Pre Conference Workshops

09:00 AM : 10:00 AM

REGISTRATIONS

10:00 AM : 10:15 AM

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THEME AND TOPICS SPEAKERS ROLE
Welcome Address Ms. Pradnya Mahatme
Head- Clinical Operations
Hector Research and Archival Pvt. Ltd. 		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
Senior Director, Enterprise Client Solutions
Fortrea 		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
Clinical Research and Drug Development  		Speaker

12:00 PM : 01:00 PM

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THEME AND TOPICS SPEAKERS ROLE
Group Case Studies: Bringing in Patient Centricity to Enhance Overall Patient Experience in Clinical Trials Ms. Pradnya Mahatme
Head- Clinical Operations
Hector Research and Archival Pvt. Ltd. 		Speaker
Mr. Manoj Karwa
Head – Clinical Trials and Pharmacovigilance
Auriga Research Pvt Ltd 		Speaker
Mr. Lavkesh Jadav
Manager- Clinical Operations
Avacare/ IQVIA 		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
Head- Clinical Operations
Hector Research and Archival Pvt. Ltd. 		Speaker
Mr. Manoj Karwa
Head – Clinical Trials and Pharmacovigilance
Auriga Research Pvt Ltd 		Speaker
Mr. Lavkesh Jadav
Manager- Clinical Operations
Avacare/ IQVIA 		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
Deputy General Manager
Sun Pharma 		Speaker

03:30 PM : 04:00 PM

TEA BREAK

04:00 PM : 05:00 PM

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THEME AND TOPICS SPEAKERS ROLE
Panel Discussion: Experience Sharing and Addressing Common Challenges Faced by CRCs Ms. Pradnya Mahatme
Head- Clinical Operations
Hector Research and Archival Pvt. Ltd. 		Moderator
Ms. Shweta Pardhan
Head- Clinical Operations
IQVIA 		Panelist
Dr. Kedar Mehta
Principal Investigator- Associate Professor, Community Medicine
GMERS Medical College Vadodara 		Panelist
Sonali Dutta
Seninor CRC
Seth GSMC and KEMH, Mumbai 		Panelist
Ms. Akshata Patil
Senior Clinical Research Co-ordinator
ACTRECT 		Panelist
Rutuja Walavalkar
Sr. CRA
Novartis, India 		Panelist

05:00 PM : 05:15 PM

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THEME AND TOPICS SPEAKERS ROLE
Closing Remarks Ms. Shweta Pardhan
Head- Clinical Operations
IQVIA 		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
Manager
Novo Nordisk 		Speaker
Avinash Santappa
Principal Regulatory Writer
GSK 		Speaker

11:30 AM : 01:00 PM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Essentials of Submission Planning and Content Preparation Md Salman
Associate Director
AstraZeneca 		Speaker
ANKIT SHAH
Principal (Regulatory Capability Lead) Medical Writing
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

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THEME AND TOPICS SPEAKERS ROLE
Best practices in Regulatory submission - Q & A session + Panel discussion Sudha Chennasamudram
Associate Director
BMS 		Speaker

04:45 PM : 05:00 PM

Summary and closing remarks

09:30 AM : 09:45 AM

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THEME AND TOPICS SPEAKERS ROLE
Welcome and Introductions GAURAB CHAKRABORTY
Head of Veramed
Veramed Data Services Private Limited 		Speaker

09:45 AM : 10:00 AM

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THEME AND TOPICS SPEAKERS ROLE
Data Science: Transforming the Future of Clinical Research Sridevi N
Associate Director, Data and Analytic
Eli Lilly 		Speaker

10:00 AM : 11:00 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Data Science & Biostatistics: Relevance to Clinical Research DEVEN BABRE
Director Life Science Centre of Excellence
Fresh Gravity 		Speaker
Dimpy Modak
Sr. Manager
Icon clinical research 		Speaker

11:00 AM : 11:15 AM

Coffee break

11:15 AM : 12:00 PM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Analytics -Tools of the Trade Sohan Dey
Statistical Specialist
Novo Nordisk 		Speaker

12:00 PM : 01:00 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Ensuring Data Quality and Regulatory Compliance -Pragmatic way to ensure highest quality data – a scientific approach Sridevi N
Associate Director, Data and Analytic
Eli Lilly 		Speaker
Mandar Panchi
Senior Principal Programmer
Novartis 		Speaker

01:00 PM : 01:45 PM

Lunch Break

01:45 PM : 02:45 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Harmonizing Data Management and Biostatistics Dr. Neeraj Pandey
Engagement delivery lead, IOA - LS Biostats
Cognizant 		Speaker
Rekha Mohan
Principal Clinical Data Science Lead
Icon clinical research 		Speaker

02:45 PM : 03:30 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Design Thinking for Clinical Research Challenges Bhaskar Subramanian
Director - Statistical Programming
AstraZeneca 		Speaker

03:30 PM : 03:45 PM

Coffee Break

03:45 PM : 04:15 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Fostering Cross-Functional Synergy Gunasekaran R
Director - Biostatistics 
IQVIA 		Speaker
Bibin Jacob
Director, Clinical Programming , Biometrics
Syneos Health 		Speaker

04:15 PM : 04:45 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Closing Session - Charting the Path Forward Dr. Bishwapriya Deb
Director – Clinical Data Science
Eli Lilly 		Speaker

04:45 PM : 05:00 PM

Networking and Wrap-Up

10:00 AM : 10:30 AM

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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 Prof. Dr. Melvin George
Professor & Head, Clinical Pharmacology
SRM Medical College Hospital & Research Centre 		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
Professor & Head, Dept of Pharmacology
D Y Patil University School of MEdicine, Navi Mumbai 		Speaker

12:15 PM : 01:30 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Presentation of protocols –group tasks Dr. Zainab Ghazala
Associate Professor
KBN University- Faculty of Medical Sciences 		Speaker
Dr. Sumana Sen
Professor and Head, pharmacology
Apollo Institute of Medical Sciences and Research, Hyderabad 		Speaker
Dr. Anant Patil
Professor, Dept. of Pharmacology
D.Y Patil University 		Speaker
Prof. Dr. Melvin George
Professor & Head, Clinical Pharmacology
SRM Medical College Hospital & Research Centre 		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 Ghazala
Associate Professor
KBN University- Faculty of Medical Sciences 		Speaker
Dr. Sumana Sen
Professor and Head, pharmacology
Apollo Institute of Medical Sciences and Research, Hyderabad 		Speaker
Dr. Anant Patil
Professor, Dept. of Pharmacology
D.Y Patil University 		Speaker
Prof. Dr. Melvin George
Professor & Head, Clinical Pharmacology
SRM Medical College Hospital & Research Centre 		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 Dakhle
Dean (Examination), Professor, Pharmacology
AIIMS, Nagpur 		Speaker

04:15 PM : 04:45 PM

Panel Discussion – Navigating challenges in academic research

04:45 PM : 05:00 PM

Valedictory

09:30 AM : 09:45 AM

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THEME AND TOPICS SPEAKERS ROLE
Welcome & Inauguration Dr Santosh Taur
Director Medical Affairs, Vaccines and Digital
Pfizer  		Speaker
Ms. Kavitha Gurram
Director-Head of Project Management, Real World Solutions
IQVIA 		Speaker

09:45 AM : 10:15 AM

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THEME AND TOPICS SPEAKERS ROLE
Defining 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

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THEME AND TOPICS SPEAKERS ROLE
Group Exercise I Case studies and publication review Dr Alok Nachane
DIRECTOR
VERITASQ RESEARCH AND ANALYTICS 		Speaker
Dr Namrata Kulkarni
Medical Lead, Adult Vaccination
Pfizer Limited 		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 DR. PUJA NAGPAL
Head Basic Research Lab
Indian Spinal Injuries Center, New Delhi 		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
Dr. Sundeep Salvi
MD, PhD, Hon FRCP(Lon) Director
Pulmocare Research and Education (PURE) Foundation 		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
Dr Arun Bhatt
Consultant
Clinical Research and Drug Development  		Speaker

04:30 PM : 05:00 PM

Summary and conclusion

09:30 AM : 09:40 AM

THEME AND TOPICS SPEAKERS ROLE
Welcome and Introductions MS. SUKANYA CHOUDHURY
Executive Vice President – Regulatory Affairs
GSK 		Speaker

09:40 AM : 10:00 AM

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

10:00 AM : 10:30 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
BA/BE Regulatory Pathways: Understanding Challenges, Leveraging Opportunities, and Best Practices for Approval Dr. Kiran Marthak
Director, MA, Phase 1 & RA
Veeda Clinical Research 		Speaker

10:30 AM : 11:00 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Navigating Regulatory Pathway for Conducting Vaccine Clinical Trials in India Mr. Parag Nagarkar
Director & Head RA
Serum Institute 		Speaker

11:00 AM : 11:30 AM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Clinical Development of Biosimilars- Regulatory Requirements India, EU and US Dr. Tazeen Aamena Idris
Head Clinical Strategy – Biologics
Dr. Reddys 		Speaker

11:30 AM : 12:00 PM

Tea Break

12:00 PM : 01:15 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Group Activity 1: Understanding Tips and Tricks of SUGAM Submission & Effective Handling of Queries In CTA Review VIVEK PADALALU
Associate Director, Site readiness and Regulatory Operations,
Fortrea 		Speaker

01:15 PM : 02:00 PM

Lunch Break

02:00 PM : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Group Activity 2: Strategies for Navigating the SEC Meeting For Successful Outcomes Yasmin Shenoy
Senior Director Regulatory Affairs, Regulatory Affairs Asia-Asia & Generics
Sanofi 		Speaker

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
PANEL DISCUSSION: Future of Clinical Research Sector in India: Trends, Challenges, and Opportunities for the Next Decade DR. SANISH DAVIS
R&D Director, Global Clinical Operations, India
Johnson & Johnson 		Speaker
Dr. Shekhar Dawkhar
Senior Director, Enterprise Client Solutions
Fortrea 		Speaker
Dr. Banavali
Director Academics & Prof. Deptt. of Medical & Pediatric Oncology
Tata Memorial Center 		Speaker
Dr. Yashashri Shetty
Additional Professor, Deptt. of Pharmacology & Therapeutics
Seth G S Medical College & KEM 		Speaker
MS. SUKANYA CHOUDHURY
Executive Vice President – Regulatory Affairs
GSK 		Moderator

04:00 PM : 04:15 PM

Tea Break

04:15 PM : 05:00 PM

THEME AND TOPICS SPEAKERS ROLE
Recent Regulatory Updates for Clinical Trials
NSWS & Export NOC Rahul Mehrotra
Manager, RA
PPD 		Speaker
CRO registration SNEHA GUPTA
Associate Director, Regulatory Affairs
IQVIA 		Speaker
Indian GCP SACHIN SATIJA
Sr. Director-Quality Assurance
Syneos Health 		Speaker

09:00 AM : 09:15 AM

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THEME AND TOPICS SPEAKERS ROLE
Introduction and Workshop Agenda ANIRBAN ROY CHOWDHURY
AVP and Head global CoE for Data Management, Biostatistics and Clinical Operation
Sun Pharma 		Speaker

09:15 AM : 09:45 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Navigating Complexity: The Evolving Landscape of Global Clinical Trials Valentina Curovic-Perisic
Vice President & Head Global Clinical Operations
Sun Pharma 		Speaker

09:45 AM : 10:15 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Decoding Regulatory inspection data for India Shehnaz Vakharia
Vice President-Asia Pacific
ADAMAS Consulting 		Speaker

10:15 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

THEME AND TOPICS SPEAKERS ROLE
Mirror Talk Managing quality in an outsourced clinical trial Prashant Mehrotra
Senior General Manager- Clinical Research
Bharat Serums and Vaccines Ltd 		Speaker
Ms. Shweta Pardhan
Head- Clinical Operations
IQVIA 		Speaker

12:15 PM : 01:00 PM

Session 4

THEME AND TOPICS SPEAKERS ROLE
Ensuring Data Integrity Through Robust Site Management and Investigator site staff Training DR. SEEMA PAI
Senior Director, Clinical Site Operations – India Cluster
Pfizer Limited 		Speaker
Dr. Ganesh Dakhle
Dean (Examination), Professor, Pharmacology
AIIMS, Nagpur 		Speaker
Ms. Shweta Pardhan
Head- Clinical Operations
IQVIA 		Speaker
ANIRBAN ROY CHOWDHURY
AVP and Head global CoE for Data Management, Biostatistics and Clinical Operation
Sun Pharma 		Moderator

01:00 PM : 02:00 PM

Lunch Break

02:00 PM : 04:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Workshop -Inspection Readiness based on recent experiences Richa Sarode
Manager, Compliance
Johnson and Johnson Innovative Medicine 		Speaker
MS. DARSHANA DHOLAKIA
Senior Manager, GCO, Janssen
Johnson and Johnson Innovative Medicine 		Speaker
Rohit Chand
Site Relationship Partner
Pfizer Limited 		Speaker

04:00 PM : 04:30 PM

Tea Break

04:30 PM : 05:15 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Best practices for Inspection readiness : bringing it all together Shehnaz Vakharia
Vice President-Asia Pacific
ADAMAS Consulting 		Speaker

05:15 PM : 05:30 PM

Q & A

Main Conference Tracks

08:00 AM : 09:00 AM

Registration - Tea/Coffee/Networking

09:00 AM : 09:45 AM

Session 1

THEME AND TOPICS SPEAKERS ROLE
Welcome and Opening Remarks Ms. Renuka Neogi
Deputy General Manager
Sun Pharma 		Speaker
Dr. Shekhar Dawkhar
Senior Director, Enterprise Client Solutions
Fortrea 		Speaker
President's Welcome Address Secretary's Report DR. SANISH DAVIS
R&D Director, Global Clinical Operations, India
Johnson & Johnson 		Speaker
DR. SEEMA PAI
Senior Director, Clinical Site Operations – India Cluster
Pfizer Limited 		Speaker
Scientific Programme Overview by SOC Chair/s Murugananthan K
Country Head SSO India, Global Clinical Operations.
Novartis 		Speaker
Dr. Ganesh Dakhle
Dean (Examination), Professor, Pharmacology
AIIMS, Nagpur 		Speaker
Guest of Honour Ms. Renuka Neogi
Deputy General Manager
Sun Pharma 		Speaker
Vote of Thanks Ms. Renuka Neogi
Deputy General Manager
Sun Pharma 		Speaker
Dr. Shekhar Dawkhar
Senior Director, Enterprise Client Solutions
Fortrea

09:45 AM : 11:30 AM

Session 2

THEME AND TOPICS SPEAKERS ROLE
Introduction RRC Oration/Citation MR. KEDAR NAYAK
SOC, Co-Chair Study Delivery Lead Team Director-Global Clinical Operations
GlaxoSmithKline Pharmaceuticals Ltd 		Speaker
Prof Ranjit Roy Chaudhury Oration followed by Felicitation Prof. Rahul Purvar
Professor at BSBE, Department of Biosciences and Bioengineering
IIT Bombay 		Speaker
Announcement of Lifetime Achievement Awards- Academia MR. KEDAR NAYAK
SOC, Co-Chair Study Delivery Lead Team Director-Global Clinical Operations
GlaxoSmithKline Pharmaceuticals Ltd 		Speaker
Felicitation-Awardee Lifetime Achievement Awards- Academia DR. SANISH DAVIS
R&D Director, Global Clinical Operations, India
Johnson & Johnson 		Speaker
Acceptance Speech
Announcement of Lifetime Achievement Awards- Industry MR. KEDAR NAYAK
SOC, Co-Chair Study Delivery Lead Team Director-Global Clinical Operations
GlaxoSmithKline Pharmaceuticals Ltd 		Speaker
Felicitation-Awardee Lifetime Achievement Awards- Industry DR. SEEMA PAI
Senior Director, Clinical Site Operations – India Cluster
Pfizer Limited 		Speaker
Acceptance Speech
Position paper launch (AI/ML) MR. MAHESH IYER
Head, Global Biometrics and Data Sciences
BMS 		Speaker

11:30 AM : 12:30 PM

Session 3

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion : Leveraging India Capability Centres for Strategic Advantage in Drug Development: How Global Pharmaceutical Companies Are Leading the Way? ANIRBAN ROY CHOWDHURY
AVP and Head global CoE for Data Management, Biostatistics and Clinical Operation
Sun Pharma 		Moderator
Debjit Biswas
Vice President and Head of Development Operations, India
Pfizer Limited 		Panelist
Sameera Kashyap
Regulatory Affairs Director and Global Regulatory Lead, Oncology
AstraZeneca 		Panelist
Suneela Thatte
Vice President & Head R&D India
Merck KGaA 		Panelist
MR. MAYANK ANAND
VP Global Clinical Operation, Data Strategy and Management
GSK 		Panelist

12:30 PM : 12:45 PM

-

THEME AND TOPICS SPEAKERS ROLE
Closing of Plenary Session Ms. Renuka Neogi
Deputy General Manager
Sun Pharma 		Speaker
Dr. Shekhar Dawkhar
Senior Director, Enterprise Client Solutions
Fortrea 		Speaker

12:45 PM : 02:00 PM

Lunch

08:00 AM : 09:00 AM

Registration/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 : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Recent Developments in Leveraging AI for Regulatory Filings and Reviews in Clinical Trials MS. SUKANYA CHOUDHURY
Executive Vice President – Regulatory Affairs
GSK 		Session Chair
Recent Developments in Leveraging AI for Regulatory Filings and Reviews in Clinical Trials Dr Arun Bhatt
Consultant
Clinical Research and Drug Development  		Speaker
Leveraging AI tools for Regulatory Review and in Clinical Trials Archana Subramanya
Executive Vice President, Head - Global Regulatory Centers
GSK 		Speaker
Regulatory Perspectives
Speakers as panel members for Q&A, moderated by moderator AMITA BHAVE
Director Regulatory Affairs.
AstraZeneca 		Speaker

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
CEO
APAR Health  		Session Chair & Moderator
How patient understanding of Clinical research creates a more active participant in clinical trials,practical steps Mr Dilip Mevada
CEO and Founder Trustee of MFCT
Myeloma Friends  		Speaker
Investigators can create practical processes to ensure patient centricity in all steps of  clinical research (ASHA project) Dr. CS Pramesh
Director
TMH 		Speaker
EC member of Tata Mumbai -survivor Hogkins -she will speak on how patient centricity can be focused during EC review,practical steps Ms Vandana Gupta
Founder
Chairperson of the EC at Breach Candy 		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
Innovations in Vaccine Research : Accomplishments and Opportunities. DR. VINOD MATTOO
Executive Director
DiagnoSearch Life Sciences 		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 DR. PRASAD KULKARNI
Executive Director
Serum Institute of India Pvt. Ltd. (SIIPL), Pune 		Panelist
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 Dr. Devasena Anantharaman
Scientist F
Rajiv Gandhi Centre for Biotechnology 		Panelist
Vaccine development and predictors of vaccine protection. This topic includes vaccine combinations and technology interventions Dr. Ashish Bavdekar
Director, Department of Paediatrics
KEM Hospital, Pune 		Panelist
Patient Centricity in Vaccine research: examples from emerging markets Mandar Vaidya
Vice President, Operations
DiagnoSearch Life Sciences 		Panelist
Audience Q&A

06:00 PM : 07:00 PM

ISCR Annual General Meeting

07:00 PM : 08:00 PM

Gala Dinner + Awards + Sponsor recognition

08:00 AM : 09:00 AM

Registration/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 : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Shaping the Future: The Role of Clinical Data Standards in an Evolving Technology Landscape DEVEN BABRE
Director Life Science Centre of Excellence
Fresh Gravity 		Session Chair
Implementing  data standards in AIML frameworks Ram Mudaliar
Senior Director, India CDI Lead
AZ 		Speaker
Arjun Sridharan
Associate Director, EDC Management and Standards
BMS 		Speaker

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 Ullas Arabhavi
Founder Proprietor
2uCDM Data Solutions 		Moderator
Anshuman Kumar
Associate Director - Clinical Data Sciences, Eli Lilly
Eli Lilly
Firasatullah Syed
Principal Solutions Consultant
Oracle
Hiren Thakkar
Founder & Managing Director
Octalsoft
BHAIRAVI BHINDE
Director, Clinical Operations, India Local Solutions
IQVIA
Pramod Kashid
CEO
Expecto Health Sciences
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
Implementing Risk-Based Quality Management (RBQM) in Clinical Trials: Case Studies and Best Practices DEBJIT CHAKRABARTI
Senior Director, Head of Centralized Monitoring FSP Services
IQVIA 		Session Chair
Signal Detection and Data Trending in Clinical Trials: Enhancing Oversight with Statistical Monitoring Madhumathi Raghunathan
Group Lead, Clinical Data Science
ICON 		Speaker
Risk Based Protocol Design Krishnendu Sengupta
Director - Centralized Monitoring
Astrazeneca 		Speaker
Audience Q&A

06:00 PM : 07:00 PM

ISCR Annual General Meeting

07:00 PM : 08:00 PM

Gala Dinner + awards + Sponsor recognition

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 : 03:00 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Driving Patient Centricity in Clinical Research: Role of MWs GARIMA PALLAVI
Director, Head of Medical Writing Centre of Excellence
GSK 		Session Chair
Key drivers to developing a patient centric informed consent form. Nivedita Sahoo
Associate Director, Medical Writing
GSK 		Speaker
Driving Patient Engagement for Protocol Design Drashti Thakkar
Senior Regulatory Writer
Novartis 		Speaker
Diversity Plans in Clinical Trials- A Step Towards Patient-Centricity by Including Underrepresented Subgroups Ramanuj Goswami
Associate Director
BMS 		Speaker

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Accelerating submissions: Elevating the Role of MWs Dr Hetal Shah
Founder-Director
MeWriT Healthcare Consulting 		Session Chair
Real Time Oncology Review (RTOR) Project ORBIS Amol Katore
Senior Associate
Eli Lilly 		Speaker
A case study: Using Dry-run outputs for improving Clinical Study Report timelines Prashant Deshmukh
Expert Regulatory Writer
Novartis 		Speaker
Clinical study report (CSR) prototypes as enabler for accelerated regulatory submissions and quicker access to medicines Rajneeta Roy
Principal Medical Writer
GSK 		Speaker

04:00 PM : 04:30 PM

Tea/Coffee Break

04:30 PM : 05:30 PM

Session 7

THEME AND TOPICS SPEAKERS ROLE
Elevating medical writers in India with essential technical and soft skills Sonali Parmar
Director, Medical Writing and Clinical Trial Disclosure
Syneos Health 		Session Chair & Moderator
DR. RAJESH KHER
Director, IDAR Business Operations
Johnson & Johnson 		Speaker
ANIMESH CHATRUVEDI
Head, Regulatory Writing and Submissions
Novartis 		Speaker
POOJA BANERJEE
Head, Medical Communications
Krystelis 		Speaker
ANKIT SHAH
Principal (Regulatory Capability Lead) Medical Writing
Eli Lilly 		Speaker

06:00 PM : 07:00 PM

ISCR Annual General Meeting

07:00 PM : 08:00 PM

Gala Dinner + awards + Sponsor recognition

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 : 02:45 PM

Session 5

THEME AND TOPICS SPEAKERS ROLE
Welcome talk GAURAB CHAKRABORTY
Head of Veramed
Veramed Data Services Private Limited 		Session Chair
Invited talk: Quantitative Decision Making in Drug Development Angshuman Sarkar
Senior Director – Statistics, Head Statistics (India), R&D
GSK 		Speaker
Audience Q&A

02:45 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Statistical Excellence in Drug Development HANUMANTHA RAO KAREDLA
Head - Oncology Data Analytics
Bayer 		Speaker
Scenario evaluation of different Dose Escalation Methods using simulation framework Shreya Bhunia
Senior Biostatistician
Merck Specialities Private Limited 		Speaker
Anubrata Roy
Biostatistician
Merck Specialities Private Limited 		Speaker
Comparative approach of Synthetic Control Arm with Traditional Clinical Trials Avijit Das
Principal Biostatistician
Fortrea 		Speaker
About Estimands, Intercurrent Events and Imputations Ramvikas Sunkavalli
Principal Statistical Programmer
Novartis 		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
Updates from the World of Standards Biplob Banerjee
Associate Director, programming
PPD, part of Thermofisher Scientific 		Speaker
Redefining Analysis with CDISC ARS Model Sarita Singh
Senior Statistical Programmer II
Veramed 		Speaker
CDISC ARS standards & machine readable Specs - eTFL Coming our Way MAYANK BHATIA
Head , Product Strategy & Management
TCS 		Speaker
Audience Q&A

06:00 PM : 07:00 PM

ISCR Annual General Meeting

07:00 PM : 08:00 PM

Gala Dinner + awards + Sponsor recognition

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
Patient-Centeric Real-World Evidence Studies and Emerging Methods Mr. Raviteja Adapa
Head- Clinical Operations
Syngene International Ltd. 		Session Chair
Integrating Patient Centricity into the Design and Conduct of the RWE Studies Dr Santosh Taur
Director Medical Affairs, Vaccines and Digital
Pfizer  		Speaker
Patient Engagement in RWE Studies: Care Gaps, Patient Preferences, Outcomes, & Emerging Tools Mr. Raviteja Adapa
Head- Clinical Operations
Syngene International Ltd. 		Moderator
Dr Santosh Taur
Director Medical Affairs, Vaccines and Digital
Pfizer  		Panelist
Sharda Kandwal
RWE Medical & Scientific Writing, Global Scientific Services
IQVIA 		Panelist
Dr Anbarasan Sekar
Associate Professor Medical Oncology ACTREC TMC
ACTREC Tata Memorial Centre, Mumbai 		Panelist
Sanjeev Sharma
Director & CEO
Lungconnect India 		Panelist

03:00 PM : 04:00 PM

Session 6

THEME AND TOPICS SPEAKERS ROLE
Evolving Pharmcovigilance Practices & Requirments Dr Babita Kirodian
Amgen Technology India Pvt Ltd
Amgen 		Session Chair & Moderator
Recent Updates in PV requirements ALICE FERNANDES
Senior Manager, Pharmacovigilance Lead
GSK 		Speaker
DR ANIKET PATIL
PV Head at Pfizer India
Pfizer India 		Speaker
Mr. John Praveen
Associate Vice President
Accenture 		Speaker
PV - Trends, Challenges and Opportunities Gurpreet Singh
Vice President, Managing Director Integrated Safety
IQVIA 		Speaker
Presentation: Life Cycle Pharmacovigilance: Shifting to a Patient-centric Narrative Dr Venkatesh Sunilrao Kulkarni
Lead Safety Physician, Fortea
Fortea 		Speaker
Q&A All the speakers

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 Ms. Shruti MP
Real World Data Solutions Associate Director
Parexel International Pvt. Ltd 		Session Chair & Moderator
Optimizing Registry Studies in India: Opportunities and Challenges Dr Prashant Mathur
Director, NCDIR
ICMR 		Speaker
Quality by Design in RWE studies Ms. Kavitha Gurram
Director-Head of Project Management, Real World Solutions
IQVIA 		Speaker
Real World Excellence: A Statistician's Touch Dr. Mahendra Bijarnia
Senior Director, Biostatistics
AstraZeneca 		Speaker
All the speakers
Audience Q&A

06:00 PM : 07:00 PM

ISCR Annual General Meeting

07:00 PM : 08:00 PM

Gala Dinner + awards + Sponsor recognition

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
Designing of Early Phase Studies with focus on Oncology Dr Bhawana Awasthy
VP- Medical Management & General Manager India
Syneos Health 		Session Chair & Moderator
Dr. Vikram Gota MD
Professor, Research
ACTREC, TMC, MUMBAI 		Speaker
Dr Wouter Bartholomeus
MD, Executive Medical Director Oncology & Hematology
Syneos Health 		Speaker

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 AMITA BHAVE
Director Regulatory Affairs.
AstraZeneca 		Session Chair & Moderator
Dr. Usharani Pingali
Professor and Head, Dept of Clinical Pharmacology and Therapeutics
Nizam's Institute of Medical Sciences 		Speaker
Dr. Jerin Jose Cherian
Scientist-E (Med)
Indian Council of Medical Research 		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
From Scientific Concept to Commercial Success – Journey and its nuances DR. AJIT NAIR
PhD, Head- Regulatory Sciences
Bristol Myers Squibb 		Moderator
Dr.Vasanthi Ramachandran
Vice President Collborations
Bugworks Research 		Speaker
Dr. Taslimarif Saiyed
Director and CEO
Centre for Cellular and Molecular Platforms (C-CAMP) 		Speaker
Audience Q&A

05:30 PM : 06:00 PM

ISCR Annual General Meeting

07:30 PM : 08:30 AM

Gala Dinner + awards + Sponsor recognition

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? Ms. Renuka Neogi
Deputy General Manager
Sun Pharma 		Session Chair
Enrolment of participants in India: Myths and Realities Dr Arun Bhatt
Consultant
Clinical Research and Drug Development  		Speaker
Indian investigator sites: selection and performance DR. SANISH DAVIS
R&D Director, Global Clinical Operations, India
Johnson & Johnson 		Speaker
Developing new sites in a smaller towns /city – challenges & opportunities Dr. Ganesh Dakhle
Dean (Examination), Professor, Pharmacology
AIIMS, Nagpur 		Speaker
How can technology enable patient referral from rural/remote areas to clinical trial sites Dr. Nilesh Atre
VP, Growth & Partnerships
Oncoshot 		Speaker

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 MR. MAHESH IYER
Head, Global Biometrics and Data Sciences
BMS 		Speaker
Clinical development DR. CHIRAG TRIVEDI
Global Head, Clinical Study Units (CSU) Early Operational Strategy 
Sanofi 		Panelist
Site Prof. Dr. Melvin George
Professor & Head, Clinical Pharmacology
SRM Medical College Hospital & Research Centre 		Panelist
Data Acquisition Elizabeth Samuel
Senior Director, Data Acquisition
GSK 		Panelist
Clinical Operations DR. SEEMA PAI
Senior Director, Clinical Site Operations – India Cluster
Pfizer Limited 		Panelist
Audience Q&A

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 Limited 		Session Chair
Prof. Bikash Medhi
Professor, & Ex- Additional Medical Superintendent (AMS)
Postgraduate Institute of Medical Education & Research, Chandigarh 		Speaker
Navneet Pratap Singh
Asst. Drugs Controller(India)
CDSCO 		Panelist
Dr.Yashashri Shetty
Professor (Addl) Department of Pharmacology & Therapeutics
Seth GSMC & KEM Hospital,Parel 		Panelist
Dr Vaibhav Salvi
Director and Head–Clinical Study Unit,India and South East Asia,R&D–Clinical Sciences and Operations
Sanofi 		Panelist
Dr. Kumar Prabash
Professor, Medical Oncology
Tata Memorial Hospital 		Panelist

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
Country Head SSO India, Global Clinical Operations.
Novartis 		Moderator
Data Disintegrity & Lack of Quality - Is this who we are ? Dr. Anupama Ramkumar
Principal Consultant &CEO
Arkus Resarch Pvt Ltd 		Speaker
Empowering Patient Voices: Integrating Patient-Centricity into Clinical Research Ethics Dr. Mrunalini Kalikar
Associate Professor, Department of Pharmacology
GMC,Nagpur 		Speaker
Trust meets patient centricity in the journey of technological innovation. Rashmi Kotian
Senior Project Leader, Project leadership
Thermo Fisher Scientific 		Speaker
Audience Q&A

03:30 PM : 04:00 PM

Vote of Thanks

08:30 AM : 09:30 AM

Tea / Coffee & Networking

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Harnessing the Power of DCTs: Addressing Barriers and Prioritizing Patient-Centricity Kedar Deshmukh
Director, Clinical Data Science
ICON 		Session Chair
Navigating the Adoption of eCOA through Digitization Strategies Pinaki Karmoker
Head, Global Data Management
Sun Pharma 		Speaker
DCT using Devices Gauravbir Dogra
Senior Manager, Statistical Data Sciences & Analytics
Pfizer 		Speaker

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Convergence of Generative AI and LLM technologies with CDM processes Kedar Deshpande
Founder and Chief Product Officer
Lifio 		Moderator
Regulatory Frameworks for AI/ML Integration in Clinical Trials Samir Kagrana
Global Head Strategic Deals
Fortrea 		Panelist
Santosh Karthikeyan
Data & AI Leader
AstraZeneca 		Panelist
Dr. Sailesh Bajpai
Solution Consultant - Medidata, a Dassault Systèmes company
3ds 		Panelist
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 APPALLA PRABHAKAR
Group Head, Clinical Data Acquisition Management
Novartis 		Session Chair
Real-World Case Studies: Harnessing Collaboration to Transform Clinical Data into Impactful Insights Namratha Murthy
Executive Director FSP
Syneos Health 		Speaker
From Raw Data to Real Impact: Case Studies in Analytics for Informed Decision-Making Mita Valera
Director - Strategic Capabilties
Eli Lilly 		Speaker

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS SPEAKERS ROLE
From Data to Delivery, a journey through Study Closeout and Submission. SURAJ RAVINDRAN
Senior Director
GSK 		Moderator
Role of Clinical Database Lock in Faster Medicine & Therapy Suresh Tupakula
Assoc Director, FSP 360
Syneos Health 		Panelist
Redefining archival needs according to current industry changing landscape Saisudha K
Group Leader - Clinical Data Science
Eli Lilly 		Panelist
Rethinking Data Protection Manuj Vangipurapu
CEO
Clinion 		Panelist
Abhishek Ghosh
Director Centralised monitoring
GSK 		Panelist
Audience Q&A

03:30 PM : 04:00 PM

-

THEME AND TOPICS SPEAKERS ROLE
Vote of Thanks DR. SANISH DAVIS
R&D Director, Global Clinical Operations, India
Johnson & Johnson

08:30 AM : 09:30 AM

Tea / Coffee & Networking

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
AI: transforming the field of MW Dr. Akshata Rao
Director, Global Medical Writing
Merck 		Session Chair
Realizing the vision of connected content ecosystem in Life Sciences with GenAI Automation Nikesh Shah
VP and Global Head, Safety and Generative AI
Indegene 		Speaker
Artificial Intelligence: Transforming the Future of Medical Writing Shravani Dudyala
Senior Regulatory Writer
Novartis 		Speaker
Ethical Concerns: AI in Medical Writing ANIMESH CHATRUVEDI
Head, Regulatory Writing and Submissions
Novartis 		Moderator
Nikesh Shah
VP and Global Head, Safety and Generative AI
Indegene 		Panelist
Shravani Dudyala
Senior Regulatory Writer
Novartis 		Panelist
Sudha Chennasamudram
Associate Director
BMS 		Panelist
Vidhi Vashisht
VP, Head of Plain Language Services
Krystellis 		Panelist

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Current trends in Regulatory Writing - everything you need to know Neeta Korlepara
Senior Group Head
Novartis 		Session Chair
Master Protocols in Clinical Development: Insights for Regulatory Writers Venkataraju Yeradesi
Associate Director
AZ 		Speaker
Empowering Patients Through Innovative Labelling: A Path to Enhanced Clinical Research Outcomes Meenu Singh
Associate Manager
Indegene 		Speaker
The triad of medical writing: Safety, Medical Communication and regulatory writing - unique and transferable skills required Divya Murarka
Senior Director, Medical Writing Services, Parexel India
Parexel 		Speaker
Jai Tilak
Associate Director, Medical Writing
Syneos Health 		Panelist
Md Salman
Associate Director
AstraZeneca 		Panelist
Ubhayabharathi Gurunath
Ad interim Group Lead - Scientific Communications
Sanofi 		Panelist
Sonica Sachdeva Batra
ASSOCIATE VICE PRESIDENT
Indegene 		Panelist
Dr. Akshata Rao
Director, Global Medical Writing
Merck 		Panelist

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
Director, Medical Writing and Clinical Trial Disclosure
Syneos Health 		Session Chair
Demystifying the grey zones in publication writing Ubhayabharathi Gurunath
Ad interim Group Lead - Scientific Communications
Sanofi 		Speaker
EU-CTD to EU-CTR Transitioning: A New Era in Clinical Trials Deepti Sehrawat
Manager, Medical Writing
Syneos Health 		Speaker
Challenges in Developing Plain Language Protocol Synopsis and Strategies to Overcome Them Akanksha Vinod
Medical Writer II
Fortrea 		Speaker
EUCTR CTIS Revised Rules - Does it Improve Data Transparency and Patient Centricity? Insights and Our Experiences Jisha Basil
Senior Transparency Manager
Novartis 		Speaker
Lean Medical Writing: Methodology and Path to Successful Implementation Sonica Sachdeva Batra
ASSOCIATE VICE PRESIDENT
Indegene 		Speaker

03:30 PM : 04:00 PM

-

THEME AND TOPICS SPEAKERS ROLE
Vote of Thanks

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Invited talk: Harnessing the Power of Statistics in Cancer Care Dr. Arijit Nag
Consultant, Dept. of Clinical Hamatology & Cellular Therapies; Clinical Lead, Leukemia
Tata Memorial Center, Kolkata 		Speaker
Audience Q&A
Patient Centricity from Statistical Perspective Pramod Reddy
Head, Biostatistics & Data Management
Dr. Reddy's 		Session Chair
Number Needed to Treat (NNT) vs Number Needed to Harm (NNH): Balancing Benefits and Risks Keerthana Udupa
Statistician
Novo Nordisk 		Speaker
Advancing Innovative Adaptive Designs in Clinical Trials using Bayesian Approaches: A Different Perspective of Patient Centricity Dr. Sabyasachi Mukherjee
Senior Biostatistician
Icon 		Speaker
Advancing Innovative Adaptive Designs in Clinical Trials using Bayesian Approaches: A Different Perspective of Patient Centricity SUPRATIK CHAKRABORTY
Principal Biostatistician
ICON 		Speaker
Audience Q&A

11:00 AM : 12:30 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
How Visualization can Aid Clinical Decision Making GARGI PAIGAONKAR
Head, Clinical & Statistical Programming
Johnson & Johnson 		Session Chair
Enhancing Clinical Trial Analysis and Interpretation Through Visual Aids Supraja Venkata Gorre
Associate Principal Statistical Programmer
Merck 		Speaker
Enhancing Clinical Trial Analysis and Interpretation Through Visual Aids Rohith Chennamaneni
Principal Statistical Programmer
Merck 		Speaker
Revolutionizing Dose Decision Making: A Validated Power BI Dashboard for Phase I Clinical Trials Bhavin Solanki
Computational Scientist
Bayer 		Speaker
Audience Q&A

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Panel Discussion: How to Prepare for an Effective Submission KRISHNENDU BISWAS
Global Group Head SP, Advanced Quantitative Sciences
Novartis 		Moderator
Biostat Role Amulya Jayadev
Manager, Statistics
GSK 		Panelist
Programming role Shuvromoy Mondal
Associate Director
J&J 		Panelist
Regulatory medical writing role Sherin Baby Kutty
Senior Manager – Global Scientific Communications
Lilly 		Panelist
Clinical role Kiran Bapatla
Global Program Clinical Head
Novartis 		Panelist
Audience Q&A

12:30 PM : 01:30 PM

Lunch Break

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS SPEAKERS ROLE
Development in Programming Techniques SMITHA NALAM
Director, Statistical Programming
Icon 		Session Chair
Optimize TFLs generated vs. CSR utilized using R shiny app Srikanth Raju Neelakantham
Associate Director Statistical Programming
Novartis 		Speaker
Bridging the data Gap: A Comparative Study of Multiple Imputation in R and SAS Liya Elizabath Selestine
Associate Statistical Data Scientist
Pfizer 		Speaker
Anji Reddy Nakka
Associate Director Statistical Programming
Pfizer Health Care 		Speaker
Audience Q&A

03:30 PM : 04:00 PM

THEME AND TOPICS SPEAKERS ROLE
Vote of Thanks DR. SANISH DAVIS
R&D Director, Global Clinical Operations, India
Johnson & Johnson

08:30 AM : 09:30 AM

Tea / Coffee & Networking

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Beyond Generative AI: Harnessing Causal AI for Next-Generation Pharmacovigilance. Dr Vijay Krishnan Ganeshan
Director, Parexel
Parexel 		Session Chair & Moderator
Dr Siva Kumar Buddha
Head of Signal and Risk Management, PV
Indegene 		Speaker
Challenges & Solutions in safety reporitng, PSURs , SUGAM and implementing new PV guidelines from CDSCO & IPC-PvPI Dr Kirti Chavan
Global PV Head
Abbot India Ltd 		Panelist
Dr Chitra Bargaje
Senior General Manager – Global Head
Lupin 		Panelist
Dr. Jamal Baig
Multi Country Safety Head
Sanofi 		Panelist
Nidhi Vaish
PV Head India
Roche 		Panelist
Vishal Shinde
PV Head India
BMS India 		Panelist

11:00 AM : 12:35 PM

Session 9

THEME AND TOPICS SPEAKERS ROLE
Global Regulatory Trends in RWD/RWE Sushmeeta Chhowala
Director-Medical Affairs, Lead- Clinical Development and Planning
Cipla Ltd. 		Session Chair & Moderator
RWE in Medical Device Aapprovals: Global Regulatory Perspective      Dr Vinay Rajan
Senior Director, Clinical Research and Medical Sciences
Medtronic 		Speaker
Ethics & Data Privacy Considerations in Real-World Evidence Studies in India Dr Renuka Munshi
Head of Dept. of Clinical Pharmacology
BYL Nair Hospital and TN Medical College, Mumbai Central 		Speaker
Evolving Role of RWE in Regulatory Decision-making Sushmeeta Chhowala
Director-Medical Affairs, Lead- Clinical Development and Planning
Cipla Ltd. 		Moderator
Dr Arun Bhatt
Consultant
Clinical Research and Drug Development  		Panelist
Dr Renuka Munshi
Head of Dept. of Clinical Pharmacology
BYL Nair Hospital and TN Medical College, Mumbai Central 		Panelist
Dr Roli Mathur
Scientist G and Head, ICMR Bioethics Unit
ICMR 		Panelist
Dr Vinay Rajan
Senior Director, Clinical Research and Medical Sciences
Medtronic 		Panelist
DR. GAURAV MATHUR
Senior Director, Regulatory Affairs & Regional Head
Parexel International 		Panelist

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
Potential of RWE in Economic Assessment of Drugs, Biologics and Devices Dr Alok Nachane
DIRECTOR
VERITASQ RESEARCH AND ANALYTICS 		Session Chair & Moderator
Enhancing Decision-Making in Health Economics: Value of Information Analysis DR BEENA JOSHI
Scientist G, & Head of Department, Operational & Implementation Research
ICMR National Institute for Research in Reproductive and Child Health, Mumbai 		Speaker
Shift from RCT to RWE for Health Economics Modeling and Assessment Dr Saurabh Kumar
Principal RWE Consulting
IQVIA 		Speaker
All the speakers
Audience Q&A

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS SPEAKERS ROLE
Advancing Pharmacovigilance: Patient-Centric Approaches, Technological Integration, and Addressing Transformation Challenges DR J VIJAY VENKATRAMAN
CEO
Oviya Medsafe 		Session Chair & Moderator
Safety Monitoring for Advanced Therapy Medicinal Products (ATMPs) Dr Deepa Arora
CEO Clinexel
Clinexel Life Sciences Private Limited 		Speaker
Presentation: Evolving endpoint adjudication, SAE notification best practices and technology's impact Mrs Naseem Banu Razak
Senior Manager, Adjucation
Fortrea Development India Pvt Ltd 		Speaker
How to overcome the current roadblocks in Transformation of PV and Safety Inder Sachdeva
"Vice President, Safety and Pharmacovigilance Clinical Development Services"
Syneos Health 		Speaker
Audience Q&A

03:30 PM : 0

-

THEME AND TOPICS SPEAKERS ROLE
Vote of Thanks DR. SANISH DAVIS
R&D Director, Global Clinical Operations, India
Johnson & Johnson

08:30 AM : 09:30 AM

Tea / Coffee & Networking

09:30 AM : 11:00 AM

Session 8

THEME AND TOPICS SPEAKERS ROLE
Introduction to ISCR-ACCRI DR. ANANYA CHAKRABORTY
Prof & HOD Pharmacology
Vydehi Institute Of Medical Sciences And Research Centre, Bangalore 		Speaker
Innovation, Technology and Patient Centricity in Academic Clinical Research DR. DENIS XAVIER
Professor & Head Pharmacology, Head -Div of Clinical Research
St. John's Medical College Bangalore 		Speaker
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 DR. ANANYA CHAKRABORTY
Prof & HOD Pharmacology
Vydehi Institute Of Medical Sciences And Research Centre, Bangalore 		Session Chair & Moderator
Dr. Kshitij Jadhav
Assistant Professor, Neuroscientist
Koita centre for Digital Health, IIT Bombay 		Panelist
DR. SANISH DAVIS
R&D Director, Global Clinical Operations, India
Johnson & Johnson 		Panelist
Dr. Deepak Langade
Professor & Head, Dept of Pharmacology
D Y Patil University School of MEdicine, Navi Mumbai 		Panelist
Dr. Usharani Pingali
Professor and Head, Dept of Clinical Pharmacology and Therapeutics
Nizam's Institute of Medical Sciences 		Panelist
Audience Q&A
Round Table Discussion
1. Informed consent process in academic clinical research
2. Gender inclusivity in Academic clinical research
3. Industry Academia collaboration in academic clinical research
4. ARO : As a source of innovation in the evolving landscape of clinical trials

12:30 PM : 01:30 PM

Lunch Break

01:30 PM : 02:30 PM

Session 10

THEME AND TOPICS SPEAKERS ROLE
1. ICMR Perspective on Ethical Guidelines in Academic Clinical Trials Dr. Zainab Ghazala
Associate Professor
KBN University- Faculty of Medical Sciences 		Session Chair & Moderator
Dr Roli Mathur
Scientist G and Head, ICMR Bioethics Unit
ICMR 		Speaker
2. Patient centricity in academic clinical research Dr Shital Patel
Project Head and Medical advisor for Patients Engage
Tata Memorial Hospital. 		Speaker
Audience Q&A

02:30 PM : 03:30 PM

Session 11

THEME AND TOPICS SPEAKERS ROLE
National Awards Dr. Ashok Shenoy
Professor, Dept of Pharmacology
Kasturba Medical College, Mangalore 		Session Chair & Moderator
National Awards Dr Amol N Patil
Additional Professor
PGIMER Chandigarh 		Panelist
Dr. Anusha Natarajan
Assistant Professor
JIPMER, Pondicherry 		Panelist
Dr Basavaraj Poojar
Tutor
Kasturba Medical College Mangalore 		Panelist
Audience Q&A

03:30 PM : 04:00 PM

-

THEME AND TOPICS SPEAKERS ROLE
Vote of Thanks DR. SANISH DAVIS
R&D Director, Global Clinical Operations, India
Johnson & Johnson