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Author

fgalzin

111 Articles

Articles by fgalzin

Getting ready for the EMA Policy 0070 – Clinical Data Publication – Relaunch
September 13, 2023
English
Getting ready for the EMA Policy 0070 – Clinical Data Publication – Relaunch next-arrow
Unlicensed 'Special' Medicinal Products in the UK: A Comprehensive Overview
September 11, 2023
English
Unlicensed 'Special' Medicinal Products in the UK: A Comprehensive Overview next-arrow
Companion Diagnostic (CDx) Regulatory Challenges in the EU
August 31, 2023
English
Companion Diagnostic (CDx) Regulatory Challenges in the EU next-arrow
Building the Best Publishing Team for Our Clients
August 21, 2023
English
Building the Best Publishing Team for Our Clients next-arrow
PLG
August 10, 2023
English
New IVDR Transitional Periods next-arrow
CGT & ATMP: Development Challenges & Way Forward
August 03, 2023
English
CGT & ATMP: Development Challenges & Way Forward next-arrow
Tackling Challenges in Optimising Pharma Artwork Labelling
August 02, 2023
English
Tackling Challenges in Optimising Pharma Artwork Labelling next-arrow
The Crucial Role of Linguistic Reviews in the Pharma Industry
August 01, 2023
English
The Crucial Role of Linguistic Reviews in the Pharma Industry next-arrow
Regulatory & development challenges of oligonucleotide therapy
July 24, 2023
English
Regulatory & development challenges of oligonucleotide therapy next-arrow
Comparison between WHO-UMC causality assessment and Naranjo ADR probability scale
July 18, 2023
English
Comparison between WHO-UMC causality assessment and Naranjo ADR probability scale next-arrow
PLG
July 11, 2023
English
Introduction to the ASEAN Common Technical Dossier (ACTD) for Pharmaceutical Registration next-arrow
The HTA Regulation, Joint Clinical Assessments and Joint Scientific Consultations across the EU: A Dream Comes True
July 07, 2023
English
The HTA Regulation, Joint Clinical Assessments and Joint Scientific Consultations across the EU: A Dream Comes True next-arrow
Revised FDA guidance on Generic Transdermal and Topical Delivery Systems
July 03, 2023
English
Revised FDA guidance on Generic Transdermal and Topical Delivery Systems next-arrow
Insight to Acquiring PL License across the United Kingdom from PLGB (Product License Great Britain) or PLNI (Product License Northern Ireland)
June 15, 2023
English
Insight to Acquiring PL License across the United Kingdom from PLGB (Product License Great Britain) or PLNI (Product License Northern Ireland) next-arrow
Evaluation of prospective service providers: Supervision of the relationship with service provider for pharmacovigilance
June 14, 2023
English
Evaluation of prospective service providers: Supervision of the relationship with service provider for pharmacovigilance next-arrow
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