37: Optimizing revenue from mature products
We talk with Paula King, Director, Regulatory Affairs at PharmaLex to better understand the growing trend toward regulatory outsourcing, particularly of the mature product portfolio. Hear how leading ...
18 Jul 20259min
36: What’s happening with eCTD 4.0: New and future developments
Join Karl-Heinz Loebel, Director, Regulatory Informatics & Operations at PharmaLex, as he discusses current progress of eCTD 4.0. Ten years after the eCTD 4.0 standard became available for submissions...
18 Jul 202520min
34: Environmental Risk Assessment and its growing importance in the German Pharma Strategy
Join Angela-Vogt Eisele, Associate Director Scientific Affairs at PharmaLex, a Cencora company for this podcast, where she shares her expertise in Environmental Risk Assessment and its growing importa...
14 Apr 202520min
33: Finding the best approach to manage sterility assurance
Join PharmaLex's Patrick Nieuwenhuizen for this podcast, where he shares his expertise in sterility assurance and how manufacturers can demonstrate that the finished product is sterile through a holis...
27 Jan 202515min
32: Commercialization Readiness
Pharmaceutical companies new to the EU market must navigate complex and varying commercialization requirements. The podcast highlights key steps for commercialization readiness in Europe, focusing on ...
4 Nov 202413min
31: Key Steps for Site Inspection Readiness
Louise Uí Fhatharta bio Quality professional with over 20 years’ experience in Microbiology, Quality Control and Quality Assurance roles in the Pharmaceutical Industry including Sterile Fill Finish a...
27 Jun 202417min
30: CSS Overview
A contamination control strategy (CCS) is integral to Annex 1 and is fundamentally about patient safety and identifying and avoiding contamination pathways. Manufacturers are expected to implement a C...
9 Mai 202414min
