Episodios

  • Weight loss drugs hit Indian Market - A temporary Fix or Long term Risk
    Mar 31 2026

    Weight-loss medications are making big headlines in India especially semaglutide-based drugs now becoming more accessible and affordable through generics.

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    19 m
  • Who Signs the Consent? LAR & Impartial Witness Explained
    Mar 17 2026

    In clinical trials, protecting patient rights is the highest priority and the Informed Consent Process plays a critical role. But many students and professionals struggle to clearly understand the roles of a Legally Acceptable Representative (LAR) and an Impartial Witness (IW) under ICH-GCP guidelines.In this video, you will learn:✅ What is a Legally Acceptable Representative (LAR)?✅ Who can act as an Impartial Witness?✅ When is an Impartial Witness required?✅ LAR vs Impartial Witness key differences explained✅ ICH-GCP requirements for informed consent✅ Real clinical trial examples✅ Common audit findings & mistakes to avoid

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    17 m
  • Clinical Research Reality in India 2026
    Mar 10 2026

    In this video, I break down the ground reality of clinical research in India including job market trends, CRA demand, salary expectations, skill gaps, regulatory impact, and future opportunities. Subscribe to our channel if you are interested in clinical research.

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    24 m
  • NDCT 2026 Amendments Explained | Major Updates in NDCT Rules #clinicalresearch #regulatoryaffairs
    Feb 24 2026

    The NDCT 2026 Amendments bring significant regulatory updates to India’s clinical research framework under the New Drugs and Clinical Trials Rules.In this video, we break down the latest changes, explain their regulatory implications, and discuss how they impact sponsors, CROs, investigators, ethics committees, and clinical research professionals across India.🔎 In this session, you will learn:• Key amendments introduced in NDCT 2026• Changes in approval timelines and regulatory processes• Updates affecting clinical trial applications• Implications for pharmacovigilance and safety reporting• Compliance strategies for sponsors and investigators• What these amendments mean for CRA, Regulatory Affairs, and PV professionalsIf you are working in pharma, biotech, medical devices, or clinical research staying updated with NDCT regulations is essential for compliance, audits, inspections, and career growth.📢 Whether you are a Clinical Research Associate (CRA), Regulatory Affairs professional, Pharmacovigilance officer, or a student preparing for a career in clinical research this video will help you stay ahead.👉 Don’t forget to Like, Comment your questions, and Subscribe for more regulatory and clinical research updates.Links to the the best Udemy Courses are given below:1️⃣ Advanced Certification in Clinical Research, CDM & PV ➡️ https://www.udemy.com/course/certification-course-in-clinical-research-cdm-pv/?referralCode=2FF04F9B4BAB080B4727 2️⃣ Advanced Certification in Clinical Data Management ➡️ https://www.udemy.com/course/clinical-data-management-masterclass-complete-certification/?referralCode=2A079D8B97F04B19B831 3️⃣ Advanced Certification in Pharmacovigilance & Drug Safety ➡️ https://www.udemy.com/course/advanced-certification-in-pharmacovigilance-and-drug-safety/?referralCode=42E2FA3B99183E7A1AF3 4️⃣ Advanced Clinical Research Associate (CRA) Training Program ➡️ https://www.udemy.com/course/advanced-clinical-research-associate-cra-training-program/?referralCode=87948D0E15091C2C2F1A 5️⃣ Cancer Clinical Research & Oncology Trials: A Complete Guide ➡️ https://www.udemy.com/course/basics-of-oncology-and-cancer-trials-a-complete-guide/?referralCode=31158303ACFF97F88E1F Video Chapters:(0:00) Introduction(0:52) Non-commercial drug manufacturing(2:37) Updates to BA/BE study timelines(4:35) Amendment scope for Rule 31(06:10) Mandatory exclusion(07:04) New operational workflow(09:44) Acknowledgment of Prior Intimation(11:35) Impact of 2026 Amendments(13:40) NDCT Rules & Forms#NDCT2026 #ClinicalResearchIndia #RegulatoryAffairs #Pharmacovigilance #CRA #clinicalresearch #clinicalresearchcareer #clinicalresearchjobs #pharmacovigilance #gcp #clinicalresearchassociate #clinicalresearchcoordinator

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    14 m
  • What is US FDA Form 483 for Clinical Trials?
    Feb 10 2026

    What is US FDA Form 483?

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    17 m
  • Root Cause Analysis in Clinical Research
    Jan 6 2026

    Root Cause Analysis in Clinical Research

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    13 m
  • Risk Based Quality Management (RBQM) | ICH GCP E6R(3) Amendment
    Dec 26 2025

    Risk Based Quality Management (RBQM) | ICH GCP E6R(3) Amendment

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    13 m
  • Clinical Trial Management System
    Nov 25 2025

    Clinical Trial Management System

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    16 m