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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

Registration

09:30 AM : 10:00 AM

Module 1: The Future of CDM and Clinical Data Science ((Primer + Setup)

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

10:00 AM : 11:00 AM

Module 2: Interactive Case Study Challenge

11:00 AM : 12:00 PM

Module 3: Innovation Café

12:00 PM : 01:00 PM

Module 4: Build Your Roadmap Workshop (Group Exercise)

01:00 PM : 02:00 PM

Module 5: Panel Discussion and Debrief

02:00 PM : 03:00 PM

Deliverables participants take home

03:05 PM : 04:00 PM

Target Audience

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

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

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

09:30 AM : 09:40 AM

Session 1

THEME AND TOPICS	SPEAKERS	ROLE
Workshop Overview	Sukanya Choudhury EVP – Regulatory Affairs GSK	Speaker

09:40 AM : 10:00 AM

Session 2

THEME AND TOPICS	SPEAKERS	ROLE
Overview of the Recent Regulatory Trends in India

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 EVP – Regulatory Affairs GSK	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
Early Phase Trials

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 03:30 PM

Workshop Session: Mission For “First Patient In” – Accelerating Study Start-up Through Strategic

03:30 PM : 04:00 PM

MedTech Trials: Overview of New CDSCO Guideline 2026

04:00 PM : 04:20 PM

Career Building Session: Regulatory Professional Version 2030: Strategic Skills Regulatory Professionals Need

04:20 PM : 04:30 PM

Vote of Thanks

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

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

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

04:00 PM : 05:05 PM

Session 7

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

22-Jan-2027

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

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

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