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25 Apr

Posted at 07:46h in Biopharmaceutical Resources, Pharmaceutical Regulatory Affairs Resources

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""]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...

22 Apr

Posted at 15:13h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""]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....

22 Apr

Posted at 10:54h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""]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,...

13 Nov

Posted at 13:52h in Medical Device & IVD Resources

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 provides...

27 Jan

Posted at 12:27h in Learning and Development in Life Sciences

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""]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...

03 Dec

Posted at 09:02h in Learning and Development in Life Sciences

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 completed...

23 Sep

Posted at 14:07h in Learning and Development in Life Sciences

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""] 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...

09 Jan

Posted at 12:50h in Learning and Development in Life Sciences

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...

08 Mar

Posted at 11:20h in Learning and Development in Life Sciences

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...

20 Jan

Posted at 12:40h in Learning and Development in Life Sciences

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...

30 Mar

Posted at 10:15h in Learning and Development in Life Sciences

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...

09 Dec

Posted at 11:32h in Learning and Development in Life Sciences

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 organisations...

08 Jun

Posted at 16:03h in Medical Device & IVD Resources

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...

21 Feb

Posted at 09:05h in Pharmaceutical Regulatory Affairs Resources

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""] 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...

21 Feb

Posted at 17:02h in Medical Device & IVD Resources, Pharmaceutical Regulatory Affairs Resources

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""]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...

18 Mar

Posted at 16:07h in Pharmaceutical Regulatory Affairs Resources

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...

24 Oct

Posted at 10:09h in Biopharmaceutical Resources, Pharmaceutical Regulatory Affairs Resources

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...

06 Mar

Posted at 16:15h in Pharmaceutical Regulatory Affairs Resources

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...

07 Jun

Posted at 18:02h in Medical Device & IVD Resources

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...

23 Jul

Posted at 13:02h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

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...

14 Jun

Posted at 11:00h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Medical Device & IVD Resources, Pharmaceutical Regulatory Affairs Resources

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...

14 Jun

Posted at 11:28h in Medical Device & IVD Resources

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...

11 Oct

Posted at 15:27h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

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...

31 Aug

Posted at 12:35h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

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...

19 Jun

Posted at 10:51h in Biopharmaceutical Resources

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...

14 Mar

Posted at 15:13h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

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...

12 Jan

Posted at 14:16h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

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 Jan

Posted at 14:12h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Medical Device & IVD Resources, Pharmaceutical Regulatory Affairs Resources

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 Fast as...

12 Jan

Posted at 14:16h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text css=""] 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...

29 Oct

Posted at 15:44h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

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...

18 Aug

Posted at 14:59h in Cell & Gene Therapy Resources

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...

30 May

Posted at 10:29h in Cell & Gene Therapy Resources

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...

05 Apr

Posted at 16:32h in Pharmaceutical Regulatory Affairs Resources

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...

13 Nov

Posted at 10:00h in Pharmaceutical Regulatory Affairs Resources

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...

25 Aug

Posted at 08:46h in Pharmaceutical Regulatory Affairs Resources

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...

23 Jan

Posted at 14:13h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

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 Jan

Posted at 12:06h in Biopharmaceutical Resources, Cell & Gene Therapy Resources, Pharmaceutical Regulatory Affairs Resources

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...

07 Jun

Posted at 09:49h in Biopharmaceutical Resources, Cell & Gene Therapy Resources

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...