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 This 2 day intensive practical programme is aimed at participants who wish to enhance their negotiating skills to master the art of negotiating for a range of legal negotiations, including one-on-one and team - on- team negotiations, negotiations with multiple partners, and one-off and continuing negotiations, also [...]
Overview Manufacturing processes should be validated prior to initiate commercial manufacturing. Regulatory bodies expect that the manufacturer understand the process so that quality, safety and efficacy of the product are designed or built into the product through the appropriate control of each manufacturing process steps. Today, process validation [...]
Overview It is common in our globalized world that, according to their specific and particular strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. It is crucial and tightly required by the Regulatory [...]
Overview Medical device manufacturers have in recent years expanded their product portfolio with digital solutions and added connectivity to their previously standalone devices. Regulatory bodies have kept the pace and updated their regulations to reflect this new reality. What do these new regulations mean for manufacturers making their [...]
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 [...]
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 [...]
