Tag Archive: EudraVigilance

Brexit Update (again)

An update on the status of Brexit and the EMA move to Amsterdam.

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EMA Move

EMA Move – The Details

It’s decided: the EMA is moving to Amsterdam, The Netherlands by March 30, 2019. Less than two years away. Bart Cobert highlights the PV/Drug Safety concerns of the EMA move.

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Laws, Regulations, Guidances, Guidelines and Best Practices

Bart Cobert attempts to clear up the confusion around Drug Safety and PV requirements in different regions of the world, with a focus on US and EU requirements.

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The French Phase I Trial Disaster

Bart Cobert discusses the lessons learned from the recent Phase I trial disaster in France.

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EudraVigilance Stakeholder Change Management Plan

EMA Changes to EudraVigilance (EV), ICSR reporting and SUSAR reporting

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Bart’s Corner: EU Regulatory Updates

EMA Working Programme for 2014 In December 2013, the EMA published its work program for 2014. It covered the many areas that the agency supervises and regulates. Much of the document is devoted to GMP, operational issues and other non-PV areas. But some comments in the PV sections are of[…]

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