Best-practice webinar on EMA Policy 0070 compliance will feature first-hand accounts of some of the experiences and lessons learnt from 21 external submissions made by 9 pharma firms
London, UK – February 5th, 2018 – Kinapse, the global consulting and operational services provider to the Life Sciences market, is to host a practical webinar illustrating how life sciences companies are managing clinical trial data anonymization in response to new EMA and FDA requirements. The exclusive, timely session, Achieving EMA Policy 0070 compliance: A practical guide to reliable anonymization of clinical data, will be streamed live on February 21.
The webinar will feature first-hand accounts of some of the experiences and lessons learnt from 21 external submissions made by 9 pharmaceutical companies in accordance with the requirements of EMA Policy 0090. These are designed to protect patient identities as clinical trial findings are published and shared beyond the boundaries of individual companies.
• 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.
What to expect
• Drawing on companies’ early experiences of publishing anonymized clinical trial findings, the session will set out common success factors and best practice tips for other life sciences companies as they implement their own clinical data anonymization projects.
• This will help them accelerate their own projects, and strike an optimal balance between safeguarding patient confidentiality and protecting the value of clinical trial findings – in a way that is reliable, efficient and repeatable.
Webinar speakers will include:
• Pooja Phogat – Kinapse’s EMA Policy 0070 regulation and compliance expert
• Adam Sherlock, Head of Business Development at Kinapse
• PLUS representatives from pharmaceutical companies that have already tackled these challenges
• Wednesday February 21st
• 3pm UK | 4pm CET | 10 am EST
Those interesting in attending are invited to register here.
Kinapse is recognised as a leading consulting and operational services provider to the global Life Sciences industry. Founded by professionals from the biopharmaceutical sector, the company provides its services across the full R&D and commercialization life-cycle, collaborating with its clients to improve the lives of patients, through a unique Advise – Build – Operate delivery model.
19 of the global top 20 life sciences companies rely on Kinapse’s world class range of advisory and operational services to analyse, implement and perform a wide range of projects and programs around the World, delivering quantifiable business benefits and operational success.
Headquartered in the UK, Kinapse has over 700 staff located in Europe, India and USA. More at www.kinapse.com or on Twitter @KinapseGlobal.