Post Graduate Diploma in Regulatory Affairs

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

Starting from: INR 25,000 Per Course (Taxes As Applicable) Request Info

• To give graduates a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialization of pharmaceutical, biopharmaceutical, and medical device products.

• To prepare graduates for regulatory affairs positions in the pharmaceutical, biopharmaceutical, and medical device industries.

• To equip graduates with the educational foundation that will help them advance in the regulatory affairs profession.

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 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

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.