Dr. B.M. Rao is an accomplished pharmaceutical quality expert with over 33 years of leadership in Analytical R&D and Quality Control at leading companies such as Dr. Reddy’s, Janssen (J&J), and Novartis. A recognized authority on data integrity, regulatory readiness, and Nitrosamine assessments, he has actively supported global audits by USFDA, EMEA, and Health Canada. With 80+ scientific publications and ten Ph.D. mentees, he now serves as CEO of QDOT Associates, providing global consultancy services. Dr. Rao is also a seasoned international speaker known for delivering insightful sessions on GMP compliance and analytical excellence.

Dr. Jason Brown is the Founder and President of Brown Pharma Consulting, Ltd., where he provides expert services and education in nitrosamine risk management tailored for regulatory, quality, and technical teams. As a seasoned professional in the pharmaceutical industry, Dr. Brown is an end-to-end nitrosamine expert, having designed and led a multi-year initiative to achieve global regulatory compliance for Adare Pharma Solutions.

With proven expertise in risk assessments, structural identification, analytical techniques, root cause analysis, reformulation, and control strategies, Dr. Brown has established himself as a leader in the field. His thought leadership is exemplified by his authorship of the July 2025 AAPS Newsmagazine cover article, "Nitrosamine Control Strategies: From Risk Identification to Implementation."

Dr. Brown is also a recognized innovator, holding a patent application for reformulation strategies and contributing to the scientific community with articles on inhibition techniques and gastric nitrosamine formation. His work continues to shape the future of nitrosamine risk management and pharmaceutical compliance.

Dr. K.M.V. Narayana Rao is a distinguished analytical chemistry professional with over 24 years of progressive experience in pharmaceutical research and development. He holds a Ph.D. in Analytical Chemistry (2000) and M.Sc. in Physical Chemistry (1992) from Andhra University, India. Currently serving as Head of Analytical R&D for API at Natco Pharma Limited, Dr. Rao has held senior leadership positions across India's leading pharmaceutical companies including Aragen Life Sciences, Sai Lifesciences, Zydus Cadila, and Dr. Reddy's Laboratories. His expertise spans regulatory compliance with global authorities (USFDA, MHRA, PMDA), advanced analytical method development, and team leadership of 50+ scientists. He has authored 30+ peer-reviewed publications on genotoxic impurity quantification and chromatographic methods, while serving as an editorial board reviewer for international journals. Dr. Rao's notable achievements include successful FDA audits, establishing analytical R&D laboratories, and developing validated methods for nitrosamine impurities, making him a recognized expert in pharmaceutical analytical development and regulatory affairs.

Dr. Vandana Singh is a distinguished regulatory affairs leader with over 25 years of experience in the pharmaceutical industry. Currently serving as Head of API Regulatory Sciences at Biocon Limited, she has spent more than 15 years driving regulatory excellence, compliance, and strategic initiatives in generic product regulations.

With a Ph.D. in Medicinal and Pharmaceutical Chemistry from the Central Drug Research Institute (CDRI), Lucknow, Dr. Singh brings deep scientific expertise to her regulatory leadership role. Her career spans the entire product lifecycle—from development and technology transfer to registration, approval, and commercialization. She has been instrumental in vertical integration strategies, B2B customer qualification, and fostering collaborative partnerships across R&D, manufacturing, and quality teams.

Prior to Biocon, Dr. Singh served as Group Leader at Ranbaxy Laboratories Limited for a decade, where she honed her expertise in GLP, regulatory affairs, and cross-functional leadership. Her strategic vision and commitment to regulatory science excellence have consistently delivered cost improvements and accelerated market access for critical pharmaceutical products.

Dr. Singh's leadership continues to shape the regulatory landscape in API sciences, ensuring the highest standards of compliance and innovation in the pharmaceutical industry.

Dr. Santosh Kumar Narla is a distinguished leader in the global pharmaceutical landscape, currently serving as the General Manager and Head of Regulatory Affairs at Shilpa Medicare Limited. With over 24 years of experience, he is a renowned expert in navigating the complex regulatory landscapes of the US, EU, and emerging global markets.

He holds a Ph.D. in Pharmaceutical Sciences from JNTU, Hyderabad. Throughout his career, Dr. Narla has held senior leadership positions at premier organizations, including Dr. Reddy’s Laboratories, Novartis, and Laurus Labs.

Dr Ashutosh is a veterinarian by education and currently working as a Lead – Nonclinical Development and Risk Assessment in Dr Reddy’s Labs

He is an American and European Board-certified Toxicologist (DABT and ERT)

He has more than 18 years of diverse experience of non-clinical drug development for generics, NCEs, complex generics, and small peptides, for different markets

He is extensively involved in conducting risk assessments & safety evaluations for different types of impurities, excipients, E&L compounds

He undertakes Environmental Risks Assessments and derivation of Health Based Exposure Limits (OEL & PDE)

He is required to regularly interact with different regulatory agencies across the geographies and is also member of selected consortium and scientific panels.

Dr. Tridib Mahapatra is a chemical expert with extensive experience in process chemistry across the pharmaceutical and agrochemical industries, having worked with leading organizations including GSK, Dr. Reddy’s, PI Industries, and Sandoz. He holds a Ph.D. in Organic Chemistry from IIT Kharagpur.

At Sandoz, he is part of Global CoE for Mutagenic impurities and Nitrosamine impurities. He specializes in impurity profiling, including mutagenic and nitrosamine risk assessment and mitigation, root-cause analysis, and the development of robust, ICH-compliant control strategies. He actively contributes to the Change Review Board, supporting process changes and supplier evaluations.

Dr. Mahapatra has extensive experience navigating complex regulatory environments with evolving nitrosamine guidelines and stringent limits. He is also actively involved in Sandoz nitrosamine task force, provide training and mentoring scientists, and strengthening impurity risk management across projects

Anirban Roy Chowdhury leads the Advanced Analytical R&D group at Amneal Pharmaceuticals, a specialized team focused on high-end analytical investigations, including nitrosamine impurities, NDSRIs, extractables & leachables (E&L), and trace-level characterization using advanced mass spectrometry platforms. This presentation will discuss current challenges in ultra-trace nitrosamine analysis, including analytical artefacts, false positives, laboratory-induced formation, data interpretation complexities, and NDSRI identification. It will further explore emerging risks associated with increasing analytical sensitivity, evolving regulatory expectations, and the need for robust artefact risk assessment frameworks to ensure scientifically sound and future-ready nitrosamine control strategies.

With over 21 years of pharmaceutical industry experience, Sudhir has built extensive expertise in process development, validation, technology transfer, project management, and manufacturing support. His experience encompasses new product development, cost optimizations, commercialization, lifecycle management, currently leading the Statin and SSP technology platforms, driving innovation, process optimization, and technology advancement.

Evolving from early-stage drug discovery research into process development and manufacturing leadership, he currently provides strategic technical leadership for manufacturing excellence and product lifecycle management at Centrient's Toansa site.

Dr. Arvind Kumar has masters in organic chemistry and Ph.D. in Photochemistry from Agra University. He is accredited with professional degrees ISO-9000, Total Quality Management, Quality Assurance, Production Management and Patent Law. He is carrying 36 years’ experience in Pharmaceutical Drug Substances, Phytochemicals and OTC solid dosage forms in various companies in United State and in India. Currently he is working as Vice-President Analytical research with Viatris at Hyderabad R&D Centre.

Previous Organizations

TEVA Pharmaceuticals India as Sr. Director Analytical Research

Deseret Laboratories Inc’ at St. George, USA as Laboratory Manager OTC-Rx

Sabinsa Corporation at New Jersey as Sr. Scientist New Jersey, USA

Ind Swift Laboratories Ltd. as Asst Manager Quality Assurance

Alchem International Ltd. as Sr. Scientist