The FDA’s new CSA guidance aims to streamline CSV by promoting risk-based validation, reducing documentation, and enhancing quality and patient safety.
Regulatory Focus
Why Is Data Integrity Important When Transferring Data in a Clinical Trial?
Explore how a new validation model helps ensure data integrity in decentralized clinical trials, reducing compliance risk and enabling inspection readiness across complex systems.
Top 6 Tips for Inspection Readiness
Learn key strategies to ensure inspection readiness in clinical trials, from TMF accuracy to sponsor oversight, SME preparation, and quality-controlled documentation.
Superior Vendor Compliance Archiving
Discover how ADAMAS ensures long-term, inspection-ready access to audit records and documentation, supporting clients with reliable, compliant records retention.
Where are we with pharmacovigilance and Brexit? (updated March 2019)
There is no doubt you are aware of the UK’s intention to leave the EU on Friday 29th March 2019, and that following the planned departure, EU law – including those on medicinal products – shall cease to apply in the UK. Nevertheless, there are still ongoing...
India: PV Guidance Document
Ministry of Health & Family Welfare, Government of India, has released the Pharmacovigilance (PV) Guidance for Marketing Authorization Holders (MAHs) and it will be effective from Jan-18. The guidance document intends to enable the MAHs to set up a PV system at...
India: EC Accreditation Process: Highlights
As informed earlier in our blog, the Ministry of Health and Family Welfare, India, has mandated the accreditation of Ethics Committees (ECs), involved in supervision of clinical trials, with effect from 01-Jan-18. The accreditation will be conducted by National...
Overview of 2016 MHRA GPvP Inspection Metrics
The Medicines and Healthcare products Regulatory Agency (MHRA) recently published their latest Good Pharmacovigilance Practice (GVP) Inspection metrics covering the period April 2015 – March 2016. Within this period a total of 35 inspections had been carried out,...
ICH (E6) R2 Addendum – Step 4
The ICH E6 (R2) has been formally adopted by the ICH assembly held in Osaka, Japan on 5-10 November 2016. All changes proposed in ICH E6 (R2) Step 2 have been accepted in principle, within the ICH E6 (R2) guideline during Step 4 adoption by the ICH Assembly. A...
