Clinical Research and Pharmacovigilance
In the growing scenario of Pharmaceutical Science with fulfilling demands of research and innovation towards new drugs discovery, development and automatization, Making Importance of Pharmaceutical Industries and healthcare sector for a well educated and skill person to maintain standard regulatory requirements, for the operation and handling as per current guidelines.
The Define Academy. is offering Job oriented training for fresh graduates and Post-graduates of Sciences and Pharmacy students.
Who wants to update their Knowledge and Skills as per the current regulatory requirements and for the promotion to a higher positions,
Who wants to start their career in Pharma Industry can join the Up-skilling Programs and make them ready for tomorrow by being constant learning partner in the changing World.
What Will I Learn?
- Introduction to clinical research
- Advanced knowledge of ICH-GCP
- Regulatory bodies
- Introduction to Pharmacovigilance
- How to prepare for an Interview
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An Introduction to this section01:03
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Introduction to clinical research02:15
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Process flow of clinical trial, detail of each step in clinical trial
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Role of International guidelines
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Advanced knowledge of ICH-GCP
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Responsibilities of major stakeholders
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Role of regulatory bodies
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Introduction to regulatory bodies of US, European Union, India
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Detail of New Drug Rules 2019
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Drug approval process
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Introduction to Pharmacovigilance (PV)
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ICH guidelines for PV
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Regulatory guidelines for PV
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Overview of PV process
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Various databases- ARGUS, ARIS etc
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Overview of case processing in database
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How you can further build clinical trial knowledge
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Step by Step guide how to start job search journey
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How to create great CV
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How to prepare for an interview