Pre Conference Workshops

09:30 AM : 10:15 AM

Session 1

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 2

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 3

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 4

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 5

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 6

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

Session 7

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
Dr. Kuldeep K Chauhan
MSOG-Clinical Research, Fortis Healthcare Research Foundation,
Fortis Healthcare Limited 		Speaker

04:15 PM : 04:45 PM

Session 8

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

Session 9

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

09:30 AM : 10:15 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Welcome and Opening Remarks RBQM Intro orienting to concept, evolution and regulatory landscape Setting the context for strategic relevance across clinical functions as a stage for next consecutive sessions PINAKI KARMOKER
Head, Global Data Management
Sun Pharmaceuticals Industries Limited 		Speaker

10:15 AM : 11:30 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Part 1 : RBQM in Clin Ops. - approach on risk identification and risk-based monitoring Study team Role in risk detection and signal interpretation; working relationship with clin. Ops. and all applicable cross function Role of QA- in terms of compliance alignment, oversight and auditing of process followed Introduction to cross function (besides DM, Clin. Ops. and QA) KRISHNENDU SENGUPTA
Director - Centralized Monitoring
AstraZeneca Pharma India Ltd. 		Speaker

11:30 AM : 11:45 AM

Tea Break

11:45 AM : 01:00 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE
PART 2: AVP - Head of India Life sciences practice VENKATA SURESHBABU BONDU
AVP – Life Sciences Solutions
Hexaware technologies 		Speaker

01:00 PM : 01:45 PM

Lunch Break

01:45 PM : 03:15 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
PART 3:Working exercise for successful RBQM Implementation using: Case studies Interactive RACT tools, QTL Guidance involving cross functional representation from audience PINAKI KARMOKER
Head, Global Data Management
Sun Pharmaceuticals Industries Limited 		Speaker
KRISHNENDU SENGUPTA
Director - Centralized Monitoring
AstraZeneca Pharma India Ltd. 		Speaker
VENKATA SURESHBABU BONDU
AVP – Life Sciences Solutions
Hexaware technologies 		Speaker
Dr. Swathi Padival
Director Risk Based Monitoring, Centralized Monitoring
IQVIA 		Speaker

03:15 PM : 03:30 PM

Tea Break

03:30 PM : 05:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion to essentially establish the Culture of risk awareness RBQM governance model for adoption Challenges and opportunities across functions PINAKI KARMOKER
Head, Global Data Management
Sun Pharmaceuticals Industries Limited 		Speaker
KRISHNENDU SENGUPTA
Director - Centralized Monitoring
AstraZeneca Pharma India Ltd. 		Speaker
VENKATA SURESHBABU BONDU
AVP – Life Sciences Solutions
Hexaware technologies 		Speaker
Dr. Swathi Padival
Director Risk Based Monitoring, Centralized Monitoring
IQVIA 		Speaker
SACHIN TONAPI
Vice President, Global Head of Centralized Delivery
Fortrea 		Speaker

05:00 PM : 05:30 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Summary of Key Notes and address Next step forward expectation with RBQM embedding across organizational practice Q&A and Feedback PINAKI KARMOKER
Head, Global Data Management
Sun Pharmaceuticals Industries Limited 		Speaker
SACHIN TONAPI
Vice President, Global Head of Centralized Delivery
Fortrea 		Speaker

09:00 AM : 09:15 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Welcome & Introduction Dr. Smita Brahma
Director - MIER
Medanta Institute of Education Research (MIER) 		Speaker
Workshop objectives and agenda overview Pre- workshop questionnaire Dr Sanish Davis
Director R&D and Country Head, GCO
Johnson & Johnson Innovative Medicines
Raman Sehgal
General Manager - Medical and Clinical Research Development
Medanta - The Medicity 		Speaker

09:15 AM : 10:30 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
CRC’s Role In Supporting Research At The Site
Industry sponsored studies versus academic studies: what should a CRC know? Dr. Shoibal Mukherjee
Director and Head - Medical Research
Medanta - The Medicity 		Speaker
What should be the CRC’s deliverables in supporting research at a site? Deepti Goel
Executive Director
Harrison's Tech Consultants 		Speaker
Hands on exercise : Roles & Responsibilities for CRCs Deepti Goel
Executive Director
Harrison's Tech Consultants 		Speaker

10:30 AM : 11:00 AM

Tea Break

11:00 AM : 12:00 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Patient Centricity In Clinical Research
Why patient centricity is crucial for ethical conduct, recruitment, retention, and overall study success Dr. Surinder Kher
Executive Head - Clinical Research
Aster Hospitals , Bengaluru 		Speaker
Investigator’s perspective on how patient centricity can enable better research outcomes Dr. Nitin Sood
Vice Chairman
Medical Oncology & Bone Marrow Transplant, Cancer Institute, Medanta - The Medicity 		Speaker
Case study on patient centricity – A Govt. Hospital Perspective Shilpi Paliwal
Site Solution Manager
Premier Research 		Speaker

12:00 PM : 12:45 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Patient Recruitment & Retention Strategies
Developing effective recruitment plans: site-specific challenges and solutions. Pre-screening and eligibility assessment best practices Dr Puja S Nagpal
Research Scientist and  Head Quality 
Amrita Research Centre,Faridabad 		Speaker
Importance of patient retention strategies for gathering long term follow up data Manoj Karwa
Head - CT and PV
Auriga Research Private Limited 		Speaker
Discussion/ Q&A/Exercises Dr Puja S Nagpal
Research Scientist and  Head Quality 
Amrita Research Centre,Faridabad 		Speaker
Manoj Karwa
Head - CT and PV
Auriga Research Private Limited 		Speaker

12:45 PM : 01:30 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Exercise: Reviewing sample source documents and identifying common errors Dr. Rajesh Saxena
Vice-President, Clinical Research
Max Healthcare Institute Limited 		Speaker

01:30 PM : 02:30 PM

-

THEME AND TOPICS SPEAKERS ROLE
Lunch Break

02:30 PM : 03:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Investigational Product (IP) Management & Accountability : Case Study Muneeb Ahsan
Deputy General Manager, Clinical Research
Mankind Pharma Limited 		Speaker

03:00 PM : 03:45 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Practical Aspects of Safety Reporting
Safety Reporting: Exercises Dr Priyadarshini Arambam
General Manager – Academics and Clinical Research
Batra Hospital and Medical Research Centre 		Speaker

03:45 PM : 04:15 PM

Tea Break

04:15 PM : 05:00 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Communication & Empathy: Essential Soft Skills for CRCs
Role-play or Group Discussion with 2 scenarios: Practicing empathetic responses to common patient concerns Dr Pooja Sharma
"Founder & CEO, APAR Health Gynecologist | Clinical Research Leader | Patient Advocate for researc
APAR Health 		Speaker
Dr. Neha Chawla
Head - Training
Clinical Development Services Agency, Translational Health Science and Technology Institute 		Speaker

05:00 PM : 05:45 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Clinical Trial Agreement (CTA) & Budget Essentials '- Live example Raman Sehgal
General Manager - Medical and Clinical Research Development
Medanta - The Medicity 		Speaker
Career trajectory for CRCs – A CRC Perspective Sutapa Roy
Research Coordinator, Institute of Critical Care and Anaesthesiology
Medanta - The Medicity 		Speaker
Career trajectory for CRCs – Industry Perspective Deepti Goel
Executive Director
Harrison's Tech Consultants 		Speaker

05:45 PM : 06:00 PM

Key Takeaways, Questions and Answers & Closing Remarks, Distribution of Certificates of Participation

09:00 AM : 09:15 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Welcome & Opening Remarks Mr Anirban Roy Chowdhury
Hon. General Secretary
Indian Society for Clinical Research (ISCR) 		Session Chair
Mr. Gregory Smith
Director, India Office
US FDA 		Speaker

09:15 AM : 09:45 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
USFDA India Outlook - BIMO program overview; inspection data for 2025 Dr. Koffi Amegadje
Consumer Regulatory Officer
US FDA 		Speaker

09:45 AM : 10:30 AM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Keynote Address ICH E6(R3) is Here—What Changes on the Ground? SHEHNAZ VAKHARIA
Vice President-Asia Pacific
ADAMAS Consulting 		Speaker

10:30 AM : 11:00 AM

Tea Break

11:00 AM : 11:30 AM

Session 4

THEME AND TOPICS SPEAKERS ROLE
21 CFR Part 11 & Electronic Systems - Audit Trails, eSignatures & Vendor Controls Ms. Alanna L. Bias
Consumer Regulatory Officer
US FDA 		Speaker

11:30 AM : 12:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
GCP – Quality Assessment in Regulatory Submissions Dr. Sudheendra Kulkarni
Senior Professional
Biocon 		Speaker

12:00 PM : 01:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Panel: Navigating Investigator Site Inspections Dr. Anupam Prakash
Investigator
Lady Hardinge Medical College, Delhi 		Speaker
Sundeep Aggarwal
MSD
Merck 		Panelist
Jestin V Thomas
Managing Director and CEO
Leads clinical Research and Bio Services Pvt.Ltd. 		Panelist
Ms. Alanna L. Bias
Consumer Regulatory Officer
US FDA 		Panelist
Dr. Koffi Amegadje
Consumer Regulatory Officer
US FDA 		Panelist

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 04:00 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Hands-On Case Lab – BIMO Case Studies Ms. Alanna L. Bias
Consumer Regulatory Officer
US FDA 		Speaker
Dr. Koffi Amegadje
Consumer Regulatory Officer
US FDA 		Speaker

04:00 PM : 05:00 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
USFDA Open House & Wrap-Up Ms. Alanna L. Bias
Consumer Regulatory Officer
US FDA 		Moderator
Dr. Koffi Amegadje
Consumer Regulatory Officer
US FDA 		Panelist
Dr. Jacquin Jones
International Relations Specialist
US FDA 		Panelist
Mr. Dhruv Shah
Senior Technical Advisor, India Office
US FDA 		Panelist
Dr. Phuc Nguyen
International Relations Specialist
US FDA 		Panelist

10:00 AM : 10:30 AM

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
Vasudha Chachra
Team Lead - Scientific Writing
Sanofi 		Speaker

01:00 PM : 02:00 PM

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
Vasudha Chachra
Team Lead - Scientific Writing
Sanofi 		Speaker

03:00 PM : 03:20 PM

Tea/Coffee 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
Dr. Chinmayee Joshi
Manager Medical Writing and Publishing
Fortrea Scientific Private Limited 		Speaker

04:50 PM : 05:00 PM

Summary and closing remarks

09:00 AM : 09:30 AM

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 		Speaker

10:00 AM : 10:15 AM

Tea Break

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
Medical Director, Global Patient Safety
Amgen 		Speaker
Mr. Vivek Gupta
Associate Director, R&D Procurement & Vendor Management
Organon 		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 		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
Ms. Hina Talwar
Safety Services Project Leader
Parexel 		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

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
Associate Director- Global Patient Safety, India Cluster
AstraZeneca 		Speaker
Dr. Aniket Patil
Country Safety (Pharmacovigilance) Lead - India & India Region countries
Pfizer 		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

09:45 AM : 10:00 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Welcome and Introduction to ISCR & Regulatory Workshop MS. SUKANYA CHOUDHURY
Executive Vice President – Regulatory Affairs
GSK 		Speaker

10:00 AM : 10:30 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Presentation: The Importance of Regulatory Convergence in a Globalized World YASMIN SHENOY
Senior Director Regulatory Affairs
Novartis Healthcare Private Limited 		Speaker

10:30 AM : 11:00 AM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Presentation: From Bench to Market: Navigating India’s Regulatory Roadmap for Cell and Gene Therapy Dr Priyadarshini Chatterjee
GENERAL MANAGER, R&D - CELL AND GENE THERAPY
MICROCRISPR 		Speaker

11:00 AM : 11:30 AM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Presentation: Decoding Clinical Trial Regulations and Registration Roadmap for Medical Devices in India Ms. Lipi Chakhaiyar
Director - Regulatory Affairs
Abbott Healthcare Pvt. Ltd 		Speaker

11:30 AM : 12:15 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Presentation: Navigating the Evolving Landscape: Recent Updates in Indian Regulatory Guidelines for Clinical Trials and Drug Approvals – Insights and Expectations for Applicants Sneha Gupta
Director Regulatory Affairs
IQVIA 		Speaker

12:15 PM : 01:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion: Strengthening Clinical Trial Harmonization: Aligning Regulatory Expectations and Operational Excellence MS. SUKANYA CHOUDHURY
Executive Vice President – Regulatory Affairs
GSK 		Moderator
AMITA BHAVE
Director Regulatory Affairs
AstraZeneca 		Panelist
Sneha Gupta
Director Regulatory Affairs
IQVIA 		Panelist
Darshana Dholakia
Sr. Manager - GCO/ India
Johnson & Johnson 		Panelist
Dr Pooja Sharma
"Founder & CEO, APAR Health Gynecologist | Clinical Research Leader | Patient Advocate for researc
APAR Health 		Panelist

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 03:00 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Workshop: From Submission to Approval - Aligning Applicant Strategy with India’s Evolving Regulatory Framework VIVEK PADALALU
Associate Director, Site readiness and Regulatory Operations,
Fortrea 		Speaker
Mr. Rahul Mehrotra 
Country Head-Regulatory Affairs-India & Sub continent
Thermo Fisher-PPD CRG Business 		Speaker

03:00 PM : 03:20 PM

Tea Break

03:20 PM : 04:20 PM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Presentation: The Digital Shift : Advancing Regulatory Submissions and Review Through Technology Ganesh Pawbake
Senior Manager Regulatory Affairs, Global Regulatory Affairs & Strategy
Amgen 		Speaker
Ben Laverty
Vice President, R&D Operations India, Sout East Asia, Australia & New Zealand
IQVIA 		Speaker

04:20 PM : 04:50 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Open Forum: From Theory to Practice: Real-World Questions, Real-Time Answers ANUPAM BENDRE
Manager, Regulatory Affairs
GlaxoSmithKline Pharmaceuticals Ltd 		Speaker
VIVEK PADALALU
Associate Director, Site readiness and Regulatory Operations,
Fortrea 		Speaker
Mr. Rahul Mehrotra 
Country Head-Regulatory Affairs-India & Sub continent
Thermo Fisher-PPD CRG Business 		Speaker

04:50 PM : 05:00 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Summary and closing remarks Mr. Rahul Mehrotra 
Country Head-Regulatory Affairs-India & Sub continent
Thermo Fisher-PPD CRG Business 		Speaker

Main Conference Tracks

13-Feb-2026 14-Feb-2026

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 : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Enabling Agile and Adaptive Regulatory Frameworks to Foster Innovation in Indian Clinical Research MS. SUKANYA CHOUDHURY
Executive Vice President – Regulatory Affairs
GSK 		Session Chair & Moderator
DR. SEEMA PAI
Indian Society for Clinical Research (ISCR)
President 		Panelist
DR. JERIN JOSE CHERIAN
Scientist-E (Med)
Indian Council of Medical Research 		Panelist
YASMIN SHENOY
Senior Director Regulatory Affairs
Novartis Healthcare Private Limited 		Panelist
Dr. Usharani Pingali
Senior Prof & HOD, Dept of Clinical Pharmacology DNB (Clinical Pharmacol); MD (Pharmacol); FCCP; FIP
Nizam's Institute of Medical Sciences, Hyderabad 		Panelist

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Adoption of innovative approaches in clinical trials : Ensuring Ethics Compliance and Quality. DR. MRUNALINI KALIKAR
Associate Professor, Department of Pharmacology
GMC,Nagpur 		Session Chair & Moderator
Dr. Ganesh Dakhale
Dean (Exam) & Professor, Pharmacology
AIIMS, Nagpur, NPT 		Panelist
DR. ASHOK SHENOY
Professor, Dept of Pharmacology
Kasturba Medical College, Mangalore 		Panelist
Shweta Pradhan
Sr. Director & Head RDS India Clinical Operations
IQVIA India R&D Solutions 		Panelist

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Quality by Design : Translating ICH-GCP E6 (R3) into Indian Clinical Trial Operations. Dr. Partha Chatterjee
Head Clinical Trials, CDM & BSP
Syngene International Ltd. 		Session Chair & Moderator
Ms Sachin Satija
Sr. Director, Quality Assurance
Syneos Health 		Panelist
Dr Sudheendra Kulkarni
AVP – Regulatory Policy, Government Affairs & Audit Liaison
Biocon Biologics Limited 		Panelist
Dr. Suman Karanth
Additional Director in Medical Oncology MBBS, MD, DNB Medical Oncology
Fortis Memorial Research Center, Gurugram, India 		Panelist
Swapnali Raut
Director, Clinical Operations
GSK 		Panelist
Pinaki Kamorkar
Head, Global Data Management, Global Clinical Development
Sun Pharmaceutical Industries Ltd 		Panelist

06:00 PM : 07:30 PM

Annual General Meeting

07:30 PM : 08:00 PM

Annual General Meeting

13-Feb-2026 14-Feb-2026

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 : 07:30 PM

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

02:00 PM : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
The Future of Clinical Data: Trends, Transformations, and the Road to 2030

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Next-Gen Tech in Action: Revolutionizing Clinical Data Management Mr Suvadeep Chatterjee
Sr. Director Clinical Data Management
IQVIA 		Session Chair & Moderator
Manmeetsingh Marwaha
Manager - Data Management Lead
Johnson & Johnson Innovative Medicinemmarwah1@its.jnj.com 		Speaker
Manuj Vangipurapu
CEO – Clinion - AI enabled
eClinical Platform 		Speaker

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Upholding Data Integrity: A Renewed Focus on Quality and Standards Ullas Arabhavi
Head of Data Management George Institute of Global Health
2uCDM Data Solutions 		Session Chair & Moderator
Shreya Mandil
Principal Study Build Programmer
Eli Lilly Services India Private Limited 		Speaker
Rashmi Thakur
Principal Study Build Programmer
Eli Lilly Services India Private Limited 		Speaker
Neha Kumari
Group Leader
ICON plc 		Speaker

06:00 PM : 07:00 PM

Annual General Meeting

07:30 PM : 08:00 PM

Awards + Gala Dinner

13-Feb-2026 14-Feb-2026

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

13-Feb-2026 14-Feb-2026

08:00 AM : 09:00 AM

Registration

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 : 03:25 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Welcome talk Gaurab Chakraborty
VP, Head of India
Veramed 		-
Accelerating Clinical Research through Adaptive Trial Designs Laurent Billot
Director of Research Innovation, Biostatistics & Data Science, Centre for Operational & Research Exc
The George Institute, Australia 		Keynote 1
Smarter, Faster, Compliant: The New Blueprint for Clinical Programming Roshan Stephen
Associate Director, Clinical Data Science
Novo Nordisk 		Session Chair
Synthetic Data Automation: An R-Based Solution to Accelerate Clinical Trials Rajni Nagi
"  Sr Principal 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 Lilly 		Panelist
Anup Kumar Banerjee
Director, Biostatistics
Fortrea 		Panelist

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:00 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Harnessing the Advancements in Computing Power 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 Lilly 		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

06:00 PM : 07:00 PM

Annual General Meeting (AGM)

07:30 PM : 0

Awards + Gala Dinner

13-Feb-2026 14-Feb-2026

08:00 AM : 09:00 AM

Registration

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 : 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
Dr. Babita Kirodian
Global Safety Manager, Amgen India? Chair, ISCR Pharmacovigilance Council
Amgen 		Session Chair
“Safety First: Empowering Patients Through Simplified Pharmacovigilance” Ms. Arshia Bhandari
Founder PhVFiT , Pharmacovigilance Consultant
PhVFIT 		Speaker
“Global Safety Leadership in Transition: Challenges, Insights & Future Directions” Dr. Abhay Chimankar
Founder & Director
Rhyme Life Sciences 		Session Chair
Dr. J Vijay Venkatraman
Managing Director & CEO
Oviya Medsafe Pvt Ltd 		Panelist
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 6

THEME AND TOPICS SPEAKERS ROLE
“Structured Benefit-Risk Assessment: Enhanced Decision Making in Drug Safety” Dr. Chitra Bargaje
Lead Consultant, Quality and Compliance (GVP/GCP), Medrenova
Medrenova 		Session Chair
Dr. Prachi Arora
VP & Head, Medical Safety
APCER Pharma 		Speaker
“Anti-Diabetic Medications: Emerging Evidence on Neurobehavioral Patient Safety” Dr. Nidhi
Associate Professor
Jamia Hamdard, New Delhi 		Speaker

06:00 PM : 07:00 PM

Annual General Meeting

07:30 PM : 0

Awards + Gala Dinner

13-Feb-2026 14-Feb-2026

08:00 AM : 09:00 AM

Registration

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 : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Patient-Centric Approaches: Redefining Value in Healthcare Evidence Sushmeeta Chhowala
"Director, Lead- Clinical Development and Strategy"
Cipla Ltd, Mumbai 		Session Chair
Patient-Centric RWE: Vision or Reality? Sushmeeta Chhowala
"Director, Lead- Clinical Development and Strategy"
Cipla Ltd, Mumbai 		Panelist
Patient-Centricity in RWE: Are We Walking the Talk Dr Sandesh Sawant
Head- Clinical Trials
Cipla Ltd 		Panelist
Jaideep Kaneria
Head: Real World Evidence ( Industry Advisor), TCS Life Sciences Strategic Advisory Group
Tata Consultancy Services Limited 		Panelist
Dr. Pooja Sharma
Founder CEO, Ethicist, and Patient Advocate
APAR Health 		Panelist
Dr Rohit Kumar
Associate Professor and Head, Department of Pulmonary Medicine, Critical Care Medicine and Sleep Dis
Vardhman Mahavir Medical College & Safdarjung Hospital (VMMC & SJH), New Delhi 		Panelist

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Ethical and Privacy: Protecting Patient Rights in the Age of Data Kavitha Gurram
"Director, APAC Head of Project Management. Chair of RWE Council"
IQVIA, ISCR 		Session Chair
Ethical Oversight in the Age of Digital Health: Challenges and Best Practices Dr Arun Bhat
Clinical Research & Drug Development
Consultant 		Panelist
Building Institutional Capacity for Ethical Oversight in RWE Studies Dr. Sirshendu Chaudhuri
Associate Professor
PHFI University of Public Health Sciences Hyderabad 		Panelist
Data Protection and Patient Trust: Building a Robust RWE Ecosystem Dr Arun Bhat
Clinical Research & Drug Development
Consultant 		Panelist
Dr. Sirshendu Chaudhuri
Associate Professor
PHFI University of Public Health Sciences Hyderabad 		Panelist
Dr. Usharani Pingali
Senior Prof & HOD, Dept of Clinical Pharmacology DNB (Clinical Pharmacol); MD (Pharmacol); FCCP; FIP
Nizam's Institute of Medical Sciences, Hyderabad 		Panelist
Dr. Charu Sachdeva
Joint Member Secretary, IRB and AMS
Rajiv Gandhi Cancer Institute Reseach Centre 		Panelist

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

THEME AND TOPICS SPEAKERS ROLE
Driving Value: The Evolving Role of HEOR in Healthcare Decision-Making Dr. Saurabh Kumar
Head & Principal RWE .Lead IQVIA India RWE & Health Economic Team. Oncology expert for consulting an
IQVIA 		Session Chair & Moderator
HTA for enhancing affordable, and accessible healthcare in India Dr Kavitha Rajsekar
"Scientist-F, ICMR, Department of Health Research Ministry of Health and Family welfare"
MoHFW and HTA 		Panelist
Health economics evaluation of vaccines in India Dr Ravdeep Kaur
Health Economics and Value Proposition Manager
Takeda 		Panelist
Use of RWD in Health economics Dr Santosh Taur
Director Medical Affairs, Vice President
Pfizer Limited, NPT 		Panelist
Q&A

06:00 PM : 07:00 PM

Annual General Meeting (AGM)

07:30 PM : 0

Awards + Gala Dinner

13-Feb-2026 14-Feb-2026

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
Kavitha Iyer Rodrigues
CEO
Zumutor Biologics 		Speaker