DDReg Knowledge Capsule

DDReg Pharma
  • 0.0（0則評分）
  • 醫學
  • 每週更新

🎧 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 小時前

    Navigating EMA’s Voluntary Data Submission Pilot for NAMs

    Welcome to the DDReg Knowledge Capsule! In this episode, we unpack the EMA’s Voluntary Data Submission pilot for New Approach Methodologies (NAMs). Learn how drug sponsors and researchers can submit non-animal testing evidence for informal regulatory feedback, understand essential briefing package requirements, and explore how this initiative compares with FDA and MHRA frameworks. For more info read our blog: https://resource.ddregpharma.com/blogs/ema-voluntary-data-submission-pilot-nams/

  2. 5 天前

    Navigate German Nutraceutical & Novel Food Compliance

    When does a nutraceutical ingredient become a Novel Food regulatory concern? 🌿 Explore Germany’s nutraceutical market, EU Novel Food regulations, ingredient approval requirements, and key compliance challenges for businesses. 🎧 Tune in for insights into nutraceutical registration and regulatory compliance. #Nutraceuticals #NovelFood #Germany #FoodRegulations #RegulatoryAffairs For more info read our Blog: https://resource.ddregpharma.com/blogs/nutraceutical-registration-germany-novel-food/

  3. 10月21日

    Japan & Malaysia: Faster Clinical Trial Approvals? 🌏

    Can regulatory reliance accelerate clinical trial approvals in Japan and Malaysia? Discover how the new pilot could streamline regulatory reviews, reduce timelines, and shape the future of clinical research. 🎧 Tune in for insights on clinical trial regulations and global regulatory strategy. #ClinicalTrials #RegulatoryAffairs #Japan #Malaysia #ClinicalResearch For more info read our blog: https://resource.ddregpharma.com/blogs/clinical-trial-regulatory-reliance-japan-malaysia/

  4. 10月19日

    Global-to-Local Pharmacovigilance: Bridging Safety Gaps

    How can Marketing Authorization Holders (MAHs) prevent gaps between global and local safety teams? 🌍 Discover key strategies for stronger pharmacovigilance governance, effective communication, and regulatory compliance. 🎧 Tune in to explore smarter safety coordination and risk management. #Pharmacovigilance #DrugSafety #PatientSafety #RegulatoryAffairs To know more read our blog: https://resource.ddregpharma.com/blogs/global-to-local-pharmacovigilance-governance/

  5. 10月17日

    Realities of EAEU Pharmaceutical Registration

    Welcome to DDReg Knowledge Capsule! In this episode, we unpack the complexities of pharmaceutical registration across the Eurasian Economic Union (EAEU)—covering Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan.While the EAEU Unified Procedure establishes a harmonised regional pathway for multi-state marketing authorisations, obtaining approval and maintaining post-market compliance still requires navigating critical member-state requirements.Key topics covered in this episode: Unified Procedure vs. National Pathways: How the reference-state and concerned-state evaluation system works, and when pursuing a national pathway (such as Russia’s Federal Law No. 61-FZ) may be strategically advantageous.EAEU CTD Dossier & Language Strategy: Navigating the 5-module CTD structure, managing local clinical data expectations, and addressing Russian, Armenian, and Kyrgyz translation requirements early.Post-Registration Fragmentations: Why a unified marketing authorization does not mean unified post-market compliance—exploring separate national pricing/reimbursement frameworks, distinct packaging/labelling guidelines, and non-centralised pharmacovigilance reporting systems (such as Roszdravnadzor in Russia).Post-2025 Compliance Realities: What marketing authorization holders need to know following the December 31, 2025 transition deadline for aligning legacy national registrations with EAEU rulesFor more check out blog - EAEU Pharmaceutical Registration: What’s Not Unified Procedure

  6. 10月16日

    Medical Device Registration in Kenya: Beyond Approval

    Entering Kenya’s medical device market? 🌍 Discover the key regulatory requirements foreign manufacturers need to know beyond product registration, including local representation, importation, compliance, and post-market obligations. To know more about the Podcast Read our Blog: https://resource.ddregpharma.com/blogs/medical-device-registration-kenya-foreign-manufacturers/

  7. 10月13日

    Dietary Supplement Registration in Brazil vs. Mexico ANVISA and COFEPRIS Market Entry Pathways

    "Welcome to the DDReg Knowledge Capsule" — This episode explores the contrasting regulatory pathways for entering the dietary supplement markets in Brazil and Mexico. It compares ANVISA's mandatory notification system in Brazil with COFEPRIS's compliance-focused framework in Mexico, detailing essential requirements for product classification, ingredient eligibility, local labeling rules, and import permit strategies needed for successful market entry.For more info Read our blog:https://resource.ddregpharma.com/blogs/dietary-supplement-registration-brazil-vs-mexico/

  8. 10月12日

    Strategic Regulatory Intelligence: Turning Regulatory Signals into Product Decisions

    DDReg Knowledge Capsule, discover how pharmaceutical leaders move beyond passive regulatory monitoring to build a decision-oriented strategy that directly shapes product development. Learn how evaluating global health authority updates through product-specific context enables teams to assess impacts across clinical trials, CMC, dossier submissions, and post-approval lifecycles—ensuring every strategic shift is targeted, timely, and defensible For more Info Visit to Our Blog: https://resource.ddregpharma.com/blogs/regulatory-intelligence-strategy-product-decisions/

顯示全部 (70)

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
    70
  • 年齡分級
    兒少適宜
  • 版權
    © DDReg Pharma
  • 節目網站
    DDReg Knowledge Capsule