PharmaLex Talks

About PharmaLex Talks

Hosted by PharmaLex and with guests comprised of leading industry figures, the PharmaLex Talks podcast is a place for discussion on important topics within the Pharmaceutical and Pharma-adjacent sectors.

Publisher

PharmaLex Talks

Category

news · science · science

Language

en

Explicit

No

First episode

6 Sept 2021

Latest episode

18 Jul 2025

Latest episodes

8 of 37 episodes have a transcript.

1. 

   18 Jul 2025TRANSCRIPT

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

2. 

   18 Jul 2025TRANSCRIPT

   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 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.

3. 

   9 May 2025TRANSCRIPT

   35: Challenges and best practices for managing local pharmacovigilance activities

   Alex Brenchat, Vice President at PharmaLex, explores pharmacovigilance challenges and best practices for local affiliates in a global context, emphasizing the importance of local expertise and streamlined processes in this interview.

Inside a recent episode

37: Optimizing revenue from mature products

Published 18 Jul 2025 · Transcript excerpt

[…] Paula it's nice to have you here today. Can we talk at the start to start looking at what has prompted a growing trend towards regulatory outsourcing and particularly of the mature product portfolio? Yes of course and thank you. I'd say top of mind are cost pressures and the need to focus on innovation. Companies are acutely aware of the need to maintain their mature product portfolio and accordance with the stringent regulatory requirements to keep those products on the market and sustain their long term revenue growth. As a result they're looking to domain experts and adopting a strategic approach to regulatory outsourcing. […]

Podcast Authority Score: 27 / 100

A composite of feed quality, social presence, YouTube performance and engagement. Read the methodology.

Quality

42

Social presence

0

YouTube

0

Engagement

30

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Based on episode analysis; this does not confirm that the show is currently accepting guests.

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