ICH and Global Compliance
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WHAT'S NEW
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The future of European drug development: An expert's view
by Fulcrum Pharma Developments
White paper
European drug development is more globally minded than any other region of the world. This white paper by Fulcrum Pharma Developments Ltd. features an interview with Frank Fildes, former senior vice president and head of global development for AstraZeneca Worldwide.
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Life sciences and biotechnology: A strategy for Europe
by European Commission
White paper
This 2002 white paper by the Commission of the European Communities (now the European Commission) proposes a framework to find ways forward on policy governing the life sciences and biotechnology industries in Europe.
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The future of European drug development: An expert's view
By Fulcrum Pharma Developments
White paper
European drug development is more globally minded than any other region of the world. This white paper by Fulcrum Pharma Developments Ltd. features an interview with Frank Fildes, former senior vice president and head of global development for AstraZeneca Worldwide.
Life sciences and biotechnology: A strategy for Europe
By European Commission
White paper
This 2002 white paper by the Commission of the European Communities (now the European Commission) proposes a framework to find ways forward on policy governing the life sciences and biotechnology industries in Europe.
EU Clinical Trials Directive: Effects on clinical research
By Fulcrum Pharma Developments
White paper
Fulcrum Pharma Developments Inc. outlines the main objectives of the European Union (EU) Clinical Trials Directive and reviews how to respond so that clinical trials can be performed in the most cost-and time-effective manner.
Methods Development and Validation
By Azopharma Inc.
Product collateral
Azopharma develops analytical methods for potency, dissolution, impurities, moisture, metals, residual solvents, and physical-chemical tests. After successful method development, Azopharma Services can validate your analytical method per ICH guidelines.
Reducing the toxicity of residual solvents used in drug manufacturing
By Teledyne Tekmar
Application note
This application note from Teledyne Tekmar discusses the use of a gas chromatograph/mass spectrometer (GC/MS) and a headspace analyzer to provide a routine method for analyzing residual solvents from drug manufacturing processes.
FDA Guidance for Industry: E15 Definitions for Genomic Biomarkers, ...
By FDA Center for Drug Evaluation and Research
White paper
This guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories.
The future of European drug development: An expert's view
By Fulcrum Pharma Developments
White paper
European drug development is more globally minded than any other region of the world. This white paper by Fulcrum Pharma Developments Ltd. features an interview with Frank Fildes, former senior vice president and head of global development for AstraZeneca Worldwide.
Life sciences and biotechnology: A strategy for Europe
By European Commission
White paper
This 2002 white paper by the Commission of the European Communities (now the European Commission) proposes a framework to find ways forward on policy governing the life sciences and biotechnology industries in Europe.
EU Clinical Trials Directive: Effects on clinical research
By Fulcrum Pharma Developments
White paper
Fulcrum Pharma Developments Inc. outlines the main objectives of the European Union (EU) Clinical Trials Directive and reviews how to respond so that clinical trials can be performed in the most cost-and time-effective manner.
