Post Graduate Diploma in GLP

At the conclusion of this training program participants should be able to

• Understand the high specific requirements and intent of this GLP regulation.

• Understand the GLP requirements and 21CFR58.

• Understand requirement for Good Laboratory Practices.

• Understand how the requirements should be implemented within your organization

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

Syllabus

Course Curriculum includes

Design and Development of Drug

• Fundamentals of Drug Developments

• CGMP

• GLP

Preclinical Studies

• Preclinical studies

• Preclinical toxicology

• Regulation in Preclinical Studies

• IND application

Clinical Research Introduction

• 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

• Role and responsibilities of CRA

• NDA

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

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