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 [...]
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 [...]
