Workshop Scientific GCP 2024
HIGHLIGHTS OF WORKSHOP
- Updated Guidelines on GCP as per CDSCO
- Credit hours by RMC
- Fulfilling the NMC requirement of PG
- Resource faculty key persons in framing GCP guidelines
Workshop Coordinator and Resource Faculty
Dr. Monica Jain
Senior Professor, Department of Pharmacology.
SMS Medical College, Jaipur
Workshop Co-coordinator
Dr. Sangeeta Khyalia
Asst. Prof., Biochemistry
SMS Medical College, Jaipur
Master of Ceremony
Dr. Jaya Dadheech
Senior Demonstrator Department of Pharmacology
SMS Medical College, Jaipur
SPEAKERS
Prof. (Dr.) Bikash Medhi
Professor, Department of Pharmacology,
PGIMER, Chandigarh
Prof. (Dr.) Anant Patil
Professor, Department of Pharmacology,
Dr DY Patil Medical College, Navi Mumbai
Dr. Anusha Vohra
PHOD, Pharmacology, MGMCH,
Jaipur
Dr. Priyanka Rathi
Professor, Department of Pharmacology, NIMS & R, Jaipur
Dr. Shivankan Kakkar
Assistant Professor, Pharmacology,
SMS Medical College, Jaipur Scientific Agenda
Scientific Agenda
ICH GCP Training Workshop
22 November 2024
Venue: Seminar Hall, Department of Microbiology, SMS Medical College, Jaipur
Workshop Program
| TIME | SESSION | FACULTY/SPEAKER |
| 09:00 am | Registration & Networking | |
| 09:20 am | Inauguration | |
| 09:40 am (20 min) | Introduction to Workshop Objectives and Goals | |
| 09:40 am 09:55 am (15 min) | Pre-Test Assessment Initial Knowledge Assessment of Participants | |
| BREAKFAST: 9:55 am- 10:10 am (15 min) | ||
| 10:10 am 10:50 am (40 min) | Keynote Session: Overview of Good Clinical Practice (GCP) The Importance of GCP in Clinical Trials and Research Integrity | Dr. Monica Jain |
| 10:50 am 11:30 am (40 min) | Stakeholder Responsibilities in Clinical Research Detailed Roles of the Sponsor, Investigator, and Ethics Committee | Dr. Bikash Medhi |
| 11:30 am 12:10 pm (40 min) | Ethics Committee: Structure and Function Composition, Roles, and Responsibilities of Ethics Committees | Dr. Anant Patil |
| 12:10 pm 12:40 pm (30 min) | Informed Consent Process in Clinical Trials Comprehensive Overview of Consent Documentation and Process | Dr. Anant Patil Dr. Monica Jain |
| LUNCH: 12:40 pm – 1:15 pm (35 min) | Dr. Rekha Bachhiwal Dr. Vijay Laxmi Dr. Mamta Lamba Dr. Suman Meena | |
| 1:15 pm 1:45 pm (30 min) | Essential Documents for Conducting a Clinical Trial Protocols, Case Report Forms, and Investigator Brochures | Dr. Shivankan Kakkar |
| 1:45 pm 2:15 pm (30 min) | Investigational Product Accountability Management and Accountability of Investigational Products | Dr. Anusha Vohara |
| 2:15 pm 2:45 pm (30 min | Adverse Event Reporting and Safety Monitoring Serious Adverse Event Reporting Requirements and Procedures | Dr. Monica Jain |
| 2:45 pm 3:05 pm (20 min | Principles of Academic Clinical Trials Design and Implementation of Academic Clinical Research | Dr. Anusha Vohara Dr. Monica Jain |
| TEA BREAK: 3:05 pm – 3:20 pm (15 min) | ||
| 3:20 pm 3:50 pm (30 min) | Quality Assurance, Audits, and Data Management Standards for Quality Control, Audits, and Data Archiving | Dr. Priyanka Rathi |
| 3:50 pm 4:10 pm (20 min | Group Activity GCP Compliance: Identifying Errors in Case Report Forms (CRFs | Dr. Monica Jain Dr. Shivankan Kakkar |
| 4:10 pm 4:30 pm (20 min) | Interactive Q&A Session Open Forum with Faculty on GCP Practices | |
| 4:30 pm 4:45 pm (15 min) | Post-Test Assessment Final Knowledge Evaluation | |
| 4:45 pm 5:00 pm (15 min) | Valedictory Ceremony and Feedback Collection Closing Remarks and Participant Feedback |
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