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Strategic Success

ICT: With the addendum to the ICH E6 (R2) Guideline for Good Clinical Practice (GCP), the GCP has seen its first significant update in over 20 years. What is the new guideline and how does it impact clinical trial design?

Patrick Hughes: The ICH GCP Guidance Integrated Addendum provides a unified standard for the EU, Japan, the US, Canada, and Switzerland. The updated ICH E6 (R2) guidelines have been introduced to encourage the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, while continuing to ensure human subject protection and reliability of trial results. Far from being considered a hurdle to overcome, the ICH E6 (R2) should be a positive step forward and an exciting opportunity for more efficient clinical R&D, with significantly better outcomes.

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Patrick Hughes is the Chief Commercial Officer at CluePoints. He holds a marketing degree from Newcastle University, UK, and a postgraduate marketing diploma in B2B marketing strategy from the Kellogg School of Management, US. Responsible for leading global sales, product, marketing, operational, and technical teams throughout his career, Patrick is a Senior Executive with over eighteen years of international commercial experience within life sciences, healthcare, and telecommunications.
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Entry now open for the PPMA Group Industry Awards 2019

The 2019 PPMA Group Industry Awards will be held at the National Conference Centre (NEC), Birmingham, on the evening of the first day of the PPMA Total Show 2019 Tuesday, 1 October 2019. 
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SCOPE Europe Summit for Clinical Ops Executives Europe

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Building on the success of its long-running US-based counterpart, Summit for Clinical Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clinical innovation leaders, clin ops execs, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the Rest of the World. The event will feature opening and closing plenary keynote sessions, five conference tracks, interactive breakout discussion groups, and networking. It is an opportunity for leaders from large, mid-sized, and small pharma, specialty pharma, biotech, vendor companies, and academic research centers to come together to share best practices and discuss the new era of analytics-driven and patient-centric trials.
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