PharmaLex Talks

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 companies are sustaining revenue streams and renewing focus on innovation by optimizing the operational costs of complying with stringent regional and local regulatory requirements.

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 to any ICH-participating regulatory agency, there is movement in some regions towards implementation. Karl-Heinz shares his knowledge and perspective on the journey so far and the outlook for further eCTD 4.0 adoption.

In this episode of the PharmaLex Talks Podcast, sits down with Alex Brenchat, Vice President of Local Affiliate Pharmacovigilance Services at PharmaLex, a Cencora company. Together, they explore the complexities of pharmacovigilance (PV) in a global context, focusing on the unique challenges faced by local affiliates in navigating diverse regulations post-marketing. With over 20 years of experience in the pharmaceutical industry, Alex shares valuable insights on balancing local requirements with global standards, the resource-intensive nature of PV activities, and effective strategies for outsourcing these critical functions. Listeners will gain a deeper understanding of the importance of local expertise, streamlined processes, and the role of technology in managing PV activities efficiently. Join us for an informative discussion that sheds light on best practices and the future of pharmacovigilance in the ever-evolving pharmaceutical landscape.

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 importance in the German Pharma Strategy

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 holistic contamination control strategy (CCS), based on a risk assessment.