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Sharan Murugan
Jul 29, 20211 min read
Guideline on Quality Documentation for Drug-Device Combination Products - EMA
The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination...
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Sharan Murugan
Jul 25, 20211 min read
Clinical Trials Information System (CTIS) Free Webinar – EMA
Clinical Trials Information System (CTIS) will act as the single entry point for clinical trials authorisation and supervision in the...
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Sharan Murugan
Jul 13, 20211 min read
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – EMA
European Medicines Agency (EMA) has assessed several rare adverse events for COVID-19 vaccines and one gene therapy for treating...
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Sharan Murugan
Jul 1, 20211 min read
Five Drugs as Preferred for COVID-19 Therapeutics - listed by EMA
The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal...
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Sharan Murugan
Jun 26, 20211 min read
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...
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Sharan Murugan
Jun 19, 20211 min read
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...
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Sharan Murugan
Jun 13, 20211 min read
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...
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Sharan Murugan
May 8, 20211 min read
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...
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Sharan Murugan
May 4, 20211 min read
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...
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Sharan Murugan
May 3, 20212 min read
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...
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