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In this ISSUE

The PUEKS Project: Process Innovation in Clinical Trial Monitoring

Interventional vs. Non-interventional Study Classification in the EU: Considerations on the Impact of Direct-to-Patient Contacts

Measuring Adoption and Value of Patient Engagement

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Regulatory Authorities, EMA
Senior Italians Confer in EU on EMA Relocation
What cannot have escaped the attention of any impartial observer is that Milan is one of the leading contenders to host the EMA and that Tajani and Rasi are both Italian. The EMA relocation is a hot topic without any bias towards Milan.
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15th Annual Global Forum
Sept 25-29, 2017
Hyatt Regency McCormick Place, Chicago, IL

Returning for its 15th iteration, the world's largest event for temperature-controlled life science supply chains heads back to Chicago this year with a focus on the next generation of temperature control! Join 850+ attendees from 30+ countries for five days of master classes, workshops, track sessions, panel discussions, roundtables, and more. With the Global Forum, your company will meet emerging and ongoing challenges for 2017 and beyond. Register now
Calendar
/ Global Risk-Based Monitoring 9/14-9/15 /
/ Real-World Evidence Forum 9/27-9/28 /
/ Rare Diseases & Orphan Products Breakthrough Summit 10/16-10/17 /
/ Speed to IND for Biologics 10/19-10/20 /
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ERT Video Series
Check out the ERT video series, filmed on the show floor at DIA 2017, for interviews on Innovating Clinical Trial Management, eCOA in Clinical Research: Trends and Advances, and Optimizing Clinical Trial Imaging through Advanced Technology.
Click here to watch all 10 short videos
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Therapeutic Specific Areas
Exploring Strategies for Testing Medical Products on Pregnant and Lactating Women
The National Institutes of Health (NIH) focuses on developing strategies that will encourage further research to support safe and effective therapies for pregnant and lactating women.
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Clinical Trial Simulation: An Efficient Tool for Improved Study Designs, Dose Selection and Go/No-go Investment Decisions
Live Webcast: Tuesday, September 19 at 2:00pm BST and Thursday, September 28 at 10am EDT
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Proactive Planning, a Transformational Revolution to Improving Clinical Trial Quality?
Live Webcast: Tuesday, September 26, 2017 at 1:00pm
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Clinical Operations
The Clinical Trial of Tomorrow
Highlighting the six broad technology themes poised to transform future R&D.
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Accelerate NASH Development: Next-generation Approaches to Overcome Recruitment and Study Execution Challenges
Live Webcast: Monday, September 18 at 11:00am EDT
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Trial Management
Components of an mHealth Consent Form
As the clinical trials industry starts to incorporate mHealth initiatives into their trials, study teams now have to determine the extent of their ICF consent forms during study deployment, and how to cover mHealth activities within these forms.
... /Read more/
Regulatory
ICH E6 R2 Roundtable Review
The release of the ICH E6 R2 guidance, which outlines a new approach to clinical trials operations, will have a major impact on the industry, writes Patrick Hughes.
... /Read more/

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