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.
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.
This podcast discusses the essentials of preparing for inspections in regulated industries. We cover key strategies for ensuring compliance, maintaining thorough documentation, and fostering a culture of continuous readiness. Our expert guest will share their insights and experiences, providing practical tips to help organisations stay prepared for any inspection.
Tune in to learn how to navigate the complexities of inspection readiness and ensure your operations are always up to standard.
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.
In this podcast, Gerardo Gomez talks about the interactions between validation and technology transfer, considering the views and expectations of the regulators. As Gerardo explains, technology transfer is really a very sophisticated and complex project management activity and therefore needs to be carefully planned to avoid discrepancies or deviations from the regulations.
Early access programs are designed to allow patients suffering from a life-threatening unmet medical need or disease to be given promising treatments that have not yet received marketing approval. Examples of these types of programs include named patient programs, which are for a specific patient suffering from a rare, ultra-rare or life-threatening disease, and cohort programs, where patients with the same disease have been identified.
Bio Patrick Nieuwenhuizen: Quality 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.
Technology transfer involves two main types: scale-up and transfer to a different site. Scale-up technology transfer involves moving a technology or process from a laboratory or pilot-scale environment to a larger production scale. Transfer to a different site involves relocating a technology or process from one location or organization to another. Listen to the podcast to learn more about technology transfer and important considerations for success.
