Qualis BioMed : Science & Regulation of Medical Products
Discussion forum for Medical Products regulatory affairs professionals
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Medical Products Guidelines from various Agencies
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Medical Products Guidelines from various Agencies
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World Health Organisation (WHO)
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General
↳ Welcome
↳ Announcements
Acts & Rules
↳ Acts
↳ Drugs & Cosmetics Act, 1940
↳ Narcotic Drugs & Psychotropic Substances Act, 1985
↳ The Drugs & Magic Remedies (Objectionable Advertisement) Act, 1954
↳ THE CODE OF CRIMINAL PROCEDURE, 1973 ACT NO. 2 OF 1974
↳ Rules
↳ Drugs & Cosmetics Rules, 1945
↳ Medical Devices Rules, 2017
↳ New Drugs & Clinical Trials Rules, 2019
↳ Cosmetics Rules, 2020
↳ Narcotic Drugs & Psychotropic Substances Rules, 1985
↳ The Drugs & Magic Remedies (Objectionable Advertisement) Act, 1955
↳ Drugs (Prices Control) Order, 1995
↳ Gazette Notifications
Pharmaceuticals
↳ Drugs
↳ Investigational New Drugs (IND) and New Drugs
↳ Subsequent New Drugs (SND)
↳ Fixed Dose Combinations (FDC)
↳ Biological Products
↳ Vaccines
↳ Phytopharmaceuticals
↳ Dosage Form
↳ Tablet
↳ Capsule
↳ Injection
↳ Pre-clinical Studies
↳ Clinical Studies
↳ Drugs Discovery
↳ Pharmaceutical Technology
↳ Quality Control
↳ Quality Assurance
↳ Quality Management System (QMS)
↳ Validation
↳ Clinical Trials
↳ Audits
↳ cGMP
↳ Water System
↳ Aseptic Processing
↳ SOPs
↳ GLP
↳ Stability Studies
↳ Instrument Calibration
↳ Production Facility
↳ Regulatory Approvals
In-Vitro Diagnostics (IVD)
↳ In-Vitro Diagnostics
↳ In-Vitro Diagnostics (IVD) Classifications
↳ Quality Management System (QMS)
↳ Clinical Performance Study
↳ Quality Control
↳ Quality Assurance
↳ Engineering Design
↳ Software Validation
↳ Regulatory Approvals
Medical Devices
↳ Medical Devices
↳ Medical Devices Classifications
↳ Quality Management System (QMS)
↳ Clinical Evaluation Reports
↳ Quality Control
↳ Quality Assurance
↳ Engineering Design
↳ Software Validation
↳ Regulatory Approval
Cosmetics
↳ Cosmetics
↳ Regulatory Approval
↳ Manufacturing of Cosmetics
↳ Export / Import of Cosmetics
↳ Pre-Clinical Studies
↳ Clinical Studies
Regulatory Updates from various National Regulatory Authorities
↳ Updates in Acts & Rules
↳ Draft Notifications
National Regulatory Authorities (NRA)
↳ List of National Regulatory Authorities and their Role Healthcare
↳ List of Non-Statutory Agencies and their Role in HealthCare
Intellectual Property Rights (IPR)
↳ Intellectual Property Rights
↳ Intellectual Property Rights classification
↳ Patent
↳ Miscellaneous
Medical Products Guidelines from various Agencies
↳ World Health Organisation (WHO)
↳ International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Pharmacopoeia
↳ USP (United States Pharmacopeia )
↳ IP (Indian Pharmacopoeia )
↳ JP (Japanese Pharmacopoeia )
↳ EP (European Pharmacopoeia )
↳ Comparative topics across various Pharmacopoeia
World Trade Organization (WTO)
↳ World Trade Organization and its role in the world economy
↳ Various treaties under WTO
Artificial Intelligence and way ahead
↳ Artificial Intelligence
↳ Artificial Intelligence in Medical Products ( diagnostics and treatments)
↳ Challenges in Artificial Intelligence
↳ Products specific Artificial Intelligence (Case Studies)