Post Graduate Diploma in Pharmacovigilance

• Pre and post marketing drug safety and Pharmacovigilance

• Risk management strategies

• How to prepare for a safety inspection

• Signal detection

• Medical approach in diagnosis and management of ADRs

It is an online post graduate Diploma course. It includes 3 months online sessions.

Syllabus

Course Curriculum includes:

Drug Discovery And Development

• Fundamentals of Drug Developments

• CGMP

Preclinical Studies

• Preclinical studies

• Preclinical toxicology

• IND application

Clinical Trial Process

• History and Introduction to clinical trials

• Definitions and Terminologies

• Types and scope of clinical research

• Evolution of clinical research

• GCP

Clinical Trials

• GCP in depth

• Responsibility of Sponsor

• Responsibility of Investigator

• Informed consent

• IP Accountability

• Role and responsibilities of CRA

• Role and responsibilities of CRC

• Essential documents and sources in clinical trial

• Protocol design

• Trial design

• Interim Analysis

• NDA

• Good Clinical Practice

Quality, Regulations and Ethics

• Quality assurance unit and responsibility

• SOPs

• Assurance of Data quality

• Audits and inspections

• Regulations in clinical trials

• Indian regulatory system

• US-FDA Guidelines for clinical trials

Post marketing Surveillance

• Adverse events/Adverse Drug Reactions

• Classification of ADRs

• Laboratory safety data

• Causality assessment

• Multiple drug prescription monitoring

• UK Yellow card scheme

• Prescription event monitoring

• ICH E2A Guidelines

• CIOMS Forms

• Package Insert

• Med Watch

Teaching Mode

• Electronic copies will be shared to students.

• Lecture slides in PowerPoint format, as used for on-campus classes, made available for Online sessions.

• Additional notes arising from on-campus lectures and tutorials will be shared via mail.

Weekly and Monthly Evaluation

• Test paper will be shared with the candidates on weekly basis and Monthly basis.

• A feedback barometer, through which students are enabled to provide anonymous feedback as to how the subject is progressing on a weekly basis.

Additional Features of the course

• E books and SOP’S will be shared via mail to the candidates.

• Recent updates of clinical research will be provided to the students via mail.

System Requirement for Students

• The broad band connection (512kbps and above)

• Head Set

• Link will be sent to the students email id, they have to click on the link and get connected