Hosted by Unknown Host · EN · 40 episodes
Established thought leaders with verified media credentials.
🎧 DDReg Knowledge Capsule Welcome to the DDReg Knowledge Capsule — your go-to podcast for concise, insightful conversations on the latest trends, innovations, and challenges in the life sciences industry. Brought to you by the experts at DDReg, this series distills complex regulatory affairs, pharmacovigilance, market access, and clinical development topics into easy-to-understand episodes. Subscribe now and empower your pharma journey, one capsule at a time.
Unknown Host hosts DDReg Knowledge Capsule, a health show with 40 episodes published.
In this episode, we explore the significant transformation of the medical device landscape in Sri Lanka under the mandate of the NMRA. We break down the risk-based classification system—from low-risk Class One items like
This episode explores the significant 2026 updates to the Ministry of Food and Drug Safety (MFDS) drug registration process in South Korea. We dive into the relaxation of mandatory domestic clinical trials in favour of m
📢 DDReg Knowledge Capsule – Episode [29]The shift in global healthcare as digital tools move from experimental pilots to core national infrastructure. It highlights the collaborative roles of the World Health Organisati
📢 DDReg Knowledge Capsule – Episode [28]This podcast covers the analysis of the regulatory complexities involved when relocating production facilities for pharmaceuticals, biologics, and medical devices. Moving a manufa
📢 DDReg Knowledge Capsule – Episode [27]This podcast covers Post-Market Clinical Follow-up (PMCF) under the European Union’s Medical Device Regulation (MDR). It describes how manufacturers must transition from passive m
📢 DDReg Knowledge Capsule – Episode [26]This podcast cover about how ethnic sensitivity influences the creation and approval of pharmaceuticals on a global scale. It highlights that biological differences, such as genet
📢 DDReg Knowledge Capsule – Episode [25]This podcast cover about ICH E5 guidelines mandate bridging studies when foreign clinical data cannot reliably predict a drug's safety or efficacy in a local population. Requireme
📢 DDReg Knowledge Capsule – Episode [24]How cultural influences create significant discrepancies in adverse event reporting and patient-reported outcomes within global pharmacovigilance. It highlights that inconsistenci
📢 DDReg Knowledge Capsule – Episode [23]importance of maintaining rigorous oversight of external vendors within the international pharmaceutical and medical device sectors. It explains that regulatory bodies hold the pr
📢 DDReg Knowledge Capsule – Episode [22]Designing clinical trials specifically for advanced medicinal products such as gene and cell therapies. Because these treatments possess unique biological complexities, the source
📢 DDReg Knowledge Capsule – Episode [22] Failure Mode and Effects Analysis (FMEA) as a dynamic tool for managing medical device risks throughout their entire lifespan. Rather than treating it as a one-time paperwork req
📢 DDReg Knowledge Capsule – Episode [21] Integration of Artificial Intelligence and the establishment of digital trust. It asserts that the pervasive use of AI in functions like pharmacovigilance and R&D has led to an e
📢 DDReg Knowledge Capsule – Episode [20] Integration of Artificial Intelligence and the establishment of digital trust. It asserts that the pervasive use of AI in functions like pharmacovigilance and R&D has led to an e
📢 DDReg Knowledge Capsule – Episode [20]Integration of Artificial Intelligence and the establishment of digital trust. It asserts that the pervasive use of AI in functions like pharmacovigilance and R&D has led to an er
📢 DDReg Knowledge Capsule – Episode [19]These products, which often exhibit characteristics overlapping categories like medicines, medical devices, and food supplements, present a significant challenge because misclassi
📢 DDReg Knowledge Capsule – Episode [18]Hong Kong is transitioning from the Medical Device Administrative Control System (MDACS), a voluntary listing mechanism, to a new statutory mandatory registration system. This sig
📢 DDReg Knowledge Capsule – Episode [17]The significant global shift toward eCTD 4.0 for regulatory dossier submissions in the pharmaceutical industry. This new standard moves regulatory management from static files to
📢 DDReg Knowledge Capsule – Episode [16]Role of the Qualified Person Responsible for Pharmacovigilance (QPPV) in the European Union (EU). It clarifies that the QPPV services is a legally mandated strategic leader for ev
📢 DDReg Knowledge Capsule – Episode [15]The regulatory landscape for combination products in 2025, defining them as items where drugs, devices, or biologics combine for a single therapeutic effect, such as insulin pens.
📢 DDReg Knowledge Capsule – Episode [14]How Artificial Intelligence (AI) is fundamentally transforming the field of pharmacovigilance (PV), specifically in case management and signal detection. It explains that AI techn
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DDReg Knowledge Capsule is hosted by Unknown Host. The show is categorised under Health (fitness) and has published 40 episodes.
DDReg Knowledge Capsule has published 40 episodes.
DDReg Knowledge Capsule regularly covers Health, Fitness, Medicine. It sits in the Health category, with a fitness focus.
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Episodes of DDReg Knowledge Capsule average 16 minutes. a focused format where a clear narrative arc and tight preparation matter most.
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