Webinar - Achieving EMA Policy 0070 compliance

A practical guide to reliable anonymization of clinical data

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  • Hear, first hand, how a cross-section of life sciences companies are tackling the challenge
  • Benefit from their experiences to accelerate your own clinical trial anonymization initiative
Evolving EMA requirements around clinical trial information sharing demand that life sciences companies take action to prevent patients from being identified. Under EMA Policy 0070, they must prepare anonymized versions of their clinical reports so that subjects cannot be re-identified, while retaining the data’s value for independent secondary analyses.

In the US, the FDA is taking similar steps now too, with the launch of a new pilot initiative around clinical study reports. This adds to the pressure on firms to find a systematic solution. Featuring first-hand accounts of some of the experiences and lessons learnt from 21 submissions made by 9 pharmaceutical companies, this timely webinar will draw together some common success factors and best practice tips for other life sciences companies as they implement their own clinical data anonymisation projects.

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Webinar speakers included:

Pooja.jpg Pooja Phogat 
Kinapse’s EMA 0070 Regulation
and Compliance Expert
 		 Adam Sherlock.jpg
Adam Sherlock
Head of Business Development
Kinapse  
     Diego Herrera Egea.jpg
 Diego Herrera Egea
Head of Global Data Management
and Project Information
Global Clinical Operations (R&D)

Almirall
 

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