100% JOB with Practical training in Pharmacovigilance

HANDS ON TRAINING IN PHARMACOVILGILANCE BY USING SOFTWARE.

PRACTICAL SESSIONS WITH CASE STUDIES. ADMISSION OPEN FOR January-2017 batch in Pharmacovigilance

Course Highlights:[refer to attached syllabus for detailed course content ]

Introduction and Objectives of Pharmacovigilance
Contents of Pharmacovigilance
Classification of ADR
The importance of reporting ADR
Post-marketing surveillance (PMS)
ICH Guidelines on Quality, Safety, Efficacy
Pharmacovigilance Methods
Passive Surveillance, Spontaneous Reports, Stimulated Reporting, Active Surveillance ,Sentinel Sites,Drug Event Monitoring
Wings of Pharmacovigilance
The WHO Quality Assurance and Safety: Medicines Team
Role of Pharmacovigilance[ Drug regulations in PV]
Risk and crisis management
Pharmacovigilance and the national drug regulatory authority
Herbal and Traditional Medicines , Vaccines and biological medicines Pharmacovigilance in Clinical Practice
Scope of Pharmacovigilance
Major challenges of Pharmacovigilance
Public health versus pharmaceutical industry economic growth
Signal Detection and Signal Analysis
Good Pharmacovigilance Practices
Periodic Safety Update Reports
European PV [EVMPD, XEVMPD]

Eligibility :
- Graduation or Post Graduation/ Pharma / PhD / B.Pharma/ M.Pharma/ Biotech/ B.Tech/ M.Tech are eligible to enroll for the course.
- Professionals from pharmaceutical BIO-TECH,CRO,BPO,KPO,companies working in various departments.
- Research Chemist, Quality Control Chemist, CRO's involved in Documentation.
- QC/QA Staff
- Documentation Department etc .


We have designed 11 pharma industrial courses which are career oriented and can help you chart your future. Drug Regulatory Affairs is an interesting and dynamic field. It is a specialized field. You can built up an excellent career in DRA and related area like RA, QA, Pharmacovigilence , clinical research , etc. You can enroll for any of our PG Diploma courses as per your interest through our CLASS ROOM or Distance Learning program.


We do have more than 150 training modules in cGMP, GLP, Validations, CSV, 21CFR Parts, QbD, GAMP, Audits & Inspections, ICH, PDR, QoS, CMC writing, CTD/ACTD/NeeS preparation which can be taylor made based on customer requirements.

Please find below attached courses details

Head Office:
Spectrum PharmaTECH Consultants Pvt. Ltd.
503 Dosti Pinnacle, Plot No E-7, Road # 22,
Wagle Estate, Thane (W) 400604, Maharashtra, India

Training center:
Unit No.144 & 145, First Floor, LODHA Boulevard Premium Mall, Above Mc Donalds, Lodha Paradise, Nasik Highway Road, Majiwada, Thane -west, Pin-400601