Pre Conference Workshops

09:00 AM : 09:30 AM

THEME AND TOPICS	SPEAKERS	ROLE
Registration & Welcome

09:30 AM : 10:30 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Audits & Inspections in Pharmacovigilance: Trends & Readiness

10:30 AM : 11:30 AM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Patient Advocacy & Centricity: Bridging the Safety Disconnect

11:30 AM : 11:45 AM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
Group Allocation & Instructions

11:45 AM : 12:45 PM

Lunch Break

THEME AND TOPICS	SPEAKERS	ROLE
Lunch Break

12:45 PM : 01:00 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
Mock Inspection Briefing

01:00 PM : 02:15 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Mock Inspection Simulation – Live Roleplay

02:15 PM : 02:45 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Debrief & Inspection Feedback

02:45 PM : 03:00 PM

Tea Break

THEME AND TOPICS	SPEAKERS	ROLE
Tea Break

03:00 PM : 04:00 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Group Brainstorm & Presentations

04:00 PM : 04:45 PM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Expert Panel Reflections & Key Takeaways

04:45 PM : 05:00 PM

THEME AND TOPICS	SPEAKERS	ROLE
Workshop Wrap-Up & Close

10:00 AM : 10:30 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Introduction to ISCR and MW Workshop

10:30 AM : 12:00 PM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Strategic and tactical publication planning in evolving clinical landscapes

12:00 PM : 01:00 PM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
From data to draft – writing with impact

01:00 PM : 02:00 PM

THEME AND TOPICS	SPEAKERS	ROLE
Lunch Break

02:00 PM : 03:00 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
From data to draft – writing with impact

03:00 PM : 03:20 PM

THEME AND TOPICS	SPEAKERS	ROLE
Tea break

03:20 PM : 04:50 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Maximizing reach and engagement beyond the manuscript

04:50 PM : 05:00 PM

THEME AND TOPICS	SPEAKERS	ROLE
Summary and closing remarks

09:30 AM : 10:15 AM

THEME AND TOPICS	SPEAKERS	ROLE
Introduction to ISCR-ACCRI Academic clinical trials – An overview	Dr Ananya Chakraborty Professor and HOD Vydehi Institute of Medical Sciences & RC, Bangalore	Speaker

10:15 AM : 10:45 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Setting the foundations right for launching an academic clinical trial	Dr. Melvin George Professor SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE	Speaker

10:45 AM : 11:00 AM

Tea Break

11:00 AM : 11:30 AM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Lessons learnt from conducting Investigator initiated trials	DR. DENIS XAVIER Professor & Head Pharmacology, Head -Div of Clinical Research St. John's Medical College Bangalore	Speaker

11:30 AM : 12:15 PM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
Navigating Challenges faced in Academic Clinical trials – panel discussion	DR. DENIS XAVIER Professor & Head Pharmacology, Head -Div of Clinical Research St. John's Medical College Bangalore	Speaker
	Dr. Aparna Mukherjee Clinical Studies and Trial Unit, Scientist F Indian Council of Medical Research	Speaker
	Dr. Suman S Karanth Additional Director, Dept of Medical Oncology Fortis Memorial Research Institute	Speaker

12:15 PM : 01:00 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
Presentation of protocols – group task	DR. DENIS XAVIER Professor & Head Pharmacology, Head -Div of Clinical Research St. John's Medical College Bangalore	Speaker
	Dr. Melvin George Professor SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE	Speaker
	DR. ASHOK SHENOY Professor, Dept of Pharmacology Kasturba Medical College, Mangalore	Speaker
	Dr Ananya Chakraborty Professor and HOD Vydehi Institute of Medical Sciences & RC, Bangalore	Speaker

01:00 PM : 01:45 PM

Lunch Break

01:45 PM : 03:15 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Presentation of protocols – group task (contd.)	DR. DENIS XAVIER Professor & Head Pharmacology, Head -Div of Clinical Research St. John's Medical College Bangalore	Speaker
	Dr. Melvin George Professor SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE	Speaker
	DR. ASHOK SHENOY Professor, Dept of Pharmacology Kasturba Medical College, Mangalore	Speaker
	Dr Ananya Chakraborty Professor and HOD Vydehi Institute of Medical Sciences & RC, Bangalore	Speaker

03:15 PM : 03:45 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Clinical research Monitoring & data management	Dr. Suman S Karanth Additional Director, Dept of Medical Oncology Fortis Memorial Research Institute	Speaker

03:45 PM : 04:15 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Digital Tools for academic trials	Dr. Animesh Jain Professor, Department of Community Medicine Kasturba Medical College, Mangalore	Speaker

04:15 PM : 04:45 PM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Open forum – Q & A	Dr Ananya Chakraborty Professor and HOD Vydehi Institute of Medical Sciences & RC, Bangalore	Speaker
	Dr. Animesh Jain Professor, Department of Community Medicine Kasturba Medical College, Mangalore	Speaker
	Dr. Aparna Mukherjee Clinical Studies and Trial Unit, Scientist F Indian Council of Medical Research	Speaker
	DR. ASHOK SHENOY Professor, Dept of Pharmacology Kasturba Medical College, Mangalore	Speaker
	DR. DENIS XAVIER Professor & Head Pharmacology, Head -Div of Clinical Research St. John's Medical College Bangalore	Speaker
	Dr. Melvin George Professor SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE	Speaker
	Dr. Suman S Karanth Additional Director, Dept of Medical Oncology Fortis Memorial Research Institute	Speaker

09:00 AM : 09:15 AM

THEME AND TOPICS	SPEAKERS	ROLE
Welcome & Introduction

09:15 AM : 10:30 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
ICH-GCP E6(R3) Refresher: Investigator Oversight and CRC Role

10:30 AM : 11:00 AM

Tea Break

THEME AND TOPICS	SPEAKERS	ROLE
Tea Break

11:00 AM : 12:00 PM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Patient Centricity in Practice

12:00 PM : 12:45 PM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE

12:45 PM : 01:30 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
Source Documentation & Case Report Form (CRF) Completion

01:30 PM : 02:30 PM

THEME AND TOPICS	SPEAKERS	ROLE
Lunch Break

02:30 PM : 03:00 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Investigational Product (IP) Management & Accountability

03:00 PM : 03:45 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Practical Aspects of Safety Reporting

03:45 PM : 04:15 PM

THEME AND TOPICS	SPEAKERS	ROLE
Tea Break

04:15 PM : 05:00 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Communication & Empathy: Essential Soft Skills for CRCs

05:00 PM : 05:30 PM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Clinical Trial Agreement (CTA) & Budget Essentials (CRC Perspective

05:45 PM : 06:00 PM

Session 9

THEME AND TOPICS	SPEAKERS	ROLE
Q&A, Key Takeaways & Closing Remarks

Main Conference Tracks

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

09:00 AM : 01:00 PM

Session 1-3 Common Sessions Across All Tracks

0 : 0

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

09:00 AM : 10:00 AM

Session 1 Session 4-6 Common Sessions Across All Tracks

0 : 0

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

09:00 AM : 01:00 PM

Session 1-3 Common Sessions Across All Tracks

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 05:30 PM

Poster Presentations & Assessments (in parallel to all ongoing tracks)

02:00 PM : 04:00 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Strategic role of medical writers in leading submissions
Strategic Role of Lead Medical Writers in Accelerating Clinical Development
Briefing Books–Strategic Communication between the Sponsor and Health Authority in Drug Development
IND Briefing documents
Accelerating Regulatory Approvals: How Lean Writing & Structured Content Authoring Drive Faster, Patient-Focused Clinical Research

Pre Conference Workshops

Main Conference Tracks

Pre Conference Workshops

PV Workshop - Inspection Ready, Patient Focused: A Hands-on Lab for Pharmacovigilance Excellence 2nd Floor, Auditorium, Medanta - The Medicity, Sector-38, Gurugram, Haryana, India

Medical Writing Workshop - Strategic Excellence in Publications: From Manuscript to Maximum Impact Vivanta New Delhi Dwarka, Metro Station Complex, Sector 21, Dwarka-110075

CDM Workshop - Risk-Based Quality Management (RBQM) For Cross-Functional Clinical Research Teams Vivanta New Delhi Dwarka, Metro Station Complex, Sector 21, Dwarka-110075

ACCRI Workshop - From Idea to Implementation through Academic Clinical Trials: A Hands-On Workshop Fortis Healthcare Research Foundation (FHRF), Meditorium, First Floor, Fortis Hospital, Gurugram, Haryana-India

ISCR – USFDA Collaborative Workshop: (TBC) Vivanta New Delhi Dwarka, Metro Station Complex, Sector 21, Dwarka-110075

Clinical Research Coordinator (CRC) Workshop - Mastering Site Operations for GCP Compliance & Patient-Centered Care 2nd Floor, Auditorium, Medanta - The Medicity, Sector-38, Gurugram, Haryana, India

Regulatory Workshop - Navigating the Future Regulatory Landscape: Working Towards Global Regulatory Harmonization Vivanta New Delhi Dwarka, Metro Station Complex, Sector 21, Dwarka-110075

Main Conference Tracks

Track 1 - Clinical Operations, Ethics and Regulatory

Track 2 - Clinical Data Management

Track 3 - Medical Writing

Track 4 -Bio Stats and Programming

Track 5 - Pharmacovigilance (PV)

Track 6 - Real World Evidence (RWE)

Track 7 - Academic Clinical Development, Basic & Translation Research