Welcome to the Educo Life Sciences Resource Hub which contains a wealth of free resources designed to elevate your career in pharmaceuticals, biotech or medical devices. Delve into our exclusive free trainer interviews, thought-provoking articles, and much more below. Use the tab filter below to pinpoint the perfect free resources tailored to your specific interests.
Introduction: The Role of Clinical Evidence in Medical Device Compliance In the European Union, gathering clinical evidence for medical devices is essential to regulatory compliance, particularly unde...
Navigating Module 3 of the Common Technical Document (CTD) is crucial for any regulatory affairs professional. This module, the quality section, presents the foundation of Chemistry, Manufacturing, an...
RNA therapeutics have emerged as a pivotal innovation in modern medicine, offering targeted treatments for a range of genetic diseases. Unlike traditional therapies, RNA-based approaches aim to manipu...
Marketing authorisation is a critical step for any medicinal product entering the European market. Unlike the US, where the Food and Drug Administration (FDA) handles approvals, Europe offers several ...
Chemistry, Manufacturing, and Controls (CMC) form a critical component of pharmaceutical drug development. This article delves into the complexities of CMC, discussing its role, processes, and regulat...
The Unique Device Identification (UDI) system is a globally recognised framework designed to provide a unique identifier for medical devices, enhancing traceability and safety within healthcare. It ha...
CMC, Chemistry, Manufacturing and Controls (CMC) refers to all the elements involved in producing pharmaceutical, biologic, or cell & gene products. CMC activities commence from product developmen...
The Person Responsible for Regulatory Compliance (PRRC) is a pivotal role introduced by the European Union’s Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) under Art...
Technology transfer (tech transfer) in biopharmaceuticals is a critical process involving the transition of production methods and materials from research and development (R&D) to manufacturing fa...
Educo Life Sciences recently caught up with Richard Young to discuss legacy products and some of the most challenging aspects when transitioning them to comply with the new medical device regulations....
Combination products, which integrate pharmaceutical and medical device components, are an innovative and expanding sector in medical solutions. This article, based on insights from expert Richard You...
Biotech startups face numerous hurdles in Chemistry, Manufacturing, and Controls (CMC) development. From regulatory requirements to balancing costs and timelines, managing these complex processes is c...
Bringing a medical device to market is a complex and multifaceted process that requires careful planning, extensive documentation, and adherence to stringent regulatory standards. In this guide, we wi...
Continuous biomanufacturing has rapidly become a vital strategy for pharmaceutical and biotech companies, offering substantial benefits such as cost reduction, faster production timelines, and enhance...
ISO 13485 is a critical standard for companies involved in the design, development, and production of medical devices. It provides a framework for implementing a quality management system (QMS) specif...
The Common Technical Document (CTD) is an essential component in pharmaceutical regulatory affairs. It streamlines the submission process across various regions and ensures that drug applications are ...
We interviewed Educo Life Sciences trainer John Faulkes to discuss a career in pharmaceuticals for those who are not scientists. We often get asked the best routes to get into the pharmaceutical indus...
We interviewed Educo Life Sciences Trainer John Faulkes to get his views on the top three trends in the pharmaceutical industry. John highlights some interesting trends such as decentralised clinical ...
A greater number of cell and gene therapies are entering development, often with innovative modalities. One of the biggest challenges during CMC development is analytics. Analytics of biologics are co...
We interviewed Educo Life Sciences trainer Nadine Ritter to discuss the most challenging analytical assays for biological products. In the interview Nadine discusses the issues scientists face with Ho...
We interviewed Educo Life Sciences trainer Nadine Ritter to find out why drugs cannot be developed as quick as the COVID vaccine. Nadine explains all the factors that led to the fastest development of...
Regulatory affairs (RA) is an integral part of the life sciences industry, bridging the gap between pharmaceutical, biotech, and medical device companies and regulatory bodies. For those considering a...
At Educo Life Sciences we have seen a recent increase in training requests/deliveries around internal audits for both devices and IVDs. As the regulatory landscape shifts to the MDR and IVDR, companie...
The main aims of Human Factors Engineering (HFE) or usability are to create safe and effective medical devices and IVDs for human use. It is concerned with the design of devices that considers human c...
Regulatory lifecycle management is an essential aspect of maintaining product compliance, particularly when dealing with Chemistry, Manufacturing, and Controls (CMC) changes. However, managing these c...
A greater number of cell and gene therapies are entering development, often with innovative modalities. One of the biggest challenges is within bioanalytics when understanding biodistribution and phar...
The In-Vitro Diagnostic Regulation (IVDR) was introduced by the EU to replace the In-Vitro Diagnostic Directive (IVDD). Under the Directive, most IVD products were self-certified. The IVDR is going to...
Overview Knowledge management is one of your organisation’s most valuable assets and is integral to your organisational culture. This is particularly important for pharmaceutical, biotech and me...
ISO 10993 is the cornerstone standard for assessing the biological safety of medical devices. By focusing on risk assessment rather than prescriptive testing, it provides a flexible framework for eval...
We interviewed Educo Life Sciences trainer Rona Middlemiss to discuss Biological Evaluation literature review and data sources. This area is critical as it is a requirement of all medical device categ...
Product and process validation is critical process that must be done for regulatory compliance to ensure patients safety. Its main aim is to make certain the product is made correctly and consistently...
Advanced Therapy Medicinal Products (ATMPs) represent a cutting-edge category of treatments in the pharmaceutical industry, designed to address unmet medical needs, particularly for complex and chroni...
If you have a piece of software as part of your device you must be aware of the regulatory requirements in place to maintain patient safety. Whether it is an app that provides some additional f...
In the medical device industry, ensuring safety and compliance with regulatory standards is paramount. Chemical characterisation and biocompatibility testing are essential steps in this process, guide...
We interviewed Educo Life Sciences trainer Margit Holzer to get her views on a career in the biopharmaceutical industry, specifically manufacturing. Margit discusses her career experiences and provide...
Listen to Educo Life Sciences’ trainer Olivier Negre discuss how the cell & gene therapy sector has changed over the past 10 years and how he expects it to change in the next 10 years...
Getting a cell and gene therapy developed, manufactured, and approved on the market is challenging. There are numerous hurdles to overcome such as supply chain issues, aseptic working, patient access,...
The cell and gene therapy (ATMPs) industry has grown significantly. The number of therapies reaching clinical trials and market approval has increased. To fuel its growth, a skilled workforce is requi...
With the introduction of the new Medical Device Regulation (MDR) in Europe, the classification of medical devices has become more structured, emphasising the importance of patient safety at every risk...
To retain your top employees, you must make sure they have clear career paths set out. A career pathway provides an individual with a structured progression roadmap. But why? If done correctly, your e...
In this interview, Sophie, an experienced professional in pharmaceutical regulatory affairs, shares her career journey, the evolution of the industry, and advice for those starting in the field. With ...
Planning and implementing an effective learning and development (L&D) strategy for your team or organisation is crucial for several reasons. Firstly, it enhances your team’s capabilities in alignm...
Throughout my experience supporting the pharmaceutical, biotech, and medical device industries with training, I have encountered a wide range of learning and development (L&D) strategies. These ra...
We interviewed two of our trainers to get their views on a career in medical devices & IVDs, specifically regulatory affairs. They share their career experiences and provide some advice for...
Training plays a major role in the development of individuals and teams in the pharmaceutical, biotech and medical device sectors. Professionals must continually update and develop their skills to sta...
The COVID-19 pandemic has fundamentally changed the way we work. This was no exception to the pharmaceutical, biopharma and medical device industries. The workforce shifted away from the office to imp...
As a leader, it is your responsibility to ensure your team is in the best possible position to hit their objectives and thus help you achieve yours. Ensuring an effective training strategy will help y...
The concept of team training or corporate training is simple. Its aim is to improve the skills of individuals within a team, which in turn will improve their overall knowledge and skill in a specific ...
For those organisations and teams who have mapped out their direction and objectives over the coming years, there is often a disconnect between the destination and the knowledge available to them with...
Introduction: The Role of Clinical Evidence in Medical Device Compliance In the European Union, gathering clinical evidence for medical devices is essential to regulatory compliance, particularly unde...
The Unique Device Identification (UDI) system is a globally recognised framework designed to provide a unique identifier for medical devices, enhancing traceability and safety within healthcare. It ha...
The Person Responsible for Regulatory Compliance (PRRC) is a pivotal role introduced by the European Union’s Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) under Art...
Educo Life Sciences recently caught up with Richard Young to discuss legacy products and some of the most challenging aspects when transitioning them to comply with the new medical device regulations....
Combination products, which integrate pharmaceutical and medical device components, are an innovative and expanding sector in medical solutions. This article, based on insights from expert Richard You...
Bringing a medical device to market is a complex and multifaceted process that requires careful planning, extensive documentation, and adherence to stringent regulatory standards. In this guide, we wi...
ISO 13485 is a critical standard for companies involved in the design, development, and production of medical devices. It provides a framework for implementing a quality management system (QMS) specif...
We interviewed Educo Life Sciences trainer Nadine Ritter to find out why drugs cannot be developed as quick as the COVID vaccine. Nadine explains all the factors that led to the fastest development of...
At Educo Life Sciences we have seen a recent increase in training requests/deliveries around internal audits for both devices and IVDs. As the regulatory landscape shifts to the MDR and IVDR, companie...
The main aims of Human Factors Engineering (HFE) or usability are to create safe and effective medical devices and IVDs for human use. It is concerned with the design of devices that considers human c...
The In-Vitro Diagnostic Regulation (IVDR) was introduced by the EU to replace the In-Vitro Diagnostic Directive (IVDD). Under the Directive, most IVD products were self-certified. The IVDR is going to...
ISO 10993 is the cornerstone standard for assessing the biological safety of medical devices. By focusing on risk assessment rather than prescriptive testing, it provides a flexible framework for eval...
We interviewed Educo Life Sciences trainer Rona Middlemiss to discuss Biological Evaluation literature review and data sources. This area is critical as it is a requirement of all medical device categ...
Product and process validation is critical process that must be done for regulatory compliance to ensure patients safety. Its main aim is to make certain the product is made correctly and consistently...
If you have a piece of software as part of your device you must be aware of the regulatory requirements in place to maintain patient safety. Whether it is an app that provides some additional f...
In the medical device industry, ensuring safety and compliance with regulatory standards is paramount. Chemical characterisation and biocompatibility testing are essential steps in this process, guide...
With the introduction of the new Medical Device Regulation (MDR) in Europe, the classification of medical devices has become more structured, emphasising the importance of patient safety at every risk...
We interviewed two of our trainers to get their views on a career in medical devices & IVDs, specifically regulatory affairs. They share their career experiences and provide some advice for...
RNA therapeutics have emerged as a pivotal innovation in modern medicine, offering targeted treatments for a range of genetic diseases. Unlike traditional therapies, RNA-based approaches aim to manipu...
Chemistry, Manufacturing, and Controls (CMC) form a critical component of pharmaceutical drug development. This article delves into the complexities of CMC, discussing its role, processes, and regulat...
CMC, Chemistry, Manufacturing and Controls (CMC) refers to all the elements involved in producing pharmaceutical, biologic, or cell & gene products. CMC activities commence from product developmen...
Combination products, which integrate pharmaceutical and medical device components, are an innovative and expanding sector in medical solutions. This article, based on insights from expert Richard You...
Biotech startups face numerous hurdles in Chemistry, Manufacturing, and Controls (CMC) development. From regulatory requirements to balancing costs and timelines, managing these complex processes is c...
We interviewed Educo Life Sciences trainer John Faulkes to discuss a career in pharmaceuticals for those who are not scientists. We often get asked the best routes to get into the pharmaceutical indus...
We interviewed Educo Life Sciences Trainer John Faulkes to get his views on the top three trends in the pharmaceutical industry. John highlights some interesting trends such as decentralised clinical ...
A greater number of cell and gene therapies are entering development, often with innovative modalities. One of the biggest challenges during CMC development is analytics. Analytics of biologics are co...
We interviewed Educo Life Sciences trainer Nadine Ritter to discuss the most challenging analytical assays for biological products. In the interview Nadine discusses the issues scientists face with Ho...
We interviewed Educo Life Sciences trainer Nadine Ritter to find out why drugs cannot be developed as quick as the COVID vaccine. Nadine explains all the factors that led to the fastest development of...
A greater number of cell and gene therapies are entering development, often with innovative modalities. One of the biggest challenges is within bioanalytics when understanding biodistribution and phar...
Advanced Therapy Medicinal Products (ATMPs) represent a cutting-edge category of treatments in the pharmaceutical industry, designed to address unmet medical needs, particularly for complex and chroni...
We interviewed Educo Life Sciences trainer Margit Holzer to get her views on a career in the biopharmaceutical industry, specifically manufacturing. Margit discusses her career experiences and provide...
Listen to Educo Life Sciences’ trainer Olivier Negre discuss how the cell & gene therapy sector has changed over the past 10 years and how he expects it to change in the next 10 years...
Getting a cell and gene therapy developed, manufactured, and approved on the market is challenging. There are numerous hurdles to overcome such as supply chain issues, aseptic working, patient access,...
The cell and gene therapy (ATMPs) industry has grown significantly. The number of therapies reaching clinical trials and market approval has increased. To fuel its growth, a skilled workforce is requi...
RNA therapeutics have emerged as a pivotal innovation in modern medicine, offering targeted treatments for a range of genetic diseases. Unlike traditional therapies, RNA-based approaches aim to manipu...
Marketing authorisation is a critical step for any medicinal product entering the European market. Unlike the US, where the Food and Drug Administration (FDA) handles approvals, Europe offers several ...
Chemistry, Manufacturing, and Controls (CMC) form a critical component of pharmaceutical drug development. This article delves into the complexities of CMC, discussing its role, processes, and regulat...
CMC, Chemistry, Manufacturing and Controls (CMC) refers to all the elements involved in producing pharmaceutical, biologic, or cell & gene products. CMC activities commence from product developmen...
Technology transfer (tech transfer) in biopharmaceuticals is a critical process involving the transition of production methods and materials from research and development (R&D) to manufacturing fa...
Combination products, which integrate pharmaceutical and medical device components, are an innovative and expanding sector in medical solutions. This article, based on insights from expert Richard You...
Biotech startups face numerous hurdles in Chemistry, Manufacturing, and Controls (CMC) development. From regulatory requirements to balancing costs and timelines, managing these complex processes is c...
Continuous biomanufacturing has rapidly become a vital strategy for pharmaceutical and biotech companies, offering substantial benefits such as cost reduction, faster production timelines, and enhance...
We interviewed Educo Life Sciences trainer John Faulkes to discuss a career in pharmaceuticals for those who are not scientists. We often get asked the best routes to get into the pharmaceutical indus...
We interviewed Educo Life Sciences Trainer John Faulkes to get his views on the top three trends in the pharmaceutical industry. John highlights some interesting trends such as decentralised clinical ...
A greater number of cell and gene therapies are entering development, often with innovative modalities. One of the biggest challenges during CMC development is analytics. Analytics of biologics are co...
We interviewed Educo Life Sciences trainer Nadine Ritter to discuss the most challenging analytical assays for biological products. In the interview Nadine discusses the issues scientists face with Ho...
We interviewed Educo Life Sciences trainer Nadine Ritter to find out why drugs cannot be developed as quick as the COVID vaccine. Nadine explains all the factors that led to the fastest development of...
A greater number of cell and gene therapies are entering development, often with innovative modalities. One of the biggest challenges is within bioanalytics when understanding biodistribution and phar...
We interviewed Educo Life Sciences trainer Margit Holzer to get her views on a career in the biopharmaceutical industry, specifically manufacturing. Margit discusses her career experiences and provide...
Navigating Module 3 of the Common Technical Document (CTD) is crucial for any regulatory affairs professional. This module, the quality section, presents the foundation of Chemistry, Manufacturing, an...
Marketing authorisation is a critical step for any medicinal product entering the European market. Unlike the US, where the Food and Drug Administration (FDA) handles approvals, Europe offers several ...
Chemistry, Manufacturing, and Controls (CMC) form a critical component of pharmaceutical drug development. This article delves into the complexities of CMC, discussing its role, processes, and regulat...
CMC, Chemistry, Manufacturing and Controls (CMC) refers to all the elements involved in producing pharmaceutical, biologic, or cell & gene products. CMC activities commence from product developmen...
Combination products, which integrate pharmaceutical and medical device components, are an innovative and expanding sector in medical solutions. This article, based on insights from expert Richard You...
Biotech startups face numerous hurdles in Chemistry, Manufacturing, and Controls (CMC) development. From regulatory requirements to balancing costs and timelines, managing these complex processes is c...
The Common Technical Document (CTD) is an essential component in pharmaceutical regulatory affairs. It streamlines the submission process across various regions and ensures that drug applications are ...
We interviewed Educo Life Sciences trainer John Faulkes to discuss a career in pharmaceuticals for those who are not scientists. We often get asked the best routes to get into the pharmaceutical indus...
We interviewed Educo Life Sciences Trainer John Faulkes to get his views on the top three trends in the pharmaceutical industry. John highlights some interesting trends such as decentralised clinical ...
We interviewed Educo Life Sciences trainer Nadine Ritter to find out why drugs cannot be developed as quick as the COVID vaccine. Nadine explains all the factors that led to the fastest development of...
Regulatory affairs (RA) is an integral part of the life sciences industry, bridging the gap between pharmaceutical, biotech, and medical device companies and regulatory bodies. For those considering a...
Regulatory lifecycle management is an essential aspect of maintaining product compliance, particularly when dealing with Chemistry, Manufacturing, and Controls (CMC) changes. However, managing these c...
In this interview, Sophie, an experienced professional in pharmaceutical regulatory affairs, shares her career journey, the evolution of the industry, and advice for those starting in the field. With ...
Overview Knowledge management is one of your organisation’s most valuable assets and is integral to your organisational culture. This is particularly important for pharmaceutical, biotech and me...
To retain your top employees, you must make sure they have clear career paths set out. A career pathway provides an individual with a structured progression roadmap. But why? If done correctly, your e...
Planning and implementing an effective learning and development (L&D) strategy for your team or organisation is crucial for several reasons. Firstly, it enhances your team’s capabilities in alignm...
Throughout my experience supporting the pharmaceutical, biotech, and medical device industries with training, I have encountered a wide range of learning and development (L&D) strategies. These ra...
Training plays a major role in the development of individuals and teams in the pharmaceutical, biotech and medical device sectors. Professionals must continually update and develop their skills to sta...
The COVID-19 pandemic has fundamentally changed the way we work. This was no exception to the pharmaceutical, biopharma and medical device industries. The workforce shifted away from the office to imp...
As a leader, it is your responsibility to ensure your team is in the best possible position to hit their objectives and thus help you achieve yours. Ensuring an effective training strategy will help y...
The concept of team training or corporate training is simple. Its aim is to improve the skills of individuals within a team, which in turn will improve their overall knowledge and skill in a specific ...
For those organisations and teams who have mapped out their direction and objectives over the coming years, there is often a disconnect between the destination and the knowledge available to them with...
Is your team merely functioning, or are you proactively developing their skills and knowledge to help them excel? The life sciences industry is a rapidly evolving and highly competitive field. To stay...
