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Tackling Barriers To Standardized Electronic Formatting And Navigating The EU Clinical Trials Regulation: A Conference Preview

 
• By Maureen Kenny

A two-day conference on European pharmaceutical regulatory affairs that is taking place in Brussels later this month will explore many of the main regulatory topics of concern to companies at the present time. Two of the speakers, Mickel Hedemand of the Danish Medicines Agency and Dr Surendra Gokhale of Roche, provide a taste of what they’ll be covering at the event

Regulatory Affairs
EU drug regulatory affairs are focus of Knect365 forum • Source: Shutterstock

Assessing the impact of current political changes in the EU on the pharmaceutical regulatory landscape, exploring the new EU Clinical Trials Regulation, and the timelines and milestones involved with the EU eSubmission roadmap are among the many topics that will be explored at an upcoming conference on EU regulatory affairs.

Also on the agenda are current practice and outlook for the future with regard to orphan drugs in the EU,...

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