Paper 1: Principles of Pharmacovigilance
· Introduction to Drug Discovery
· Pharmacovigilance in International Health
· Pharmacovigilance in India
· The Role of Pharmacist in Pharmacovigilance
· Pharmacovigilance in Clinical Trials/Practice and Different Types of Treatments
· Glossary and Abbreviations
Paper 2: Methodologies in Pharmacovigilance and Signal Detection
· Statistical Methods in Pharmacovigilance
· Cohort Studies in Pharmacovigilance
· Odds Ratio
· Data Mining Techniques in Pharmacovigilance
· Adverse Event/Adverse Drug Reactions
· Spontaneous Reporting
· Adverse Drug Reactions from Spontaneous Reporting Systems: The Influence of Under reporting On Odds Ratios
· Pharmacovigilance Signal Detection
Paper 3: Pharmacovigilance Compliance and Management
· Risk Management of Pharmaceutical Products
· Risk Management
· Pharmacovigilance Compliance and Management
· Guidance on Monitoring Compliance
· Quality Management System
· Risk Management System
· Guidance on Risk Management Systems
· FDA Drug Safety
· Pharmacovigilance in EU
· Guideline on Good Pharmacovigilance Practices
· V9 Compliance Guideline
Paper 4: Pharmacovigilance Regulations and Guidelines
· Drug Safety and Post-Marketing Surveillance
· Regulation and WHO Monitoring of Herbal Medicines
· Pharmacovigilance Planning
· Management of Adverse Drug Reactions
· Good Pharmacovigilance Practice(GVP)
· European GVP
· Safety Communication
· Signal Management
· Adverse Reaction Management
· Periodic Safety Update Report(PSUR)
· Post-Authorization Safety Studies
· Pharmacovigilance Audits
· Pharmacovigilance System Master File
· Pharmacovigilance Systems and Quality Systems
· Regulation 2010 EU
· New European Pharmacovigilance Legislation
· FDA-Drug Safety
India has become a major hub for clinical trials. Despite this, several problems related to availability of drugs, distribution, accessibility and consumption still remain at large.
Pharmacovigilance is the discipline which takes care of such aspects and is concerned with identifying, validating, quantifying and evaluating adverse reactions associated with the use of drugs thereby improving the safety of medicines in use.
IBRI NOIDA, offers a 6 Months weekend Advanced Diploma in Pharmacovigilance.
It deals with all aspects right from the basic principles of Pharmacovigilance to Pharmacovigilance in clinical research, setting up a Pharmacovigilance centre in industry, management of Pharmacovigilance data, risk management in Pharmacovigilance.
Their goal is to establish safety of the drug and oversee the well-being of the consumers.
Course Mode: For benefit of working professionals and full time students, the course is conducted every Saturday and Sunday.
The total strength of each batch is 10 so that each student is given individual care and support during the training course.
Course Fees: The course fee for working professionals and the students pursuing higher studies have to pay Rs 35,000. The course fees can be paid in three equal installments of Rs 12000/- by DD/Cheque/Cash.
Technical Strengths: The course is taught by a pool of expert faculty and well known national faculty who have several years of Pharmacovigilance experience who impart practical and theoretical training for this course.
Pharmacovigilance is still in its infancy in India, therefore higher standards of Pharmacovigilance are warranted to be at par with the rest of the world in terms of not only compliance to regulations but also to implement quality systems in all pharmaceutical companies especially the generic companies which manufacture bulk drugs that are marketed in India and the Western countries.
There is no dearth of jobs in this field as good Pharmacovigilance practice makes for good business sense.
Students of this field can get jobs in various pharmaceutical companies and expect attractive salaries with robust increments.