PV- Pharmacodynamics
PV- Pharmacodynamics
Clintech Informatics is a leading fully integrated Pharmacovigilance training organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes for betterment of new healthcare professionals.
We strive to be innovative in everything we do from leveraging new technologies to finding smarter ways of teaching.
Productivity and quality driven culture makes our organization a top destination for all the services of Pharmacovigilance.
Programme Modules
- Definition and Importance
- - What is pharmacovigilance?
- - Historical context and regulatory frameworks
- Objectives of Pharmacovigilance
- - Ensuring patient safety
- - Risk-benefit analysis
- Global Regulatory Bodies
- - FDA, EMA, WHO, ICH
- National Regulations
- - Overview of pharmacovigilance regulations in various countries
- Guidelines and Standards
- - ICH E2E guidelines
- - GVP (Good Pharmacovigilance Practices)
- Types of ADRs
- - Mild, moderate, severe
- - Idiosyncratic vs. predictable reactions
- Classification of ADRs
- - Type A (augmented) vs. Type B (bizarre)
- Case Studies and Examples
- Sources of Data
- - Clinical trials, post-marketing surveillance, spontaneous reports
- Data Collection Methods
- - Electronic reporting systems, registries
- Signal Detection and Evaluation
- - Statistical methods and tools
- - Role of Artificial Intelligence
- Role in Clinical Development
- - Safety monitoring during trials
- Ethical Considerations
- Informed consent, patient safety
- Analysis of Historical ADR Cases
- - Lessons learned from past incidents
- Group Discussions and Presentations
- - Analyzing current events in pharmacovigilance
- Evolving Regulatory Landscape
- - New challenges and opportunities
- Role of Digital Health
- - Mobile apps, social media monitoring
- Exams and Assessments
- - Multiple-choice questions, case study evaluations
- Certification Process
- - Criteria for certification in pharmacovigilance