Post Graduate Diploma in GLP

Postgraduate Diploma by ACRI (Avigna Clinical Research Institute) Bangalore View Contact

Starting from: INR 45,000 Per Course (Taxes As Applicable) Request Info

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

ACRI (Avigna Clinical Research Institute)

Avigna Clinical Research Institute is modeled on the lines of some of the premier Clinical Research Institutes of India. We are dedicated and committed to provide excellent Clinical Research Professionals to the Clinical Research Industries.
Students and Professionals from the Health Science/Allied Health Science/Life Science can look forward to a robust curriculum and training in the area of Clinical Research coupled with additional training in soft skills and internships in leading Clinical Research Organizations.