK and the EU on businesses dominated talks at CHEMUK 2024, which saw its largest turnout yet. ⛵ For instance, Chris Hughes, Technical Director of Environmental Chemistry and Toxicology at Ricardo, warned of "choppy waters" ahead due to the regulatory changes post-Brexit while speaking on a panel about sustainability and regulation. He emphasized that the divergence we see now is just the "tip of the iceberg." With the EU's updated CLP regulations introducing new hazard classes like Persistent, Mobile, Toxic (PMT), businesses face significant challenges and increased costs. 📊 Elaine McGavin from the Chemical Business Association noted that while large chemical businesses view divergence negatively, some smaller companies still see potential benefits from Brexit. The new UK REACH alternative transitional registration model (ATRm), anticipated to cut registration costs by 70%, was also a key topic. However, clarity on details is crucial as businesses prepare for upcoming compliance deadlines. As regulatory landscapes shift, it’s essential for businesses to stay informed and adaptable. See below for more details on insights from ChemUK and the current Regulatory context in the UK for the Chemicals industry
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A responsible company must be able to rely on the fact that its entire supply chain respects the environment, human rights and labour laws. 🌎 Read our article to find out 💡 what is the biggest environmental challenge facing the pharmaceutical industry? 💡 how do we select and monitor our partners' activities throughout the supply chain? 💡 how have we succeeded in improving our energy efficiency and reducing our carbon dioxide emissions? #EnvironmentalResponsibility #ResponsiblyForward #Orion
Aiming for net zero emissions by 2050 – The sustainability of Orion's supply chain starts with choosing good partners
orion.fi
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Guideline on the environmental risk assessment (ERA) of medicinal products for human use (Eco PV)․ Date for coming into effect: 01 September 2024 While the updated regulation aims to address emerging environmental concerns more comprehensively, it also introduces significant challenges for stakeholders: ~New guideline mandates ERA for all new marketing authorization applications, which increases the data requirements, particularly for older products and formulations, which may lack historical data. ~With enhanced focus on environmental persistence, bioaccumulation, and chronic toxicity endpoints for aquatic and terrestrial species, generating this data is time-consuming and costly, requiring advanced studies and access to specialized laboratories. ~With new emphasis on understanding the cumulative environmental impact of APIs, particularly in mixtures with other pharmaceuticals, there is a lack of standardized testing methodologies and insufficient data on interaction effects. ~Periodic reporting of environmental monitoring data may become mandatory so developing a robust framework to collect, analyze, and report data systematically becomes a necessity.
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‼️EMA JUST RELEASED ‼️Environmental risk assessment of medicinal products for human use - Scientific guideline ➡️ Current version - effective from 1/09/2024 💠Executive summary💠 It is mandatory for a marketing authorisation application (#MAA) for a medicinal product for human use (HMP) to include an environmental risk assessment (ERA). This ERA is based on the use of the product and the physico-chemical, ecotoxicological, and fate properties of its #activesubstance(s). This guideline describes how to perform this ERA and how to evaluate potential risks to the environment arising from the use of the medicinal product, with the aim of protecting aquatic and terrestrial #ecosystems including surface water, groundwater, soil, species at risk of secondary poisoning and the risk for the microbial processes in #sewagetreatmentplants (#STPs). Furthermore, the identification of potential hazards of the active substance of a medicinal product is described. The guideline also includes consideration of potential precautionary and #riskmitigationmeasures and provides guidance on how to report the #findings in an Environmental Risk Assessment #Report. 💠Introduction (background)💠 The purpose of this guideline is to describe the assessment of the potential #environmentalrisks and #hazards of #humanmedicinalproducts #HMP. It outlines general considerations and the recommended stepwise procedure of #assessment. 👀⬇️ Below the link for download the Overview of comments received on the ’Guideline on the environmental risk assessment of medicinal products for human use’ (EMEA/CHMP/SWP/4447/00 Rev. 1) https://lnkd.in/dU6_Fzrc If you like this post follow me on LinkedIn https://lnkd.in/dcS-DJiZ #Environmentalriskassessment #ERA #persistence #bioaccumulation #toxicity #PBT #predicted #environmentalconcentration #PEC #EMA
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🌡️ Enhancing Temperature Monitoring with Wireless Technology and Real-Time Alerts 🌐 Efficient temperature monitoring is crucial for maintaining safety and quality in industries like healthcare, food storage, and logistics. With the integration of wireless technology, monitoring systems are now more flexible and reliable than ever! 🚀 What Sets This Solution Apart: Wireless Freedom: No more complex wiring setups—easily deploy sensors in any location. Real-Time Data Access: Monitor temperature conditions in real time. Instant Alerts: Receive immediate notifications if temperatures fall outside the optimal range, enabling swift corrective action. Comprehensive Analytics: Gain valuable insights and generate automated reports for better decision-making. 🌍 By leveraging wireless technology, businesses can enhance operational efficiency and minimize risks with ease. Ready to take your temperature monitoring to the next level? Let’s connect and explore the possibilities! #WirelessMonitoring #TemperatureControl #RealTimeData #Innovation #SmartSolutions #BusinessEfficiency
When it comes to monitoring environmental parameters, every seconds counts. This is why the testo Saveris 1 environmental monitoring system impresses with reports in real time: https://lnkd.in/gmQwTxx7 #Testo #TestoSMI #realtimereports #datamonitoringsystem #environmentalmonitoring #innovation #testoSaveris1 #TestoSolutions #pharma
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At Teva, we know that providing medicines is an important job—and conducting business ethically and responsibly is non-negotiable. In 2021, we trained 20,000+ employees on ethics (99.6% of those assigned), published three new position statements on patient safety, responsible supply chain and risk management, and ranked in the top 1% in our industry in the @EcoVadis sustainable procurement assessment—as we consider our supply chain partners to be an extension of our company. Find our latest #governance highlights in our 2021 ESG Progress Report: #ESG #sustainability #environment #ethics #socialimpact #Tevapharm #TevaESG
ESG Progress Report | Our Impact | Teva Pharmaceuticals
teva.dsmn8.com
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🌿 Eco-pharmacovigilance and Sustainability 🌿 I recently came across this thought-provoking post about eco-pharmacovigilance, a term I hadn’t hear about before. Reading John Praveen’s article, "From Pills to Pollution: Need for Eco-pharmacovigilance to Safeguard Environmental Sustainability", https://lnkd.in/dCMRJCm7 I’m inspired to reflect on how this concept aligns with our collective responsibility for environmental sustainability. More sustainable world. Industries and governments are increasingly prioritizing sustainability whether through renewable energy, waste reduction, or green manufacturing. In this context, eco-pharmacovigilance represents a pivotal step for the pharmaceutical sector to contribute meaningfully to these efforts. The article explains that eco-pharmacovigilance combines pharmacology, toxicology, and environmental science to assess the impact of pharmaceutical residues on ecosystems. The idea that our industry could unintentionally harm ecosystems, disrupt biodiversity, and even contribute to Antimicrobial resistance (AMR) , Endocrine disruption caused by pharmaceutical residues, such as hormones and antidepressants, can act as endocrine-disrupting chemicals (EDCs) , Chronic low-level exposure as NSAIDs & Bioaccumulation underscores the importance of addressing pharmaceutical waste at its source. To quote the article: "As the global demand for pharmaceuticals continues to rise, we must take proactive steps to ensure that the benefits of modern medicine do not come at the expense of our planet’s health. By improving monitoring, regulation, and public awareness, we can reduce the environmental footprint of pharmaceuticals and work towards a more sustainable future where human health and environmental preservation go hand in hand". #EcoPharmacovigilance #Sustainability#
eco-pharmacovigilance? It's a new term I learned today reading Accenture's John Praveen's article "From pills to #pollution: Need for eco-pharmacovigilance to safeguard environmental sustainability" https://lnkd.in/dCMRJCm7 It's a serious global issue, particularly so in a country like #Australia, where the Pharmaceutical Benefits Scheme makes medication very affordable. I'd see it as one of my big learnings in 2024. John explains, "Eco-pharmacovigilance is a multidisciplinary field that combines pharmacology, toxicology, and environmental science to assess the effects of pharmaceutical residues on wildlife, ecosystems, and environmental health. While traditional pharmacovigilance is concerned with monitoring the safety of drugs for human populations, eco-pharmacovigilance expands this focus to include the impact of these substances on humans (indirect exposure), non-human species and natural systems. The rapid global consumption of pharmaceuticals has led to their widespread presence in natural environments—water bodies, soils, and sediments. Drugs can enter the environment through a variety of pathways: improper disposal of unused medications, agricultural runoff, wastewater treatment plant effluent, and the excretion of unmetabolised drugs by humans and animals. Over time, these pharmaceutical residues accumulate in the environment, posing serious risks to biodiversity, contributing to the rise of antimicrobial resistance (AMR), and disrupting delicate ecological balances." FYI Bridie Kristen Jason Jo David Rob
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When it comes to monitoring environmental parameters, every seconds counts. This is why the testo Saveris 1 environmental monitoring system impresses with reports in real time: https://lnkd.in/gmQwTxx7 #Testo #TestoSMI #realtimereports #datamonitoringsystem #environmentalmonitoring #innovation #testoSaveris1 #TestoSolutions #pharma
All-round carefree monitoring - with testo Saveris 1
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Interesting post about eco-pharmacovigilance, which is important as it goes beyond the safety of human health to also include the health and sustainability of our planet 🌍
eco-pharmacovigilance? It's a new term I learned today reading Accenture's John Praveen's article "From pills to #pollution: Need for eco-pharmacovigilance to safeguard environmental sustainability" https://lnkd.in/dCMRJCm7 It's a serious global issue, particularly so in a country like #Australia, where the Pharmaceutical Benefits Scheme makes medication very affordable. I'd see it as one of my big learnings in 2024. John explains, "Eco-pharmacovigilance is a multidisciplinary field that combines pharmacology, toxicology, and environmental science to assess the effects of pharmaceutical residues on wildlife, ecosystems, and environmental health. While traditional pharmacovigilance is concerned with monitoring the safety of drugs for human populations, eco-pharmacovigilance expands this focus to include the impact of these substances on humans (indirect exposure), non-human species and natural systems. The rapid global consumption of pharmaceuticals has led to their widespread presence in natural environments—water bodies, soils, and sediments. Drugs can enter the environment through a variety of pathways: improper disposal of unused medications, agricultural runoff, wastewater treatment plant effluent, and the excretion of unmetabolised drugs by humans and animals. Over time, these pharmaceutical residues accumulate in the environment, posing serious risks to biodiversity, contributing to the rise of antimicrobial resistance (AMR), and disrupting delicate ecological balances." FYI Bridie Kristen Jason Jo David Rob
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