The responsibilities for all stakeholders involved are set out in GVP Module XVI for Risk Minimisation . It is important to ensure that additional risk minimisation measures, including assessment of their effectiveness, do not introduce undue burden on the healthcare delivery system, the marketing authorisation holders, the regulators, and, most importantly, on the patients. The necessity to have a clearly defined objective in order to minimis...

Energy Risk are delighted to offer this highly interactive two-day training course which covers a range of techniques and practices in the field of energy risk management. The programme has been expertly designed to expand the knowledge of participants in relation to risk, exposures, managing uncertainty, portfolio management, portfolio management, limit setting and the implementation of controls. In addition the programme will focus on specif...

The latest legislation waives the obligation to submit PSURs routinely for generic products, well-established use products, homoeopathic products, and traditional herbal products. The submission frequency will be variable and risk based. For these, PSURs shall be submitted where there is a condition in the MA or when requested by a Competent Authority on the basis of concerns relating to pharmacovigilance data or due to the absence of PSURs fo...

For more than a dozen years, AML professionals from across Canada have gathered each spring at The Canadian Institute's Forum on Anti-Money Laundering. They know they can count on top-notch speakers, including regulators, from Canada and other countries. Plus, they benefit from networking and sharing ideas with their peers from a wide variety of reporting entities.2014 will be no exception. With significant new regulations in force January 31...

This specialist training course has been designed to focus on the assessment of risk models in the context of concrete risk model implementation. Over the last few decades we have seen the use of quantitative risk models become a cornerstone of financial regulation. Financial institutions now have to determine capital buffers based on increasingly complex modelling techniques. In addition, the crisis has highlighted the need for rigorous and c...

In the wake of the financial crisis, Basel III, CRD IV and central clearing regulatory reforms have dictated a steep increase in the capital cost of bilateral OTC derivative trades. Central counterparty clearing houses (CCP's) are now viewed as the main tool to mitigate counterparty credit risk, and the new credit value adjustment (CVA) capital charge has also been introduced for non-cleared derivatives. Moreover, transactions cleared through...

International Copyright Law is THE meeting place for lawyers, policy makers, artist's representatives, publishers & academics. You will hear from Mr Jens Bammel, Secretary General of the International Publishers Association and Richard Hooper. Richard will share the latest on the progress of the Copyright Hub Limited, the key recommendation of his review for the Government into copyright licensing. The 'Copyright Hub' is a central registry...

Asset Integrity Management Houston 2013 will focus on the expanding role of the asset integrity manager and as part of an international series of conferences, will draw upon 10 years of research with the global asset management community. The latest in a global series spanning from Aberdeen to Abu Dhabi and Stavanger to Singapore the event will explore the new complexities within this business critical function, highlighting new facets and cha...

Delegates can develop knowledge, skills , understanding ,share ideas and good practice in relation to Critical Incident Management within own organisational structures & multi agency inter-operabilit. During an incident, managers are crucial and employees will look to them for guidance, information and instruction. How management behave in the immediate aftermath of an event has a major impact on recovery , closure and the ability to move...

Regulatory investigations around the globe have reached an all time high. According to recent studies, the number of UK companies retaining outside counsel for advice in regulatory investigations jumped from 25% to over 75% in 2012. Today's reality is that compliance risk reaches far beyond domestic borders. Multijurisdictional investigations and agency cooperation are becoming the norm. Global Investigations Summit, taking place in London on...