Aris Global Posts - TopicsExpress

Understanding True eTMF Requirements: Meeting the Expectations of
Understanding True eTMF Requirements: Meeting the Expectations of Industry and Regulatory! Given that eTMF solutions have been available for a while, ...

The #clinical development industry is entering a new era of change
The #clinical development industry is entering a new era of change and opportunity. It faces an increasing array of drivers from the commercial, #regu...

The ICH EWG planned to develop an Addendum to E6, Good Clinical
The ICH EWG planned to develop an Addendum to E6, Good Clinical Practices (#GCP), made good progress towards a Step 2a document (expected in June 2015...

#FDA improving medical device approval times:A new analysis by the
#FDA improving medical device approval times:A new analysis by the California Healthcare Institute (CHI) indicates that after years of unprecedentedly...

#IMDRF Opens Consultation on National Competent Authority Report
#IMDRF Opens Consultation on National Competent Authority Report (NCAR) Exchange Criteria &Report Form. A proposed document has been released by the I...

#EMA has mandated that organizations doing business in the EU will
#EMA has mandated that organizations doing business in the EU will need to submit product information according to the #ISO-IDMP standard by July 2016...