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Draft Guideline on Computerised Systems & Electronic Data in Clinical Trials -EMA
Computerised systems are being increasingly used in clinical research. The complexity of such systems has evolved rapidly during the last...

Sharan Murugan
Jun 26, 20211 min read
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PIC/S Adapting EU GMP Annex 16 on Authorised Person and Batch Release
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection...

Sharan Murugan
Jun 19, 20211 min read
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Open Consultation for EU common standard on electronic product information- EMA
The European Medicines Agency (EMA) on 8th June 2021 launched a stakeholder consultation on a draft EU common standard for electronic...

Sharan Murugan
Jun 13, 20211 min read
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Expectations & Challenges in Conducting Virtual Inspections- USFDA and EMA
Regulators from 11 agencies, representing the US, the UK, Spain, Germany, and Russia, discussed their views on these challenges and...

Sharan Murugan
May 8, 20211 min read
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Finalized Guidance on Parallel MAA, EU-M4all procedure -EMA
The European Medicines Agency (EMA) on 22 April 2021 released the final version of its guidance for parallel EU-M4all (Article 58) and...

Sharan Murugan
May 4, 20211 min read
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EU IDMP Implementation Guide - version 2.0
EMA published the current version, version 2.0 (EU IG v2.0), in February 2021. It mainly serves to support the European medicines...

Sharan Murugan
May 3, 20212 min read
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