9th Annual Pharma Regulatory Summit 2026
9th Annual Pharma Regulatory Summit 2026
24 March, 2026
Kohinoor Continental Hotel, Mumbai
5 Reasons to attend the event
Knowledge
Gain insights from experts, researchers, and professionals to stay updated on the latest pharma advancements.
An Agenda Made For You
High quality content that addresses your biggest challenges and uncovering hidden opportunities.
Cutting-Edge Insights
Discover the latest trends, innovations, and breakthroughs shaping the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with actionable strategies, real-world case studies, and learn best practices to implement in your work.
Knowledge
Gain insights from experts, researchers, and professionals on the latest pharma advancements.
An Agenda Made For You
High quality content that addresses your biggest challenges and uncovering hidden opportunities.
Cutting-Edge Insights
Explore the latest trends, innovations, and breakthroughs driving the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with practical strategies, case studies, and proven best practices to apply in real-time.
Key Focus Areas
Event Speakers
MAYUR PARMAR
FDA
NAGENDRAN I
Aurobindo Pharma
RAMANARAYANA PARHI
Alkem Laboratories
JULIET REBELLO
Cipla
ANJU AGARWAL
Advanz Pharma
AMITA BHAVE
AstraZeneca
MILIND ANTANI
Nishith Desai Associates
PALLAVI TRIVEDI
Novo Nordisk
SANTOSH TAUR
Pfizer
AKSHAYA ODAK
Lupin
PROTITI BAGCHI
GSK
SUCHITA MORE
Merck Sharp & Dohme
MANASA K
DeepForrest.ai (A CtrlS Company)
AMARNATH S
Cipla
SAKSHI S D
Johnson & Johnson Innovative Medicine
SHUVANKAR B
Ipca Laboratories
PANKAJ C
Abbott
AMOL CHOULWAR
Cipla
MINOO BIJU
Piramal Pharma Solutions
MARTINA GOMES
Bayer
PRIYA C
Bayer
SHIRAZ K
Ferring Pharma
SADANAND K
Fresenius Kabi
JAYASHRI P
Novo Nordisk
SUSHMITA KUSWA
Piramal
OMPRAKASH S. S
FDA (Former)
SAMIR SHAH
Zydus Lifesciences
RUCHIR SHAH
Reckitt Benckiser
RASHMI HEGDE
GSK (Former)
NEELU GOEL
Sun Pharma
PRIYA PRASAD
Lupin
KAVITA LAMROR
Maxis Clinical Sciences
Download Brochure
Event Schedule
Meet to learn and network with your conference colleagues.
08:30 – Coffee and Registration – An opportunity to meet, greet & network with your conference colleagues
09:20 – Welcome Address & Opening Remarks
CLINICAL DEVELOPMENT
- Standalone vs abbreviated regulatory path
- Challenges in development of biosimilars
- Strategies to be adopted in development of biosimilars
- Concept and regulations around interchangebility, extrapolation of data etc
Speaker
SUMIT BHUSHAN
Deputy General Manager- Clinical Studies and Global Medical Affairs
Glenmark Pharmaceutical
09:30 – Regulatory Readiness in New Drug Innovation: Advancing Global Health Safely
NEW DRUG INTO MARKET
- Global regulatory updates shaping new drug development
- Early regulatory engagement and scientific advice pathways
- Streamlined clinical development and accelerated approval routes
- Ensuring safety, immunogenicity, and quality standards
- Strengthening CMC and manufacturing compliance
- Global health priorities and pandemic-readiness frameworks
- End-to-end patient safety and post-market surveillance
Speaker
10:00 – KEYNOTE TECH PANEL DISCUSSION - AI & Technology in Regulatory Affairs: Uncover game-changing AI for tomorrow. Ensuring Compliance every step of the way, Building a future-ready pharma ecosystem
DIGITAL TRANSFORMATION
Moderator
Panellists
SUCHITA MORE
Director Medical Modernization, Asia Pacific & Japan
Merck Sharp & Dohme
PROTITI BAGCHI
Associate Director- Digital Transformation
GSK
10:50 – Morning Coffee/Tea & Discussion
11:20 – DISCUSSION WITH EXPERTS: Regulatory Roadmap for Biologics & Biosimilars: Challenges, Changes & Compliance - What’s New and What’s Next? Key Priorities moving forward
BIOLOGICS & BIOSIMILARS
Moderator
Panellists
AKSHAYA ODAK
Head Regulatory Affairs (Biotech)
Lupin
PANKAJ CHAUDHARI
Head – Global Regulatory Affairs (Biosimilar)
Abbott
AMOL CHOULWAR
Group Leader – Regulatory Affairs (Biosimilar
Peptides New Drugs Vaccines), Cipla
JAYASHRI PRAMOD
Regulatory Principal Specialist
Novo Nordisk
12:10 – Medical Device Regulations: Key Updates, Expectations & Industry Impact
MEDICAL DEVICES
- Overview of recent regulatory changes for medical devices
- Key updates across US FDA, EU MDR/IVDR, and other major markets to learn from
- Quality system expectations and documentation requirements
- Post-market surveillance, vigilance, and reporting obligations
- Common compliance gaps and how to avoid regulatory setbacks
- Harmonisation trends and implications for global market access
- Preparing for future regulatory shifts and emerging technologies
Speaker
SAMIR KULKARNI
Head – DBT ICT Center
Institute of Chemical Technology
12:40 - Networking luncheon
13:30 – KEYNOTE PANEL DISCUSSION: Best Practices in Regulatory Writing / Submissions - Everything You Need to Know for a better tomorrow
REGULATORY WRITING / SUBMISSIONS
Moderator
Panellists
JULIET REBELLO
Director – Clinical Dev Strategy & Medical Writing
Cipla
NEELU GOEL
Regulatory Affairs – Head Business Continuity &
Compliance, Sun Pharma
SUSHMITA KUSWA
Head Medical & Regulatory Affairs
Piramal
14:20 - Re-imagining Dossier Authoring: From Manual Compilation to AI-Assisted Authoring and Lifecycle Management
- AI-driven automation in dossier creation: Transition from time-consuming manual compilation to intelligent automation where AI tools structure, draft, and validate regulatory dossiers using pre-designed templates as per ICH guidelines and real-time data processing.
- Enhanced compliance and efficiency: AI-assisted authoring ensures alignment with global regulatory standards (e.g., EMA, USFDA, CDSCO) by auto-updating changes in guidance and improving accuracy, traceability, and submission timelines.
- Lifecycle intelligence and version management: Integrating AI into the dossier lifecycle enables continuous monitoring, smart version control, and predictive updates across product changes, fostering a fully connected regulatory ecosystem.
Speaker
MANASA KASIVAJJULA
CEO and Co-Founder
DeepForrest.ai (A CtrlS Company)
14:40 - Regulatory Roadmap for Generics: Compliance Strategies for a Competitive Market
GENERIC DRUGS
- Global regulatory updates shaping new drug development
- Early regulatory engagement and scientific advice pathways
- Streamlined clinical development and accelerated approval routes
- Ensuring safety, immunogenicity, and quality standards
- Strengthening CMC and manufacturing compliance
- Global health priorities and pandemic-readiness frameworks
- End-to-end patient safety and post-market surveillance
Speaker
MINOO BIJU
Head-Regulatory Affairs
Piramal Pharma Solutions
15:10 – Afternoon Tea/Coffee
15:30 – DISCUSSION WITH EXPERTS: RWE under Regulatory Scrutiny: Quality, Integrity & Governance. From Data to Decisions: Regulatory Guardrails for High-Quality RWE
RWE
Moderator
Panellists
SAKSHI SHRIVASTAVA DESAI
Director, LMS regional Lead APAC
Johnson & Johnson Innovative Medicine
SAMIR SHAH
Sr. General Manager, Head, Regulatory Affairs (API)
Zydus Lifesciences
16:10 – DISCUSSION WITH EXPERTS: Regulatory Clarity for Clinical Trials: Adapting to Emerging Standards, Staying aligned with recent updates, Complying from Start to Finish while ensuring Patient safety
CLINICAL TRIALS
Moderator
MILIND ANTANI
Leader, Pharma & Healthcare
Nishith Desai Associates
Panellists
NAGENDRAN IRUKULAPATI
Sr. Vice President – Global Regulatory Affairs
Aurobindo Pharma
AMITA BHAVE
Director Regulatory Affairs
AstraZeneca
ANJU AGARWAL
Director Global Patient Safety
Advanz Pharma
PALLAVI TRIVEDI
Associate Director – Diabeties and Obesity, Global
Business Services (GBS), Novo Nordisk
PRIYA CHATTERJEE
Head Regulatory Affairs – South Asia
Bayer
RUCHIR SHAH
Head Medical Devices Category, Regulatory & Safety
Manager, Reckitt Benckiser
17:00 - Closing remarks and end of conference
08:30 – Coffee and Registration – An opportunity to meet, greet & network with your conference colleagues
09:20 – Welcome Address & Opening Remarks
CLINICAL DEVELOPMENT
- Standalone vs abbreviated regulatory path
- Challenges in development of biosimilars
- Strategies to be adopted in development of biosimilars
- Concept and regulations around interchangebility, extrapolation of data etc
Speaker
SUMIT BHUSHAN
Deputy General Manager- Clinical Studies and Global Medical Affairs
Glenmark Pharmaceutical
09:30 – Regulatory Readiness in New Drug Innovation: Advancing Global Health Safely
NEW DRUG INTO MARKET
- Global regulatory updates shaping new drug development
- Early regulatory engagement and scientific advice pathways
- Streamlined clinical development and accelerated approval routes
- Ensuring safety, immunogenicity, and quality standards
- Strengthening CMC and manufacturing compliance
- Global health priorities and pandemic-readiness frameworks
- End-to-end patient safety and post-market surveillance
Speaker
10:00 – KEYNOTE TECH PANEL DISCUSSION - AI & Technology in Regulatory Affairs: Uncover game-changing AI for tomorrow. Ensuring Compliance every step of the way, Building a future-ready pharma ecosystem
DIGITAL TRANSFORMATION
Moderator
Panellists
SUCHITA MORE
Director Medical Modernization, Asia Pacific & Japan
Merck Sharp & Dohme
PROTITI BAGCHI
Associate Director- Digital Transformation
GSK
10:50 – Morning Coffee/Tea & Discussion
11:20 – DISCUSSION WITH EXPERTS: Regulatory Roadmap for Biologics & Biosimilars: Challenges, Changes & Compliance - What’s New and What’s Next? Key Priorities moving forward
BIOLOGICS & BIOSIMILARS
Moderator
Panellists
AKSHAYA ODAK
Head Regulatory Affairs (Biotech)
Lupin
PANKAJ CHAUDHARI
Head – Global Regulatory Affairs (Biosimilar)
Abbott
AMOL CHOULWAR
Group Leader – Regulatory Affairs (Biosimilar
Peptides New Drugs Vaccines), Cipla
JAYASHRI PRAMOD
Regulatory Principal Specialist
Novo Nordisk
12:10 – Medical Device Regulations: Key Updates, Expectations & Industry Impact
MEDICAL DEVICES
- Overview of recent regulatory changes for medical devices
- Key updates across US FDA, EU MDR/IVDR, and other major markets to learn from
- Quality system expectations and documentation requirements
- Post-market surveillance, vigilance, and reporting obligations
- Common compliance gaps and how to avoid regulatory setbacks
- Harmonisation trends and implications for global market access
- Preparing for future regulatory shifts and emerging technologies
Speaker
SAMIR KULKARNI
Head – DBT ICT Center
Institute of Chemical Technology
12:40 - Networking luncheon
13:30 – KEYNOTE PANEL DISCUSSION: Best Practices in Regulatory Writing / Submissions - Everything You Need to Know for a better tomorrow
REGULATORY WRITING / SUBMISSIONS
Moderator
Panellists
JULIET REBELLO
Director – Clinical Dev Strategy & Medical Writing
Cipla
NEELU GOEL
Regulatory Affairs – Head Business Continuity &
Compliance, Sun Pharma
SUSHMITA KUSWA
Head Medical & Regulatory Affairs
Piramal
14:20 - Re-imagining Dossier Authoring: From Manual Compilation to AI-Assisted Authoring and Lifecycle Management
- AI-driven automation in dossier creation: Transition from time-consuming manual compilation to intelligent automation where AI tools structure, draft, and validate regulatory dossiers using pre-designed templates as per ICH guidelines and real-time data processing.
- Enhanced compliance and efficiency: AI-assisted authoring ensures alignment with global regulatory standards (e.g., EMA, USFDA, CDSCO) by auto-updating changes in guidance and improving accuracy, traceability, and submission timelines.
- Lifecycle intelligence and version management: Integrating AI into the dossier lifecycle enables continuous monitoring, smart version control, and predictive updates across product changes, fostering a fully connected regulatory ecosystem.
Speaker
MANASA KASIVAJJULA
CEO and Co-Founder
DeepForrest.ai (A CtrlS Company)
14:40 - Regulatory Roadmap for Generics: Compliance Strategies for a Competitive Market
GENERIC DRUGS
- Global regulatory updates shaping new drug development
- Early regulatory engagement and scientific advice pathways
- Streamlined clinical development and accelerated approval routes
- Ensuring safety, immunogenicity, and quality standards
- Strengthening CMC and manufacturing compliance
- Global health priorities and pandemic-readiness frameworks
- End-to-end patient safety and post-market surveillance
Speaker
MINOO BIJU
Head-Regulatory Affairs
Piramal Pharma Solutions
15:10 – Afternoon Tea/Coffee
15:30 – DISCUSSION WITH EXPERTS: RWE under Regulatory Scrutiny: Quality, Integrity & Governance. From Data to Decisions: Regulatory Guardrails for High-Quality RWE
RWE
Moderator
Panellists
SAKSHI SHRIVASTAVA DESAI
Director, LMS regional Lead APAC
Johnson & Johnson Innovative Medicine
SAMIR SHAH
Sr. General Manager, Head, Regulatory Affairs (API)
Zydus Lifesciences
16:10 – DISCUSSION WITH EXPERTS: Regulatory Clarity for Clinical Trials: Adapting to Emerging Standards, Staying aligned with recent updates, Complying from Start to Finish while ensuring Patient safety
CLINICAL TRIALS
Moderator
MILIND ANTANI
Leader, Pharma & Healthcare
Nishith Desai Associates
Panellists
NAGENDRAN IRUKULAPATI
Sr. Vice President – Global Regulatory Affairs
Aurobindo Pharma
AMITA BHAVE
Director Regulatory Affairs
AstraZeneca
ANJU AGARWAL
Director Global Patient Safety
Advanz Pharma
PALLAVI TRIVEDI
Associate Director – Diabeties and Obesity, Global
Business Services (GBS), Novo Nordisk
PRIYA CHATTERJEE
Head Regulatory Affairs – South Asia
Bayer
RUCHIR SHAH
Head Medical Devices Category, Regulatory & Safety
Manager, Reckitt Benckiser
17:00 - Closing remarks and end of conference
Pricing Details
You can simply email or call and book your conference delegate seats on:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
CONFERENCE SPONSOR & EXHIBITION STALL
Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
Venue details
The venue is easily accessible, well-equipped with modern amenities, and offers a comfortable, professional setting for all attendees.
Venue
Kohinoor Continental Hotel,
Andheri – Kurla Rd, J B Nagar, Andheri East, Mumbai, Maharashtra 400059
+91 022 6769 3500
Venue – Kohinoor Continental Hotel
Andheri – Kurla Rd, J B Nagar, Andheri East, Mumbai, Maharashtra 400059
+91 022 6769 3500
