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Current Awareness in Regulatory Affairs

As well as the requirement for a 'refresher' course on basic regulatory topics, there is also a need, particularly for more senior professionals, to have an overview of some of the emerging issues of the day.

In the past, TOPRA has dealt with all of these in the same way – by planning a full-day programme involving the leading names in the regulatory agencies and industry to deliver their perspective in a series of presentations with a significant amount of time devoted to panel sessions and Question and Answer sessions.

For some topics, this remains the most time efficient way for an audience to gain an overview in these emerging issues of the day.

The TOPRA Symposium also offers members a chance to update themselves on a wide range of topics in this way and this is especially true for those people who require to provide strategic direction within their organisations. TOPRA has also in recent times developed briefing meetings with particular EU centric agencies such as the European Medicines Agency (EMEA) and European Commission where the latest Regulatory developments can be discussed.

However, if a topic is changing substantially but over a protracted period of time, it can be difficult to schedule a full-day meeting at precisely the right moment to capture the latest news. Also, for such topics, the formal presentation may not be the most useful information for the regulatory manager to hear – this can effectively be gleaned from articles in the TOPRA Regulatory Rapporteur, Tarius news and from the many regulatory agency web sites.

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