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RSSL

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Key to Outsourcing Method Development and Validation A Pragmatic Approach

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation.
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News and Press Releases

The need for a blueprint emergency plan to avoid a HPAPI crisis

SMi reports: Taro Pharmaceuticals, Purdue Pharma and Sakari Consultants to present at HPAPI USA taking place on October 21st – 22nd in Boston
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White Papers

Pharmacovigilance and Risk Management Information in Centralised Applications in the EU

United BioSource Corporation (UBC)

Getting a new medication approved for the EU market through the centralised procedure can be complex and needs expertise. The new EU pharmacovigilance legislation (Good Vigilance Practice, GVP) is now in effect and applicants need to be fully compliant. It is critical to have a thorough understanding of the regulatory process and requirements, and the expectations with regards to the pharmacovigilance system and the risk management plan. Ensuring consistency and an appropriate level of detail in the documentation submitted as part of the approval process will help prevent unnecessary delays.
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Industry Events

SCOPE Europe – Summit for Clinical Ops Executives Europe

17-18 September 2019, Barcelona, Spain

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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