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Sharan Murugan
- Jul 13, 2021
- 1 min
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, 2021
- 1 min
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, 2021
- 1 min
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, 2021
- 1 min
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, 2021
- 1 min
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, 2021
- 1 min
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, 2021
- 1 min
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, 2021
- 2 min
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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