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...

  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...

  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...

  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...

  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...

  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...

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...

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...

A combination product refers to a medical device that contains an element of a pharmaceutical. Recognising this and understanding which regulations need to be met is essential to ensure the successful marketing of your product. Educo Life Sciences caught up with Richard Young, who explained some...

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 requirements...

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...

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 interviewed...

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...

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...

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...

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...

  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...

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.   Watch...

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...