Michael joined Lhasa Limited in 2015 as part of the Mirabilis project, aiding the research and curation of knowledge relevant to understanding the potential for purging of mutagenic impurities from drug substance syntheses. In 2017, Michael took over leadership of the scientific development of Mirabilis, working closely with leading members of the purge calculation community to develop both Mirabilis and the broader purge concept. More recently, Michael has been involved with a number of projects focusing on the ongoing nitrosamine challenges facing the pharma industry. As part of this work Michael has been working with academic institutions and industry bodies, such as the IQ consortium and USP, to find collaborative approaches to both understanding and subsequently addressing nitrosamine issues related to drug quality.  

Dr. Rose is pharmacist by training and obtained his PhD in pharmaceutical chemistry in 1985. Before joining the EDQM in 1991 he was assistant professor and lecturer for pharmaceutical analysis and physico-chemistry at the University of Mainz in Germany.

Until 2011 he was responsible for the establishment, monitoring and management of European Pharmacopoeia reference standards in the EDQM. Moreover, he was involved in the elaboration and revision of Ph. Eur. monographs. After that he became co-ordinator and auditor for EDQM’s Mutual Joint Audit program. Within this function he audited the Official Medicines Control Laboratories in and sometimes outside Europe. Since 2014 he has been head of division A and deputy head of the European Pharmacopoeia department where he was overlooking the monograph work on chemically defined substances, herbals, medicinal products and general chapters and was involved in the international harmonisation of pharmacopoeias. Currently he is still active as trainer and consultant for different topics like reference standards, impurity control, quality control of herbals or Pharmacopoeias.

Dr. Mrunal is a Senior Director R&D in the Chemical Medicines Department at USP India. She is responsible for Compendial Development Laboratory, Analytical Research and Development Laboratory and also, for the Development of Documentary Standards (Monographs) at USP India. Dr. Mrunal has over 20 years of Industrial experience that includes about 1 year association with USP India. Her experience includes several years in Pharmaceutical Industry where she has successfully led Analytical Research and Development Department at various capacities in Indian as well as Multi-National Organizations such as Perrigo, Watson, Unichem, Cipla. She has played a key role in Development, Validation and Transfer of Stability Indicating Analytical Methods for Drug Substance and Drug Products such as Assay, Related Substances by HPLC, Residual Solvents by GC etc. She has also been actively involved in Development of Analytical Methods for Estimation of Potential Genotoxic Impurities by LC-MS/ GC-MS etc. 
She has vast experience in handling/ answering Regulatory Queries from US FDA and EDQM. She is well versed with the concept of QbD and has been instrumental in effectively implementing the same in R&D during Product/ Process/ Method Development. She has faced US FDA, MHRA and several customer audits during her Industrial tenure. She is having sound knowledge of FDA/ Regulatory requirements, ICH Guidelines and ISO 9001/ 17025 Standards. 
Dr. Mrunal has several publications to her credit. She is also an approved referee for Ph. D. candidates. 

Dr. Sebastian is a Veterinarian and a Board certified toxicologist, and currently working as Senior Director, Head of Toxicology & Non-Clinical, Development Consulting & Scientific Affairs at Cencora Pharmalex. Dr. Sebastian has over 18 years of industrial experience that include drug discovery, non-clinical development, toxicology, Good Laboratory Practices (GLP) and medical writing. In his past assignment he gained hands-on experience in design, conduct, review, analysis, interpretation, and reporting of in vitro and in vivo (rodent and non-rodent) toxicology and pharmacology experiments. He established number of in vitro and in vivo safety pharmacology models and contributed significantly in establishing an integrated safety pharmacology facility. He has extensive knowledge of OECD principles of GLP, its implementation and application in a regulatory environment for the safety evaluation of pharmaceuticals. He functioned as Study Director for toxicology and safety pharmacology studies and also as Study Monitor for outsourcing key investigational new drug (IND) application enabling studies. He strategized and developed non-clinical development strategy for the preclinical development of new chemical entities (oncology/inflammation) and number of differentiated products in support of USFDA 505b2 application and Article 8(3) hybrid pathway applications. Dr. Sebastian provided strategic and tactical leadership on toxicology issues affecting drug development and commercialisation to wide range of global clients. He has extensively worked on toxicological risk assessment including permitted daily exposure (PDE) and occupational exposure limit (OEL) derivation; environmental risk assessment (ERA); evaluation of extractables and leachables; qualification of organic and inorganic impurities, excipients; and setting limits for genotoxic/carcinogenic compounds. His complete Curriculum Vitae are available upon request.

Dr. Pravin Karmuse, an esteemed figure in the realm of pharmaceutical analysis and scientific research, brings to the forefront a rich tapestry of academic prowess, professional achievements, and a dedication to scientific excellence. Holding a Ph.D. in Chemistry from the Department of Chemistry at the University of Mumbai, Dr. Karmuse's doctoral thesis, titled “Impurity Profile study of some Antimalarial and Antifungal Drugs by Mass Spectrometry and Related Techniques”, underscores his expertise in cutting-edge analytical methodologies.

With over 28 years of experience in pharmaceutical analysis, quality research, and organic synthesis, Dr. Karmuse has carved a niche for himself as a trailblazer in the field. His remarkable journey encompasses roles of significant responsibility and influence, including serving as Global Scientific Advisor at Veeprho Pharma s.r.o. in Europe, Associate Director of Scientific Excellence and Analytics at Novartis Healthcare in Hyderabad, and General Manager of Analytical Research Development at Parabolic Drugs Ltd in Chandigarh, among others. 

Dr. Karmuse's unwavering dedication to scientific inquiry, coupled with his breadth of expertise in pharmaceutical analysis and research, positions him as a beacon of excellence in the global scientific community. His relentless pursuit of innovation and his indomitable spirit continue to inspire and shape the future of pharmaceutical science.

Dr. Ravi is Head of the Department of pharmaceutical analysis at NIPER- Ahmedabad. He has received his M.S. (Pharm) and PhD from NIPER, Mohali under the guidance of Prof. Saranjit Singh. Before joining back to academic research, he served at various levels in industry to understand the needs of pharma sector. He had started his career with Biocon-BMS research and development center, where he was responsible for analytical activities related to IND and NDA fillings of drug discovery leads. Post drug discovery understanding, he joined Dr. Reddy’s in 2015 as associate director and department head for Analytical R&D Bangalore facility to learn generic drug development. He gathered vast experience on analytical method development, and regulatory requirements pertaining to DMF/ ANDA fillings at US and EU. He also worked significantly on complex generics for getting pharmaceutical equivalence through robust CQA, CPP and CMA correlations through QbD approaches. He has published many research articles in almost every international analytical journal like Analytical Chemistry, Drug Testing and Analysis, Journal of Chromatogaphy A, Journal of Chromatogaphy B, Journal of Pharmaceutical and Biomedical Analysis, Trends in Analytical Chemistry, Analytical Methods, Analytical and Bioanalytical Chemistry, Rapid communications in mass spectrometry etc. Currently, his lab at NIPER-Ahmedabad is working on diverse analytical fields including impurity profiling, drug-excipient compatibility studies, Dissolution studies, biomarker quantification to understand stress etc. His team also supports industries by solving their analytical and regulatory challenges. 

A visionary and a veteran in the field of Organic & Analytical Chemistry, Dr. Rao, the Founder and Managing Director of Simson Pharma Limited has a vast experience of more than 25 years in leading pharmaceutical companies in India. He has worked as a Scientist with Torrent Pharma Research Centre, Sun Pharma Advance Research Centre, Aurobindo Pharma Research Centre, Macleods Pharma Research Centre, and other leading pharma companies.
Analytical Research is his core area of expertise with specialization in NMR, LC-MS, and in characterization of Impurities. He has vast experience in Organic Synthesis, Analytical Science, Instrumentation, Material Science and Chemistry. He has done his Ph.D in Chiral Chemistry from Osmania University.
He has been awarded with the prestigious “Young Analytical Scientist” Award in 2004 for his contribution in Pharma Research work.

B. Karthikeyan is the Business Manager for Mass Spectrometry at Spinco Biotech Pvt Ltd. He holds a Master’s degree in chemistry and has 16 years of analytical experience, including working at SGS, TUV-SUD, and Malladi Drugs.

His responsibilities include overseeing activities at the Customer Support Centre lab (CSC), focusing on LCMS method development and transfer for Nitrosamines projects nationwide. He leads both the in-house and field application teams, demonstrating strong leadership skills.

Karthikeyan also conducts training sessions, workshops, seminars, and webinars covering various topics from basic mass spectrometry to advanced workflow techniques and Nitrosamine method development workflows.

Parag Gadkari is currently an Associate Director at CleanChem Laboratories LLP, where he has been working since January 2024. His role involves overseeing various research and development projects, particularly in the area of innovative drug delivery systems. Prior to this, he has held significant positions in other pharmaceutical companies, contributing to numerous patented inventions, especially in the formulation of multilayer tablet compositions for hyperglycemia management. His expertise is well-recognized in the industry, reflecting a career dedicated to advancing pharmaceutical technologies​.