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DRUG SAFETY PHYSICIAN TRAINING

Training by ACI- Pharmacovigilance Training Specialist

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Academy of Clinical Intelligence ( ACI ) 17A Sector 17, Chandigarh, Chandigarh, India 160017

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The training modules for Drug Safety Physician are defined as per the roles & responsibilities with Industry standards and include the real time practices of job functions.

Outline

KNOWLEDGE BASED

• Pharmacovigilance System and Practices Globally
• Pharmacovigilance Industry Regulations
• Regulatory reporting in Pharmacovigilance – Expedited and Aggregate
• Sources of ICSRs

TECHNICAL BASED

• ICSR Processing
• Pharmacovigilance Safety Database
• MedDRA Coding
• WHO-DD Coding
• Causality Assessment
• Medical Review of ICSRs – Procedure and Practices
• Quality Management
• Aggregate Reports – Introduction and Overview
• Writing & Review of Aggregate Reports – Medical Assessments, Recommendations, and Conclusions
• RSI Updates and Procedures
• Signal Detection and Analysis

MANAGMENT BASED:

• Review of Pharmacovigilance technical and regulatory documents
• Handling Safety management plans
• Global Business Units and Functional Team Management and Communications with real time scenarios
• Medical interpretation and consistency to system documents, product labels, and adverse event case assessment etc.

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ACI is a globally recognized, Pharmacovigilance Training Management Company primarily focused on creating qualified pharmacovigilance professionals through our high quality and Industry recognized trainings. ACI has been instituted to cater to the growing demand for ‘skilled professionals', essentially addressing the gaps that exists between what an educational institution teaches and what an organization requires.

Since its foundation in 2013, ACI is a leading Professional Training company located in Chandigarh, specializes in Pharmacovigilance training. ACI has been dedicated to create Pharmacovigilance Professionals through technical training program from a fresher to corporate level.

Our programs are customized as per the global regulatory and industry standards with a progressive approach to ensure that the Pharmacovigilance trainings are imparted with focus on creating Pharmacovigilance professionals.

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