International Regulators’ Consortium Offers Joint Pipeline Discussions With Pharma
Regulators in Australia, Canada, Singapore, Switzerland and the UK are offering to host joint pipeline meetings under the ACCESS Consortium initiative to advise drug companies on their future product development plans.
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Regulators Back More Reliance On GMP Inspection Results
As medicines agencies increasingly turn to worksharing and other mechanisms to reduce duplication of effort, the Access Consortium has thrown its weight behind the use of reliance processes for national good manufacturing practice inspection outcomes.
EMA To Explain How Trial Transparency & Data Redaction Can Live Together
The European Medicines Agency is working to align the redaction and data anonymization principles underpinning two EU clinical trial transparency initiatives to ensure consistency in disclosure requirements.
ICH Consults On Modernized GCP Principles To Make Clinical Trials More Efficient
The International Council for Harmonisation has issued updated Good Clinical Practice principles to accommodate new clinical trial and data types.