Feb 13 2020

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NewsPharmaceutical regulatory affairs

On October 2nd 2017, the FDA held a 2-day meeting to discuss how generic drug development – especially that for complex generics – could be better streamlined. More

The final countdown: Transition from paper/NeeS to eCTD format submission for all regulatory activities 18/09/2017

eCTD is of great interest nowadays for the pharmaceutical industries, as the EMA disposed mandatory use of eCTD format for all submissions before 2019. More

Marketing Authorisation Holders, the impact of the UK’s decision to invoke Article 50 of the Treaty on European Union. How could this affect MAH’s products currently registered in the UK and EU? 04/07/2017

Signal Management

Flow chart to illustrate the process of signal generation, detection and evaluation

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