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9th Annual Pharma Regulatory Summit 2026

9th Annual Pharma Regulatory Summit 2026

24 March, 2026

Kohinoor Continental Hotel, Mumbai

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    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

    PALLAVI TRIVEDI

    Novo Nordisk

    SUCHITA MORE

    Merck Sharp & Dohme

    MILIND ANTANI

    Nishith Desai Associates

    AKSHAYA ODAK

    Lupin

    PROTITI BAGCHI

    GSK

    AMARNATH S

    Cipla

    PRITHWIJIT K

    Wockhardt

    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)

    RUCHIR SHAH

    Reckitt Benckiser

    RASHMI HEGDE

    GSK (Former)

    NEELU GOEL

    Sun Pharma

    PRIYA PRASAD

    Lupin

    KAVITA LAMROR

    Maxis Clinical Sciences

    Book Now
    ×

    Download Brochure

      Event Schedule

      Meet to learn and network with your conference colleagues.

      March 24
      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

      MARTINA GOMES
       
       
      Head, Reg Affairs – CH
       
       
      Bayer
      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

      RASHMI HEGDE
       
       
      Former Executive Vice President – Medical
       
       
      GSK

      Panellists

      RAMANARAYANA PARHI
       
       
       
      Vice President & CIO
       
       
       
      Alkem Laboratories

      SUCHITA MORE

      Associate Director Medical Affairs

      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

      OMPRAKASH S. SADHWANI
       
       
      Former Joint Commissioner & Controlling Authority
       
       
      FDA (Maharashtra State)

      Panellists

      AKSHAYA ODAK


      Head Regulatory Affairs (Biotech)

      Lupin

      SHUVANKAR BALLAV
       
       
       
      Head, Regulatory Affairs – Advanced Biotech Lab
       
       
       
      (ABL, Ipca Laboratories

      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
      13:40 – KEYNOTE PANEL DISCUSSION: Best Practices in Regulatory Writing / Submissions - Everything You Need to Know for a better tomorrow

      REGULATORY WRITING / SUBMISSIONS

      Moderator

      SADANAND KULKARNI
       
       
      Head – Medical, Regulatory, Vigilance & Quality (South Asia)
       
       
      Fresenius Kabi

      Panellists

      SHIRAZ KANDAWALLA
       
       
       
      Head – Regulatory, Quality & Safety – India
       
       
       
      Ferring Pharma

      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

      PRIYA PRASAD
       
       
      General Manager – PV
       
       
      Lupin
      14:30 - 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

      15:00 – Afternoon Tea/Coffee
      15:20 – DISCUSSION WITH EXPERTS: RWE under Regulatory Scrutiny: Quality, Integrity & Governance. From Data to Decisions: Regulatory Guardrails for High-Quality RWE

      RWE

      Moderator

      KAVITA LAMROR
       
       
      Partner, RWE & Digital Transformation
       
       
      Maxis Clinical Sciences

      Panellists

      AMARNATH SUGUMARAN
       
       
      Associate Director & Cluster Head Medical Affairs
       
       
      Cipla
      PRITHWIJIT KUNDU
       

      Chief Medical Officer NCE NDD
       
       
      Wockhardt
      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

      MAYUR PARMAR
       
       
      Drugs Inspector (Deputy Collector, Gujarat
       
       
      Government), FDA

      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

      MARTINA GOMES
       
       
      Head, Reg Affairs – CH
       
       
      Bayer
      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

      RASHMI HEGDE
       
       
      Former Executive Vice President – Medical
       
       
      GSK

      Panellists

      RAMANARAYANA PARHI
       
       
       
      Vice President & CIO
       
       
       
      Alkem Laboratories

      SUCHITA MORE

      Associate Director Medical Affairs

      Merck Sharp & Dohme

      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

      OMPRAKASH S. SADHWANI
       
       
      Former Joint Commissioner & Controlling Authority
       
       
      FDA (Maharashtra State)

      Panellists

      AKSHAYA ODAK


      Head Regulatory Affairs (Biotech)

      Lupin

      SHUVANKAR BALLAV
       
       
       
      Head, Regulatory Affairs – Advanced Biotech Lab
       
       
       
      (ABL, Ipca Laboratories

      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
      13:40 – KEYNOTE PANEL DISCUSSION: Best Practices in Regulatory Writing / Submissions - Everything You Need to Know for a better tomorrow

      REGULATORY WRITING / SUBMISSIONS

      Moderator

      SADANAND KULKARNI
       
       
      Head – Medical, Regulatory, Vigilance & Quality (South Asia)
       
       
      Fresenius Kabi

      Panellists

      SHIRAZ KANDAWALLA
       
       
       
      Head – Regulatory, Quality & Safety – India
       
       
       
      Ferring Pharma

      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

      PRIYA PRASAD
       
       
      General Manager – PV
       
       
      Lupin
      14:30 - 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

      15:00 – Afternoon Tea/Coffee
      15:20 – DISCUSSION WITH EXPERTS: RWE under Regulatory Scrutiny: Quality, Integrity & Governance. From Data to Decisions: Regulatory Guardrails for High-Quality RWE

      RWE

      Moderator

      KAVITA LAMROR
       
       
      Partner, RWE & Digital Transformation
       
       
      Maxis Clinical Sciences

      Panellists

      AMARNATH SUGUMARAN
       
       
      Associate Director & Cluster Head Medical Affairs
       
       
      Cipla
      PRITHWIJIT KUNDU
       

      Chief Medical Officer NCE NDD
       
       
      Wockhardt
      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

      MAYUR PARMAR
       
       
      Drugs Inspector (Deputy Collector, Gujarat
       
       
      Government), FDA

      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
      Book Now
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        Event Sponsors 

        We wouldn’t be able to host our conferences without help from these amazing companies. A huge thanks to all our sponsors and partners!

        Silver Sponsor 

        SoftGroup is a global software company with more than two decades of experience in delivering end-to-end serialization and aggregation solutions for the pharmaceutical industry. Our expertise spans the full compliance spectrum—from line-level software to centralized serialization management and seamless connectivity with regulatory and business partners. At the core of our portfolio is the SATT PLATFORM® - an advanced, Azure-based Track & Trace brand line built for enterprise scalability, security, and regulatory alignment. The platform supports pharmaceutical companies in achieving real-time traceability, operational efficiency, and global compliance across diverse markets. Trusted by over 130 pharmaceutical companies in 32 countries, SoftGroup supports a broad range of clients, including multinational corporations, regional MAHs, and CMOs. Our solutions are certified and approved by key national and international systems, including: • European Medicines Verification System (EMVS) • National Medicines Verification Systems (NMVS) in almost all EU countries • AIS MT (Armenia) • NIS MPT “Asl Belgisi” (Uzbekistan) • IS MPT (Kazakhstan) • IS EBD (Kyrgyzstan) • DVTIS (Azerbaijan) • Tatmeen (UAE) • TRVST (UNICEF Vaccine Traceability System) • and additional regional platforms across Eurasia and the Middle East. SoftGroup is a Certified Gateway Provider of the EMVO, a recognized partner of the BgMVO, and a global partner of GS1.

        Conceptualized by

        Virtue Insight was founded in 2009. We equip business professionals around the world with the latest in-depth industry knowledge and provide networking opportunities in telecom, technology and pharmaceutical industries. Our aim is to provide a platform to share knowledge, insight and provide our clients to network effectively and deliver maximum ROl by making new business alliances.
        • Phone:+91 44 42108101
        • Email:info@virtueinsight.com

        Supported by

        All Conference Alert is the world’s leading information portal for the upcoming Conferences, Events, Seminars, Expo, Webinars & Workshops. All Conference Alert helps professionals and enthusiasts to attain international conferences, communicate and collaborate with scientists, research scholars, and industry leaders from various regions and capacities. This platform helps both organizers and participants.

        Event Testimonials

        A huge thanks to all our sponsors, attendees and partners!

        Insightful Session

        “Very useful Conference. Panelists were really having experience & expertise on the subjects”

        Director, Y Point Analytics India
        Great Event

        “Conference conducted nicely. Nice platform for Regulatory professionals. Very informative ”

        Regulatory Affairs Officer, BDR Pharmaceuticals

        “The Conference is very useful as well as very knowledgeable and lots of new learning things throughout the conference”

        Officer Regulatory Affairs, BDR Pharmaceuticals

        “Conference is very useful informative and gaining knowledge. Please keep many conferences in future”

        QA, Clinwave Research

        “Very Insightful session on RWE was very interesting and useful. How it can be useful in drug approval with good examples ”

        Lead Ideation - Medical Affairs, Dr Reddy's Laboratories

        “One day conference has covered most of all the topics, had good networking and knowledge sharing.”

        General Manager – Regulatory Affairs, Emcure Pharmaceuticals

        “The sessions were insightful and addressed critical industry challenges. The line up speakers provided in depth and practical takeaways.”

        Assistant General Manger – Regulatory Affairs, Emcure Pharmaceuticals

          Pricing Details

           

          SUPER EARLY BIRD PRICE — INR 10,000 + GST (18%) PER DELEGATE ( Valid till 06 Feb 2026 )
           
          STANDARD PRICE — INR 15,000 + GST (18%) PER DELEGATE

          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

          ×

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            Book Now

            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

            Get Involved

            Conference Production

            Conference Production

            Fen Castro
            fen@virtueinsightevents.com
            +91 44 42108101
            Sponsorship & Delegate Sales

            Sponsorship & Delegate Sales

            Piyush Patel
            piyush@virtueinsightevents.com
            +44 20 3509 3779
            #VIpry202621st Biosimilars Congregation 2026annualpharmapharma regulatory
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            41<span>st</span> Pharmacovigilance USA 2026

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