Post Graduate Diploma in BA/BE Studies

Students will gain knowledge in the core competencies of clinical research and investigation such as study design, research implementation, statistical approaches, responsible conduct of research, scientific communication and Pharmacokinetics etc

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

Preclinical Studies

• Preclinical studies

• preclinical toxicology

• 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

• 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

BA/BE Studies

• Bioavailability and Bioequivalence study

• Clinical process in BA/BE Study

• Sample storage in BA/BE Study

• Bioanalytical Process

• Method development and validation of biosamples

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