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 [...]
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 [...]
Overview The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a [...]
Overview The focus of this two days training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide the participants with practical advice on RMP drafting and preparation as well as the accessor's point [...]
Overview This public training course will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life Who should attend? The course will provide practical advice for chemists and pharmacists [...]
Overview The principles of Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) were introduced in the ICH E6 (R2) guidance several years ago and have been strongly encouraged by regulatory bodies since 2011. This training will explore lessons learned, challenges, and best practices for remote and centralized monitoring [...]
