Some of the hot topics The In vitro Medical Devices Directive has been the route to CE marking of in vitro medical devices in Europe since 2002. In 2017 the new In Vitro Medical Devices Regulation (IVDR) was published [...]
Some of the hot topics Gain insight into the process behind traditional project risk analysis and management (PRAM) Get to know more about how to identify, assess & motivate key stakeholders Learn about the use of different leadership/management styles using the continuum of shared decision making [...]
Introduction For well over a decade interest rates have been trading at ultra low and even negative levels. It would seem likely that at some stage interest rates will rise, resulting in a fall in bond rices. This course considers some of the tactics that could [...]
Some of the hot topics Foundational understanding of Blockchain/Distributed Ledger Technology A methodology to incorporate Blockchain initiatives into an organisation strategy A review of Pharmaceutical Uses Cases and Case Studies A structured framework to assess project suitability With an ever increasing regulatory [...]
Introduction The increasing demand for digitalization is currently challenging large to small sized company globally and hardly any company can ignore the digitalization trends today. This training will provide delegates clarity of which prerequisites need to be considered to prepare for the demanding task. This course [...]
Introduction This course covers the theory AND practice of Blockchains/Distributed Ledger Technology. It is based on the trainer’s extensive background as both an educator, consultant and advisor to numerous blockchain initiatives. The online course has been developed for business executives, leaders and managers. It provides far [...]
Overview Electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets) is becoming increasingly important in providing patients and medical staff with product data. A number of Regulatory Authorities now permit and indeed encourage this delivery mechanism and others are soon to follow suit. Organisations that prepare early will [...]
Overview With regulatory inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming even more important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. A company’s ability to identify and select the right CRO/ vendor for the right project [...]
Overview The understanding, development, implementation, follow-up and improvement of the GLP Principles is fundamental for the application of non-clinical health and environmental safety studies. The GLP Principles are mandatory for non-clinical safety testing of test items in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as [...]
How would you know if your company is protected from fraud? If you don’t know, let’s tackle fraud risk! Many people think that by having a hotline or report line the company is protected from fraud. They think that if there are no reports, everything is fine. Here is the first lesson: there is a [...]
