Resource Hub - Educo Life Sciences

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Learning and Development in Life Sciences
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Knowledge Management in Life Sciences

What is it? Why is it important? How to implement it

Knowledge management is one of your organisations 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 critical foundation for achieving success. All R&D, manufacturing, engineering, clinical and regulatory work...

03 December, 2021

How to Make the Most of Your Training Budget

For the Pharmaceutical, biotech and medical device industries

Delivering training to your staff has always been important to ensure they develop and maintain the skills to keep you competitive. More recently, training has become essential as today’s workforce values development opportunities more than ever before. As we get towards the end of the...

23 September, 2021

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

20 December, 2020

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

09 January, 2021

10 Tips for Turning Your Training Online

Advice for team leaders in the pharmaceutical, biotech and medical device industries

2020 saw a huge shift in the way many of us work due to the COVID-19 pandemic which is still being felt as we begin the new year. This was no exception to the pharmaceutical, biopharma and medical device industries. The workforce shifted away from...

26 January, 2021

5 Reasons to Have a Learning and Development Strategy for Your Team

Advice for leaders in the pharmaceutical, biotech and medical device industries

During my time supporting the pharmaceutical, biotech and medical devices industries with training I have encountered a variety of different learning and development plans. They range from complex and sophisticated to minimal and ineffective. For an industry that is knowledge intensive (reliant on the knowledge...

08 March, 2021

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

30 April, 2021

Three Tips to Maximise Your Team’s Development in 2021

Advice for team leaders in the pharmaceutical, biotech and medical device industries

As a leader, you are responsible for your team's development. You must ensure your team is in the best possible position to hit its objectives. An effective training strategy will help you hit these goals. Research has shown organisations with higher training budgets are more...

20 January, 2021

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

26 January, 2021

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 executing an effective learning and development plan for your team or organisation is critical for several reasons. Firstly, it is important to grow your team’s capabilities, in line with the overall business goals. Secondly, it helps attract and retain talent who are far...

30 March, 2021

Important Considerations When Developing Your Team

Pharmaceutical, biotech and medical device training

Is your team just running? Or are you proactively developing their skills and knowledge to help them run faster? The life science industry is an ever changing and fast paced environment. To stay ahead of competition, to meet deadlines and ensure successful projects teams and organisations...

09 December, 2020

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. Olivier also discusses the latest increase in gene editing therapies...

04 June, 2021

Short Guide to Chemical Characterisation in Medical Devices

Watch Educo Life Science Trainer Phil Clay discuss extractables and leachables testing

Watch Educo Life Science trainer Phil Clay discuss chemical characterisation. He discusses whether an extractables and leachables study is necessary. Whether or not an extractables and leachables study can avoid biocompatibility testing. What needs to be tested and how to select a good testing lab. Learn...

08 June, 2021

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

22 September, 2021

A Short Guide to ISO 10993 Biological Evaluation of Medical Devices | Aims, Challenges and Top Tips

Interview with Jeremy Tinkler from ICON

ISO 10993 Biological Evaluation of Medical Devices lays out a set of principles to minimise the risk of the materials used in a device. The aim is to ensure the device is safe toxicologically and safe when it comes into contact with human tissue/blood. Applying...

30 November, 2021

Regulatory Lifecycle Management of Worldwide Products: Filing Variations

Interview with Educo Life Sciences expert Sophie Nageotte

Regulatory lifecycle management is a major task when your product is approved in multiple countries. You must consider each countries process, regulations and timelines when filing a variation. It is important to understand these complexities to develop an efficient plan of action. We interviewed our regulatory...

18 March, 2022

A Short Guide to the ICH CTD (Common Technical Document)

Interview with Educo Life Sciences expert Sophie Nageotte

The ICH CTD (Common Technical Document is a structure, format and set of requirements for application dossiers for the registration of medicinal therapeutics (pharmaceuticals, biologics and ATMPs). It is widely used across the US, Europe, Japan and many other countries. Many regulatory affairs professionals are...

06 March, 2023

A Quick Guide to ISO 13485 Quality Management System

Interview with Educo Life Sciences expert Anne Jury

We interviewed Educo Life Sciences trainer Anne Jury to discuss the ISO 13485 Quality Management System (QMS) for Medical Devices & IVDs. We discuss the basics of the standard and why it is different from ISO 9001. We also discuss the different challenges faced by...

07 June, 2023

Overcoming CMC Challenges for a Start-Up Company

Interview with Educo Life Sciences expert Raz Eliav

We interviewed Educo Life Sciences trainer Raz who teaches on the CMC Essentials course. During our discussion, we delved into the significant challenges that small biotech start-ups encounter when embarking on CMC development. Importantly, Raz also offered valuable insights into potential solutions to overcome these...

31 August, 2023

A Short Guide to Continuous Biomanufacturing

Interview with Educo Life Sciences expert Margit Holzer

We interviewed Educo Life Sciences expert Margit Holzer to discuss continuous manufacturing in biopharmaceuticals. Margit explains what continuous manufacturing is and why biotech companies are trying to implement it. She goes on to provide some top tips for people looking to implement a continuous approach...

19 June, 2023

A Short Guide to Technology Transfer in Biopharmaceuticals

Interview with Educo Life Sciences expert Margit Holzer

During our discussion on technology transfer in biopharmaceuticals, we had the pleasure of interviewing Margit Holzer, an expert from Educo Life Sciences. Margit provided valuable insights on what technology transfer entails and shared helpful advice for professionals who are embarking on their own tech transfer...

19 June, 2023

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

14 March, 2022

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

12 January, 2023

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 drug in history. Watch the full interview below: [embed]https://youtu.be/-4B6qiVuM9Y[/embed] Why Can't We Develop...

12 January, 2023

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 Host Cell Protein assays. She also discusses the challenges of potency assays and how early decisions can...

12 January, 2023

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

13 February, 2022

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

20 July, 2022

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

24 May, 2022

How to get a Medical Device on the Market

Watch Educo Life Sciences Trainer Anne Jury discuss the regulatory roadmap to CE marking

We interviewed Educo Life Sciences’ trainer Anne Jury to discuss the roadmap to get a medical device on the UK/EU market. We discuss the important elements you should consider when getting your device to market. This is a must watch video interview for start ups...

18 August, 2021

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

09 September, 2021

What are Cell and Gene Therapies?

Watch Educo Life Science Trainer Melody Janssen discuss the basics of Cell and Gene Therapies

We interviewed Educo Life Sciences trainer Melody Janssen to discuss the basics of cell and gene based therapies. In the interview we discuss: What are cell and gene therapies – How are they defined by the FDA and EMA? What is a gene therapy and is mRNA a...

18 August, 2021

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 features or specialised software that is critical to the device...

22 June, 2021

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

30 May, 2021

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

30 May, 2021

Examples of Medical Device Classification | EU MDR

Class 1, 2a, 2b and 3 | Classification Rules | Regulatory Implications

Knowing the correct class for your Medical Device is critical. The class has an number of regulatory, clinical, quality and risk implications. If completed incorrectly the Notified Body may decide your product should go up a class, which can cause significant delays and cost. In the...

06 May, 2021

What does it mean if you are the Person Responsible for Regulatory Compliance (PRRC)?

Interview with Educo Life Sciences trainer Anne Jury

The Person Responsible for Regulatory Compliance (PRRC) is a requirement of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Medical Device and IVD professionals across the globe are taking on this responsibility for their organisation. But what does it mean if you are the...

11 March, 2021

Pharmaceutical Regulatory Affairs Career Advice: CMC Regulatory Affairs

An interview with Educo Life Sciences Trainer Sophie Nageotte

We interviewed Educo Life Sciences trainer Sophie Nageotte to get her views on a career in pharmaceutical regulatory affairs, specifically CMC. Sophie discusses her career experiences and provides some advice for those working in regulatory CMC. She also discusses why CMC regs is an exciting...

05 April, 2021

Regulatory Affairs Career Advice

An interview with Educo Life Sciences Trainer Andrew Willis

We interviewed Educo Life Sciences trainer Andrew Willis to get his views on a career in regulatory affairs. We discuss top tips to those looking to start out in regulatory affairs but also provide some great advice for people looking to transition into new areas...

25 August, 2022

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

23 January, 2023

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

23 January, 2023

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 provides some advice for those starting out in biotech. She also discusses future trends such as cell and...

07 June, 2021

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

03 February, 2021