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Intellectual Property Rights (IPR) – Industry & Academic Perspectives
(5)
(3 Reviews)
05:54:47 Hours
23 Lectures
Beginner
₹ 4999₹ 999
Last updated Sun, 11-Aug-2024
23 Lessons
05:54:47 Hours
English
This course covers the fundamental aspects and practical knowledge about Intellectual Property Rights (IPR) in detail including the academic & industry prevalence and existence, Scope and career opportunities and the importance of IPR in R&D platforms and businesses.
- Type of Intellectual Property Rights
- Why are Patents Required?
- How to Read Patent
- Patentability Analysis - Prior Art Search
- Patent Infringement Analysis
- Patent Filing Procedures (India & International)
- Trademarks & Registration procedure
- Copy Rights & Registration procedure
- Geographical Indications & Registration procedure
- Designs and Registration procedure
- Career Opportunities
Statistical Applications in Clinical Research and Pharmaceuticals
(5)
(8 Reviews)
03:19:46 Hours
15 Lectures
Beginner
₹ 4999₹ 999
Last updated Sat, 06-May-2023
15 Lessons
03:19:46 Hours
English
This course covers the applications of statistics in pharmaceutical Product
development (Design of Experiments/Quality by Design) & clinical research, fundamental aspects of statistical analysis including types of data, choosing appropriate choice of statistical tools based on type of data etc.
- Overview of Statistical Applications in Clinical Research/Pharma
- Types of Data
- Commonly Used Statistical Analysis Methods
- Hypothesis Testing
- Sample Size Determination
- Randomization Procedures
- Clinical Trial Designs
- Statistical Analysis Plan
- Statistical Approaches in Bioequivalence Studies
- Statistical Approaches in BE of Narrow Therapeutic Index Drugs
- Statistical Approaches in BE of Highly Variable Drugs
Clinical Data Management - Industry Perspectives
(0)
(0 Reviews)
04:48:09 Hours
14 Lectures
Beginner
₹ 4999₹ 999
Last updated Sat, 06-May-2023
14 Lessons
04:48:09 Hours
English
This course is designed to provide students with an overview of the clinical data management process, including the elements involved in CRF designing, Programming, data collection and management, data quality assurance and assurance processes.
- Introduction to Data management
- Clinical data management Lifecycle
- CRF Designing and Programming Edit checks
- Planning, implementation and data validation
- Data capture and presentation
- Query Management
- Clinical Data Extraction and review
- Clinical data quality assurance and quality control
- Introduction to documents involved in all phases of Data management (Start Up Phase, Conduct Phase and Closeout Phase)
- Career Opportunities
Pharmaceutical Formulation Development
(4)
(3 Reviews)
04:37:03 Hours
10 Lectures
Beginner
₹ 4999₹ 999
Last updated Sat, 06-May-2023
10 Lessons
04:37:03 Hours
English
This course covers the basis and practical knowledge about Formulation Development in general in Pharmaceutical Industry.
- Scope of Formulation Development
- Selection of Product for Development
- Pre-formulation Studies
- Quality by Design
- Design of Experiments
- Risk Assessment in Formulation Development
- Selection of API and Excipients
- Selection of Packaging Materials
- Test Methods Developments for Formulations
- Stability Studies During Development
- Process Optimizations
- Documentations during Formulation Development
Pharmaceutical Analysis & Instrumentation
(5)
(5 Reviews)
07:37:28 Hours
19 Lectures
Beginner
₹ 4999₹ 999
Last updated Sat, 06-May-2023
19 Lessons
07:37:28 Hours
English
This course is designed to provide students with an overview of the Pharmaceutical Analysis process, including the purpose of pharmaceutical analysis, analytical laboratory set up, analytical techniques, chromatographic techniques, instrumentation techniques (Spectrophotometry methods, HPLC, LCMS, GCMS), analytical method development, analytical method validation, calculation methods and extractables & leachable.
- Purpose of Pharmaceutical Analysis
- Analytical Laboratory Set Up
- Chemical Analysis
- Spectrophotometric Analysis (UV, IR & AAS)
- Liquid Chromatography Techniques (HPLC/LCMS)
- Gas Chromatography Techniques
- Analytical Method Development
- Analytical Method Validation
- Extractable & Leachable
- Calculation Methods
- Career Opportunities
- Advanced Analytical Techniques
Pharmacovigilance - Industry Perspectives
(5)
(1 Reviews)
02:57:19 Hours
11 Lectures
Beginner
₹ 4999₹ 999
Last updated Sat, 06-May-2023
11 Lessons
02:57:19 Hours
English
This course covers the fundamental aspects and knowledge about pharmacovigilance including the academic & industry prevalence and existence.
- Introduction to pharmacovigilance
- Basic terminology
- Sources of Adverse Drug Reactions (ADRs)
- Case processing
- MedDRA Coding
- Aggregate reports
- Signal Management
- Risk Management Plan
Pharmaceutical Regulatory Affairs - Industry Perspectives
(4)
(1 Reviews)
04:25:36 Hours
11 Lectures
Beginner
₹ 4999₹ 999
Last updated Sat, 06-May-2023
11 Lessons
04:25:36 Hours
English
This course covers the fundamental aspects and practical knowledge about Regulatory Affairs (RA) in detail including the academic & industry prevalence and existence, Scope and career opportunities and the importance of RA in pharmaceutical industry.
- What is Regulatory Affairs
- The role of Regulatory Affairs department
- What is DMF and types of DMF
- Preparation and submission of DMF
- Organization of the common technical document for the registration of pharmaceuticals for human use
- Major Regulatory Authorities
- Registration of Drug and Dossier Preparation (CTD and eCTD submissions)
- Regulatory requirements of EU, MHRA, TGA and ROW countries
- Global submission of IND, NDA, ANDA
- Regulatory Affairs in Clinical trials
- Product Life Cycle - Regulatory Affairs Perspective
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