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🎧 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.
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Advanced FMEA in Medical Device Lifecycle Management
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📢 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 requirement, the source advocates for a comprehensive framework that evolves alongside design, manufacturing, and real-world usage. It…
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10 Rules For 2026 Life Sciences Approvals
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12:24
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12:24
📢 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 erosion of digital trust, necessitating that automated systems be audited with the same rigor as traditional validated processes. Re…
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FDA 510(k) Submission Process Guide for 2026
11:40
11:40
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📢 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 erosion of digital trust, necessitating that automated systems be audited with the same rigor as traditional validated processes. Re…
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AI Auditability: The Foundation of Digital Trust in Pharma
14:52
14:52
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📢 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 erosion of digital trust, necessitating that automated systems be audited with the same rigor as traditional validated processes. Reg…
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The Regulatory Nexus: Borderline Product Classification
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📢 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 misclassification carries substantial compliance risks and can severely delay market entry. Regulatory authorities determine the necessary …
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Hong Kong's Mandatory Medical Device Registration Transition
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14:50
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📢 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 significant shift is driven by the Department of Health’s goal to strengthen patient safety and align with mature international regula…
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eCTD 4.0: Redefining Regulatory Submission Strategy and Digitization
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📢 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 a data-driven connected information system, emphasising features like a unified XML backbone, unique document identifiers (UUIDs),…
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The Essential Role of the EU QPPV in Pharmacovigilance
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18:46
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📢 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 every Marketing Authorisation Holder, continuously ensuring the safety and benefit-risk profile of marketed medicines in line with E…
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Combination Products: Global Regulatory Convergence and Complexity
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18:02
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📢 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. It highlights the rapid growth of this market, which is projected to reach USD 251.9 billion by 2030, reflecting both innovation a…
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AI Reshaping Pharmacovigilance Signal Detection and Case Management
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12:57
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📢 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 technologies, such as Natural Language Processing (NLP) and Machine Learning (ML), are moving drug safety surveillance from a slow, manu…
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Pharmacovigilance for Cell and Gene Therapies
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📢 DDReg Knowledge Capsule – Episode [13]This Podcast explains that because CGTs are transformative but complex, specialised pharmacovigilance (PV) is essential throughout the entire product lifecycle, from preclinical evaluation to long-term follow-up (LTFU), which can extend up to 15 years. The text outlines key components of PV, including risk as…
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AI Utility in Regulatory Intelligence: Beyond the Hype
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16:52
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📢 DDReg Knowledge Capsule – Episode [12] Discusses the application of Artificial Intelligence (AI) in Regulatory Intelligence (RI), seeking to differentiate the genuine utility of the technology from industry hype. It defines RI as the process of evaluating regulatory data to support strategic decision-making and compliance, particularly within sec…
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mRNA Technology: Expansion Beyond Vaccines
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📢 DDReg Knowledge Capsule – Episode [11]while the COVID-19 pandemic accelerated mRNA visibility, its scope now includes cancer immunotherapies, treatments for genetic and metabolic disorders, and regenerative medicine, with the global market projected for significant growth. The text also outlines both the key benefits of mRNA, such as speed and ve…
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UAE Pharma Gateway: A Guide to UAE Pharmaceutical Registration
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The United Arab Emirates is one of the Middle East's fastest-growing pharmaceutical markets, offering a strategic gateway for global manufacturers But entering this lucrative market requires navigating a complex regulatory landscape.In this episode, we unpack the essential guidelines for the drug product registration process in UAE. We explore the …
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📢 DDReg Knowledge Capsule – Episode [9]Overview of pharmacovigilance in New Zealand, highlighting the regulatory framework overseen by Medsafe under the Medicines Act 1981. It explains that the country participates in the WHO International Drug Monitoring Programme and uses systems like the Suspected Medicine Adverse Reaction Search (SMARS) databas…
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PV Inspection Guide For Your Auditing Mastery in FDA and EMA
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13:21
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📢 DDReg Knowledge Capsule – Episode [9]pharmacovigilance (PV) inspections preparedness, conducted globally by regulatory bodies to ensure compliance among marketing authorization holders. These inspections, which can be announced or unannounced, verify that systems, facilities, and processes adhere to PV requirements and aim to identify non-complia…
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Mexico Drug Registration Process via COFEPRIS
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📢 DDReg Knowledge Capsule – Episode [8]In-depth guide to the drug registration process in Mexico, highlighting its importance as the second-largest pharmaceutical market in Latin America. The core of the process is overseen by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), which categorises medicines into distinct regu…
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New Drug Approval Roadmap According to CDSCO
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12:07
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📢 DDReg Knowledge Capsule – Episode [8]In this podcast, we cover the steps and points that any global and local entity should follow when planning to register their new drug product in the Indian market.
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📢 DDReg Knowledge Capsule – Episode [7] In-depth analysis of the European Union’s Packaging and Packaging Waste Regulation (EU PPWR), officially designated as Regulation (EU) 2024/1781, which replaces a previous directive to mandate stricter sustainability standards across the EU. This new regulation, which entered into force in February 2025, a…
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Translational Biology Accelerating Tomorrow's Therapies
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15:49
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📢 DDReg Knowledge Capsule – Episode [6]Introduces the concept of Translational Biology and explains how this field is accelerating the development of new therapies by creating a continuous feedback loop between laboratory discovery and patient care. The article outlines the multi-stage Translational Biology Pipeline (T0 to T4), which moves finding…
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Biosimilar Safety in 2025 | Your Strategic Pharmacovigilance Checklist
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📢 DDReg Knowledge Capsule – Episode [6]Strategic Pharmacovigilance Checklist for Biosimilar Safety in 2025," which offers guidance on managing the increasing complexities of biosimilar safety. The article explains that the biosimilar market is rapidly expanding, necessitating robust pharmacovigilance (PV) to ensure patient safety and mitigate risks…
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China Pharma Market Innovation Regulation and Global Impact
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14:22
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14:22
📢 DDReg Knowledge Capsule – Episode [5]Overview of the drug approval process in the Chinese pharmaceutical market, highlighting its significance as the world's second-largest. It details the types of drugs approved, including innovative medicines, generics, and traditional Chinese medicines, and identifies the key regulatory bodies, namely the Nati…
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Staying Vigilant When the Patient Volume Is Low
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13:15
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📢 DDReg Knowledge Capsule – Episode [5] Low data doesn’t mean low risk. In this episode, we unpack how PV teams detect signals in low-volume markets, using smarter tools, sharper strategies, and local expertise to keep drug safety ahead of the curve. For mor Visit our blog https://resource.ddregpharma.com/blogs/signal-detection-in-low-volume-market…
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📢 DDReg Knowledge Capsule – Episode [4] This DDReg Knowledge Capsule focuses on cybersecurity in connected medical devices, highlighting the critical balance between technological advancement and patient safety. It discusses the evolving landscape of cyber threats and the regulatory frameworks put in place by bodies like the FDA and the Department …
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How On-the-Spot Testing Brings Care Closer
15:26
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📢 DDReg Knowledge Capsule – Episode [3] In this episode of the DDReg Knowledge Capsule,introduce point-of-care diagnostics (POC) as a rapidly expanding sector within the in-vitro diagnostics industry. It explains that POC devices facilitate quick medical testing near the patient, leading to faster diagnoses and improved outcomes, particularly in si…
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How Apps Are Changing the Way We Manage Chronic Illness
15:59
15:59
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📢 DDReg Knowledge Capsule – Episode [2] In this episode of the DDReg Knowledge Capsule, we dive into Digital Therapeutics (DTx), highlighting their role in transforming chronic disease management. It details how DTx, which are clinically validated, software-driven interventions, empower patients through personalised, data-driven care, evidence-base…
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📢 DDReg Knowledge Capsule – Episode [1] In this episode of the DDReg Knowledge Capsule, we dive into the evolving landscape of Software as a Medical Device (SaMD) — a transformative area in digital health that's reshaping patient care and healthcare delivery. Join us as we explore: 🔹 What qualifies as SaMD under global regulatory frameworks 🔹 Key r…
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