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.
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Essential Guide to Clinical Evidence for Medical Devices in the EU
Explore Key Standards and Guidance Documents
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 CTD for CMC Regulatory Professionals
Discover Key Steps for Regulatory Success
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...
-
Understanding RNA Therapeutics
Revolutionising Medicine Through Precision Treatments
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...
-
Navigating EU Marketing Authorisation: Key Routes and Procedures Explained
Centralised vs Decentralised vs Mutual Recognition Procedures
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 ...
-
Understanding CMC Development
A Guide to Chemistry, Manufacturing, and Controls in Drug Development
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...
-
What is UDI (Unique Device Identification)?
Learn More About UDI Labelling for Medical Devices
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...
-
Pharmaceutical CMC: Career Advice When Working in Chemistry, Manufacturing and Controls
Interview with Educo Life Sciences expert Raz Eliav
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...
-
What is a PRRC (Person Responsible for Regulatory Compliance)?
Learn More about the Role of a PRRC
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...
-
Mastering Tech Transfer in Biopharmaceuticals
Discover Best Practices, Challenges, and Key Considerations
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...
-
Medical Device Design & Development – Challenges When Transitioning Legacy Products
Interview with Educo Life Sciences expert Richard Young
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....
-
Navigating the Regulatory Landscape for Combination Products in Pharmaceuticals and Medical Devices
Unlock the complexities of combination product development
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...
-
Navigating CMC Challenges for Biotech Startups
Discover Practical Solutions for Success
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...
-
How to get a Medical Device on the Market
Discover the Regulatory Roadmap to CE Marking
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...
-
Key Strategies for Successful Implementation of Continuous Biomanufacturing
Discover how to reduce costs, speed up timelines, and ensure product quality
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...
-
Understanding ISO 13485: A Guide for Medical Device Professionals
Learn more about ISO 13485 and how to successfully implement it
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...
-
Understanding the Common Technical Document (CTD)
A Comprehensive Guide of the ICH CTD for Pharmaceutical Professionals
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 ...
-
Getting into the Pharmaceutical Industry: Alternative Routes and Roles for Non-Scientists
An interview with Educo Life Sciences trainer John Faulkes
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...
-
Top Three Trends in the Pharmaceutical Industry
An interview with Educo Life Sciences trainer John Faulkes
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 ...
-
Cell and Gene Therapy Career Advice: CMC Analytical
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
What Are the Most Challenging Analytical Assays for Biological Products?
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
Can We Develop Products as Fast as the COVID Vaccines?
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
Career Advice: Regulatory Affairs Insights, Career Progression, and Future Trends
An interview with Educo Life Sciences Trainer Andrew Willis
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...
-
A Quick Guide to Internal Audits for Medical Devices and IVDs
Interview with Educo Life Sciences trainer Richard Young
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...
-
A Short Guide to Human Factors in Medical Devices
Interview with Educo Life Sciences trainer Richard Young
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...
-
Challenges and Strategies in Regulatory Lifecycle Management
Focus on CMC Changes and A Global Perspective
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...
-
Bioanalytics In The Development of Cell and Gene Therapies
What are the major challenges compared to biotech?
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...
-
How Will The IVDR Impact You?
Interview with Educo Life Sciences trainer Richard Young
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...
-
Best Practice for Knowledge Management in Life Sciences
What is it? Why is it important? How to implement it
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...
-
Understanding ISO 10993: Navigating Biological Safety for Medical Devices
Explore the Standards Aims and Challenges
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...
-
A Guide to Data Sources and Literature Review During ISO 10993 Biological Evaluation
Watch Educo Life Science Trainer Rona Middlemiss
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...
-
What is Medical Device Product and Process Validation?
Watch a short video guide with Educo Life Science Trainer Richard Young
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...
-
What are ATMPs (Cell and Gene Therapies)?
Learn more about cell & gene therapies
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...
-
A Short Guide to Software as a Medical Device
Watch Educo Life Science trainer Richard Young discuss the biggest challenges and common mistakes
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...
-
Comprehensive Guide to Chemical Characterisation and Biocompatibility in Medical Devices
Understand Chemical Characterisation to Ensure a Safe and Compliant Medical Device
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...
-
Biopharmaceutical Career Advice: Bioprocessing
An interview with Educo Life Science Trainer Margit Holzer
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...
-
Cell and Gene Industry | How Has it Changed and Future Trends
Watch Educo Life Science Trainer Olivier Negre discuss the Cell and Gene Landscape and Trends
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...
-
A Guide to the Main Challenges When Developing a Cell and Gene Therapy (ATMP)
Advice from a range of Educo Life Sciences' trainers
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,...
-
Top Tips When Moving into Cell and Gene Therapies (ATMPs)
Advice from Educo Life Sciences' 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 requi...
-
A Comprehensive Guide to Medical Device Classification Under the MDR
From Class I to Class III Requirements with Examples
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...
-
Why are Career Pathways Important and How to Create Them
In the pharmaceutical, biotech and medical device industries
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...
-
Career Advice: Sophie’s Journey in CMC Regulatory Affairs
An interview with Educo Life Sciences Trainer Sophie Nageotte
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 ...
-
Creating a Successful Learning and Development Strategy for Your Team
A 7-point plan for leaders in the pharmaceutical, biotech and medical device industries
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...
-
5 Reasons to Have a Learning and Development Strategy for Your Team
Advice for leaders in the pharmaceutical, biotech and medical device industries
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...
-
Medical Device & IVD Career Advice: Regulatory Affairs
An interview with Educo Life Sciences Trainers Anne Jury and Richard Young
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...
-
Benefits of Live Online Training
In the pharmaceutical, biotech and medical device industries
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...
-
10 Tips for Turning Your Training Online
Advice for team leaders in the pharmaceutical, biotech and medical device industries
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...
-
Essential Guide to Clinical Evidence for Medical Devices in the EU
Explore Key Standards and Guidance Documents
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...
-
What is UDI (Unique Device Identification)?
Learn More About UDI Labelling for Medical Devices
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...
-
What is a PRRC (Person Responsible for Regulatory Compliance)?
Learn More about the Role of a PRRC
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...
-
Medical Device Design & Development – Challenges When Transitioning Legacy Products
Interview with Educo Life Sciences expert Richard Young
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....
-
Navigating the Regulatory Landscape for Combination Products in Pharmaceuticals and Medical Devices
Unlock the complexities of combination product development
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...
-
How to get a Medical Device on the Market
Discover the Regulatory Roadmap to CE Marking
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...
-
Understanding ISO 13485: A Guide for Medical Device Professionals
Learn more about ISO 13485 and how to successfully implement it
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...
-
Can We Develop Products as Fast as the COVID Vaccines?
An Interview with Educo Life Sciences Trainer Nadine Ritter
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 Quick Guide to Internal Audits for Medical Devices and IVDs
Interview with Educo Life Sciences trainer Richard Young
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...
-
A Short Guide to Human Factors in Medical Devices
Interview with Educo Life Sciences trainer Richard Young
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...
-
How Will The IVDR Impact You?
Interview with Educo Life Sciences trainer Richard Young
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...
-
Understanding ISO 10993: Navigating Biological Safety for Medical Devices
Explore the Standards Aims and Challenges
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...
-
A Guide to Data Sources and Literature Review During ISO 10993 Biological Evaluation
Watch Educo Life Science Trainer Rona Middlemiss
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...
-
What is Medical Device Product and Process Validation?
Watch a short video guide with Educo Life Science Trainer Richard Young
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...
-
A Short Guide to Software as a Medical Device
Watch Educo Life Science trainer Richard Young discuss the biggest challenges and common mistakes
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...
-
Comprehensive Guide to Chemical Characterisation and Biocompatibility in Medical Devices
Understand Chemical Characterisation to Ensure a Safe and Compliant Medical Device
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...
-
A Comprehensive Guide to Medical Device Classification Under the MDR
From Class I to Class III Requirements with Examples
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...
-
Medical Device & IVD Career Advice: Regulatory Affairs
An interview with Educo Life Sciences Trainers Anne Jury and Richard Young
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...
-
Understanding RNA Therapeutics
Revolutionising Medicine Through Precision Treatments
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...
-
Understanding CMC Development
A Guide to Chemistry, Manufacturing, and Controls in Drug Development
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...
-
Pharmaceutical CMC: Career Advice When Working in Chemistry, Manufacturing and Controls
Interview with Educo Life Sciences expert Raz Eliav
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...
-
Navigating the Regulatory Landscape for Combination Products in Pharmaceuticals and Medical Devices
Unlock the complexities of combination product development
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...
-
Navigating CMC Challenges for Biotech Startups
Discover Practical Solutions for Success
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...
-
Getting into the Pharmaceutical Industry: Alternative Routes and Roles for Non-Scientists
An interview with Educo Life Sciences trainer John Faulkes
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...
-
Top Three Trends in the Pharmaceutical Industry
An interview with Educo Life Sciences trainer John Faulkes
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 ...
-
Cell and Gene Therapy Career Advice: CMC Analytical
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
What Are the Most Challenging Analytical Assays for Biological Products?
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
Can We Develop Products as Fast as the COVID Vaccines?
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
Bioanalytics In The Development of Cell and Gene Therapies
What are the major challenges compared to biotech?
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...
-
What are ATMPs (Cell and Gene Therapies)?
Learn more about cell & gene therapies
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...
-
Biopharmaceutical Career Advice: Bioprocessing
An interview with Educo Life Science Trainer Margit Holzer
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...
-
Cell and Gene Industry | How Has it Changed and Future Trends
Watch Educo Life Science Trainer Olivier Negre discuss the Cell and Gene Landscape and Trends
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...
-
A Guide to the Main Challenges When Developing a Cell and Gene Therapy (ATMP)
Advice from a range of Educo Life Sciences' trainers
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,...
-
Top Tips When Moving into Cell and Gene Therapies (ATMPs)
Advice from Educo Life Sciences' 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 requi...
-
Understanding RNA Therapeutics
Revolutionising Medicine Through Precision Treatments
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...
-
Navigating EU Marketing Authorisation: Key Routes and Procedures Explained
Centralised vs Decentralised vs Mutual Recognition Procedures
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 ...
-
Understanding CMC Development
A Guide to Chemistry, Manufacturing, and Controls in Drug Development
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...
-
Pharmaceutical CMC: Career Advice When Working in Chemistry, Manufacturing and Controls
Interview with Educo Life Sciences expert Raz Eliav
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...
-
Mastering Tech Transfer in Biopharmaceuticals
Discover Best Practices, Challenges, and Key Considerations
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...
-
Navigating the Regulatory Landscape for Combination Products in Pharmaceuticals and Medical Devices
Unlock the complexities of combination product development
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...
-
Navigating CMC Challenges for Biotech Startups
Discover Practical Solutions for Success
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...
-
Key Strategies for Successful Implementation of Continuous Biomanufacturing
Discover how to reduce costs, speed up timelines, and ensure product quality
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...
-
Getting into the Pharmaceutical Industry: Alternative Routes and Roles for Non-Scientists
An interview with Educo Life Sciences trainer John Faulkes
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...
-
Top Three Trends in the Pharmaceutical Industry
An interview with Educo Life Sciences trainer John Faulkes
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 ...
-
Cell and Gene Therapy Career Advice: CMC Analytical
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
What Are the Most Challenging Analytical Assays for Biological Products?
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
Can We Develop Products as Fast as the COVID Vaccines?
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
Bioanalytics In The Development of Cell and Gene Therapies
What are the major challenges compared to biotech?
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...
-
Biopharmaceutical Career Advice: Bioprocessing
An interview with Educo Life Science Trainer Margit Holzer
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 CTD for CMC Regulatory Professionals
Discover Key Steps for Regulatory Success
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...
-
Navigating EU Marketing Authorisation: Key Routes and Procedures Explained
Centralised vs Decentralised vs Mutual Recognition Procedures
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 ...
-
Understanding CMC Development
A Guide to Chemistry, Manufacturing, and Controls in Drug Development
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...
-
Pharmaceutical CMC: Career Advice When Working in Chemistry, Manufacturing and Controls
Interview with Educo Life Sciences expert Raz Eliav
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...
-
Navigating the Regulatory Landscape for Combination Products in Pharmaceuticals and Medical Devices
Unlock the complexities of combination product development
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...
-
Navigating CMC Challenges for Biotech Startups
Discover Practical Solutions for Success
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...
-
Understanding the Common Technical Document (CTD)
A Comprehensive Guide of the ICH CTD for Pharmaceutical Professionals
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 ...
-
Getting into the Pharmaceutical Industry: Alternative Routes and Roles for Non-Scientists
An interview with Educo Life Sciences trainer John Faulkes
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...
-
Top Three Trends in the Pharmaceutical Industry
An interview with Educo Life Sciences trainer John Faulkes
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 ...
-
Can We Develop Products as Fast as the COVID Vaccines?
An Interview with Educo Life Sciences Trainer Nadine Ritter
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...
-
Career Advice: Regulatory Affairs Insights, Career Progression, and Future Trends
An interview with Educo Life Sciences Trainer Andrew Willis
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...
-
Challenges and Strategies in Regulatory Lifecycle Management
Focus on CMC Changes and A Global Perspective
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...
-
Career Advice: Sophie’s Journey in CMC Regulatory Affairs
An interview with Educo Life Sciences Trainer Sophie Nageotte
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 ...
-
Best Practice for Knowledge Management in Life Sciences
What is it? Why is it important? How to implement it
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...
-
Why are Career Pathways Important and How to Create Them
In the pharmaceutical, biotech and medical device industries
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...
-
Creating a Successful Learning and Development Strategy for Your Team
A 7-point plan for leaders in the pharmaceutical, biotech and medical device industries
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...
-
5 Reasons to Have a Learning and Development Strategy for Your Team
Advice for leaders in the pharmaceutical, biotech and medical device industries
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...
-
Benefits of Live Online Training
In the pharmaceutical, biotech and medical device industries
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...
-
10 Tips for Turning Your Training Online
Advice for team leaders in the pharmaceutical, biotech and medical device industries
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...
-
Three Tips to Maximise Your Team’s Development in 2025
Advice for team leaders in the pharmaceutical, biotech and medical device industries
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...
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What Your Team Really Wants When you Organise Training
3 things to consider when creating training for your pharmaceutical, biotech or medical device team
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 ...
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Reasons to Consider a Customised Training Solution
For the Pharmaceutical, biotech and medical device industry
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...
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Important Considerations When Developing Your Team
For Leaders in the Pharmaceutical, Biotech and Medical Device Industries
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...