Coming Soon

The agenda details are currently being finalized. Please stay tuned for updates!

Pre Conference Workshops
Main Conference Tracks

Pre Conference Workshops

08:00 AM : 09:00 AM

REGISTRATION

09:00 AM : 09:30 AM

WELCOME ADDRESS and introduction to ISCR ACCRI and brief objectives of the workshop

09:30 AM : 10:15 AM

The Renaissance of academic CLINICAL RESEARCH IN INDIA: From Evidence to Practice

10:15 AM : 11:00 AM

The triple helix of innovation: The synergy between academia, policy (Biopharm Shakti) and digital technology

11:00 AM : 11:15 AM

TEA BREAK

11:15 AM : 11:45 AM

Designing a Clinically Relevant Research Question (30–40 min)

11:45 AM : 01:00 PM

Group tasks to evaluate given protocols based on science, technology, and the National ecosystem

01:00 PM : 01:30 PM

LUNCH BREAK

01:30 PM : 03:00 PM

Presentation of group tasks

03:00 PM : 03:30 PM

PANEL DISCUSSION - INDIA’S CLINICAL RESEARCH RENAISSANCE - WHERE ARE WE NOW ? ( progress , gaps and the road to global leadership)

03:30 PM : 03:45 PM

QA session

03:45 PM : 04:00 PM

Closing remarks

09:00 AM : 09:15 AM

Welcome & Objectives – Workshop goals; tool setup check (RStudio, Git, Quarto, AI platform)

09:15 AM : 09:45 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Debugging Deep Dive
- Breakpoint strategies
- Traceback()/browser()/Debug()/trycatch() workflows

09:45 AM : 10:15 AM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Hands-on

10:15 AM : 10:45 AM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
Git Essentials
Branching, Commit
Manage workflows

10:45 AM : 11:00 AM

Break

11:00 AM : 11:30 AM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
Git Hands-on

11:30 AM : 12:15 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Dashboard Foundations – Shiny/reactivity basics, shinydashboard; intro to Quarto

12:15 PM : 01:00 PM

Hands - On

01:00 PM : 02:00 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Lunch

02:00 PM : 02:30 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
From Process to Prompt: Agentic AI & Finding the Right Problem – How Agentic AI connects scientific knowledge with clinical data; identifying high value automation opportunities (ADaM/TFL generation, Protocol/SAP interpretation, study Q&A)

02:30 PM : 03:00 PM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Hands-on

03:00 PM : 03:30 PM

Session 9

THEME AND TOPICS	SPEAKERS	ROLE
Workflow Creation – Connecting the AI agent to ADaM/TFL generation and SAP/Protocol interpretation

03:30 PM : 03:45 PM

Break

03:45 PM : 04:15 PM

Session 10

THEME AND TOPICS	SPEAKERS	ROLE
Hands-on

04:15 PM : 04:45 PM

Session 11

THEME AND TOPICS	SPEAKERS	ROLE
Capstone Hands-on – End-to-end workflow: Debug → Git → Dashboard/Report → AI Agent

04:45 PM : 05:00 PM

Closing remarks , Key takeaways- Resource toolkit

08:00 AM : 09:00 AM

Welcome & Setting the Challenge: From CDM to Clinical Data Science

09:00 AM : 09:30 AM

Module 1: The Future of CDM – Technology, AI & the Clinical Data Science Shift

THEME AND TOPICS	SPEAKERS	ROLE
The Future of CDM and Clinical Data Science ((Primer + Setup)	Ms. Hina Talwar Safety Services Project Leader Parexel	Speaker

09:30 AM : 10:30 AM

Use-Case Prioritization: Where Should We Apply AI?

10:30 AM : 11:00 AM

Case Study Lab 1: Detecting Data Quality Drift & Anomalies

11:00 AM : 11:30 AM

Break

11:30 AM : 12:00 PM

Lab Debrief: What Would You Implement in the Real World?

12:00 PM : 01:00 PM

Lunch Break

01:00 PM : 02:00 PM

Case Study Lab 3: Medical Coding Consistency & Reconciliation Signals

02:00 PM : 03:00 PM

Case Study Lab 4: Risk-Based Oversight & Centralized Monitoring

03:00 PM : 04:00 PM

Innovation Café: Moving from Possibility to Responsible Adoption

04:00 PM : 04:30 PM

Break

04:30 PM : 05:00 PM

Module 4: Build Your CDM Tech + AI Implementation Blueprint

05:00 PM : 05:30 PM

Blueprint Showcase – Pitch, Challenge & Refine

05:30 PM : 06:00 PM

Module 5: Expert Panel – Lessons from the Front Line

06:00 PM : 06:30 PM

From Workshop to Workplace: What Will You Do on Monday?

06:30 PM : 07:00 PM

10:00 AM : 10:15 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Introduction	Mohammed Salman Associate Director AstraZeneca Pharma India Ltd.	Speaker
	Garima Pallavi Sr. Director, Medical Writing Services GSK	Speaker
	Sonali Parmar Director, Medical Writing Syneos Health	Speaker

10:15 AM : 11:15 AM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Basic Statistical Concepts	Mahendra Kumar Bijarnia Sr Director- Biostatistics AstraZeneca India Pvt Ltd	Speaker

11:15 AM : 11:30 AM

Session 2A

THEME AND TOPICS	SPEAKERS	ROLE
Exercise / Q&A	Mahendra Kumar Bijarnia Sr Director- Biostatistics AstraZeneca India Pvt Ltd	Speaker

11:30 AM : 11:45 AM

Mid Break

11:45 AM : 12:45 PM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
Statistical Evidence and Interpretation	Kohinoor Dasgupta Senior Director, Biostatistics Novartis Healthcare Private Limited	Speaker

12:45 PM : 01:00 PM

Session 3A

THEME AND TOPICS	SPEAKERS	ROLE
Exercise / Q&A

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 03:00 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
Advanced Statistical Concepts	Mahendra Kumar Bijarnia Sr Director- Biostatistics AstraZeneca India Pvt Ltd	Speaker
Advanced Statistical Concepts	Kohinoor Dasgupta Senior Director, Biostatistics Novartis Healthcare Private Limited	Speaker

03:00 PM : 03:15 PM

Session 4A

THEME AND TOPICS	SPEAKERS	ROLE
Q & A

03:15 PM : 03:30 PM

Tea Break

03:30 PM : 04:30 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Learning with LLMs for Medical Writing	Parul Nain Deputy General Manager Sun Pharmaceuticals Industries Ltd	Speaker
Learning with LLMs for Medical Writing	Juliet Rebello Director Cipla Ltd.	Speaker

04:30 PM : 05:00 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Summary and Closing Remarks	Mohammed Salman Associate Director AstraZeneca Pharma India Ltd.	Speaker

09:00 AM : 09:05 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Welcome Address – PV Council Chair	Dr. Babita Kirodian Global Safety Manager, Amgen India Chair, ISCR Pharmacovigilance Council Amgen	Speaker

09:05 AM : 09:15 AM

Session 1A

THEME AND TOPICS	SPEAKERS	ROLE
Setting the Context: From Last Year's Learnings to This Year's Focus Recap of last year's workshop, followed by highlights from the PV Symposiums and Annual PV Track — framing this year's focus on safety assessment and AI-enabled decision support.	Indu Nambiar _ Oppela	Speaker

09:15 AM : 09:25 AM

Session 1B

THEME AND TOPICS	SPEAKERS	ROLE
Workshop Objectives	Dr. J Vijay Venkatraman Managing Director & CEO Oviya Medsafe Pvt Ltd	Speaker

09:25 AM : 09:50 AM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
SESSION 1\| The Changing PV Professional Why PV roles are evolving with AI, what AI can and cannot do, and why scientific judgement continues to matter across the PV function.	Dr. Vikram K Deputy Site Head & Medical Review TA Head (Patient Safety) Bristol Myers Squibb	Speaker

09:50 AM : 10:15 AM

Session 2A

THEME AND TOPICS	SPEAKERS	ROLE
SESSION 2\| From Data Quality to Medical Insight What case-processing and QC teams need to know about causality assessment — how accurate, complete, and clinically coherent case data enables reliable causality review.	Dr. Harish Gnanasekharan _ _	Speaker

10:15 AM : 10:30 AM

Q&A with Session 1 and Session 2 Speakers

10:30 AM : 10:50 AM

Tea & Networking Break

10:50 AM : 11:40 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
SESSION 3\| The Medical Assessment Reality Making safety decisions when the evidence is incomplete.	Ms. Neha Kapoor _ Opella	Moderator

11:40 AM : 12:10 PM

Session 1A

THEME AND TOPICS	SPEAKERS	ROLE
SESSION 4\| AI Agents in Causality Assessment Enhancing evidence review while preserving human medical judgement. This session will include a demonstration and case-based exercise showing how AI agents can retrieve relevant evidence, structure case narratives, identify missing information, assess temporal relationships and alternative causes, and support consistent causality assessment, while maintaining medical review, human accountability, traceability, and governance.	Dr. Vikram K Deputy Site Head & Medical Review TA Head (Patient Safety) Bristol Myers Squibb	Speaker
	Ms. Neha Kapoor _ Opella	Speaker

12:10 PM : 01:00 PM

Session 1B

THEME AND TOPICS	SPEAKERS	ROLE
GROUP EXERCISE - Participants will identify the critical clinical, temporal, laboratory, treatment, and follow-up data needed for a meaningful medical assessment, and will discuss how missing or poor-quality information affects causality conclusions.	Dr. Vikram K Deputy Site Head & Medical Review TA Head (Patient Safety) Bristol Myers Squibb	Speaker
	Ms. Neha Kapoor _ Opella	Speaker

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 02:30 PM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
SESSION 5\| Development & Validation of a Causality Assessment Tool for Medical-Device Adverse Events	Ms. Jeesa George Assistant Professor, Dept. of Pharmacy Practice, Faculty of Pharmacy M. S. Ramaiah University of Applied Sciences, Bangalore	Speaker

02:30 PM : 04:15 PM

Session 1A

THEME AND TOPICS	SPEAKERS	ROLE
WORKSHOP\| Prompting AI for Medical Assessment of Literature Reports Participants will use a published literature case report to practise writing prompts that retrieve clinically relevant information for pharmacovigilance assessment. Each group will build a structured prompt, review the AI-generated extraction against the source article, identify inaccuracies and omissions, and distinguish AI-supported extraction from conclusions that still require human medical assessment.	Dr. Vikram K Deputy Site Head & Medical Review TA Head (Patient Safety) Bristol Myers Squibb	Speaker
	Ms. Neha Kapoor _ Opella	Speaker

04:15 PM : 04:35 PM

Tea Break

09:30 AM : 09:40 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Workshop Overview	Sukanya Choudhury Executive Vice President – Regulatory Affairs GlaxoSmithKline Pharmaceuticals Limited.	Speaker

09:40 AM : 10:00 AM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Overview of the Recent Regulatory Trends in India	Sneha Gupta Associate Director Regulatory Affairs IQVIA	Speaker

10:00 AM : 10:45 AM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
AI Session: A Global Perspective
Navigating the SAHI/ICMR vs. US FDA & EMA Guidelines
Use of Artificial Intelligence in Clinical Research

10:45 AM : 11:00 AM

Tea Break

11:00 AM : 12:10 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
Panel Discussion: India 2030: Building a Predictable & Innovative Clinical Research Ecosystem	Sukanya Choudhury Executive Vice President – Regulatory Affairs GlaxoSmithKline Pharmaceuticals Limited.	Moderator
India Pharma Representative
MNC Pharma Representative
Site Administrators
ICMR Representation
CDSCO nominee
CRO Nominee

12:10 PM : 01:00 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Spotlight Session: Discussing Regulatory Strategy for:
Radioactive substance Trials
CAGT Trials, CAR-T cells	Shweta Pradhan Head, RDS Operations - India IQVIA India	Panelist
Early Phase Trials

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 03:30 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Workshop Session: Mission For “First Patient In” – Accelerating Study Start-up Through Strategic	Vivek Padalalu Associate Director, Site Readiness and Regulatory Operations Fortrea	Speaker
	Anupam Bendre Manager - Regulatory Affairs GSK	Speaker

03:30 PM : 04:00 PM

MedTech Trials: Overview of New CDSCO Guideline 2026

04:00 PM : 04:20 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Career Building Session: Regulatory Professional Version 2030: Strategic Skills Regulatory Professionals Need	Rahul Mehrotra Country Head-Regulatory Affairs-India & Sub continent Thermo Fisher- PPD	Speaker

04:20 PM : 04:30 PM

Session 8

THEME AND TOPICS	SPEAKERS	ROLE
Vote of Thanks	Nitin Wani Manager - Regulatory Affairs AstraZeneca	Speaker

08:10 AM : 08:45 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
RWE Study Design

08:00 AM : 08:10 AM

Opening and Workshop Orientation

Main Conference Tracks

22-Jan-2027

08:00 AM : 09:00 AM

Registration /Tea/Coffee

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

09:00 AM : 01:00 PM

Session 1-4

THEME AND TOPICS	SPEAKERS	ROLE
Common Sessions Across All Tracks

01:00 PM : 02:00 PM

Lunch Break

THEME AND TOPICS	SPEAKERS	ROLE
Quality by Design : Translating ICH-GCP E6 (R3) into Indian Clinical Trial Operations

02:00 PM : 03:00 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Harnessing Biopharma Shakti: Building Innovation Capability in Clinical Research	Seema Pai Senior Director Clinical Site Operations Pfizer Limited	Session Chair

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Topic: India's Clinical Research Renaissance Through a Global Regulatory Lens	Sukanya Choudhury Executive Vice President – Regulatory Affairs GlaxoSmithKline Pharmaceuticals Limited.	Session Chair
Major Regulatory Agencies	Dr Chandrashekhar Ranga Jt DCGI CDSCO	Speaker

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Changemaker's session	Dr Sanish Davis Senior Medical Director, Clinical Science - Oncology. Takeda Biopharmaceuticals India Pvt. Ltd	Session Chair

05:30 PM : 07:00 PM

Annual General Meeting

07:15 PM : 08:00 PM

Awards + Gala Dinner

22-Jan-2027

22-Jan-2027 23-Jan-2027

01:45 PM : 02:00 PM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Introdcution to MW Council & MW Track Agenda	Garima Pallavi Sr. Director, Medical Writing Services GSK	Speaker
Introdcution to MW Council & MW Track Agenda	Sonali Parmar Director, Medical Writing Syneos Health	Speaker

02:00 PM : 02:15 PM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
AI & Innovation: Reimagining the Medical Writer’s Toolkit	Santosh Gadekar Manager, Medical Writing Icon plc	Session Chair
Protocol-First Orchestration: AI Adoption from Silos to Synergy	Deepali Chaku Regulatory Writer Novartis	Speaker
Driving Regulatory Excellence: GxP Compliance and Inspection Readiness for MW Platforms	Sonali Parmar Director, Medical Writing Syneos Health	Speaker
From Silos to Synchronization: Harmonizing Protocols, SAPs, CSRs, and ICFs Through Structured Content and AI-Enabled Authoring	Parag Pipalava Principal Medical Writer ThermoFisher Scientific	Speaker
Q&A Panel

03:00 PM : 04:00 PM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Medical Writer in 2030: Author, Architect, or AI Orchestrator?	Animesh Chatruvedi Head, Regulatory Writing Novartis Healthcare Pvt Ltd	Session Chair
	Vijay Shinde Associate Director GSK	Panelist
	Tapasya Bhardwaj Director - Product Strategy & AI Syneos Health Clinical Solutions	Panelist
	Akshata Rao Director Merck Group	Panelist
	Shubha Rao Director Bristol Myers Squibb	Panelist
	Pooja Srivastava Banerjee Vice President Krystelis Ltd	Panelist

04:00 PM : 04:15 PM

Tea Break

04:15 PM : 05:30 PM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
Scientific Writing & Disclosure: Trust, Transparency, Access	Pooja Phogat Co-Founder and Co-CEO Krystelis Pvt Ltd	Session Chair
Beyond Words: Data Visualization in Medical Communications	Mukul Rastogi Group Lead Sanofi Healthcare Pvt Ltd	Speaker
Human Expertise Meets Artificial Intelligence: Evolution of the Publication Writer to AI-Enabled Scientific Communicator	Priyanka Malla Team Lead GSK	Speaker
European Health Data Space (EHDS) – A Walkthrough of the Regulation: What It Means for Global Pharma	Sandeep Undavalli Clincal Transparency Specialist Novonordisk	Speaker
Q&A Panel

22-Jan-2027 23-Jan-2027

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

09:00 AM : 01:00 PM

Common Sessions Across All Tracks

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 03:05 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Key Note
Enabling Statistical Workflow enhancement	Shilpakala Vasudevan . Pfizer	Session Chair
Always in Context: How MCP Connects AI to the Statistical Programming Ecosystem	Anudeep Divi Junior Associate, Associate Statistical Data Scientist Pfizer	Speaker
AI-Assisted Generation of SDTM Trial Design Domains (TI/TS) Using a Secure On-Premise LLM Framework.	Habis Rizvi PC Associate Programmer VERAMED DATA SERVICES PRIVATE LIMITED	Speaker
Audience Q&A

03:05 PM : 04:00 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
Applying Bayesian Methods to Derisk Clinical Development	Neha Singh . Eli Lily	Session Chair
Faster, Safer dose escalation/findings in Phase-I Trial with Time-to-Event Bayesian Optimal Interval (TITE-BOIN) design	Srinivas S Biostatistician Precision for Medicine	Speaker
Beyond Maximum Tolerated Dose: Modern Statistical Approaches Driving Oncology Dose Optimization in the Project Optimus Era	Sreejita Das Biostatistician - 1 Inference Inc.	Speaker
From Phase 2 to Phase 3: An Endpoint-Agnostic Bayesian Probability-of-Success Framework Unifying Assurance and Conditional Power	Samrit Pramanik Senior Statistical Modeler Sanofi Healthcare India Private Limited	Speaker
Audience Q&A

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Bringing in innovation at everyday activities – AI, Automation and Standards	Karthik Darbha . Novartis	Session Chair
A Metadata-Driven, Chat-Assisted Framework for Automated Clinical TFL Generation
How AI Generated Patients Can Help Causal Inference – From Synthetic Data to Target Trial Emulation	Priyanka Rane Senior Principal Biostatstician Merck Specialties Pvt. Ltd.	Speaker
AI-Augmented Biostatistics: The Statistical Copilot	Anetta Mary Xavier Biostatistician II eClinical Solutions Pvt Ltd	Speaker
Audience Q&A

05:30 PM : 06:00 PM

Vote of Thanks to Sponsors followed by AGM

22-Jan-2027 22-Jan-2027

08:00 AM : 09:00 AM

Registration & Welcome

THEME AND TOPICS	SPEAKERS	ROLE
The Patient as Partner: Rethinking PV Communication in the Digital Age”
Safety First: Empowering Patients Through Simplified Pharmacovigilance

09:00 AM : 01:00 PM

Session 1-3

THEME AND TOPICS	SPEAKERS	ROLE
Common Sessions Across All Tracks

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 05:30 PM

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

02:00 PM : 03:00 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
The Paent as Partner: Rethinking PV Communicaon in the Digital Age
	Safety First: Empowering Paents Through Simplified Pharmacovigilance

03:00 PM : 03:10 PM

Session 5A

THEME AND TOPICS	SPEAKERS	ROLE
Patient-Centricity in RWE: Are We Walking the Talk	Sanjay Das Coordinator HCL	SOC Chair
Patient-Centric Approaches: Redefining Value in Healthcare Evidence	Arjun Tiwari VP Bajaj	SOC Chair

03:10 PM : 03:50 PM

Session 5B

THEME AND TOPICS	SPEAKERS	ROLE
Patient-Centric RWE: Vision or Reality?	Arjun Tiwari VP Bajaj	SOC Chair
Building Institutional Capacity for Ethical Oversight in RWE Studies	Arjun Singh CTO Tech Mahindra	SOC Chair

03:50 PM : 04:35 PM

Sessions 4 & 5

THEME AND TOPICS	SPEAKERS	ROLE
Building Regulatory - Ready, Real World Evidence in India: From Data generation to Submission	Alice Fernandes Senior Manager GSK	Speaker
From BQuality First: Advancing Standards in Real-World Evidence Generationlueprint to Execution: Quality Standards and Overcoming Challenges in Real-World Evidence Studies	Atharva Kumar CEO Prometheus Solutions	Session Chair
From Blueprint to Execution: Quality Standards and Overcoming Challenges in Real-World Evidence Studies	Arjun Singh CTO Tech Mahindra	Chair

22-Jan-2027 23-Jan-2027

02:00 PM : 03:00 PM

Session 5

THEME AND TOPICS	SPEAKERS	ROLE
Operationalizing RWE in India: Site Readiness, Investigator Capability, and Data Governance at Ground Level	Raviteja Adapa Assistant General Manager Syngene Internation Limited	Session Chair & Moderator

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS	SPEAKERS	ROLE
AI in RWE: From Data to Trusted Evidence	Kavitha Gurram Director &Head - Clinical Project Management Real-World Solutions, APAC IQVIA	Session Chair & Moderator

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS	SPEAKERS	ROLE
Advancing RWD Systems through Federated Data Networks: Driving Standardization, Collaboration, and Scalable Insights	Dr. Amritanshu Kumar Group Lead- RWE Novartis	Session Chair & Moderator

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

09:00 AM : 01:00 PM

Common Sessions Across All Tracks

01:00 PM : 02:00 PM

Lunch Break

05:30 PM : 06:00 PM

Vote of Thanks to Sponsors followed by AGM

22-Jan-2027 22-Jan-2027

08:00 AM : 08:15 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
new 1

08:30 AM : 10:00 AM

Session 1A

THEME AND TOPICS	SPEAKERS	ROLE
new 2

10:00 AM : 11:00 AM

Session 3

THEME AND TOPICS	SPEAKERS	ROLE
new 3
sub 3
	sub 3 new

11:00 AM : 12:00 PM

Session 4

THEME AND TOPICS	SPEAKERS	ROLE
new 4
sub 4 new
aegs

12:00 PM : 12:30 PM

Session 4A

THEME AND TOPICS	SPEAKERS	ROLE
test 123

12:30 PM : 01:00 PM

Session 4B

THEME AND TOPICS	SPEAKERS	ROLE
test 456
tegeafae

01:00 PM : 01:50 PM

tea & breakfast

THEME AND TOPICS	SPEAKERS	ROLE
ses 5

01:50 PM : 02:00 PM

Session 5A

THEME AND TOPICS	SPEAKERS	ROLE
order 8

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

AGENDA

Coming Soon

Pre Conference Workshops

Main Conference Tracks

Pre Conference Workshops

ACCRI WS: Academic Clinical Trials through Science, Technology & the National Ecosystem

BIOS Workshop: Modern Scientific Collaboration, Reproducible Code, GIT and Intelligent Agents

CDM Workshop: CDM Tech + AI/ML in Action: Hands-on Case Studies Driving the Future of Clinical Data Management

ISCR - USFDA Workshop

MW Workshop: Statistical Thinking for Non-statisticians - Interpret Evidence with Confidence, Write with Precision, and Leverage AI Effectively

PV WS: Safety Assessment Across the Product Life Cycle: From Evidence Review to AI-Enabled Decision Support

Regulatory Workshop: Accelerating Regulatory Excellence: Enabling Innovation, Quality & Collaboration

RWE Workshop: Regulatory-Grade Real-World Evidence: From Research Question to Regulatory Decision-Making

Training & Quality Workshop: From Readiness to Recruitment: India's Clinical Research Renaissance in Action

Main Conference Tracks

Track 1 : Clinical Operations, Ethics, Regulatory and Quality

Track 2 : Clinical Data Management

Track 3 Medical Writing

Track 4 : BioStats and Programming

Track 5 Pharmacovigilance (PV)

Track 6 : Real World Evidence (RWE)

Track 7 : Academic Clinical Development

Track 8 - Early Clinical Development