ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH Updates: What’s Coming in 2019 and Beyond

US Food and Drug Administration (FDA) officials on Monday morning held a meeting to offer a rundown of what needs to be done and...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – Guideline : General Principles for Planning and Design of Multi-Regional Clinical Trials...

Objectives of the Guideline With the increasing globalisation of drug development, it has become important that data from multi-regional clinical trials (MRCTs) can be accepted by...
EU files WTO dispute with Turkey over pharma laws

International – EU files WTO dispute with Turkey over pharma laws

According to Commissioner for Trade Cecilia Malmström, Turkey is effectively forcing manufacturers of pharmaceuticals to move production into the country if they want their...
Big Pharma come together for better drug side effect detection

International – Big Pharma come together for better drug side effect detection

The Drug Safety Research Unit (DSRU) established the international group that consists of pharma giants such as Pfizer, Roche, BMS, Takeda, Lilly, Gilead, Alexion...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH guideline E19 on optimisation of safety data collection

This Guideline is intended to provide internationally harmonised guidance on an optimised approach to safety data collection in some late-stage pre-approval or post-approval studies when...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – Guideline for Elemental Impurities Q3D(R1)

Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present...
WHO drafts guidance for pharma supply chain tracking

International – WHO Consults on QMS Guideline for Regulators

The World Health Organization (WHO) in January released for consultation a draft of its upcoming guideline on implementing quality management systems (QMS) for national...
WHO drafts guidance for pharma supply chain tracking

International – WHO Warns of Falsified Leukemia Drug in Supply Chain

The World Health Organization issued a warning about fake versions of Iclusig (ponatinib) that have been circulating throughout Europe and the Americas. A wholesaler in...
Ajovy bags NICE approval

International – NICE and Canadian counterpart to offer joint advice service

The service will offer guidance that will help pharma develop value-based evidence by providing feedback on the company’s clinical and economical evidence generation plans. Feedback...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH Offers Updates on Guidelines, Working Groups

In addition to updates on how ICH regulatory members are implementing ICH guidelines, the ICH Assembly at its meeting in Charlotte, NC, on 14-15...

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