Total duration of course is 2 months Which includes 1-month theory and 1 month Practical. In Practical’s we provide training on "Practical applications of Pharmacovigilance softwares including MedDRA Software". 

Eligibility: Pharm-D, MPharm, BPharm, MBBS, MD, BAMS, BHMS, BUMS, BNYS, BSc Nursing, BTech (Biotechnology) Bachelor in Physiotherapy and other life science Graduates.

Topics Covered in this course

I)  CLINICAL RESEARCH

1. Drug Discovery, Development and Preclinical Studies
2. Basics of Clinical Trials & Clinical Research
3. Terminology & Definitions in Clinical Trials
4. Types and Phases of Clinical Trials
5. Good Clinical Practices (GCP)
6. Responsibilities of Clinical Research Professionals
7. 21 CFR Part 11
8. Introduction to regulatory bodies

 2) PHARMACOVIGILANCE

1. Introduction and history of Pharmacovigilance
2. Pharmacovigilance overview
3. Basic Terminology used in PV
4. Types of adverse events
5. Guidelines related to PV
6. MedDRA coding
7. Case seriousness assessment
8. Labelling assessment
9. Causality assessment
10. Signal detection
11. Expedited reporting
12. Narrative writing
13. Some special case scenarios
14. Handling of Pregnancy cases

Features and Benefits of Training

• Highly-skilled, Certified and Dedicated faculty members with over 12 years of industry experience.
• Flexible and update course content.
• Free Demonstration sessions.
• Live interactive sessions.
• Real-time case studies.
• Sophisticated and professional tools for web-based training.
• Hassle-free Server access without any interruption.
• Practical sessions with trainer after every week to know the grasping level of the learners.
• 24/7 Lab support with Lab Faculties.
• Affordable pricing.
• Access to recorded videos from our servers.
• Providing Softwares & Materials
• Certificate will be issued after the training
• Providing 100% Placement Assistance after Training

100% Placement Assistance provided for all the students. Our students are placed in reputed organizations like:

Covance,  TataConsultancy Services, ICON, PPD, Accenture,Cognizant, TechMahindra, Chiltren, Inventive Health, Paraxel, PRA Health   sciences, Pfizer, Novartis,Merck, I3, Theorem, Bioclinica, Quanticate, Clinasia, SIRO Pharma, Cliantha, Clinirx, GVK Bio, Dr. Reddy’s Labs, Cipla, Syntel, GSK, Lupin, Zydus Cadilla, Glenmark, Igate,IQVIA, Charles River Labs, IBM, Novo Nordisk, Sun Pharma, Ranbaxy, Mylan,

Aurobindo, Hetro, Makrocare, Axis Clinical Research, Indoasia Clinical Research, Croissance Clinical Research, Aizant Drug research Pvt. Ltd, Vimta Labs etc…