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Regulatory News and Trends

Phact Blog Workshop Auditing

Workshop Auditing – The Professional Use of Auditing Techniques

The Professional Use of Auditing Techniques Requires Exercise Some of us feel uncomfortable when talking about audits. And indeed, a number of audits lack of efficiency, miss systematic approaches, demonstrate
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SPOR – EMA’s Concept to Implement ISO IDMP Standards

SPOR – EMA’s Concept to Implement ISO IDMP Standards
 

‘SPOR’ – you are reminded of your Latin lessons during school years long ago and it is ‘SPQR’ that emerges before your mind’s eye? Mind the difference – the little stroke that makes the latin letter “Q”.
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EU: GMP for IMPs in View of the Revision of the EU Clinical Trial Provisions

EU: GMP for IMPs in View of the Revision of the EU Clinical Trial Provisions

Separate legal provision for ‘GMP for IMPs’ and for ‘GMP for medicinal products’ The legal framework for conducting clinical trials within the European Union (EU) has undergone major revisions and
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