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18 Mar

Posted at 16:07h in Pharmaceutical Regulatory Affairs Resources

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...

06 Mar

Posted at 16:15h in Pharmaceutical Regulatory Affairs Resources

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...

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

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...

31 Aug

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

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...

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

  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...

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...