PharmaLex Talks

PharmaLex Talks
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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.

  1. Optimizing revenue from mature products

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    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.

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  2. What’s happening with eCTD 4.0: New and future developments

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    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.

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  3. Challenges and best practices for managing local pharmacovigilance activities

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    Challenges and best practices for managing local pharmacovigilance activities

    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.

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  4. Environmental Risk Assessment and its growing importance in the German Pharma Strategy

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    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 importance in the German Pharma Strategy

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  5. Finding the best approach to manage sterility assurance

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

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  6. Commercialization Readiness

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    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 the challenges non-EU companies face, including supply chain logistics and regulatory complexities. Early planning, strategic partnerships, and understanding local regulations are essential for successful product launches in diverse European markets.

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  7. Key Steps for Site Inspection Readiness

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    Key Steps for Site Inspection Readiness

    Louise Uí Fhatharta bioQuality professional with over 20 years’ experience in Microbiology, Quality Control and Quality Assurance roles in the Pharmaceutical Industry including Sterile Fill Finish and Medical Device.Involved in site and laboratory expansion projects from design through to method transfer and operational readiness. Supported site in a capacity of Quality, Sterility Assurance and Microbiology Lead oversight during projects. Through Industry experience strong analytical and problem-solving skills have been attained and highly developed strong leadership skills. Successful experience of leading FDA, HPRA and DEKRA Health Authority inspections.

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  8. CSS Overview

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    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 CCS across their facilities in order to define all critical control points and assess the effectiveness of all the controls and monitoring measures employed to manage risks associated with contamination. The CCS should be actively updated and should drive continuous improvement of manufacturing and control methods. Join our podcast where Londa Ritchey and Patrick Nieuwenhuizen, PharmaLex experts in quality management and compliance, share their insights on the purposes and pathways of a CCS.Bio: Londa RitcheyLonda Ritchey is currently a Quality Director at PharmaLex with 30 years of experience in pharma/biopharma/ATMP quality assurance emphasizing sterile drug substance and drug product operations. Londa's experience includes quality risk management, aseptic quality operations, quality systems design and implementation, contamination risk management, supplier quality management, training program design and inspection readiness. Her educational background includes degrees in Microbiology, Biostatistics, and an MBA.Bio: Patrick NieuwenhuizenQuality professional with a Microbiology & Sterile Manufacturing background with over 25 years’ experience in the Pharmaceutical Industry. Worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Fill Finish and Solid Oral Dose.Involved with several site and laboratory expansion projects from construction design through to method transfer and operational readiness, and has provided Quality, Sterility Assurance and Microbiology oversight where relevant during these projects.In addition to site responsibilities, involved in several corporate initiatives such as Sterility Assurance Council and the roll-out of corporate standard programs that required collaboration and communication across multiple diverse sites for the improvement and maintenance of organisational quality standards. Next to that acting as a lead auditor and have been involved with audits facing several competent authority inspections including but not limited to the HPRA, FDA, ANVISA, Chinese FDA and Canadian Health Authority inspections.Acted as risk facilitator for Quality Risk Management programs and have gained significant experience with problem-solving and management of complex investigations.

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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.

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    PharmaLex Talks
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    PharmaLex Talks