DDReg Knowledge Capsule

DDReg Pharma
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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.

  1. 1 天前

    Pharmacovigilance Launch Readiness For Marketing Authorization Holders

    Welcome back to the DDReg Knowledge Capsule! In this episode, we explore how Marketing Authorization Holders (MAHs) build and maintain compliant Pharmacovigilance (PV) governance structures as products transition to commercialization.We break down the core operational components of PV systems, including Qualified Person for Pharmacovigilance (QPPV) services, Individual Case Safety Report (ICSR) processing, literature monitoring, and signal managementWe also highlight how MAHs manage risk management strategies, aggregate safety reports, and audit and compliance controls to ensure ongoing patient safety and fulfill regulatory obligations post-approval.Finally, we outline how PV teams work alongside Regulatory Affairs to update regulatory authorities and maintain accurate product documentation. Visit our blog for more information - https://resource.ddregpharma.com/blogs/global-to-local-pharmacovigilance-governance/

  2. 3 天前

    The Strategic Role of Regulatory Affairs in Pharma Industry

    In this edition of the DDReg Knowledge Capsule, we explore how Regulatory Affairs guides medicinal products from early research through market authorization and post-approval lifecycle management. Learn how RA teams establish global regulatory strategies, coordinate complex submissions, manage health authority interactions, and leverage digital tools to accelerate approval timelines while maintaining public health safety, quality, and efficacy Visit our blog - https://resource.ddregpharma.com/all-category/role-of-regulatory-affairs-in-the-pharmaceutical-industry/

  3. 9月24日

    Global Biosimilar Pathways 2026 : US, EU, UK & Asia

    Welcome to the DDReg Knowledge Capsule! In this episode, we unpack the rapidly changing global regulatory landscape for biosimilar development across key target markets: the US (FDA), European Union (EMA), UK (MHRA), China (NMPA/CDE), and Japan (PMDA).We examine the pivotal 2026 transition away from routine comparative clinical efficacy trials toward tailored, risk-based evaluation frameworks grounded in high-resolution comparative analytical data, pharmacokinetic (PK) studies, and immunogenicity assessments.Key topics covered in this episode: Tailored Evidence Pathways: How regulators like the FDA, EMA, MHRA, and PMDA are evaluating biosimilarity without automatically requiring comparative efficacy studies.Reference Product Selection & Bridging: Navigating jurisdiction-specific reference rules and establishing scientific bridging between foreign comparators and local originators.Global Core Strategy: Designing one unified scientific dossier with planned regional adaptations to avoid duplicated clinical trials and submission delaysVisit our blog - https://resource.ddregpharma.com/blogs/global-biosimilar-regulatory-strategy/

  4. 9月23日

    Registering Biosimilar Drugs with Health Canada

    Welcome to DDReg Knowledge Capsule! In this episode, we explore Health Canada's regulatory framework for registering biosimilar biologic drugs. We break down the fundamental differences between biosimilars and generic small-molecule drugs, explain why biosimilars are authorized through the New Drug Submission (NDS) pathway, and discuss the pivotal role of the Canadian Reference Biologic Drug (CRBD). Listeners will also gain actionable insights into scientific reviews by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), indication extrapolation requirements, and post-market pharmacovigilance obligationsCheck out our blog - https://resource.ddregpharma.com/blogs/biosimilar-registration-in-canada-guide/

  5. 9月18日

    Global Regulatory Operating Model For Pharma Leaders

    This episode explores how pharmaceutical organisations can effectively structure regulatory roles across global, regional, and local markets. Based on the DDReg guide to global regulatory operating models, the discussion highlights the strategy of "controlled decentralization"—maintaining global consistency for core scientific positions while ensuring local authority ownership where jurisdiction-specific knowledge is critical.Key topics covered include: The five-layer operational structure: Defining decision rights across enterprise regulatory governance, product strategy, regional translation, local execution, and regulatory operations.Cross-functional coordination: Clarifying accountabilities between regulatory affairs, clinical development, CMC/quality, pharmacovigilance, and supply chain functions.Modern data standards & technology: How eCTD v4.0, ISO IDMP master data standards, Regulatory Information Management (RIM) systems, and AI in 2026 are reshaping regulatory workflows and data governance

  6. 9月11日

    Mastering Global CMC Variations & Life Cycle Management

    Welcome to DDReg Knowledge Capsule! In this episode, we dive into the complex world of global post-approval change management in the pharmaceutical industry.When a drug product undergoes a single internal scientific or manufacturing modification—such as a site transfer, process modification, or analytical method update—it can trigger dozens of distinct regulatory submissions across international jurisdictions. This episode explores why global pharmaceutical companies must separate the globally controlled scientific change from market-specific regulatory pathways. For more, visit our blog: https://resource.ddregpharma.com/blogs/global-variation-management-post-approval-change/

  7. 9月4日

    Malaysia NPRA 2026: Fast Route for Biosimilar Registration

    Welcome to the DDREG Knowledge Capsule. In this episode, we unpack the National Pharmaceutical Regulatory Agency's (NPRA) landmark 2026 reliance pilot pathway in Malaysia. We explore how eligible biosimilars with prior US FDA or EMA approval can now access an accelerated 60-working-day registration timeline.However, this rapid timeline is far from automatic. We break down the strict parameters sponsors must navigate to succeed, including the critical three-month post-approval submission window, rigorous dossier sameness requirements, and NPRA-specific local additions like ASEAN Zone IVb stability data. Tune in to discover how global biopharma teams can proactively adapt their launch strategies to successfully leverage this new pathway For more ready this blog - https://resource.ddregpharma.com/blogs/biosimilar-registration-malaysia-npra/

  8. 8月31日

    Mandatory EUDAMED Compliance for German Medical Devices 2026

    Welcome to this episode of the DDReg Knowledge Capsule. In this session, we break down Germany's critical regulatory transition from the national DMIDS database to the EU-wide EUDAMED platform. We explore the operational modules that became mandatory on 28 May 2026—including Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance—and clarify the upcoming 28 November 2026 transition deadline for legacy and MDR/IVDR devices. Listeners will learn about the process for validating Single Registration Numbers (SRNs) in Germany, the special requirements for non-EU manufacturers working with authorised representatives, and how to avoid costly compliance errors like assuming automatic data migration from DMIDS. For more, visit our blogs: https://resource.ddregpharma.com/blogs/eudamed-mandatory-registration-germany-bfarm/

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簡介

🎧 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.

資訊

  • 創作者
    DDReg Pharma
  • 活躍年代
    2026年
  • 集數
    60
  • 年齡分級
    兒少適宜
  • 版權
    © DDReg Pharma
  • 節目網站
    DDReg Knowledge Capsule