The “Workshop on Good Clinical Practice” aims to equip postgraduate students with comprehensive knowledge and practical skills essential for conducting clinical trials in accordance with international standards. This workshop is a valuable opportunity for students to learn about ethical guidelines, regulatory requirements, and best practices in clinical research. It is supported by the Department of Pharmacology and the Medical Education Unit of Narayana Medical College.

Program Schedule and Session Details

Day 1: 29th June 2024

09:30 AM – 10:00 AM:

Registration & Inauguration

The workshop will begin with the registration of participants, followed by a formal inauguration ceremony. This session will set the stage for the day’s activities and provide an overview of the workshop’s objectives and structure.

10:00 AM – 10:45 AM:

ICH – GCP Introduction & Evolution

Speaker: Dr. G. Bhawani MD, Professor of Pharmacology, NMC, Nellore

This session will cover the origins and evolution of the International Council for Harmonisation (ICH) guidelines and Good Clinical Practice (GCP). Dr. Bhawani will provide insights into the importance of GCP in ensuring the ethical and scientific quality of clinical trials.

10:45 AM – 11:30 AM:

Institutional Ethics Committee Registrations, Composition and Roles & Responsibilities

Speaker: Dr. P. Rama Mohan MD DM, Professor of Pharmacology, NMC, Nellore

Dr. Rama Mohan will discuss the structure and functions of Institutional Ethics Committees (IECs), focusing on their role in overseeing clinical trials. He will explain the processes for registering and composing an IEC, as well as the responsibilities of its members in safeguarding the rights and welfare of trial participants.

11:30 AM – 11:45 AM:

Tea Break

A short break for refreshments, allowing participants to network and discuss the morning sessions informally.

11:45 AM – 12:30 PM:

Investigator & Sponsor Responsibilities

Speakers: Dr. G. Bhawani MD & Dr. P. Rama Mohan MD DM

This session will delve into the specific responsibilities of clinical trial investigators and sponsors. Dr. Bhawani and Dr. Rama Mohan will outline the ethical and regulatory obligations that investigators and sponsors must adhere to, ensuring the integrity and quality of clinical trials.

12:30 PM – 01:15 PM:

Clinical Trial Protocol and Protocol Amendment(s)

Speakers: Dr. G. Bhawani MD & Dr. P. Rama Mohan MD DM

Participants will learn about the critical components of a clinical trial protocol, including how to design, implement, and amend protocols. The speakers will highlight the importance of following a well-structured protocol to ensure consistent and reliable trial results.

01:15 PM – 02:00 PM:

Lunch Break

A break for lunch, providing an opportunity for participants to relax and interact with each other and the faculty members.

02:00 PM – 02:45 PM:

Investigator’s Brochure, Informed Consent, Insurance to Participants, Certificate of Analysis of Unmarked Medicinal Products

Speaker: Dr. P. Rama Mohan MD DM

Dr. Rama Mohan will explain the purpose and contents of the Investigator’s Brochure, which provides detailed information on the investigational product. He will also cover the informed consent process, insurance requirements for trial participants, and the certification needed for unmarked medicinal products.

02:45 PM – 03:30 PM:

Safety Reporting & Pharmacovigilance

Speakers: Dr. G. Bhawani MD & Dr. P. Rama Mohan MD DM

This session will focus on the procedures for safety reporting and the role of pharmacovigilance in clinical trials. The speakers will discuss the identification, assessment, and reporting of adverse events, emphasizing the importance of ongoing safety monitoring.

03:30 PM – 04:30 PM:

NDCT (New Drugs and Clinical Trials) Rules 2019, Updates on GCP & NDCT Rules

Speakers: Dr. P. C. Kavitha MD, Assistant Professor of Pharmacology, Dr. G. Bhawani MD, Dr. P. Rama Mohan MD DM

The session will provide an overview of the New Drugs and Clinical Trials (NDCT) Rules 2019, along with the latest updates on GCP and NDCT regulations. The speakers will highlight key changes and their implications for clinical trial conduct in India.

04:30 PM – 05:00 PM:

Q & A Session

An interactive session where participants can ask questions and seek clarifications on any topics covered during the workshop. The faculty will provide detailed answers and practical advice to address the participants’ queries.

Workshop Organizers:

Secretary, IEC, NMCH: Dr. P. Rama Mohan

PG Academic Cell In-Charge: Dr. V. Krishna Chaithanya

Principal: Dr. P. Sreenivasulu Reddy

This detailed workshop is designed to provide postgraduate students with a thorough understanding of Good Clinical Practice, ensuring they are well-equipped to conduct ethical and high-quality clinical trials. Through expert-led sessions and interactive discussions, participants will gain valuable insights and practical knowledge to enhance their clinical research skills.