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    Complex Injectables for Highly Regulated Markets

    Overview

    Navigating the highly regulated markets of the US and Europe with complex generic injectables is a monumental challenge that requires a deep understanding of evolving regulatory frameworks and technical excellence. Unlike simple generics, these products, which include nanosuspensions, liposomes, and complex drug-device combinations, often lack a clear regulatory pathway. This necessitates a proactive approach where developers engage with agencies like the FDA and EMA early on to align on development strategies and data requirements. Demonstrating "sameness" or bioequivalence is not straightforward and often requires a combination of advanced physicochemical characterization, in vitro release testing, and sometimes, even comparative clinical studies. The goal is to provide a comprehensive, model-integrated evidence package that not only meets but anticipates regulatory expectations, ensuring a faster and more predictable route to market approval. This strategic navigation is key to unlocking the immense value of these products and increasing patient access to affordable, high-quality treatments.

    InjectablesX (Complex Injectables for Highly Regulated Markets) is meticulously crafted for R&D scientists, formulators, analytical experts, regulatory professionals, process development as well as manufacturing personnel who are at the forefront of developing next-generation parenteral products. Our agenda is a comprehensive exploration of the entire product and production lifecycle, from initial portfolio selection and rational formulation design to advanced characterization and rigorous bioequivalence studies. We will tackle the complexities of portfolio management for injectable generics and demystify the challenges in lifecycle management. Discover the secrets of reverse engineering innovator products and master "fit for purpose" characterization techniques for complex APIs and excipients. The conference will feature dedicated sessions on the rational design of intricate delivery systems, including long-acting injectables, nanomaterials like liposomes and self-assembling nanotubes, and cutting-edge drug-device combination products. You'll gain practical insights into the latest in vitro dissolution and release testing methods, including establishing crucial in vitro-in vivo correlations (IVIVC).

    Beyond formulation, InjectablesX will address the critical aspects of manufacturing and quality control. Learn about robust process control strategies for ensuring sterility, explore the role of specialized equipment in aseptic environments, and understand how to mitigate human error through effective training. We will also explore the transformative potential of AI/ML and digitalization in modern injectable R&D. Join us at InjectablesX to stay ahead of the curve, build invaluable connections, and shape the future
    Embark on a journey into the future of pharmaceutical innovation with InjectablesX, a premier technical conference dedicated to advancing the science of injectable complex generics. Join us in Ahmedabad on January 29-30, 2026, for two days of intensive knowledge exchange, collaboration, and extensive research into the technical intricacies that define this high-growth sector.

    Please note that photography/videography of the scientific contents presented at the conference is strictly prohibited. We will share the presentations with the delegates only if provided and allowed by the respective speakers.

    Conference Dates

    29-01-2026 to 30-01-2026

    Arvind Bansal
    Arvind Bansal
    Professor - Department of Pharmaceutics, NIPER-Mohali, India
    Matthias G. Wacker
    Matthias G. Wacker
    Associate Professor at the Department of Pharmacy and Pharmaceutical Sciences - National University of Singapore, Singapore
    Vikram Shukla
    Vikram Shukla
    President, Parenteral BU - Zydus Lifesciences, India
    Ashish Sehgal
    Ashish Sehgal
    President-R&D & Regulatory Affairs - Alkem Laboratories Limited, India
    Govind S. Pandey
    Govind S. Pandey
    Director - Gamp Technologies Private Limited, India
    Mukesh Kumar
    Mukesh Kumar
    Founder Director - Ortiv-Q3, India

    Arvind Bansal's Biography

    Arvind Bansal

    Professor

    Department of Pharmaceutics, NIPER-Mohali

    Dr. Arvind Kumar Bansal is a Professor in the Department of Pharmaceutics at the National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Punjab, India. With a career spanning over three decades, he is a globally recognized leader in pharmaceutical research and development, renowned for bridging academic innovation with industrial application.

    Dr. Bansal earned his M.Pharm. in Pharmaceutics (1988) and Ph.D. (1993) from the University of Delhi, India. Before joining NIPER in 2000, he honed his expertise as a Senior Scientist and Group Leader at JK Pharmaceuticals and Ranbaxy Research Laboratories for eight years. There, he spearheaded the conceptualization, formulation strategy, and technology transfer of novel chemical entities (NCEs) and generic drug products, laying the groundwork for his impactful academic career.

    At NIPER, Dr. Bansal has pioneered advancements in pre-formulation and formulation development, with expertise in amorphous form stabilization, polymorphism, pseudo-polymorphism, particle engineering, salt form screening, oral bioavailability enhancement, compaction physics, and lyophilization. Guided by his mission to develop \"science-based, industrially viable pharmaceutical technologies,\" his research group collaborates closely with the pharmaceutical industry to translate innovations into commercially viable products.

    Dr. Bansal’s contributions have earned him prestigious accolades, including being named the first India-based Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 2016. His awards include the AAPS Distinguished Educator and Researcher Award, the Innocentive Award, the Organization of Pharmaceutical Producers of India (OPPI) Award, and the Indian Pharmaceutical Association (IPA)-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form.

    His prolific research output includes over 650 industry-sponsored projects in pharmaceutical material characterization, de-formulation studies, and formulation development. Dr. Bansal holds 11 granted patents, has filed 27 additional patents, and has authored 200 research articles and 27 review articles, with a Google Scholar h-index of 60. He serves on the editorial boards of RSC Pharmaceutics, Journal of Excipients and Food Chemicals, Drug Development Research, and Pharmaceutics, and advises the editorial boards of Journal of Pharmaceutical Sciences and Molecular Pharmaceutics.

    Dr. Bansal’s leadership extends beyond research, fostering strong academia-industry partnerships and mentoring the next generation of pharmaceutical scientists. His visionary work continues to shape the future of drug development, making significant contributions to global healthcare.


    Matthias G. Wacker's Biography

    Matthias G. Wacker

    Associate Professor at the Department of Pharmacy and Pharmaceutical Sciences

    National University of Singapore

    Matthias G. Wacker is an Associate Professor at the Department of Pharmacy and Pharmaceutical Sciences of the National University of Singapore (NUS), where he contributes to research and education in the field of pharmaceutical sciences. He earned his Ph.D. in pharmaceutical technology from Goethe University Frankfurt, Germany, and completed his habilitation at the Institute of Pharmaceutical Technology under the guidance of Jennifer Dressman and Jörg Kreuter. Before joining NUS, he led the Department of Pharmaceutical Technology and Nanosciences at the Fraunhofer Institute for Molecular Biology and Applied Ecology (IME). His research focuses on in vitro testing and the characterization of complex, dispersed dosage forms, with a particular interest in biopredictive release methods, in vitro-in vivo correlations (IVIVC), and the process of disassembly in physiological environments. He applies a quality-by-design approach and uses computational modeling to support formulation development and improve translational success.

    ​Prof. Wacker contributes to several international scientific and regulatory initiatives, including expert committees of the United States Pharmacopeial Convention and the ISO Technical Committee 229 on nanotechnology standards. He also serves on the editorial boards of journals such as the European Journal of Pharmaceutics and Biopharmaceutics, the European Journal of Pharmaceutical Sciences, the Journal of Pharmacy and Pharmacology, and is Associate Editor of Frontiers in Chemistry. His work has been recognized by awards such as the Eudragit® Best Paper Award and the Phoenix Pharmaceutics Science Award. Since 2022, he has been listed every year among the World’s Top 2% of Scientists by the Stanford University Ranking.

     


    Vikram Shukla's Biography

    Vikram Shukla

    President, Parenteral BU

    Zydus Lifesciences

    Vikram Shukla is a seasoned pharmaceutical professional with over 30 years of distinguished experience in world-class formulation development and manufacturing. Known for his unwavering integrity, strategic foresight, and transformative leadership, Vikram has consistently driven operational excellence across global pharmaceutical landscapes.

    He has played pivotal roles in leading manufacturing and quality units, with a strong track record in navigating complex regulatory audits and successfully resolving warning letter challenges. His expertise spans compliance with international regulatory standards, including USFDA, EMA, MHRA, and WHO.

    Vikram has held leadership positions at several leading multinational organizations, including Pfizer Inc., Dr. Reddy’s Laboratories, Fresenius Kabi, Lupin, and Zydus Lifesciences, where he currently serves as President of the Injectable vertical. In this role, he oversees end-to-end operations and quality functions, championing innovation and excellence across the business unit.

    His technical portfolio encompasses a wide range of dosage forms, including injectables (SVP, LVP, lyophilized, dry powder), sterile APIs, and solid orals. He is also deeply committed to fostering quality-centric cultures, optimizing manufacturing processes, and delivering impactful training in GMP compliance, microbiology, cleanroom practices, and validation methodologies.

    An alumnus of INSEAD France, Vikram holds a postgraduate degree in Microbiology from Bombay University (1995) and is a Gold Medallist graduate from Nagpur University (1993).


    Ashish Sehgal's Biography

    Ashish Sehgal

    President-R&D & Regulatory Affairs

    Alkem Laboratories Limited


    Govind S. Pandey's Biography

    Govind S. Pandey

    Director

    Gamp Technologies Private Limited

    Dr. Govind S. Pandey is Director of Gamp Technologies Private Limited. He has over three decades of experience in the pharmaceutical industry. He is a professional experienced in sterile operations, solid oral dosage forms, semi solid dosage forms and API. He possesses a deep understanding of business strategy relating to Operations, Quality Assurance, Quality
    control, CMC submissions, Facility design, Tech transfer& Regulatory guidelines. In addition, he is black belt certified person on “Six Sigma- Process optimization and Problem solving”. He has provided expert scientific support for the timely resolution of issues raised by USFDA & other Regulatory agencies.

    He has held several positions including Chief Operating Officer and Board of Director - Sentiss Pharma Pvt. Ltd., Sr. Vice President - Operations head, responsible for all formulation sites of Wockhardt, Sr. Vice President -Responsible for Intas Pharma sites operations including API, Director - Ranbaxy Labs ltd Mohali, Vice president - Operations head, responsible for Mylan Nashik Site, Vice president - Operations head, responsible for Alkem Baddi site.

    He is Six sigma black belt certified on ‘Process Optimisation and Problem Solving’ and an Expert on Computer system Validation and GAMP 5 guideline as well as data integrity assessments in Quality Control laboratories. He has sound knowledge of HVAC and Water system and is good in Engineering, Facility design and Validations.


    Mukesh Kumar's Biography

    Mukesh Kumar

    Founder Director

    Ortiv-Q3

    Mukesh is one of the founder directors of Ortiv-Q3 (A Sotax joint venture), a pioneering pharmaceutical research and testing organization well acknowledged globally for its specialized skill set in IVRT, Q2/Q3 characterization and complex parenterals formulation development. He is a pharmaceutical veteran with over 30 years of industrial experience. He earned his M Pharm (Pharmaceutics) from Jamia Hamdard, New Delhi in (1992) and Ph.D. (2021) from BAMU, Aurangabad. His expertise includes Niche steriles, Value added generics, Topicals and NCEs. He holds 18+ US/EU Patents/Application to his credit and is specially versed in nanotechnology-based platforms including Nanoemulsions, Nanosuspensions, Liposomes, Microspheres, Insitu forming depots and associated Q2/Q3 characterization. He has profound knowledge in formulation development, Quality & compliance, preclinical evaluation, process development, optimisation, and scale-up of formulations for regulated markets. In his past assignments he was associated with many reputed companies like Ranbaxy, Dabur Pharma, Fresenius Kabi, Emcure, Wockhardt and Claris in Sr positions like, Asst. Director, AVP & Technical head (R&D).  He is co-inventor of the innovative microdialysis based IVRT technology developed by Ortiv-Q3 which has been successfully commercialized globally (Indian patent granted, US patent applied). He is also the co-inventor of indigenously developed patented nanoparticle technology for Polymeric micellar delivery of Paclitaxel (NanoxelTM - Fresenius Kabi) that reached from bench scale to the market.  He contributed in many products approvals for various markets including US, EU in his past career. He has also been ranked as the top 2% most-cited scientists in a list published by Stanford University (2021).


    Conference Agenda

    • Portfolio development for complex injectables
    • Characterization of complex injectable API, excipient and formulations
    • Rational design of complex injectable delivery systems
    • In vitro dissolution & release testing for complex injectables
    • Bioequivalence approaches for complex injectable API and formulations
    • Process control strategies for ensuring sterility and product quality throughout manufacturing

    Agenda Topics for Injectables X

    • Portfolio development for complex injectables
      • Life cycle management, Portfolio selection
    • Characterization of complex injectable API, excipient and formulations
      • API sameness, Q1, Q2, Q3, Reverse engineering, Excipient characterization,
    • Rational design of complex injectable delivery systems
      • Complex API products, Nanomaterial containing, Long-acting injectables, Complex drug-device combinations
    • In vitro dissolution & release testing for complex injectables
      • Biorelevant dissolution methods, IVRT/IVIVC for complex injectables
    • Bioequivalence approaches for complex injectable API and formulations
      • Demonstrating bioequivalence, MIE, 505(b)(2) injectables
    • Process control strategies for ensuring sterility and product quality throughout manufacturing
      • CPP/CQA in aseptic filling, Sterile manufacturing, Sterility assurance, Specialized equipment, R&D Digitalization

    Speakers & Panelists

    Arvind Bansal

    Arvind Bansal's Biography

    Arvind Bansal

    Professor

    Department of Pharmaceutics, NIPER-Mohali

    Dr. Arvind Kumar Bansal is a Professor in the Department of Pharmaceutics at the National Institute of Pharmaceutical Education and Research (NIPER), SAS Nagar, Punjab, India. With a career spanning over three decades, he is a globally recognized leader in pharmaceutical research and development, renowned for bridging academic innovation with industrial application.

    Dr. Bansal earned his M.Pharm. in Pharmaceutics (1988) and Ph.D. (1993) from the University of Delhi, India. Before joining NIPER in 2000, he honed his expertise as a Senior Scientist and Group Leader at JK Pharmaceuticals and Ranbaxy Research Laboratories for eight years. There, he spearheaded the conceptualization, formulation strategy, and technology transfer of novel chemical entities (NCEs) and generic drug products, laying the groundwork for his impactful academic career.

    At NIPER, Dr. Bansal has pioneered advancements in pre-formulation and formulation development, with expertise in amorphous form stabilization, polymorphism, pseudo-polymorphism, particle engineering, salt form screening, oral bioavailability enhancement, compaction physics, and lyophilization. Guided by his mission to develop \"science-based, industrially viable pharmaceutical technologies,\" his research group collaborates closely with the pharmaceutical industry to translate innovations into commercially viable products.

    Dr. Bansal’s contributions have earned him prestigious accolades, including being named the first India-based Fellow of the American Association of Pharmaceutical Scientists (AAPS) in 2016. His awards include the AAPS Distinguished Educator and Researcher Award, the Innocentive Award, the Organization of Pharmaceutical Producers of India (OPPI) Award, and the Indian Pharmaceutical Association (IPA)-ACG Scitech Innovation Award 2018 for Best Innovative Development of Solid Dosage Form.

    His prolific research output includes over 650 industry-sponsored projects in pharmaceutical material characterization, de-formulation studies, and formulation development. Dr. Bansal holds 11 granted patents, has filed 27 additional patents, and has authored 200 research articles and 27 review articles, with a Google Scholar h-index of 60. He serves on the editorial boards of RSC Pharmaceutics, Journal of Excipients and Food Chemicals, Drug Development Research, and Pharmaceutics, and advises the editorial boards of Journal of Pharmaceutical Sciences and Molecular Pharmaceutics.

    Dr. Bansal’s leadership extends beyond research, fostering strong academia-industry partnerships and mentoring the next generation of pharmaceutical scientists. His visionary work continues to shape the future of drug development, making significant contributions to global healthcare.


    Professor,  Department of Pharmaceutics, NIPER-Mohali,
    India

    Matthias G. Wacker

    Matthias G. Wacker's Biography

    Matthias G. Wacker

    Associate Professor at the Department of Pharmacy and Pharmaceutical Sciences

    National University of Singapore

    Matthias G. Wacker is an Associate Professor at the Department of Pharmacy and Pharmaceutical Sciences of the National University of Singapore (NUS), where he contributes to research and education in the field of pharmaceutical sciences. He earned his Ph.D. in pharmaceutical technology from Goethe University Frankfurt, Germany, and completed his habilitation at the Institute of Pharmaceutical Technology under the guidance of Jennifer Dressman and Jörg Kreuter. Before joining NUS, he led the Department of Pharmaceutical Technology and Nanosciences at the Fraunhofer Institute for Molecular Biology and Applied Ecology (IME). His research focuses on in vitro testing and the characterization of complex, dispersed dosage forms, with a particular interest in biopredictive release methods, in vitro-in vivo correlations (IVIVC), and the process of disassembly in physiological environments. He applies a quality-by-design approach and uses computational modeling to support formulation development and improve translational success.

    ​Prof. Wacker contributes to several international scientific and regulatory initiatives, including expert committees of the United States Pharmacopeial Convention and the ISO Technical Committee 229 on nanotechnology standards. He also serves on the editorial boards of journals such as the European Journal of Pharmaceutics and Biopharmaceutics, the European Journal of Pharmaceutical Sciences, the Journal of Pharmacy and Pharmacology, and is Associate Editor of Frontiers in Chemistry. His work has been recognized by awards such as the Eudragit® Best Paper Award and the Phoenix Pharmaceutics Science Award. Since 2022, he has been listed every year among the World’s Top 2% of Scientists by the Stanford University Ranking.

     


    Associate Professor at the Department of Pharmacy and Pharmaceutical Sciences,  National University of Singapore,
    Singapore

    Vikram Shukla

    Vikram Shukla's Biography

    Vikram Shukla

    President, Parenteral BU

    Zydus Lifesciences

    Vikram Shukla is a seasoned pharmaceutical professional with over 30 years of distinguished experience in world-class formulation development and manufacturing. Known for his unwavering integrity, strategic foresight, and transformative leadership, Vikram has consistently driven operational excellence across global pharmaceutical landscapes.

    He has played pivotal roles in leading manufacturing and quality units, with a strong track record in navigating complex regulatory audits and successfully resolving warning letter challenges. His expertise spans compliance with international regulatory standards, including USFDA, EMA, MHRA, and WHO.

    Vikram has held leadership positions at several leading multinational organizations, including Pfizer Inc., Dr. Reddy’s Laboratories, Fresenius Kabi, Lupin, and Zydus Lifesciences, where he currently serves as President of the Injectable vertical. In this role, he oversees end-to-end operations and quality functions, championing innovation and excellence across the business unit.

    His technical portfolio encompasses a wide range of dosage forms, including injectables (SVP, LVP, lyophilized, dry powder), sterile APIs, and solid orals. He is also deeply committed to fostering quality-centric cultures, optimizing manufacturing processes, and delivering impactful training in GMP compliance, microbiology, cleanroom practices, and validation methodologies.

    An alumnus of INSEAD France, Vikram holds a postgraduate degree in Microbiology from Bombay University (1995) and is a Gold Medallist graduate from Nagpur University (1993).


    President, Parenteral BU,  Zydus Lifesciences,
    India

    Ashish Sehgal

    Ashish Sehgal's Biography

    Ashish Sehgal

    President-R&D & Regulatory Affairs

    Alkem Laboratories Limited


    President-R&D & Regulatory Affairs,  Alkem Laboratories Limited,
    India

    Govind S. Pandey

    Govind S. Pandey's Biography

    Govind S. Pandey

    Director

    Gamp Technologies Private Limited

    Dr. Govind S. Pandey is Director of Gamp Technologies Private Limited. He has over three decades of experience in the pharmaceutical industry. He is a professional experienced in sterile operations, solid oral dosage forms, semi solid dosage forms and API. He possesses a deep understanding of business strategy relating to Operations, Quality Assurance, Quality
    control, CMC submissions, Facility design, Tech transfer& Regulatory guidelines. In addition, he is black belt certified person on “Six Sigma- Process optimization and Problem solving”. He has provided expert scientific support for the timely resolution of issues raised by USFDA & other Regulatory agencies.

    He has held several positions including Chief Operating Officer and Board of Director - Sentiss Pharma Pvt. Ltd., Sr. Vice President - Operations head, responsible for all formulation sites of Wockhardt, Sr. Vice President -Responsible for Intas Pharma sites operations including API, Director - Ranbaxy Labs ltd Mohali, Vice president - Operations head, responsible for Mylan Nashik Site, Vice president - Operations head, responsible for Alkem Baddi site.

    He is Six sigma black belt certified on ‘Process Optimisation and Problem Solving’ and an Expert on Computer system Validation and GAMP 5 guideline as well as data integrity assessments in Quality Control laboratories. He has sound knowledge of HVAC and Water system and is good in Engineering, Facility design and Validations.


    Director,  Gamp Technologies Private Limited,
    India

    Mukesh Kumar

    Mukesh Kumar's Biography

    Mukesh Kumar

    Founder Director

    Ortiv-Q3

    Mukesh is one of the founder directors of Ortiv-Q3 (A Sotax joint venture), a pioneering pharmaceutical research and testing organization well acknowledged globally for its specialized skill set in IVRT, Q2/Q3 characterization and complex parenterals formulation development. He is a pharmaceutical veteran with over 30 years of industrial experience. He earned his M Pharm (Pharmaceutics) from Jamia Hamdard, New Delhi in (1992) and Ph.D. (2021) from BAMU, Aurangabad. His expertise includes Niche steriles, Value added generics, Topicals and NCEs. He holds 18+ US/EU Patents/Application to his credit and is specially versed in nanotechnology-based platforms including Nanoemulsions, Nanosuspensions, Liposomes, Microspheres, Insitu forming depots and associated Q2/Q3 characterization. He has profound knowledge in formulation development, Quality & compliance, preclinical evaluation, process development, optimisation, and scale-up of formulations for regulated markets. In his past assignments he was associated with many reputed companies like Ranbaxy, Dabur Pharma, Fresenius Kabi, Emcure, Wockhardt and Claris in Sr positions like, Asst. Director, AVP & Technical head (R&D).  He is co-inventor of the innovative microdialysis based IVRT technology developed by Ortiv-Q3 which has been successfully commercialized globally (Indian patent granted, US patent applied). He is also the co-inventor of indigenously developed patented nanoparticle technology for Polymeric micellar delivery of Paclitaxel (NanoxelTM - Fresenius Kabi) that reached from bench scale to the market.  He contributed in many products approvals for various markets including US, EU in his past career. He has also been ranked as the top 2% most-cited scientists in a list published by Stanford University (2021).


    Founder Director,  Ortiv-Q3,
    India

    Venue

    Novotel Hotel, Ahmedabad

    Address: Iscon Cross Roads, Sarkhej - Gandhinagar Hwy, next to Wide Angle Cinema, Ahmedabad, Gujarat 380015

    Novotel Ahmedabad offers a perfect blend of comfort, elegance, and convenience. Ideally located on S.G. Highway, it provides easy access to the city’s business hubs, shopping destinations, and cultural landmarks. The hotel features modern, spacious rooms, exceptional dining options, and thoughtful amenities, ensuring a relaxing and memorable stay. With its welcoming ambiance and warm hospitality, Novotel Ahmedabad is an ideal choice for both business and leisure travelers.

    Explore some of India's most celebrated attractions including ISKCON temples, the Gandhi Ashram and Swaminarayan Akshardham complex. Punctuate an unforgettable day with a refreshing dip in our sparkling outdoor pool, or indulge in a massage or treatment at our hotel.

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    Registration Inclusions
    • Access to all conference sessions
    • Conference kit & materials
    • Tea/Coffee & Lunch (as per program)
    • Certificate of participation

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