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In regulated pharmaceutical environments, method validation is a cornerstone of quality assurance. Yet many validated methods still fail to perform reliably in routine use. This disconnection between regulatory compliance and real-world functionality is all too common. The good news? With a more pragmatic and risk-based...

The establishment and management of a comprehensive cell bank system is central to biologics and cell and gene therapy manufacturing. Yet, navigating the requirements, best practices, and regulatory expectations from research through to end-of-production can be complex. In this article, we provide an in-depth look...

In the complex and regulated world of biologics, potency assays are among the most critical tools used to ensure the quality, efficacy, and consistency of therapeutic products. Whether it’s for release testing, stability studies, or development milestones, a robust potency assay is essential. Yet, developing...

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 under the Medical Device Regulation (MDR. Clinical evidence helps demonstrate that a device is safe, performs as intended, and…

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 has become a cornerstone of regulatory efforts in both the United States and Europe, ensuring that medical devices,…

As the pharmaceutical, biopharmaceutical, and medical device industries continue to evolve at a rapid pace, the need for continuous professional development has never been greater. In this article, we explore the findings of the Educo Life Sciences Training Report 2025, which analyses training motivations across...

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 medical device companies where knowledge is the foundation for success. All R&D, manufacturing, engineering, clinical and regulatory work is…

Training has always been essential for equipping staff with the skills needed to stay competitive. In recent years, however, it has become even more critical as today’s workforce increasingly values development opportunities. As we approach the end of the year, it’s important to maximise your...

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 within the organisation. Resourcing for this gap will always be a balance between recruiting…

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 area. Consequently, the team will perform with greater competence and…

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 improvised desks on the kitchen worktop, dining room table or maybe even on the garden…

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 range from complex and highly effective plans to minimal and often ineffective ones. Despite being knowledge-intensive industries, heavily reliant…

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 employees will have a clear understanding of where they stand within an…

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 you achieve these goals. Research has repeatedly shown that organisations with…

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 stay on top of an ever-evolving sector where techniques and regulations change. One training approach is…

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 alignment with overall business goals. Secondly, it plays a vital role in attracting and retaining talent, especially as…

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 ahead of the competition, meet deadlines, and ensure successful project outcomes, teams and…

  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. Olivier also discusses the latest increase in gene editing…

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, guided by frameworks such as ISO 10993. These evaluations help manufacturers understand the materials in their devices and assess potential…

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 categories as per ISO 10993. It aims are to assess the risk and benefits of…

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 under the Medical Device Regulation (MDR. Clinical evidence helps demonstrate that a device is safe, performs as intended, and…

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 has become a cornerstone of regulatory efforts in both the United States and Europe, ensuring that medical devices,…

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, guided by frameworks such as ISO 10993. These evaluations help manufacturers understand the materials in their devices and assess potential…

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 categories as per ISO 10993. It aims are to assess the risk and benefits of…

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 evaluating device materials in their final form. This guide delves into the scope, challenges, updates, and…

Combination products pose regulatory difficulties as the requirements of medical devices must merge with pharmaceuticals and biotech. As biotech and advanced therapeutics grows, so too does the need for specialised device delivery systems resulting in an increase in combination products. Similarly, device companies are increasingly...

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) specifically tailored for the unique regulatory requirements of this sector. In this article, we will delve…

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 Young, covers the unique regulatory challenges faced by manufacturers and developers working with these products, especially in Europe and…

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. The new European Medical Device Regulations means that legacy products need to meet new…

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 drug in history.   Why Can’t We Develop Products as…

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 change all that with a new risk based classification system, many now need notified bodies…

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, companies may be increasing their activities to demonstrate compliance. We interviewed our regulatory and…

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 capabilities, limitations, and characteristics. HFE in medical devices has become more…

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 will break down the essential steps for obtaining CE or UK CA marking, discuss the importance of…

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. We interviewed Educo Life Sciences trainer Richard Young to discuss product and process…

  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 features or specialised software that is critical to the…

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 level. From low-risk products in Class I to high-risk Class III devices, each category comes…

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 Article 15. As of 2017, all manufacturers, regardless of size, are required to appoint a PRRC to ensure…

  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 those at different points in their device career. They discuss the many reasons…

In regulated pharmaceutical environments, method validation is a cornerstone of quality assurance. Yet many validated methods still fail to perform reliably in routine use. This disconnection between regulatory compliance and real-world functionality is all too common. The good news? With a more pragmatic and risk-based...

The establishment and management of a comprehensive cell bank system is central to biologics and cell and gene therapy manufacturing. Yet, navigating the requirements, best practices, and regulatory expectations from research through to end-of-production can be complex. In this article, we provide an in-depth look...

In the complex and regulated world of biologics, potency assays are among the most critical tools used to ensure the quality, efficacy, and consistency of therapeutic products. Whether it’s for release testing, stability studies, or development milestones, a robust potency assay is essential. Yet, developing...

  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. Olivier also discusses the latest increase in gene editing…

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 complex regulatory pathways. This article explores the various marketing authorisation routes available in the European Economic…

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 development and progress through pre-clinical, clinical, and eventual marketing. Various skilled professionals work in CMC to develop and manufacture…

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 Young, covers the unique regulatory challenges faced by manufacturers and developers working with these products, especially in Europe and…

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 regulatory aspects. This knowledge is essential for professionals involved in drug development, especially in navigating the intricacies of bringing…

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 crucial for survival in the highly competitive pharmaceutical industry. In this article, we explore key CMC challenges biotech startups face…

Continuous biomanufacturing has rapidly become a vital strategy for pharmaceutical and biotech companies, offering substantial benefits such as cost reduction, faster production timelines, and enhanced process efficiency. Initially introduced in the 1980s, the technology has significantly evolved, now being applied to both upstream and downstream…

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 facilities. It ensures that the quality and efficacy of the product are maintained throughout its life cycle, from clinical trials…

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 pharmacokinetics of cell and gene therapies. As discussed below, a new way of thinking is often required to…

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 complex enough, but with cell and gene therapies a new range of analytical issues arise.  We…

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 drug in history.   Why Can’t We Develop Products as…

In the fast-paced world of biologics development, analytical assays play a pivotal role in ensuring product safety, efficacy, and regulatory compliance. Yet, despite technological advances, some assays continue to pose significant challenges across the product lifecycle. In a recent conversation with Dr Nadine Ritter, a...

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 manipulate gene expression or replace faulty proteins, thus providing a powerful tool for combating complex diseases. This article…

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 chronic conditions. These therapies fall under four broad categories: gene therapies, somatic-cell therapies, tissue-engineered products, and combined ATMPs. This article…

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, efficacy and safety.  Below are short interviews with a range of Educo Life Science Trainers…

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 required in all areas of development such as regulatory, clinical, manufacturing (process), analytical and commercialisation….

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 industry and John highlights alternative routes that are perfect for non-scientists. In this…

In regulated pharmaceutical environments, method validation is a cornerstone of quality assurance. Yet many validated methods still fail to perform reliably in routine use. This disconnection between regulatory compliance and real-world functionality is all too common. The good news? With a more pragmatic and risk-based...

The Chemistry, Manufacturing, and Controls (CMC) section of a regulatory dossier is critical in ensuring product quality and regulatory compliance. Educo delivers the course “Completing the Quality/CMC Module of the CTD” which includes a free-to-attend module 1 training session. Over the years, attendees of the...

Combination products pose regulatory difficulties as the requirements of medical devices must merge with pharmaceuticals and biotech. As biotech and advanced therapeutics grows, so too does the need for specialised device delivery systems resulting in an increase in combination products. Similarly, device companies are increasingly...

Regulatory lifecycle management is an essential aspect of maintaining product compliance, particularly when dealing with Chemistry, Manufacturing, and Controls (CMC) changes. However, managing these changes on a global scale introduces unique challenges due to differing regulations across countries. In this article, we explore the key…

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 complex regulatory pathways. This article explores the various marketing authorisation routes available in the European Economic…

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 evaluated efficiently. For professionals working within the pharmaceutical, biopharmaceutical, and regulatory sectors, understanding the structure and functionality of…

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 development and progress through pre-clinical, clinical, and eventual marketing. Various skilled professionals work in CMC to develop and manufacture…

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 Young, covers the unique regulatory challenges faced by manufacturers and developers working with these products, especially in Europe and…

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 regulatory aspects. This knowledge is essential for professionals involved in drug development, especially in navigating the intricacies of bringing…

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 crucial for survival in the highly competitive pharmaceutical industry. In this article, we explore key CMC challenges biotech startups face…

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 drug in history.   Why Can’t We Develop Products as…

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 over 22 years of experience, Sophie offers valuable insights for professionals interested in Chemistry, Manufacturing, and…

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, and Controls (CMC) data that demonstrate the suitability, safety, and efficacy of a pharmaceutical product. From a practical…

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 career in this field or looking to advance, understanding the right entry points, necessary skills, and…

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 industry and John highlights alternative routes that are perfect for non-scientists. In this…

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 trials, digitalisation & AI and agile working. You can watch or read the video below….

As the pharmaceutical, biopharmaceutical, and medical device industries continue to evolve at a rapid pace, the need for continuous professional development has never been greater. In this article, we explore the findings of the Educo Life Sciences Training Report 2025, which analyses training motivations across...

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 medical device companies where knowledge is the foundation for success. All R&D, manufacturing, engineering, clinical and regulatory work is…

Training has always been essential for equipping staff with the skills needed to stay competitive. In recent years, however, it has become even more critical as today’s workforce increasingly values development opportunities. As we approach the end of the year, it’s important to maximise your...

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 within the organisation. Resourcing for this gap will always be a balance between recruiting…

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 area. Consequently, the team will perform with greater competence and…

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 improvised desks on the kitchen worktop, dining room table or maybe even on the garden…

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 range from complex and highly effective plans to minimal and often ineffective ones. Despite being knowledge-intensive industries, heavily reliant…

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 employees will have a clear understanding of where they stand within an…

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 you achieve these goals. Research has repeatedly shown that organisations with…

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 stay on top of an ever-evolving sector where techniques and regulations change. One training approach is…

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 alignment with overall business goals. Secondly, it plays a vital role in attracting and retaining talent, especially as…

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 ahead of the competition, meet deadlines, and ensure successful project outcomes, teams and…