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
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

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: Technology enablers- Orientation to Central Monitoring and use of dashboards and analytics

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
	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

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

THEME AND TOPICS	SPEAKERS	ROLE
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
Discussion/ Q&A/Exercises	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

THEME AND TOPICS	SPEAKERS	ROLE
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

Session 9

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

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

09:00 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

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

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 : 12:15 PM

Session 4

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	Mamta Sharma Director, Regulatory Affairs PAREXEL International	Speaker

12:15 PM : 01:00 PM

Session 5

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	Speaker
	AMITA BHAVE Director Regulatory Affairs AstraZeneca	Speaker
	Sneha Gupta Director Regulatory Operations IQVIA	Speaker
	Darshana Dholakia Sr. Manager - GCO/ India Johnson & Johnson	Speaker
	Dr Pooja Sharma "Founder & CEO, APAR Health Gynecologist \| Clinical Research Leader \| Patient Advocate for researc APAR Health

01:00 PM : 02:00 PM

LUNCH BREAK

02:00 PM : 03:00 PM

Session 6

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 7

THEME AND TOPICS	SPEAKERS	ROLE
Presentation: The Digital Shift : Advancing Regulatory Submissions and Review Through Technology

04:20 PM : 04:50 PM

Session 8

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 9

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

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 : 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

09:30 AM : 10:45 AM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Unified Voices for Patient-Centric Clinical Research and value creation

10:45 AM : 11:30 AM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Patient Voice - Insights, Challenges for driving operational efficiency in clinical trials

11:30 AM : 12:30 PM

Session 9

THEME AND TOPICS	SPEAKERS	ROLE
Harnessing Technology to drive Efficiency in Clinical Study Life Cycle: Design, Planning, and Patient-Centric Approaches

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS	SPEAKERS	ROLE
Bridging Clinical and Commercial Development: Accelerating Patient Access to Innovative Medicines

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS	SPEAKERS	ROLE
Repurpose for Patients : Showcasing work/ideas for Digital Innovation, Global Collaboration and Patient Centric Value Creation	Darshana Dholakia Sr. Manager - GCO/ India Johnson & Johnson	Session Chair & Moderator
Scaling Remote Pre-Screening in Oncology Trials: Operational Lessons from Japan and Contextual Adaptation for India
Transcending Laboratory Services in Globally Harmonized and Precision-Driven Health Research: Insights from the ReMAPP Study
Patient Centric Audit Approaches in Clinical Trials
Vote of Thanks	DR. SEEMA PAI Indian Society for Clinical Research (ISCR) President	Panelist

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

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Panel Discussion : Ethics, Trust, and Transparency in Clinical Data Science

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS	SPEAKERS	ROLE
The Rise of Digital Risk-Based Quality Management (RBQM)

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS	SPEAKERS	ROLE
Panel Discussion: Navigating the Regulatory Landscape in a Digital Age

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS	SPEAKERS	ROLE
The Data Manager of Tomorrow: From Custodian to Patient Data Custodian

03:30 PM : 03:45 PM

Vote of Thanks

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

08:00 AM : 09:30 AM

Tea/Coffe

09:30 AM : 11:00 AM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Empowering Patients for enhanced engagement	Shakti Ranjan Rath Senior Manager BMS	Session Chair
Medical Writing for Adaptive Trials in India: Framework and Future	Seema Abhijeet Kaveeshwar Associate Manager, Regulatory & Medical Writing? MMS Holdings	Speaker
Tokenization: Innovation In Drug Development To Improve Patient Outcomes	Monal Shah Regulatory writer Novartis	Speaker
Harnessing Patient Engagement and Digital Innovation to Elevate Clinical Trial Documents	Shima Shaikh Senior Manager Novartis	Speaker
Publication of CSRs- Protecting privacy while promoting transparency	Hitesh Manchanda Associate Director, Medical Writing Syneos Health	Speaker

11:30 AM : 12:30 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Elevating skills, competencies and talent development: Unleashing the Value of Medical Writers as Content Strategists	Garima Pallavi Director, Head of Medical Writing Centre of Excellence GSK	Session Chair
A Leader’s Roundtable: Innovation, Talent, and Efficiency in Medical Writing	Divya B P Senior Director, Global Scientific Communications Eli Lilly and Company	Panelist
	Sonali Parmar Director, Medical Writing Syneos Health	Panelist
	Meha Mayuri Senior Manager, Medical & Scientific Writing and Clinical Operations Syngene International Limited	Panelist
	Dev Baruah Associate Director - Clinical Regualatory Writing AstraZeneca	Panelist
	Sudha Chennasamudram Associate Director- Submissions, GRSO BMS	Panelist
	Divya Murarka Senior Director PAREXEL International (India) Private Ltd	Panelist
Speaker felicitation

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 03:30 PM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Beyond the Algorithm: Medical writers thriving in an AI-Driven world	Santosh Ghatol Senior Manager , Clinical Reporting Novo Nordisk	Session Chair
Accuracy and Reliability of Large Language Models in Medical Writing: A Comparative Experimental Study	Rajashekar Reddy N Manager-Regulatory Solutions Indegene Limited	Speaker
Leveraging Generative AI to Automate the Presentation of Clinical Trial Exposure Data in DSURs-PBRERs	Srikanth Ramesh Ankkam Senior Scientific Writer I BMS	Speaker
Cutting Through Complexity: Structured Content for Accelerated Regulatory Submission	Vijay Shinde Associate Director – Medical Writing GSK	Speaker
Data Visualization for Publication Writers: Enhancing Visual Storytelling in Scientific Publications	Moksha Shah Senior Scientific Writer Eli Lilly and Company	Speaker
Speaker felicitation

03:30 PM : 03:45 PM

Vote of Thanks

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

09:30 AM : 11:05 AM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Welcome talk	Krishnendu Biswas Sr. Director, Statistical Programming, Advanced Quantitative Sciences Novartis	-
Accelerating Innovation in Clinical Trials – experiences and key learnings from Europe, US, Japan and China’	Christine Fletcher VP Biostatistics GSK,UK	Keynote 1
AI-Driven Transformation in Clinical Programming	Mayank Bhatia Head of Product TCS , ADD	Session Chair
What the future holds for the Clinical Programmers in the AI World	Nishanth Nalan Director/Practice Head – Life Sciences ACL Digital	Panelist
Federated Learning (FL) for Clinical Trials: Breaking Barriers to Multi-Site Data Sharing with AI-Driven Approach	Mrityunjay Kumar Associate Director II - Statistical Programming Ephicacy Life Science Analytics, Bengaluru	Panelist
No Fear, Just Power: Making AI Your Copilot in Statistical Programming	Sujoy Ghosh Associate Manager MercK KgaA, Darmstadt, Germany?	Panelist
Audience Q&A

11:05 AM : 12:30 PM

Session 9

THEME AND TOPICS	SPEAKERS	ROLE
Statistical Models and its Applications	Dr. Gayatri Vishwakarma Principal Scientist Zydus Lifesciences Ltd	Session Chair
AI Is Changing the Game - and Statistical Programmers Are Poised to Lead	James Gallagher Chief Growth Officer MARS Group	Keynote 2
Statistical Innovations in Longitudinal Data Analysis in Clinical Trials: The Case for Constrained MMRM	Praman Dwivedi Senior Statistical Programmer Eli lily & Co	Panelist
Exploring the Mathematical and Statistical constructs of Population Pharmacokinetics and Exposure-Response Data Structures and their respective modeling frameworks.	Abhishek Dey Statistical Programmer Novartis	Panelist
Identifying Influential Observations in Cox Proportional Hazards Models Using Residual Diagnostics	Dr. Pritam Gupta Director, Biostatistics Bristol Myers Squibb	Panelist

12:30 PM : 01:30 PM

Lunch break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS	SPEAKERS	ROLE
Panel Discussion: Beyond Tables, Listings, and Figures: Redefining the Role of Statistical Programmers in Patient-Centric Value Creation	Bhavesh S Patkar Executive Director Syneos Health	Moderator
	Neeraj Malhotra Expert Data Sciences Product Leader Roche, UK	Panelist
	Angshuman Sarkar Senior Director, Head Statistics, India GSK, India	Panelist
	Varsha Mahajan Senior Director, Head of Clinical & Safety Data Insights & Analytics Bristol Myers Squibb, India	Panelist
	Vahe Martirosyan Founder & CEO Gurus CRO, Armenia	Panelist

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS	SPEAKERS	ROLE
Regulatory Strategy and Clinical Trial Optimization	Shubhramoy Mandal Associate Director Johnson & Johnson	Session Chair
Lead Programmer's Role in Accelerated Submissions through Reverse Engineering	Sowmya Singuluri Principal Statistical Programmer Novartis	Panelist
Regulatory Bodies & Approval Process in Clinical Research: The Indian Landscape	Nagarjuna Reddy Badduri Principal Statistical Programmer Fortrea	Panelist
	Nishanth Sungaram Associate Manager Statistical Programming Fortrea	Panelist
From Code to Clearance: Empowering Statistical Programmers in BLA Application Orientation Walkthrough with Data-Driven Confidence	Shrikant Lokhande Senior Statistical Programmer Novartis	Panelist

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS	SPEAKERS	ROLE
Regulatory Strategy and Clinical Trial Optimization	Shubhramoy Mandal Associate Director Johnson & Johnson	Session Chair
Lead Programmer's Role in Accelerated Submissions through Reverse Engineering	Sowmya Singuluri Principal Statistical Programmer Novartis	Panelist
Regulatory Bodies & Approval Process in Clinical Research: The Indian Landscape	Nagarjuna Reddy Badduri Principal Statistical Programmer Fortrea	Panelist
	Nishanth Sungaram Associate Manager Statistical Programming Fortrea	Panelist
From Code to Clearance: Empowering Statistical Programmers in BLA Application Orientation Walkthrough with Data-Driven Confidence	Shrikant Lokhande Senior Statistical Programmer Novartis	Panelist
Audience Q&A

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. Prachi Arora VP & Head, Medical Safety, APCER Pharma APCER Pharma	Speaker
“Anti-Diabetic Medications: Emerging Evidence on Neurobehavioral Patient Safety”	Dr. Nidhi Associate Professor, Jamia Hamdard, New Delhi Jamia Hamdard	Speaker

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
“PV Literacy for All: Building a Culture of Safety Awareness”	Dr. Jaiprakash Senior Principal Scientific Officer and Officer-in-Charge Pharmacovigilance Programme of India,Indian Pharmacopoeia Commission	Speaker
“Making Precision Pharmacovigilance a Reality”	Dr. Kausik Maiti Executive Director, Safety Medical Sciences Parexel International	Speaker

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS	SPEAKERS	ROLE
“Agentic vs Scientific AI: Balancing Autonomy and Human-Centric Intelligence in Pharmacovigilance and Clinical Research”	Dr. Vijaykrishnan Ganesan Global Safety Operational Group Lead Opella Consumer Healthcare	Speaker
“Accelerating AI-Powered Safety”	Dr Siva Kumar Buddha Director Amgen	Moderator
	Dr. Alok Nachane Director VeritasQ Research & Analytics Pvt Ltd	Panelist
	Mr. Raghavendra Parvataraju CEO, Graph AI Inc Graph AI Inc	Panelist
	Mr. Naveen Nirmal Kumar Principal Consultant – R&D, Infosys Consulting Infosys Consulting	Panelist

12:30 PM : 01:30 PM

Lunch break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS	SPEAKERS	ROLE
“Herbal Horizons: Integrating Traditional Remedies”	Dr. Rajesh Kumawat Head, Medical Services & Clinical Development Himalaya Wellness Company	Speaker
“PV Country Safety Heads at the Helm: Challenges, Insights, and Impact”	Dr. Chitra Bargaje Lead Consultant, Quality and Compliance (GVP/GCP), Medrenova Medrenova	Moderator
	Dr. Babita Kirodian Global Safety Manager, Amgen India? Chair, ISCR Pharmacovigilance Council Amgen	Panelist
	Ms. Indu Nambiar Pharmacovigilance Lead & Country Safety Head Opella Consumer Healthcare	Panelist
	Dr. Aniket Patil Pharmacovigilance Country Safety Lead Pfizer India	Panelist
	Ms. Neha Sharma Head of Patient Safety (India & Asia Frontier) AstraZeneca India	Panelist

02:30 PM : 03:00 PM

Session 11

THEME AND TOPICS	SPEAKERS	ROLE
Risk Management Plan for Advanced Treatment Medicinal Products (ATMPs)	Dr. Ashish Adgaonkar Aggregate Reporting & Risk Management, Novartis Novartis	Speaker
“Stakeholders Perspectives on developing a signal detection strategy: Reflection on challenges & solutions”	Dr. Amita Sawhney Director, Medical Writing, Parexel Parexel	Moderator
	Dr. Pranav Sikka Global Head, Safety Signal Detection and MedDRA Query Management Novartis	Panelist
	Ms. Garima Mishra Manager, Patient Safety AstraZeneca	Panelist

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	Speaker
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, APAR Health Gynecologist \| Clinical Research Leader \| Patient Advocate for researc APAR Health	Panelist
	Dr Rohit Kumar "Associate Professor and Head, Department of Pulmonary Medicine, Critical Care Medicine and Sleep Di 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. Charu Sachdeva Joint Member Secretary, IRB and AMS Joint Member Secretary, IRB and AMS	Panelist

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

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
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
Helath economoics evaluaiton 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
Audience Q&A

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
From Innovation to Implementation: Evidence Generation in a Digital World	"Hanumantha Rao Karedla" Director, Biostatistical Programming - Center for Observational Research (CfOR) Amgen India	Session Chair & Moderator
AI-Augmented Medical Chart Abstraction: Accelerating RWE and HEOR Generation for Clinical Studies in India	Dr. Giles Devasahayam Associate Manager, RWD & Biostatistics Indegene	Panelist
Real-World Data in the Digital Era: Accelerating Research and Transforming Human Health	Sivaranjani Sankaranarayanan Assistant Vice President, Life Sciences? Hexaware Technologies	Panelist
" Bridging Discovery and Delivery: Digital Health Technologies as Evidence Sources"	"Hanumantha Rao Karedla" Director, Biostatistical Programming - Center for Observational Research (CfOR) Amgen India	Moderator
	Amritanshu Kumar Group Lead – Real World Evidence Novartis	Panelist
	Dr. Jugnu Jain Co-Founder and CEO Sapien Biosciences	Panelist
	Dr Alben Sigamani Senior Consultant Clinical Trials Karkinos Healthcare P Ltd	Panelist
	Uma Janapareddy Founder & Managing Director SyMetric	Panelist

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS	SPEAKERS	ROLE
Integrating Real-World Evidence into Regulatory and Policy Frameworks	Dr. Deepa Naik Chodankar Medical Director Synoeshealth	Session Chair & Moderator
Regulatory acceptance of RWE studies	Dr Vikas Dhikav Deputy Director, Scientist E (Medical), MoHFW, ICMR ICMR	Panelist
Navigating RWE in Regulatory Landscape: CRO perspective	Shalini Dwivedi VP , Head of Medical writing and clinical trial transparency Krystelis Ltd.	Panelist
Building Regulatory - Ready, Real World Evidence in India: From Data generation to Submission	Sneha Gupta Director Regulatory Operations IQVIA	Panelist

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS	SPEAKERS	ROLE
Harnessing Big Data: Innovative RWE Designs for Scalable Insights
Clinical Trial Emulation through advanced real-world evidence study designs	Dr Prasoona Karra Senior Manager, Observation Research Amgen India	Panelist
From Traditional Cohort to Data-Driven Designs: RWE Innovation in Practice	Dr Prasoona Karra Senior Manager, Observation Research Amgen India	Panelist
	Sharda Rohit Kandwal Research Manager, RWE Medical & Scientific Writing, Epidemiology and Global Database studies IQVIA	Panelist
	Hiren Thakkar Senior Director, Project Management, RWS, APAC Icon Plc	Panelist
Audience Q&A

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS	SPEAKERS	ROLE
Quality First: Advancing Standards in Real-World Evidence Generation	Dr. Alok Nachane Director VeritasQ Research & Analytics Pvt Ltd	Session Chair & Moderator
Advancing a Principled Framework for Real-World Evidence in Regulatory and Clinical Decision-Making: An Industry Experience	Jeff Lange, PhD Center for Observational Research Amgen Asia	Panelist
Reimagining Patient Recruitment with Quality First: Integrating Real-World Evidence and Digital Innovation	Dr Sumit Bhushan "Deputy General Manager- Clinical Studies, Global Medical Affairs" GLENMARK PHARMACEUTICALS LIMITED	Panelist
From Blueprint to Execution: Quality Standards and Overcoming Challenges in Real-World Evidence Studies	Dr Chintan Khandedhia "Lead- Clinical Research RWE & New Product Ideation " Sun Pharma Laboratories Limited	Panelist
	Raviteja Adapa Head- Clinical Operations ,Translational & Clinical research Syngene international limited	Panelist
Audience Q&A

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 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

08:00 AM : 08:05 AM

THEME AND TOPICS	SPEAKERS	ROLE
TEst Remove	Dr Jeemon Panniyammakal Additional Professor of Epidemiology Sree Chitra Tirunal Institute for Medical Sciences	-
	Arjun Samanta Associate II Stat Programmer Johnson & Johnson	SOC Chair
	Chetna Joshi Manager APCER Life Sciences	Speaker

0 : 0

Pre Conference Workshops

Main Conference Tracks

Pre Conference Workshops

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

CDM Workshop - Risk-Based Quality Management (RBQM) For Cross-Functional Clinical Research Teams 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

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

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

PV Workshop - Inspection Ready, Patient Focused: A Hands-on Lab for Pharmacovigilance Excellence 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