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...

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...

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...

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...

Summary: Discover the very best methods in oil and gas contract drafting, negotiation and clarification. Description: Effective Contract risk management represents one of the biggest challenges faced by legal counsels, contract managers and supply chain specialists in the oil and gas industry. The scope that contracts are required to cover on new projects are often wide and varied, adding to the complexity. It is essential that legal professio...

Summary This October 21-24, sees Risk magazine's biggest and most renowned event: Risk USA, returning to New York for the 19th annual conference. Description Risk USA is the most authoritative conference for CROs, CIOs, regulators, traders, portfolio managers and other senior financial decision makers within the risk community. The 4 day agenda offers 6 different streams of content delivered by industry experts who will come to together to sha...

Taking place in London 22-24 April 2013, the Acquisition and Divestiture Summit offers the perfect platform to meet with leading A and D professionals from the UK, Norway and Continental Europe. With high level speakers from the most active companies in the market, it gives you an opportunity to gain a thorough understanding of the changing A&D landscape. Case study examples of pioneering strategies coupled with exceptional partnerships wi...