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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...

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...

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...

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...

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...