Pre Conference Workshops

09:00 AM : 10:00 AM

REGISTRATIONS

10:00 AM : 10:15 AM

-

THEME AND TOPICS SPEAKERS ROLE
Welcome Address Ms. Pradnya Mahatme
.
Hector 		Speaker

10:15 AM : 11:00 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Keynote Speech: The Evolving Role of CRCs in Clinical Trials in the era of Decentralized Clinical Trials Dr. Shekhar Dawkhar
.
. 		Speaker

11:00 AM : 12:00 PM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Presentation: Understanding and Focussing on Scientific Aspects of the Protocol Dr Arun Bhatt
Consultant
. 		Speaker

12:00 PM : 01:00 PM

-

THEME AND TOPICS SPEAKERS ROLE
Group Case Studies: Bringing in Patient Centricity to Enhance Overall Patient Experience in Clinical Trials Ms. Pradnya Mahatme
.
Hector 		Speaker
Mr. Manoj Karwa
.
. 		Speaker
Mr. Lavkesh Jadav
.
. 		Speaker

01:00 PM : 02:00 PM

LUNCH BREAK

02:00 PM : 03:00 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Simulation Session: Revolutionizing CRC’s Ways of Working Ms. Pradnya Mahatme
.
Hector 		Speaker
Mr. Manoj Karwa
.
. 		Speaker
Mr. Lavkesh Jadav
.
. 		Speaker

03:00 PM : 03:30 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Presentation: Identification and Management of Deviations and Implementation of Effective CAPA at Sites Ms. Renuka Neogi
CPL Manager
Sun Pharma 		Speaker

03:30 PM : 04:00 PM

TEA BREAK

04:00 PM : 05:00 PM

Panel Discussion: Experience Sharing and Addressing Common Challenges Faced by CRCs

05:00 PM : 05:15 PM

-

THEME AND TOPICS SPEAKERS ROLE
Closing Remarks Ms. Shweta Pradhan
.
. 		Speaker

10:00 AM : 10:15 AM

Introduction to ISCR and MW Workshop

10:15 AM : 11:15 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Overview of Regulatory Submission Process Shima Shaikh
.
Novo Nordisk 		Speaker
Avinash Santappa
.
GSK 		Speaker

11:30 AM : 01:00 PM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Essentials of Submission Planning and Content Preparation Md Salman
.
AstraZeneca 		Speaker
ANKIT SHAH
Regulatory Capability Lead, Global Scientific Communications
Eli Lilly 		Speaker

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 03:30 PM

Case study + Exercise

03:30 PM : 04:00 PM

Tea Break

04:00 PM : 04:45 PM

-

THEME AND TOPICS SPEAKERS ROLE
Best practices in Regulatory submission - Q & A session + Panel discussion Sudha C
BMS - Moderator
. 		Speaker

04:45 PM : 05:00 PM

Summary and closing remarks

10:00 AM : 10:30 AM

-

THEME AND TOPICS SPEAKERS ROLE
Introduction to ISCR - AC CRI Academic clinical trials – An overview DR. ANANYA CHAKRABORTY
Prof & HOD Pharmacology
Vydehi Institute Of Medical Sciences And Research Centre, Bangalore 		Speaker

10:30 AM : 11:00 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Planning an academic clinic al trial DR. DENIS XAVIER
Professor & Head Pharmacology, Head -Div of Clinical Research
St. John's Medical College Bangalore 		Speaker

11:00 AM : 11:30 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Management of randomization, blinding, allocation concealment Dr. Melvin George
.
. 		Speaker

11:35 AM : 11:45 AM

Tea Break

11:45 AM : 12:15 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Data management & quality assurance in clinical trials Dr. Deepak Langade
.
. 		Speaker

12:15 PM : 01:30 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Presentation of protocols –group tasks Dr. Zainab
.
. 		Speaker
Dr. Sumana
.
. 		Speaker
Dr. Anant
.
. 		Speaker
Dr. Melvin George
.
. 		Speaker
DR. DENIS XAVIER
Professor & Head Pharmacology, Head -Div of Clinical Research
St. John's Medical College Bangalore 		Speaker
DR. ANANYA CHAKRABORTY
Prof & HOD Pharmacology
Vydehi Institute Of Medical Sciences And Research Centre, Bangalore 		Speaker

01:30 PM : 02:30 PM

Lunch Break

02:30 PM : 03:30 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Presentation of protocols – group task (contd.) Dr. Zainab
.
. 		Speaker
Dr. Sumana
.
. 		Speaker
Dr. Anant
.
. 		Speaker
Dr. Melvin George
.
. 		Speaker
DR. DENIS XAVIER
Professor & Head Pharmacology, Head -Div of Clinical Research
St. John's Medical College Bangalore 		Speaker
DR. ANANYA CHAKRABORTY
Prof & HOD Pharmacology
Vydehi Institute Of Medical Sciences And Research Centre, Bangalore 		Speaker

03:30 PM : 03:45 PM

Tea Break

03:45 PM : 04:15 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Budgeting and safe ty management in clinical trials Dr. Ganesh Dhakale
M.D. Pharmacology, PGDHHM, LL.B
AIIMS 		Speaker

04:15 PM : 04:45 PM

Panel Discussion – Navigating challenges in academic research

04:45 PM : 05:00 PM

Valedictory

10:00 AM : 11:00 AM

Session 1 Lead discovery & optimization

11:00 AM : 11:30 AM

Session 2 Preclinical evaluation, Genomics in drug discovery

11:30 AM : 11:45 AM

Q&A

12:00 PM : 12:45 PM

Drug Metabolism & Pharmacokinectics

12:45 PM : 01:00 PM

Q&A

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 02:45 PM

Session 3 Concepts of toxicology

02:45 PM : 03:00 PM

Q&A

03:15 PM : 03:45 PM

Session 4 Regulatory strategy for First in Man study

03:45 PM : 04:00 PM

Q&A

04:00 PM : 05:00 PM

First in Human study: Design and conduct

09:30 AM : 09:45 AM

-

THEME AND TOPICS SPEAKERS ROLE
Welcome & Inauguration Dr Santosh Taur
Director Medical Affairs, Vaccines and Digital
Pfizer  		Speaker
Ms. Kavitha Gurram
Director
IQVIA 		Speaker

09:45 AM : 10:15 AM

-

THEME AND TOPICS SPEAKERS ROLE
Introduction to Ambispective studies Dr Namrata Kulkarni
Medical Lead, Adult Vaccination
Pfizer Limited 		Speaker

10:15 AM : 10:45 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Designing Ambispective studies Dr Alok Nachane
DIRECTOR
VERITASQ RESEARCH AND ANALYTICS 		Speaker

10:45 AM : 11:15 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Statistical approaches in Ambispective studies Mr Pattabhi Machiraju
Senior Director
Indegene Pvt. Ltd. 		Speaker

11:15 AM : 11:30 AM

Tea Break

11:30 AM : 12:45 PM

-

THEME AND TOPICS SPEAKERS ROLE
Group Exercise I Case studies and publication review Dr Arun Bhatt
Consultant
. 		Speaker

12:45 PM : 02:00 PM

Lunch Break

02:00 PM : 02:30 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Regulatory & Ethics in Ambispective Studies Mr. Raviteja Adapa
Head- Clinical Operations
Syngene International Ltd. 		Speaker

02:30 PM : 03:00 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Operational Excellence in Ambispective Studies Ms. Shruti MP
Real World Data Solutions Associate Director
Parexel International Pvt. Ltd 		Speaker

03:00 PM : 03:15 PM

High Tea

03:15 PM : 04:30 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Group Exercise II Designing Hybrid study Ms. Shruti MP
Real World Data Solutions Associate Director
Parexel International Pvt. Ltd 		Speaker

04:30 PM : 05:00 PM

Summary and conclusion

09:30 AM : 09:40 AM

THEME AND TOPICS SPEAKERS ROLE
Welcome and Introductions Sukanya Chowdhury
.
. 		Speaker

09:40 AM : 09:50 AM

-

THEME AND TOPICS SPEAKERS ROLE
Workshop Objectives and Key Highlights of Regulatory Requirements in India SNEHA GUPTA
Associate Director, Regulatory Affairs
IQVIA 		Speaker

09:50 AM : 10:00 AM

KNOWLEDGE SHARING SESSIONS/BE Regulatory Pathways: Understanding Challenges, Leveraging Opportunities, and Best Practices for Approval

10:00 AM : 10:30 AM

Session 1 Session1: BA/BE Regulatory Pathways: Understanding Challenges, Leveraging Opportunities, and Best Practices for Approval

10:30 AM : 11:00 AM

Session 2 Session2: Navigating Regulatory Pathway for Conducting Vaccine Clinical Trials in India

11:00 AM : 11:30 AM

Session 3 Session3: Clinical Development of Biosimilars- Regulatory Requirements India, EU and US

11:30 AM : 11:45 AM

Tea Break

11:45 AM : 12:00 PM

WORKSHOP SESSION

12:00 PM : 01:15 PM

Group Activity 1: Understanding Tips and Tricks of SUGAM Submission & Effective Handling of Queries In CTA Review

01:15 PM : 02:00 PM

Lunch Break

02:00 PM : 03:00 PM

Group Activity 2: Strategies for Navigating the SEC Meeting For Successful Outcomes

03:00 PM : 04:00 PM

PANEL DISCUSSION: Future of Clinical Research Sector in India: Trends, Challenges, and Opportunities for the Next Decade

04:00 PM : 04:15 PM

TEA BREAK

04:15 PM : 05:00 PM

Session 4 Session 4: Recent Regulatory Updates for Clinical Trials NSWS Export NOC CRO Registration Indian GCP

05:00 PM : 05:05 PM

Vote of Thanks

09:00 AM : 09:15 AM

-

THEME AND TOPICS SPEAKERS ROLE
Welcome note by ISCR Opening remarks by USFDA ANIRBAN ROY CHOWDHURY
AVP and Head global CoE for Data Management, Biostatistics and Clinical Operation
Sun Pharma 		Speaker
Gregory Smith
Deputy Director, INO, FDA
FDA 		Speaker

09:15 AM : 10:00 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Regulatory Perspective on Data Integrity: A Deep Dive into USFDA Expectations Gregory Smith
Deputy Director, INO, FDA
FDA 		Speaker

10:00 AM : 10:30 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Navigating Complexity: The Evolving Landscape of Global Clinical Trials Valentina Curovic-Perisic
.
Sun Pharma 		Speaker

10:30 AM : 11:00 AM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Importance of quality management systems in data reliability SACHIN SATIJA
Sr. Director-Quality Assurance
Syneos Health 		Speaker

11:00 AM : 11:30 AM

Tea Break

11:30 AM : 12:15 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Mirror Talk Managing quality in an outsourced clinical trial Prashant Mehrotra
.
BSV 		Speaker
SNEHA GUPTA
Associate Director, Regulatory Affairs
IQVIA 		Speaker

12:15 PM : 01:15 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion: Ensuring Data Integrity Through Robust Site Management and Investigator site staff Training Gregory Smith
Deputy Director, INO, FDA
FDA 		Speaker
DR. SEEMA PAI
Senior Director, Clinical Site Operations – India Cluster
Pfizer 		Speaker
Jestin Thomas
.
. 		Speaker
ANIRBAN ROY CHOWDHURY
AVP and Head global CoE for Data Management, Biostatistics and Clinical Operation
Sun Pharma 		Speaker

01:15 PM : 02:30 PM

Lunch Break

02:30 PM : 04:30 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Case Studies Gregory Smith
Deputy Director, INO, FDA
FDA 		Speaker

04:30 PM : 05:00 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Open House with USFDA Gregory Smith
Deputy Director, INO, FDA
FDA 		Speaker

05:00 PM : 05:30 PM

Wrap Up

Main Conference Tracks

08:00 AM : 09:00 AM

Registration/Tea

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 : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Recent Developments in Leveraging AI for Regulatory Filings and Reviews in Clinical Trials Sukanya Chowdhury
.
. 		Session Chair
Leveraging AI tools for Regulatory Submission Authoring and HAQs
Leveraging AI tools for Regulatory Review and in Clinical Trials
Speakers as panel members for Q&A, moderated by moderator (1 -2 questions)

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Patient Centricity : Strategies for Patient Engagement in Clinical Trials - Real World Examples and Best Practices. Dr. Pooja Sharma
.
. 		Session Chair
How patient understanding of Clinical research creates a more active participant in clinical trials,practical steps
Investigators can create practical processes to ensure patient centricity in all steps of  clinical research (ASHA project)
ICMR perspective towards improving patient centricity
EC member of Tata Mumbai -survivor Hogkins -she will speak on how patient centricity can be focused during EC review,practical steps

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Innovations in Vaccine Research : Accomplishments and Opportunities. DR. VINOD MATTOO
Commercial Lead, India
Amgen Technology 		Session Chair
Innovative trial designs and analyses for vaccine clinical development. This topic will cover adaptive design features and Bayesian designs that accommodate historical data borrowing
Learnings from COVID-19 vaccine development. This topic will cover Industry- academic – sponsor collaboration; data analyses methodology of these learnings and extrapolate to other disease conditions
Vaccine development and predictors of vaccine protection. This topic includes vaccine combinations and technology interventions
Patient Centricity in Vaccine research: examples from emerging markets
Audience Q&A

08:00 AM : 09:00 AM

Registration/Tea

09:00 AM : 01:00 PM

THEME AND TOPICS SPEAKERS ROLE
Registration/Breakfast/Tea

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Shaping the Future: The Role of Clinical Data Standards in an Evolving Technology Landscape
Implementing  data standards in AIML frameworks

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Selecting the Unified Platform for Clinical Trials: Key Criteria and Strategic Considerations
One of the Points of discussion - Leveraging External Data Sources (CGMS, Central Lab, Devices) to Optimize and Validate Dosing Algorithms

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Implementing Risk-Based Quality Management (RBQM) in Clinical Trials: Case Studies and Best Practices
Sub topic: Signal Detection and Data Trending in Clinical Trials: Enhancing Oversight with Statistical Monitoring
Audit Trail Review (ATR) in Clinical Trials: Ensuring Data Integrity and Compliance.
Audience Q&A

05:30 PM : 06:00 PM

Vote of Thanks to Sponsors followed by AGM

08:00 AM : 09:00 AM

Registration/Tea

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 : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Driving Patient Centricity in Clinical Research: Role of MWs GARIMA PALLAVI
Senior Director, Medical Writing Services
Parexel 		Session Chair
Key drivers to developing a patient centric informed consent form.
Driving Patient Engagement for Protocol Design
Empowering Patients: How the FDA is Transforming Drug Development through Patient-Centricity
Diversity Plans in Clinical Trials- A Step Towards Patient-Centricity by Including Underrepresented Subgroups

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Accelerating submissions: Elevating the Role of MWs
RTOR Project ORBIS
A case study: Using Dry-run outputs for improving Clinical Study Report timelines
The role of medical writers in bringing medicines faster to patients
Clinical study report (CSR) prototypes as enabler for accelerated regulatory submissions and quicker access to medicines

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Conversation with the MW council: Sharing Experiences and Initiatives that enhance power skills for Medical writers HETAL SHAH
Founder-Director
MeWriT 		Session Chair

05:30 PM : 06:00 PM

Vote of Thanks to Sponsors followed by AGM

07:30 PM : 09:30 AM

Gala Dinner

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

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 : 02:45 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Welcome talk
Invited talk: Quantitative Decision Making in Drug Development

02:45 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Statistical Excellence in Drug Development
Scenario evaluation of different Dose Escalation Methods using simulation framework
Comparative approach of Synthetic Control Arm with Traditional Clinical Trials
About Estimands, Intercurrent Events and Imputations
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

05:30 PM : 06:00 PM

Vote of Thanks to Sponsors followed by AGM

07:30 PM : 0

Gala Dinner

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

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 : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Evolving Pharmcovigilance practices & requirments
PV - Trends, Challenges and Opportunities
Safety Monitoring for Advanced Therapy Medicinal Products (ATMPs)
Recent Updates in PV requirments
All the speakers

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Patient-Centeric Real-World Evidence and Emerging Methods
Designing patient-centric RW study – Case scenarios and Best Practices.
Panel: Patient Engagement in RW Studies: Emerging tools, outcomes, Patient preferences and care gaps.
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
Harnessing power of Quality in RWE studies
Quality by designe in RWE studies
Balancing speed and quality in real world studies
Rare Disease Registries: Transforming Patient Care with Innovative Real-World Evidence Data with high quality
Audience Q&A

05:30 PM : 06:00 PM

Vote of Thanks to Sponsors followed by AGM

07:30 PM : 08:00 PM

Gala Dinner

08:00 AM : 09:00 AM

Registration/Breakfast/Tea

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 : 03:00 PM

Session 5 Designing of Early Phase Studies with focus on Oncology

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Execution of Phase 1 Studies in India – Regulatory Scenario /Challenges/ Practical Considerations/Recommendations
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
From Scientific Concept to Commercial Success – Journey and its nuances
Audience Q&A

05:30 PM : 06:00 PM

Vote of Thanks to Sponsors followed by AGM

07:30 PM : 08:30 AM

Gala Dinner

Main Conference Tracks

08:30 AM : 09:00 AM

Tea / Coffee & Networking

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
How do we develop new sites to provide benefit for patients in remote areas? Dr Arun Bhatt
Consultant
. 		Session Chair
Enrolment of participants in India: Myths and Realities
Indian investigator sites: selection and performance
Developing new sites in a smaller towns /city – challenges & opportunities
How can technology enable patient referral from rural/remote areas to clinical trial sites
Q A
Concluding remarks

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Harnessing Digital Innovation to Transform Clinical Development and Trials: Best Practices and Future Opportunities
Clinical development
Site
Data Acquisition
Clinical Operations

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Strengthening Clinical Research Ecosystem in India : Impact of the Revised GCP Guidelines DR. SEEMA PAI
Senior Director, Clinical Site Operations – India Cluster
Pfizer 		Session Chair

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS SPEAKERS ROLE
Repurpose for Patients : Trust, Accountability, Transparency, ( A 3 ingredient Receipe) Murugananthan K
.
. 		Session Chair
Trust meets patient centricity in the journey of technological innovation.
Empowering Patient Voices: Integrating Patient-Centricity into Clinical Research Ethics
Data Disintegrity & Lack of Quality - Is this who we are ?
Audience Q&A

03:30 PM : 03:45 PM

Poster Presentation Results – Live Telecast in all tracks

03:45 PM : 04:00 PM

Vote of Thanks (President’s Live Telecast 5 mins + 10 mins Live by Track SOC Lead + LOC Lead)

08:30 AM : 09:30 AM

Tea / Coffee & Networking

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
From Data to Delivery, a journey through Study Closeout and Submission.
Role of Clinical Database Lock in Faster Medicine & Therapy
Redefining archival needs according to current industry changing landscape
Rethinking Data Protection

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Harnessing the Power of DCTs: Addressing Barriers and Prioritizing Patient-Centricity
Navigating the Adoption of eCOA through Digitization Strategies
Audience Q&A

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Turning Data into Actionable Insights: Practical Applications of Data Analytics for Informed Decision-Making
Unveiling the Role of Clinical Data Science: A Collaborative approach from Statisticians and Medical
Master Protocols: Transforming Clinical Trials for Efficiency and Precision

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS SPEAKERS ROLE
Convergence of Generative AI and LLM technologies with CDM processes
Regulatory Frameworks for AI/ML Integration in Clinical Trials
Audience Q&A

03:30 PM : 03:45 PM

Poster Presentation Results – Live Telecast in all tracks

03:45 PM : 04:00 PM

Vote of Thanks (President’s Live Telecast 5 mins + 10 mins Live by Track SOC Lead + LOC Lead)

08:30 AM : 09:30 AM

Tea / Coffee & Networking

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Current trends in Regulatory Writing - everything you need to know Neeta
.
. 		Session Chair
Master Protocols in Clinical Development: Insights for Regulatory Writers
Medical Writing Essentials for Developing and Managing Paediatric Investigational Plan
Empowering Patients Through Innovative Labelling: A Path to Enhanced Clinical Research Outcomes
Audience Q&A
EUCTR CTIS Revised rules - Does it improve data transparency and patient centricity? Insights and Our experiences
Challenges in Developing Plain Language Protocol Synopsis and Strategies to Overcome Them
Clinical data publication under EMA policy 0070
Audience Q&A

11:00 AM : 12:00 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
AI: transforming the field of MW Akshata Rao
.
. 		Session Chair
Realizing the vision of connected content ecosystem in Life Sciences with GenAI Automation
Ethical Concerns on the Use of Artificial Intelligence in Medical Writing
Using AI for writing plain language summaries: A case study
Artificial Intelligence: Transforming the Future of Medical Writing
Audience Q&A

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Medical Writing and Communications : Practices and Updates Sonali Parmar
.
. 		Session Chair
Demystifying the grey zones in publication writing
Lean Medical Writing: Methodology and Path to Successful Implementation
EU-CTD to EU-CTR Transitioning: A New Era in Clinical Trials
Enhancing Clinical Decision-making: The Integral Role of Real-world Data and Patient Centricity

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS SPEAKERS ROLE
TBD ANIMESH CHATRUVEDI
Head, Regulatory Writing and Submissions
Novartis 		Session Chair

03:30 PM : 03:45 PM

Poster Presentation Results – Live Telecast in all tracks

03:45 PM : 04:00 PM

Vote of Thanks (President’s Live Telecast 5 mins + 10 mins Live by Track SOC Lead + LOC Lead)

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Invited talk: Harnessing the Power of Statistics in Cancer Care
Audience Q&A
Patient Centricity from Statistical Perspective
Number Needed to Treat (NNT) vs Number Needed to Harm (NNH): Balancing Benefits and Risks
Advancing Innovative Adaptive Designs in Clinical Trials using Bayesian Approaches: A Different Perspective of Patient Centricity
Audience Q&A

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
How Visualization can Aid Clinical Decision Making
Enhancing Clinical Trial Analysis and Interpretation Through Visual Aids
Revolutionizing Dose Decision Making: A Validated Power BI Dashboard for Phase I Clinical Trials
Audience Q&A

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion: How to Prepare for an Effective Submission
Biosstat role
Programming role
Regulatory medical writing role
Clinical role
Audience Q&A

02:30 PM : 03:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Development in Programming Techniques
Optimize TFLs generated vs. CSR utilized using R shiny app
Bridging the data Gap: A Comparative Study of Multiple Imputation in R and SAS
Audience Q&A

03:30 PM : 03:45 PM

Session 10 Poster Presentation Results – Live Telecast in all tracks

03:45 PM : 04:00 PM

Session 11 Vote of Thanks (President’s Live Telecast 5 mins + 10 mins Live by Track SOC Lead + LOC Lead)

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Beyond Generative AI: Harnessing Causal AI for Next-Generation Pharmacovigilance. Panel discussion: Challenges & Solutions in safety reporitng, PSURs , SUGAM and implementing new PV guidelines from CDSCO & IPC-PvPI

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
" Global regulatory trends in RWE study (90 min) (Real-world Data standards for Regulatory submission: challenges and solution )"
RWE in Medical device approvals: Globa regulatory perspective     
Ethical challenges in Real World Academic Studies in India.
Panel: Evolving role of RWE in regulatory decision making . FDA & EMA approaches to RW
Audience Q&A

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
The potential of RWE In economical assessment of drugs and devices
Enhancing Decision-Making in Health Economics: The Role of Value of Information Analysis
Shift from RCT to RWE for Health Economics Modeling and assement
Audience Q&A

02:30 PM : 03:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Presentation: Life Cycle Pharmacovigilance: Shifting to a Patient-centric Narrative
Presentation: Evolving endpoint adjudication, SAE notification best practices and technology's impact
Skills & Expertise for career progression in PV
Audience Q&A

03:30 PM : 03:45 PM

Poster Presentation Results – Live Telecast in all tracks

03:45 PM : 04:00 PM

Vote of Thanks (President’s Live Telecast 5 mins + 10 mins Live by Track SOC Lead + LOC Lead)

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Innovation, Technology and Patient Centricity in Academic Clinical Research
Audience Q&A

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Unlocking Potential: The Vital Need for Research Units in Indian Academic Institutions
Audience Q&A

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
1. From Participants to Partners: Integrating Patient Perspectives in Indian Research Growth
2. "Empowering Society Through Patient-Centered Awareness Programs and Its Benefits in Academic Clinical Research
3. "Harnessing Digital Tools for Active Patient Participation in Clinical Research"
Audience Q&A

02:30 PM : 03:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
National Awards
Audience Q&A

03:30 PM : 03:45 PM

Session 10 Poster Presentation Results – Live Telecast in all tracks

03:45 PM : 04:00 PM

Vote of Thanks (President’s Live Telecast 5 mins + 10 mins Live by Track SOC Lead + LOC Lead)