Pre Conference Workshops

09:00 AM : 09:30 AM

Registration & Welcome

THEME AND TOPICS	SPEAKERS	ROLE
Registration & Welcome

09:30 AM : 10:00 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Patient Advocacy & Centricity: Bridging the Safety Disconnect	Ms. Hina Talwar Safety Services Project Leader Parexel International India Pvt Ltd	Speaker

10:00 AM : 10:15 AM

Tea Break

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

10:15 AM : 10:45 AM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Audits & Inspections in Pharmacovigilance: Trends & Readiness	Dr Anchal Shukla Senior Manager, International Pharmacovigilance Merck Sharp & Dohme LLC (MSD)	Speaker

10:45 AM : 11:30 AM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
Panel Discussion: Beyond Checklists: Building Trust and Accountability Through PV Vendor Audits	Dr Siva Kumar Buddha Director Amgen	Speaker
	Mr. Vivek Gupta Associate Director, R&D Procurement & Vendor Management Organon	Panelist
	Dr. Kiran Kandula Senior Director, Head, Pharmacovigilance Operations India Propharma	Panelist
	Mr. Rajesh Rajendran Director, Projects & Vendor Management Team Lead Pfizer	Panelist
	Dr. Raghunath Dhule Senior Manager Pharmacovigilance /QPPV/Pharmacovigilance Officer In-charge (PvOI) Eli Lily and Company	Panelist

11:30 AM : 12:00 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
Scaling Regulatory Excellence in Pharmacovigilance: Challenges and Enablers for Risk-Based Audit Planning	Mr. Nirav Soni Senior Consultant (GVP Auditor) Adamas Consulting	Speaker

12:00 PM : 01:00 PM

Lunch Break

01:00 PM : 01:15 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Mock Inspection Briefing	Ms. Hina Talwar Safety Services Project Leader Parexel International India Pvt Ltd	Speaker

01:15 PM : 02:15 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Mock Inspection Simulation – Live Roleplay	Dr. Abhay Chimankar Founder & Director Rhyme Life Sciences	Speaker
Mock Inspection Simulation – Live Roleplay	Ms. Hina Talwar Safety Services Project Leader Parexel International India Pvt Ltd	Speaker

02:15 PM : 02:45 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Debrief & Inspection Feedback	Dr. Abhay Chimankar Founder & Director Rhyme Life Sciences	Speaker

02:45 PM : 03:00 PM

Tea Break

THEME AND TOPICS	SPEAKERS	ROLE
Expert Panel Reflections & Key Takeaways

03:00 PM : 04:00 PM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Group Brainstorm & Presentations	Ms. Indu Nambiar Pharmacovigilance Lead & Country Safety Head Opella Consumer Healthcare	Speaker
	Dr. Vijaykrishnan Ganesan Global Safety Operational Group Lead Opella Consumer Healthcare	Panelist
	Ms. Nidhi Vaish Das Manager, Local Safety Roche	Panelist

04:00 PM : 04:45 PM

Session 9

THEME AND TOPICS	SPEAKERS	ROLE
Expert Panel Reflections & Key Takeaways	Ms. Neha Sharma Head of Patient Safety (India & Asia Frontier) AstraZeneca India	Speaker
	Dr. Aniket Patil Pharmacovigilance Country Safety Lead Pfizer India	Panelist
	Dr. Jamal Baig Director, Safety MSD Pharmaceuticals Pvt. Ltd.	Panelist
	Dr. Abhay Chimankar Founder & Director Rhyme Life Sciences	Panelist
	Dr. Vijay Venkatraman Managing Director & CEO Oviya Medsafe	Panelist

04:45 PM : 05:00 PM

Session 10

THEME AND TOPICS	SPEAKERS	ROLE
Workshop Wrap-Up & Close	Dr. Babita Kirodian Global Safety Manager, Amgen India? Chair, ISCR Pharmacovigilance Council Amgen	Speaker

10:00 AM : 10:30 AM

Introduction to ISCR and MW Workshop

THEME AND TOPICS	SPEAKERS	ROLE
Introduction to ISCR and MW Workshop

10:30 AM : 12:00 PM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Strategic and Tactical Publication Planning in Evolving Clinical Landscapes	Dr. Shalini Nair Asso. Director, Scientific Excellence Novartis	Speaker
	UBHAYABHARATHI GURUNATH Ad interim Group Lead - Scientific Communications Sanofi	Speaker

12:00 PM : 01:00 PM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
From Data to Draft – Writing with Impact	Pooja Banerjee Sr Director & Head, Medical Communications Krystelis	Speaker
From Data to Draft – Writing with Impact	Vasudha Chachra Team Lead - Scientific Writing Sanofi	Speaker

01:00 PM : 02:00 PM

Lunch Break

THEME AND TOPICS	SPEAKERS	ROLE
Lunch Break

02:00 PM : 03:00 PM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
From Data to Draft – Writing with Impact	Pooja Banerjee Sr Director & Head, Medical Communications Krystelis	Speaker
From Data to Draft – Writing with Impact	Vasudha Chachra Team Lead - Scientific Writing Sanofi	Speaker

03:00 PM : 03:20 PM

Tea/Coffee Break

THEME AND TOPICS	SPEAKERS	ROLE
Tea break

03:20 PM : 04:50 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
Maximizing reach and Engagement beyond the Manuscript	Anushree Srivastava Associate Manager, Clinical Affairs Stryker	Speaker
Maximizing reach and Engagement beyond the Manuscript	Dr. Chinmayee Joshi Manager Medical Writing and Publishing Fortrea Scientific Private Limited	Speaker

04:50 PM : 05:00 PM

Summary and closing remarks

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

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

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

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

03:30 PM : 04:15 PM

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
Clinical research Monitoring & data management	Dr. Kuldeep K Chauhan MSOG-Clinical Research, Fortis Healthcare Research Foundation, Fortis Healthcare Limited	Speaker

04:15 PM : 04:45 PM

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

04:45 PM : 05:00 PM

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

09:00 AM : 09:30 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Welcome and Opening
President's Welcome Address	DR. SEEMA PAI Indian Society for Clinical Research (ISCR) President	Speaker
General Secretary's Report	Mr Anirban Roy Chowdhury Hon. General Secretary Indian Society for Clinical Research (ISCR)	Speaker
Scientific Programme Overview	Mr Kedar Nayak Study Delivery Team Director – Global Clinical Operations GlaxoSmithKline Pharmaceuticals Ltd	Speaker
Scientific Programme Overview	DR. JERIN JOSE CHERIAN Scientist-E (Med) Indian Council of Medical Research	Speaker
Vote of Thanks
Lamp Lighting

09:30 AM : 11:30 AM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Introduction RRC Oration/Citation
Prof Ranjit Roy Chaudhury Oration	Dr. Sudeep Gupta, M.D., D.M., FNASc Tata Memorial Centre Director	Speaker
Felicitation	DR. SEEMA PAI Indian Society for Clinical Research (ISCR) President	Speaker
Announcement of Lifetime Achievement Awards- Academia	DR. JERIN JOSE CHERIAN Scientist-E (Med) Indian Council of Medical Research	Speaker
Felicitation-Awardee Lifetime Achievement Awards- Academia	DR. SEEMA PAI Indian Society for Clinical Research (ISCR) President	Speaker
Acceptance Speech	Dr. Upendra Kaul Chairman, Batra Heart Centre and Dean of Academics and Clinical Research Batra Hospital and Medical Research Centre, New Delhi.	Speaker
Announcement of Lifetime Achievement Awards- Industry
Felicitation-Awardee Lifetime Achievement Awards- Industry	Mr Anirban Roy Chowdhury Hon. General Secretary Indian Society for Clinical Research (ISCR)	Speaker
Acceptance Speech

11:30 AM : 12:15 PM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
TBC

12:15 PM : 01:00 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
Panel Discussion: Repositioning India as a Global Hub for Clinical Research: Harnessing Innovation and Patient-Centric Approaches for developing medicines for unmet medical needs in India

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

09:00 AM : 01:00 PM

Session 1-4 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 : 02:30 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Enabling Agile and Adaptive Regulatory Frameworks to Foster Innovation in Indian Clinical Research

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

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 4

THEME AND TOPICS	SPEAKERS	ROLE
Strategic role of medical writers in leading submissions	Ankit Shah Director, Scientific Writing Eli Lilly and Company	Session Chair
Strategic Role of Lead Medical Writers in Accelerating Clinical Development	Tanmay Ghosh Associate Director GSK	Speaker
Strategic Writing that De‑Risks and Accelerates Early Development: From Pre‑IND Questions to First‑in‑Human Execution	Shreekrishna Parpani Manager II – Global Clinical Regulatory Writing AstraZeneca	Speaker
Briefing Books–Strategic Communication between the Sponsor and Health Authority in Drug Development	Sunil Kumar Reddy Khambam Senior Scientific Writer II, GSRD BMS	Speaker
Accelerating Regulatory Approvals: How Lean Writing & Structured Content Authoring Drive Faster, Patient-Focused Clinical Research	Chetna Joshi Manager APCER Life Sciences	Speaker

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Scientific Depth or Strategic Breadth for medical writers	Priyanka Tiwari Associate Director - Medical Writing Thermo Fisher Scientific Inc.	Session Chair
Debate Topic: What Matters More for Growing into a Submission Lead Writer: Scientific Depth or Strategic Breadth?	Mohammed Salman Associate Director - Clinical Regualatory Writing AstraZeneca	Panelist
	Shakti Ranjan Rath Senior Manager BMS	Panelist
	Meenakshi Mudiraj Director, International Markets Regulatory Affairs Teva Pharamceuticals	Panelist
	Santosh Ghatol Senior Manager , Clinical Reporting Novo Nordisk	Panelist
	Ankit Shah Director, Scientific Writing Eli Lilly and Company	Panelist

06:00 PM : 07:00 PM

Annual General Meeting (AGM)

07:30 PM : 08:00 PM

Awards + Gala Dinner

02:00 PM : 03:25 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Welcome talk	Gaurab Chakraborty VP, Head of India Veramed	Speaker
Accelerating clinical research through adaptive trial designs	Laurent Billot Director of Research Innovation & Director of Biostatistics and Data Science, Centre for Operational The George Institute, Australia	Keynote 1
Smarter, Faster, Compliant: The New Blueprint for Clinical Programming	Roshan Stephen Associate Director Novo Nordisk	Session Chair
Synthetic Data Automation: An R-Based Solution to Accelerate Clinical Trials	Rajni Nagi " Sr Principle Statistical Programmer" Syneos Health	Panelist
Predicting ECG Scan results through Deep (Machine) Learning	Arjun Samanta Associate II Stat Programmer Johnson & Johnson	Panelist
Integrating Time as the Fourth Dimension: Enhanced Visualization of Clinical Trial Data Using Dynamic Bubble Charts	Swetha Mandava Principal Statistical Programmer Sanofi	Panelist
	Ranga Suresh Sannidhi Principal Biostatistician Sanofi	Panelist

03:25 PM : 04:00 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Fire side Chat : Evolution of Biometrics in India through Global Collaboration and regulatory excellence	Krishnendu Biswas Sr. Director, Statistical Programming, Advanced Quantitative Sciences Novartis	Session Chair
	Deepak Venkataraman AVP , Statistics, Data and Analytics Eli Lily	Panelist
	ANUPAM BENDRE Manager, Regulatory Affairs GlaxoSmithKline Pharmaceuticals Ltd	Panelist

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Federated Learning (FL) for Clinical Trials: Breaking Barriers to Multi-Site Data Sharing with AI-Driven Approach	R Gunasekaran Director, Biostatistics IQVIA	Session Chair
Beyond Assumptions: Machine Learning's Impact on Sample Size Estimation in Clinical Trials	Varun Kumar Associate Statistical Data Scientist Pfizer	Panelist
Network Meta-Analysis for Evidence Synthesis	Amritendu Bhattacharya Advisor Statistics Eli Lily	Panelist
The power of penalty: Harnessing high dimensional data - A comparative evaluation of penalized regression techniques	Dechamma B P Biostatistician II Syneos Health	Panelist
Audience Q&A

0 : 0

02:00 PM : 03:00 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
“The Patient as Partner: Rethinking PV Communication in the Digital Age”	Dr. Kiran Marthak Director - Medical Affairs Veeda Lifesciences	Speaker
“Safety First: Empowering Patients Through Simplified Pharmacovigilance”	Ms. Arshia Bhandari Founder PhVFiT , Pharmacovigilance Consultant PhVFIT	Speaker

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
“Global Safety Leadership in Transition: Challenges, Insights & Future Directions”	Dr. Jamal Baig Director, Safety MSD Pharmaceuticals Pvt. Ltd.	Session Chair
	Dr. J Vijay Venkatraman Managing Director & CEO Oviya Medsafe Pvt Ltd	Moderator
	Dr. Mohit Trivedi Country Safety Head, India, Sanof Sanofi	Panelist
	Dr. Vikram K Deputy Site Lead, Medical Review TA Head (Patient Safety) Bristol Myers Squibb	Panelist
	Mr. Inder Sachdeva Vice President, Safety & PV, Large Partnerships, Business Transformation, APAC Markets, Site Head Syneos Health	Panelist
	Dr. Shalu Kasliwal Founder and Managing Director Klinforsche Clinical Science Pvt. Ltd	Panelist

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
“Structured Benefit-Risk Assessment: Enhanced Decision Making in Drug Safety”	Dr. Prachi Arora VP & Head, Medical Safety, APCER Pharma APCER Pharma	Speaker
“Structured Benefit-Risk Assessment: Enhanced Decision Making in Drug Safety”	Dr. Nidhi Associate Professor, Jamia Hamdard, New Delhi Jamia Hamdard	Speaker
“Anti-Diabetic Medications: Emerging Evidence on Neurobehavioral Patient Safety”

08:00 AM : 09:00 AM

Registration

09:00 AM : 01:00 PM

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 : 02:40 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Regulatory Aspects of Translational and Early Phase Research	AMITA BHAVE Director Regulatory Affairs AstraZeneca	Session Chair
	Professor Y.K.Gupta President, AIIMS - Jammu, and Former President AIIMS Bhopal AIIMS	Panelist

02:40 PM : 03:20 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Designing and Conducting Early Phase Clinical Research – Evolving Landscape	Dr. Charu Gautam Senior Medical Director- Medical Sciences and Strategy, Asiapacific IQVIA	Session Chair
	Dr. Kiran Marthak Director - Medical Affairs Veeda Lifesciences	Speaker

03:20 PM : 04:00 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Early Phase Research in India – Opportunities and Challenges (40 min)	Ajit Nair Head- Regulatory Sciences Bristol Myers Squibb	Speaker

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Bench to Bedside Asset Journey – Zumutor Biologics (60 min)	Ajit Nair Head- Regulatory Sciences Bristol Myers Squibb	Session Chair
Bench to Bedside Asset Journey – Zumutor Biologics (60 min)	Kavitha Iyer Rodrigues CEO Zumutor Biologics	Speaker

09:45 AM : 11:00 AM

Session 9

THEME AND TOPICS	SPEAKERS	ROLE
Introduction to ISCR ACCRI & Welcome [15 mins] Digital innovations in academic clinical research. [40 mins] ICMR Perspective on supporting Indigenous therapeutics	Dr Ananya Chakraborty Professor and HOD Vydehi Institute of Medical Sciences & RC, Bangalore	Session Chair
	Dr Prabhakaran D Director Center for Chronic Disease Control	Keynote 1
	Dr. Aparna Mukherjee Clinical Studies and Trial Unit, Scientist F Indian Council of Medical Research	Keynote 2

11:00 AM : 12:30 PM

Session 10

THEME AND TOPICS	SPEAKERS	ROLE
Panel Discussion : Navigating the terrain: Challenges and opportunities for successful academic clinical research in India	DR. DENIS XAVIER Professor & Head Pharmacology, Head -Div of Clinical Research St. John's Medical College Bangalore	Panelist
	Dr. Aparna Mukherjee Clinical Studies and Trial Unit, Scientist F Indian Council of Medical Research	Panelist
	Dr Asita De Silva Cadre Chair & Senior Professor University of Kelaniya, Sri Lanka	Panelist
	Dr Usharani Pingali Professor Pharmacology NIZAMS	Panelist
	Dr Vaibhav Salvi Head - Clinical Study Unit, India and South East Asia, Sanofi	Panelist

01:30 PM : 02:30 PM

Session 11

THEME AND TOPICS	SPEAKERS	ROLE
Short talks: [30*2 = 60 mins] Strengthening clinical trials in academia: Sites, efficiency & innovation	Dr Anuradha HV Professor & HOD Pharmacology MSRMC	Session Chair
	Dr Arun Bhat Clinical Research & Drug Development Consultant	Speaker
	Dr Nitya Wadhwa Senior Professor Translational Health Science & Technology Institute	Speaker

0 : 0

Session 12

THEME AND TOPICS	SPEAKERS	ROLE
National Awards	DR. ASHOK SHENOY Professor, Dept of Pharmacology Kasturba Medical College, Mangalore	Session Chair
	Dr Debjyoti Halder Academic Professor Midnapore Medical College	Session Chair
	Dr Raktim Swarnakar Assistant Professor AIIMS Delhi, Physical Medicine and Rehabilitation	Panelist
	Dr Ashish Kakkar Assistant Professor Clinical Pharmacology PGIMER	Panelist
	Dr Pramila Kalra Professor of Endocrinology MS Ramaiah Medical College	Panelist
	Dr Ambuj Roy Professor of Cardiology AIIMS	Panelist
	Dr Jeemon Panniyammakal Additional Professor of Epidemiology Sree Chitra Tirunal Institute for Medical Sciences	Panelist

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

Inauguration Session

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