Pharmaco - Articles

One of the most exciting changes in the pharmaceutical sector over the last 10 years has been a shift from chemically synthesised drugs to focus more on a biologics. While biologics have the potential to revolutionise treatment for millions of people dealing with conditions such as rheumatoid arthritis, diabetes, autoimmune diseases and certain cancers, there is a significant wrinkle that needs attending to: delivery.
One of the most exciting changes in the pharmaceutical sector over the last 10 years has been a shift from chemically synthesised drugs to focus more on a biologics. While biologics have the potential to revolutionise treatment for millions of people dealing with conditions such as rheumatoid arthritis, diabetes, autoimmune diseases and certain cancers, there is a significant…

Technological advancements, climate change, and geopolitical tensions have transformed the global manufacturing landscape in recent decades. Along the way, academics and industry experts have explored concepts such as Industry 4.0 which encompasses the industrial internet of things, and ‘smart’ manufacturing, to help define the multitude of ways in which technological innovation has changed manufacturing processes.
Technological advancements, climate change, and geopolitical tensions have transformed the global manufacturing landscape in recent decades. Along the way, academics and industry experts have explored concepts such as Industry 4.0 which encompasses the industrial internet of things, and ‘smart’ manufacturing, to help define the multitude of ways in which technological innovation…

In your journey toward mental well-being, understanding the intricate interplay between brain chemistry and mental health is vital. Psychopharmacology, the study of how drugs affect the mind, plays a pivotal role in the treatment of various mental disorders.
In your journey toward mental well-being, understanding the intricate interplay between brain chemistry and mental health is vital. Psychopharmacology, the study of how drugs affect the mind, plays a pivotal role in the treatment of various mental disorders. Understanding the Basics of Psychopharmacology At its core, psychopharmacology explores the effects of medications on the brain, aiming to rectify imbalances in neurotransmitters — the chemical messengers that facilitate communication between nerve cells.1 Through a comprehensive un…

There have been several changes to the pharmaceutical and biotech regulatory landscape in 2023. The short and long-term impacts of these changes are relatively unknown; however, all could shape the regulatory landscape for life sciences in 2024 and beyond. What are the regulatory changes? 1. Reform of the European Union’s Pharmaceutical Legislation. 2. Medicines & Healthcare products Regulatory Agency’s (MHRA’s) International Recognition Procedure (IRP). 3. Food and Drug Administration’s (FDA’s) Benefit-Risk guidance. 4. European Medicines Agency’s (EMA’s) revised CTIS transparency rules.
There have been several changes to the pharmaceutical and biotech regulatory landscape in 2023. The short and long-term impacts of these changes are relatively unknown; however, all could shape t…

New Gens & Associates research focuses on the evolving role and importance of local affiliates in efforts to make global regulatory processes more consistent and effective through optimised systems and tools. Steve Gens outlines the findings.
Achieving regulatory excellence in Life Sciences companies depends on a combination of process optimisation, effective global systems, high data quality, and better Affiliate collaboration. One weak link in that chain could risk compromising all of the other efforts and investment. Yet highly manual processes, specific local market requirements, and tool usage inconsistencies have often meant a gap in global information visibility and flow which adds risk to key regulatory processes. These processes include submission forecasting and planning; product…

Everyone wants the best outcome possible when they’re a patient or caregiver in the healthcare industry. Technology makes that easier to achieve. The advantages of digitalization enhance the industry’s efficiency, productivity, and quality control. Those in the pharmaceutical industry particularly stand to benefit from digitization. These are the most important ways digital technologies are revolutionizing pharmaceutical manufacturing and the industry as a whole.
Everyone wants the best outcome possible when they’re a patient or caregiver in the healthcare industry. Technology makes that easier to achieve. The advantages of digitalization enhance the industry’s efficiency, productivity, and quality control. Those in the pharmaceutical industry particularly stand to benefit from digitization…

We are delighted to announce that the second edition of our popular introductory guide: ‘Market access and reimbursement in key European markets’ is now available. Our market access experts have updated the reimbursement routes and added new market insights for 2023/24.
We are delighted to announce that the second edition of our popular introductory guide: ‘Market access and reimbursement in key European markets’ is now available. Our market access experts have updated the reimbursement routes and added new market insights for 2023/24. In this introductory guide, our Global market access experts present an overview of the reimbursement landscape in key European healthcare systems. We highlight the differences between key markets and provide a high-level guide for…

Maria Dimitrova (Consultant – HTA) and Samantha Gillard (Director – HTA) provide an overview of the EU Joint Clinical Assessment (JCA) and what it means for Pharma and Medical Device manufacturers launching new technologies from 2025.
What is the EU JCA? In January 2022, the European Parliament enacted a new EU Health Technology Assessment (HTA) Regulation, with the aim of standardising clinical assessment of medicines and high-risk medical devices across the EU and avoiding duplication of work. Currently, Pharma and Medtech manufacturers have to submit evidence individually in each of the 27 EU markets; the intention of the JCA is that at least some of the assessment can be done centrally. The JCA report will act as a universal information source for relative treatment effects, safety…

The 18th Project Portfolio and Resource Management Excellence Conference, set for February 13-15, 2024 in Northern New Jersey, is a crucial event for industry leaders. The conference focuses on optimizing resource management, aligning project strategies, navigating market pressures, and embracing innovation. With a lineup of industry experts and insightful sessions, attendees can expect to gain actionable strategies and valuable connections.
Northern New Jersey, February 13-15, 2024 In an ever-evolving pharmaceutical and biotechnology landscape, effective portfolio and project management are paramount. The 18th Project Portfolio and Resource Management Excellence Conference, set to take place in Northern New Jersey from February 13th to 15th, 2024, promises to be a crucible of insights and…

There is no doubt that Generative AI will transform IT delivery. Dirk Bode, CEO of fme, recommends optimising core business strategy and identifying where Generative AI could be harnessed to support the strategy.
AI, and specifically Generative AI, is going to transform IT delivery as well as a whole host of other corporate functions. Via secure company-wide intranets that draw on open, cloud-based AI platforms, to intelligent bot-enabled business functions and regulatory processes, ChatGPT and tools like it are going to transform the way entire organisations access, collate and distribute knowledge, and create new assets – as well as what they do with all of it. Very soon (if they aren’t already piloting projects) companies will first scrutinise and clean up, then migrate content to a sec…

In this article, we highlight some of the top associations dedicated to regulatory affairs for you to explore. These associations have a proven track record of providing exceptional opportunities for regulatory affairs professionals, and of working collaboratively with members to advocate for excellence in the field.
As a regulatory affairs professional, you’ll know how challenging it can be to navigate complex regulations and ensure compliance. To excel in this dynamic field and advance your career, you could benefit greatly from joining a reputable professional association dedicated to regulatory affairs, opening you up to endless networking and learning and development opportunities. In this article, we highlight some of the top associations dedicated to regulatory affairs for you to exp…

EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products have come into force. Anna Cluet of Rephine delves into the challenges faced by certain manufacturers when implementing effective Contamination Control Strategies and practical Quality Risk Management, sharing valuable insights and tips for addressing the issues.
In August, the revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products came into force, with implications for contamination control strategies and, by extension, for plant facilities, equipment, manufacturing processes and Quality systems. The updated requirements are designed to increase confidence in these products. Now that they are live, the expectations of auditors have adapted accordingly which will have a…

The pharmaceutical industry is a huge contributor to climate change - what changes can help it go green at last?
The pharmaceutical industry is currently responsible for over four per cent of global carbon emissions and this figure is on track to grow in the coming years. The UK Government has committed in legislation to reach net-zero carbon emissions by 2050, but achieving this goal could hinge on whether or not the industry finds a way to go green. Here Simon Farnfield, event director at Lab Innovations, discusses the changes that are allowing the pharmaceutical industry to go green at last.  Despite being an emissions-producing juggernaut, the pharmaceutical industry rarely faces the same level of scrutiny as other industries because of its role in providing crucial healthcare solu…

Nobody likes being sick. Viruses often overstay their welcome, and symptoms like coughing could linger far beyond when you start feeling better. Big pharma and the flu go hand-in-hand during the winter. You'll start seeing signs for free flu shots at participating businesses. You might even get a flu shot yourself — or you might think they don't really work.
Nobody likes being sick. Viruses often overstay their welcome, and symptoms like coughing could linger far beyond when you start feeling better. Big pharma and the flu go hand-in-hand during the winter. You'll start seeing signs for free flu shots at participating businesses. You might even get a flu shot yourself — or you might think they don't really work. The 2022–2023 season alone saw around 650,000 hospitalizations with tens of tho…

People rely on the pharmaceutical industry to save lives and improve patient care. It’s a vital industry that’s continually looking for ways to improve, including implementing drones. Leaders and team members know drones can improve the pharmaceutical industry in many ways. Whether they’re flying across manufacturing plants or a neighborhood, drones are becoming necessary tools for daily operations.
People rely on the pharmaceutical industry to save lives and improve patient care. It’s a vital industry that’s continually looking for ways to improve, including implementing drones. Leaders and team members know drones can improve the pharmaceutical industry in many ways. Whether they’re flying across manufacturing plants or a neighborhood, drones are becoming necessary tools for daily operati…

The life sciences supply chains support life-saving business models. They supply medical institutions with quick turnaround deliveries while prioritizing consumers through each step of each company’s operations. Putting consumers first directly connects those supply chains with corporate social responsibility policies. Read about how these policies work and what they mean for the life sciences supply chains. They’re leading the health sector into the future with person-focused initiatives.
The life sciences supply chains support life-saving business models. They supply medical institutions with quick turnaround deliveries while prioritizing consumers through each step of each company’s operations. Putting consumers first directly connects those supply chains with corporate social responsibi…

While inflation and economic pressures force pharmaceutical brands to watch their pennies, they will do well to not tackle cost efficiency as a solo issue. Brands require resilience in an array of areas and chief among these is compliance. Stringent regulations must be followed, although the supply chains from which they are navigated, are incredibly complex.
Let’s approach the components of supply chain resilience holistically While inflation and economic pressures force pharmaceutical brands to watch their pennies, they will do well to not tackle cost efficiency as a solo issue. Brands require resilience in an array of areas and chief among these is compliance. Stringent regulations must be followed, although the supply chains from which they are navigated, are incredibly complex. So, can…

While the current volatility in our global supply chains is likely to remain in the foreseeable future, there are steps that businesses can take to adapt, and those that do may find themselves at a competitive advantage. As Lee Metters, Group Business Development Director, Domino Printing Sciences, highlights.
For manufacturers, polycrisis-related supply disruptions have rendered any concept of ‘business as usual’ a thing of the past as businesses grapple with production and shipping delays; inventory management issues; quality control issues; increased costs; penalties; and customer dissatisfaction. While the current volatility in our global supply chains is likely to remain in the foreseeable future, there are steps that businesses can take to adapt, and those that do may find themselves…

Following a series of disruptions to worldwide supply chains, regulators across the globe have initiated fresh guidelines for manufacturers in the Life Sciences sector and those responsible for marketing authorisations. The aim is to safeguard uninterrupted global availability of crucial medication supplies. Juan Torrijos Lopez, GMP consultant at Rephine, discusses the regulatory requirements set by the FDA and EMA regarding the maintenance of robust supply chains.
Following a series of disruptions to worldwide supply chains, regulators across the globe have initiated fresh guidelines for manufacturers in the Life Sciences sector and those responsible for marketing authorisations. The aim is to safeguard uninterrupted global availability of crucial medication supplies. Juan Torrijos Lopez,…