Pertecnica Engineering stands as a distinguished Employee training institute in India, specializing in the Pharmaceutical Industry. Recognized for our commitment to Good Manufacturing Practices (GMP), we extend our expertise to Pharmaceutical Safety and Pharmacovigilance training.
🔬 Pharmaceutical Safety and Pharmacovigilance Training: Dive into the crucial realm of Safety and Pharmacovigilance with Pertecnica Engineering. Our training module is meticulously crafted to equip you with the knowledge and skills necessary for ensuring the safety of pharmaceutical products.
🎓 Key Features of Our Training Module:
- Industry-Experienced Trainers: Learn from seasoned professionals with hands-on experience in Safety and Pharmacovigilance.
- Practical Training: Gain real-world insights through case studies and hands-on exercises.
- Customized Syllabus: Covering a broad spectrum of topics to ensure a comprehensive understanding.
- Interactive Learning: Engage in discussions, Q&A sessions, and collaborative learning.
Course Syllabus: Module 1: Fundamentals of Pharmaceutical Safety
- Introduction to Safety in Pharmaceuticals
- Role of Pharmacovigilance
- Regulatory Framework and Guidelines
Module 2: Adverse Event Reporting
- Identification and Reporting of Adverse Events
- Data Collection and Analysis
- Signal Detection and Management
Module 3: Drug Safety Monitoring
- Risk Assessment and Mitigation
- Post-Marketing Surveillance
- Safety Communication Strategies
Module 4: Quality Management in Pharmacovigilance
- Good Pharmacovigilance Practices (GVP)
- Audits and Inspections
- Documentation and Record-keeping
Module 5: Regulatory Compliance in Safety
- Compliance with Regulatory Authorities
- International Safety Reporting Requirements
- GMP Integration with Safety Practices
Module 6: Case Studies and Practical Applications
- Analyzing Real-world Safety Scenarios
- Problem-solving and Decision-making Exercises
- Hands-on Projects in Pharmacovigilance