Advanced Certified Program In Pharmacovigilance
Pharmacovigilance is pharmacological science relating to detection, assessment and prevention of adverse effects of drugs. Improving drug safety is a task concerning not only regulatory authorities and pharmaceutical industry but also prescribing physicians. This is done right from the drug research and development stage to post marketing drug surveillance.
This course will provide extensive theoretical & training in Pharmacovigilance. All the topics will be presented by team of Doctors. It incorporates end-to-end theoretical & practical training on Pharmacovigilance processes including case assessment practical’s (seriousness of the events, reportablity of case, expectedness of the event) , Data Entry, Case Processing, Medical coding & Narrative Writing.
Who can learn?
- Life sciences (M.Pharm., B.Pharm., M.Sc.)
- MBBS, BDS, BHMS, and BAMS
Following Course Content will be covered during the training:
- Welcome and Introduction, History & Overview of Pharmacovigilance
- Drug Development and Clinical Trial Phases
- Pharmacovigilance Roles & Responsibilities in a CROs & Sponsor.
- Pharmacovigilance Process & Life cycle
- Introduction and responsibilities: USFDA, EMA and CDSCO
- Pharmacovigilance in India
- Clinical Development process
- Different phases of clinical Trials
- Adverse events and its types
- Drug Safety in clinical trials and post marketed drugs
- Different sources of Adverse events reporting
- Different types of AE reporting Forms
- Expedited reporting and its timelines
- Different departments working on Pharmacovigilance
- Roles and responsibilities of case receipt unit
- Roles and responsibilities of Triage unit
- Four factors for the reportable case
- Seriousness criteria of adverse event
- Expectedness or Listedness of adverse event
- Causality assessment of the adverse event
- Introduction to safety database and different types
- Narrative writing
- Case quality check, Medical review and its submission.
- The Qualified Person for Pharmacovigilance (QPPV) in the European Economic Area
- PSUR and its submission timelines
ELIGIBILITY:
Minimum Eligibility Criteria For Application To The Course Would Be Either Of The Following:
Applicants are recommended to have one of the following life Science degrees: Bachelor’s, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.
SELECTION PROCEDURE:
To Maintain High Academic Standard, Gratisol Labs Gives Due Importance To The Quality Of Students Enrolled. To Ensure This, The Selection Of Individual Student Will Undergo The Following Procedure:
- Personal Interview
- Screening And Selection Of Students
GRATISOL LABS ADVANTAGE
- Complete Course Material will be provided including detailed information about the entire work flow of Drug Safety Associate.
- 2 months internship available after rigorous training in Pharmacovigilance.
- Own CRO live Projects
- We Provide Real Time Experience on Global Drug Safety Software with PSUR & DSUR Training.
- Highest Placement record across all training institutes
- Industry based SOP’s training
- Trainers with minimum of 7+ years of experience
- Comprehensive teaching by Medical Doctors
- Hands on experience on Global Safety Databases used in the Industry.
- Total 150 hours of exposure to theory, case studies and practicals.
- Practical Hands on Training will be provided on Case Processing, Narrative Writing, MedDRA 16.1 & Who DRUG Coding.
Pharmacovigilance Training
Course Details
- Pharmacovigilance
- Introduction
- Historical Overview
- Basic principles of Pharmacovigilance in Clinical Trials
- Methodologies for Pharmacovigilance
- Pharmacovigilance Regulations in Clinical Research
- FDA and EU perspectives
- Drug regulatory activities MedDRA
- Regulatory aspects in Pharmacovigilance
- Eudra Vigilance
- Pharmacovigilance Regulations in clinical research
- Adverse Drug Reactions and Safety Reporting with ORACLE AERS and ARGUS
- ADR Reporting – an introduction
- Causality Assessment of suspected Adverse Drug Reactions
- Periodic Safety Update Reports (PSUR) for Marketed Drugs (ICH E2C)
- Expedited Reporting Requirements
- Individual case safety reports
- Electronic safety update reports
- WHO & safety monitoring
- Case Processing and Narrative writing
- Data Entry
- MedDRA/ WHO-DRL/DD Coding of reported primary diagnosis & Concomitant medications
- Case Narrative Writing
- Query generation and forwarding of queries
- Quality control- an overview
- Active Case / Query follow up – an overview
- Compliance to Clinical Safety and Pharmacovigilance Regulations
- Review of benefits-risk assessments and management
- Scope of Pharmacovigilance inspection and conduct of inspection
- Internal audit of Pharmacovigilance activities of a company
- Pharmacovigilance inspection reports
- Pharmacovigilance compliance and inspection
- Quality System in Pharmacovigilance: Good Practices, SOPs, Preparation for Audits & Inspections
- Scope of Pharmacovigilance inspection and Conduct
- Internal audit of Pharmacovigilance activities of a company
- Key functionalities of the Adverse Event Systems
OUR TEAM OF EXPERIENCED DRUG SAFETY SPECIALISTS ALSO PROVIDES THE FOLLOWING UPON SUCCESSFUL COMPLETION OF TRAINING:
- Resume Preparation
- Interview Preparation with real time questions and answers
- Mock Interview Sessions
- Communication Skills and Personality development Sessions
- Placement Assistance
- Placement Assurance
Certification:
Certificate will be provided for this Course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.
A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry. For more information, please contact Gratisol Labs at info@gratisol.com
