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Pharmacovigilance: The Regulatory Outlook
by Pharmacovigilance Team
publish date icon February 15, 2018

Pharmacovigilance: The Regulatory Outlook

Quanticate looks at some of the challenges and pharmacovigilance regulations the industry faces since 2012 with the introduction of GVPs, Brexit and ICH E2B(R3)

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ICH E2B(R3): Are You Ready For The New Update?
by Pharmacovigilance Team
publish date icon December 4, 2017

ICH E2B(R3): Are You Ready For The New Update?

The ICH E2B(R3) update is intended to standardize the definition of the data elements used in electronic transmission of different types of ICSRs. Learn more

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ICH GCP E6 Addendum R2 - What do you need to know?
by Commercial Team
publish date icon February 13, 2017

ICH GCP E6 Addendum R2 - What do you need to know?

Explore the ICHGCP E6 Addendum R2 changes and what they mean for sponsors and vendors in clinical trial conduct, risk-based monitoring and emerging technologies

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Traceability - Where is Your Clinical Information?
by Commercial Team
publish date icon September 28, 2011

Traceability - Where is Your Clinical Information?

Quanticate blogs on the importance of traceability of clinical information and challenges of meeting regulatory requirements with outsourced clinical data

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