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Today, the pharmaceutical industry emits more greenhouse gases globally than the automotive sector, equating to about 48.5 tonnes of carbon dioxide for every $1m generated. Every single stage of the pharmaceutical supply chain has a carbon footprint, from the moment raw materials are sourced, to the energy-intensive processes in building molecules, and all the way to shipping packaged products to hospitals and pharmacy shelves.
Today, the pharmaceutical industry emits more greenhouse gases globally than the automotive sector, equating to about 48.5 tonnes of carbon dioxide for every $1m generated. Every single stage of the pharmaceutical supply chain has a carbon footprint, from the moment raw materials are sourced, to the energy-intensive processes in building molecules, and all the way to…
EU GMP Annex 1 requirements for Manufacture of Sterile Medicinal Products were revised in August 2022, starting the clock for compliance by August 2023. Anna Cluet of Rephine offers some practical steps to address the requirements relating to Contamination Control Strategy (CCS), reducing the possibility of human contamination, and ensuring quality throughput the product lifecycle.
In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled by August 2023. The updated requirements, designed to protect and increase confidence in the sterility of these products, are significant and wide-ranging, spanning the Quality system and the manufacturing p…
Since 2020, market disruption created by COVID-19 has primed every aspect of the pharma industry for change: something that they have been reluctant to do in the decades previous. Today, with more crises potentially awaiting around the corner, there is an openness across the pharmaceutical world to embrace new technologies with a sense of urgency. Here are five important ways technology and automation can support pharma companies with mitigating increased complexity and seizing opportunities.
Since 2020, market disruption created by COVID-19 has primed every aspect of the pharma industry for change: something that they have been reluctant to do in the decades previous. . Today, with more crises potentially awaiting around the corner, there is an openness across the pharmaceutical world to e…
As the life science industry continues to embrace more flexible ways of working, you may find yourself managing a team of hybrid or remote workers. As hybrid and remote working come with their own set of both challenges and opportunities, these ways of working also require a very different managerial approach.
As the life science industry continues to embrace more flexible ways of working, you may find yourself managing a team of hybrid or remote workers. As hybrid and remote working come with their own set of both challenges and opportunities, these ways of working also require a very different managerial approach. We’ve put together this list of 14 best practices when it comes to managing your remote pharma employees, from retraining to recognising signs of burnout… Provide Training on Ke…
Bachem, the Swiss pharmaceutical company, invested in a capacity expansion for large-scale production of oligonucleotide active pharmaceutical ingredients (APIs).
Each step within the company’s oligonucleotide manufacturing process uses unique, innovative equipment to deliver the highest-quality products and to increase sustainability. Tailor-made oligonucleotide synthesisers To ensure only the highest-quality oligonucleotide is supplied to customers, Bachem designed a large-scale oligonucleotide synthesiser. This synthesiser optimises the process of oligonucleotide synthesis and has been qualified for GMP batches from a 0.2 mol to 2 mol scale. One of the engineering solutions used for the innovative synthesiser is in-line mixing of dichloroacetic acid (DCA) and toluene. This solution is u…
Health actors can draw on the contributions of interdisciplinarity, big data and modelling to improve their foresight capacities alongside the public authorities.
The pharmaceutical industries are naturally at the forefront of scientific innovation and emergency treatments, rather than of long-term intelligence and monitoring activities. This is further evidenced by the very short period of time – less than a year – that elapsed between discovery of the first cases of an unknown disease in Wuhan and the roll-out of the large-scale vaccine campaign.  The scope and complexity of prospective phenomena – over and above their scientific and logistical components – requires the pooling of intelligence and anticipation by combining a range of expertise and talent, and this cannot be left to…
Health actors can draw on the contributions of interdisciplinarity, big data and modelling to improve their foresight capacities alongside the public authorities.
The pharmaceutical industries are naturally at the forefront of scientific innovation and emergency treatments, rather than of long-term intelligence and monitoring activities. This is further evidenced by the very short period of time – less than a year – that elapsed between discovery of the first cases of an unknown disease in Wuhan and the roll-out of the large-scale vaccine campaign.  The scope and complexity of prospective phenomena – over and above their scientific and logistical components – requires the pooling of intelligence and anticipation by combining a range of expertise and talent, and this cannot be left to…
If you’re currently looking for your next Life Science role in the United States, or if you’re a recruiter searching for top talent in the country, New Jersey is an excellent location to carry out your search. In this article, we’ve rounded up 8 of the top pharmaceutical companies in New Jersey based on their physical presence as well as their impact on the local workforce…
New Jersey is home to one of the United States’ strongest life science ecosystems and was ranked the #3 U.S. Life Science cluster in March 2021.  Home to 14 of the top 20 pharmaceutical companies and over 3,200 life science companies operating across all sectors, New Jersey is a state where scientific research and discovery thrives. According to Choose New Jersey, the state also ranks: #3 for employed Biochemists and Bi…
Top Pharmaceutical and Life Science events taking place in September 2022, including Biotechnology, Clinical Research, Drug Discovery and Medical Device events.
Top Pharmaceutical and Life Science events taking place in September 2022, including Biotechnology, Clinical Research, Drug Discovery and Medical Device events. 3rd Operationalize: Decentralized Clinical Trials (September 7th-8th) Join over 150 DCT leaders to hear exclusive case-studies and engage in open discussions offering practical, implementable, and grounded insights. This is your best opportunity to clarify the complex issues through end-to-end hybrid and siteless clinical trial program operationalization. Intelligent Health AI (September 7th-8th) This event will once again bring together the global AI and health community in…
In recent years, governments worldwide have emphasised the need to shift towards a circular economy for packaging, with a particular focus on phasing out single-use, virgin, and unrecyclable plastics and exploring options for reusable products and refillable packaging. Many brands have also established ambitious commitments to make their packaging more sustainable by 2025. More than 500 organisations have signed up to the Ellen MacArthur Foundation’s New Plastics Economy Global Commitment.
In recent years, governments worldwide have emphasised the need to shift towards a circular economy for packaging, with a particular focus on phasing out single-use, virgin, and unrecyclable plastics and exploring options for reusable products and refillable packaging.  Many brands have also established a…
Product-level serialisation has historically been associated with compliance mandates within highly regulated industries such as pharmaceuticals, medical devices, and tobacco. Its central premise was to prevent counterfeit goods from entering these markets. However, as organisations within these sectors have realised, having full traceability within the supply chain offers benefits beyond compliance alone, providing opportunities for greater visibility, data exchange, and more.
Product-level serialisation has historically been associated with compliance mandates within highly regulated industries such as pharmaceuticals, medical devices, and tobacco. Its central premise was to prevent counterfeit goods from entering these markets.  However, as organisations within these sectors have realise…
Pharmaceutical Sales Representatives (Reps) are employed by pharmaceutical, biotechnology, or healthcare companies to sell their pharmaceutical products to external stakeholders, e.g., physicians. Rather than making direct sales, they are tasked with influencing and educating these stakeholders on the company’s products, acting as a reliable information source and the key bridge between the companies and healthcare professionals (HCPs).
Pharmaceutical Sales Representatives (Reps) are employed by pharmaceutical, biotechnology, or healthcare companies to sell their pharmaceutical products to external stakeholders, e.g., physicians. Rather than making direct sales, they are tasked with influencing and educating these stakeholders on the company’s products, acting as a reliable information sour…
Top Pharmaceutical and Life Science events taking place in August 2022, including Biotechnology, Clinical Research, Drug Discovery, and Medical Device events.
Top Pharmaceutical and Life Science events taking place in August 2022, including Biotechnology, Clinical Research, Drug Discovery and Medical Device events. Healthcare Payers and Providers Virtual Assembly (August 2nd-3rd) In the midst of a global crisis, innovation and leadership are more important than ever, and The Millennium Alliance is here to facilitate collaboration among industry leaders. The assembly will promote Executive Education and Digital Transformation through peer-to-peer connection, thought leadership, and more. 2nd REMS Innovation Summit (August 2nd-3rd) 15 years have passed since REMS was first implemented. This s…
The Massachusetts Life Science industry continues to grow at an exceptional rate, and in this article, we’ve rounded up ten of the top Pharmaceutical and Biotechnology companies in Massachusetts in 2022.
Massachusetts is home to one of the world’s leading Life Science hubs. In 2020, more than 89,000 individuals were employed by Massachusetts-based Life Science companies, representing a growth of over 67% in the last decade. The state is also widely regarded as the top biopharma cluster in the USA; thanks to its leading health systems, world-leading universities, state government support and robust venture capital pipeline. The Massachusetts Life Science industry continues to grow at an exceptional rate, and in this article, we’ve rounded up ten of the top Pharmaceutical and Biotechnology co…
EMA’s latest shift in its IDMP implementation guidance has been well documented. At the coal face, it’s causing all kinds of confusion as pharma companies try to figure out what they should do now. At Amplexor Life Sciences’ BE THE EXPERT 2022, K2 Consulting’s Kelly Hnat drew on her ‘insider’ knowledge as an active participant in the EMA SPOR Task Force and member of the EMA PMS Process Focus Group, to provide some welcome clarity.
As most Regulatory teams know well, EMA has made some last-minute adjustments to its EU IDMP implementation plan, meaning that the Digital Application Dataset Integration Project (DADI) interface rather than FHIR will serve as the means for making data submissions - at least initially - once these become mandatory just under a year from now. To many, the move may…
At Amplexor Life Sciences’ BE THE EXPERT 2022 conference, Dr. Thierry Dietrich of pharm@dviser, discussed the different levels of cloud use and the best approaches to ensuring compliance in each case, as regulators pay closer attention to cloud-based data management.
As pharmaceutical companies become more confident and ambitious in their use of the cloud to host, run and source applications, more recently extending the model to regulated applications, important considerations arise - particularly around associated systems validation and data governance. At Amplexor Life Sciences' BE THE EXPERT 2022 conference, Dr. Thierry Dietrich of pharm@dviser, discussed the different levels of cloud use and the best approaches to ensuring compliance in each case, as regulators pay closer attention to c…
With over 15 years of experience across their senior leadership team, The Global Life Science Hub provides functional services and consulting with a solid mission to accelerate, strengthen and enhance global clinical trials.
Introducing GLS With over 15 years of experience across their senior leadership team, The Global Life Science Hub provides functional services and consulting with a solid mission to accelerate, strengthen and enhance global clinical trials. Financially backed by specialist head-hunting firm AL Solutions, they are primed to continue the growth and development of the Clinical Development and Biometrics sectors with the support of AL2S3 to effectively expand their functional services globally. The Global Life Science Hub strives to ensure that all their clinical research c…
Whenever a foreign substance is introduced into the body, there will be a chance of rejection or having an adverse reaction. This reaction is the risk taken when trusting the pharmaceuticals that we have come to rely on for our wellness. We need these drugs, but sometimes other circumstances tell us otherwise.
Whenever a foreign substance is introduced into the body, there will be a chance of rejection or having an adverse reaction. This reaction is the risk taken when trusting the pharmaceuticals that we have come to rely on for our wellness. We need these drugs, but sometimes other circumstances tell us otherwise. What is an Adverse Drug Reaction? An Adverse Drug Reaction is also known as an ADR - the unwanted or uncomfortable effects of a drug. ADRs can also be dangerous to the one exper…
15 Pharma and Life Science events taking place in June 2022, including Pharmaceutical, Biotechnology, Clinical Research and Medical Devices events.
15 Pharma and Life Science events taking place in June 2022, including Pharmaceutical, Biotechnology, Clinical Research and Medical Devices events. 13th Edition Biologics Formulation Development and Drug Delivery Conference (June 1st-3rd) This industry-wide known marcus evans conference will gather experienced pharma industry scientists and academics to discuss key challenges around biologics drug development. International Congress of Micro-Immunotherapy (ICoMI) (June 2nd-4th) This virtual conference is open to researchers, healthcare and medical professionals looking for up-to-date knowledge and medical experience, new impulses for research an…
Centred Solutions Sales and Marketing Director, Louise Laban, gives her view on the current consultation into hub and spoke dispensing and questions some of the information included in the associated impact assessment.
“The second long awaited consultation on proposed changes to UK legislation to allow all community pharmacies to access hub and spoke dispensing is finally underway. Six years on from the original consultation, there remains speculation within the pharmacy market that the proposals may allow larger chains with automated hubs to charge smaller chains and independent pharmacies for “prescription assembly services” leading to an erosion of profits that cannot be recouped by any amount of patient facing services. Unfortunately the impact assessment into hub and spoke published by…