Qualis BioMed : Science & Regulation of Medical Products
Discussion forum for Medical Products regulatory affairs professionals
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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)
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