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Regulatory Intelligence : a challenging emerging issue Friday 15 January 2010

This petit dejeuner will explore some aspects of this rapidly emerging field, with our invited expert, Tim Felgate.

The framework for the regulation of medicines continues to grow more complex. The development of new product types, the harmonisation of requirements and the addition of new countries to the EU all have resulted in an environment where it's becoming increasingly hard to predict how the regulatory agencies will view applications.

As a result the discipline of regulatory intelligence is becoming increasingly important as a means for gathering information, interpreting and analysing it to more accurately predict and manage the expectations of regulatory agencies at both the national supranational level.

Tim FELGATE's website: http://www.appliedregulatory.com/

 

Agenda (presentations will be held in french):

8:30 : Registration & coffee

10:30 : Questions to the speakers

11:00 :  Open discussion

 

CONDITIONS : 

The attendance is free of charge. Please register early, because the seats are limited.

Please Confirm your presence


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Focus

Outsourcing electronic submission filing: From strategy to training, from consultancy to services

Managing the development projects portfolio of an R&D organisation

eCTD: Taking what exists and inserting into GED

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