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. Mayank Bhanti has been with USP since 2019 and holds the position of Director in the Compendial Development Laboratory at USP India. He leads a team of scientists involved in the modernization of monographs for small molecules (drug substances and drug products), excipients, and food ingredients. Dr. Bhanti obtained his Ph.D. from Dr. B.R. Ambedkar University, Agra, and acquired General Management certification from IIM, Ahmedabad, under the Senior Management Programme (SMP). He has around 20 years of experience in Analytical R&D with a specialization in trace analysis. He has authored many publications and peer reviewed articles. Dr. Mayank Bhanti is also an approved instructor (faculty) for USP education courses and delivers courses across the globe. He is also part of USP’s Nitrosamine Impurities Workstream. Prior to joining USP, he was associated with different contract research organizations, testing, and certification laboratories.

Dr. Narender Rao Somisetti, General Manager-API Process Development, Lupin Ltd. Pharmaceutical professional having Core Competencies & Capabilities in API Process development. Skilled in Process Research & development of large volume Generic APIs and contract manufacturing in pharma. Currently works with Lupin Ltd, and previously associated with Piramal Enterprises Ltd, GVK Biosciences Pvt. Ltd and Dr. Reddy’s Labs. He is successful in designing and developing robust and commercially viable processes for APIs through green chemistry approaches, principles of DOE and Quality Risk analysis. Seasoned professional having experienced in efficient scaleup, Technology Transfer, anticipating and resolving API manufacturing problems on large scale.

Dr Priyanka Pawar is a Pharmaceutical Regulatory Affairs Professional. She is holding a Ph.D Degree in Chemistry, Master’s in Analytical Chemistry, PG Diploma is Management & Computer Applications. She is having over 22 years of experience. Presently she is working with US based MNC, Amneal Pharmaceuticals as an Associate Vice President-Regulatory Affairs & located at Ahmedabad. She is a hardcore RA person, prior to Amneal, she was based in Mumbai & worked with Calyx,Glenmark & Indoco Remedies. Her major area of expertise is US market, though she also worked for Europe & Emerging Markets. In her 12 years tenure in Amneal, she worked for different regulatory portfolios including ANDA Lifecycle, DMF Lifecycle, Labeling, Clinical & ePublishing areas. She worked for different dosage forms like Solid Orals, Oral Suspensions & Solutions, Ophthalmic Solutions & Injectables. She handled 150+ ANDAs, 10 MAAs, 50+Type II DMFs, 5 CEPs & over 2000 Deficiency Responses. She developed Subject Matter Experts (SMEs) for ANDAs & DMFs, to ensure 1st cycle approvals. She also developed the post approval function to support timely launch & business objectives. She is a core member of Amneal’s Global Leadership Taskforce for Nitrosamine Impurities & other scientific forums. She actively participated in various successful regulatory inspections. She is an effective trainer & involved in regulatory/motivational trainings since many years. She developed various internal guidelines & innovative regulatory tools. She participated as a speaker in different forums. She is also involved in conducting lectures in various universities & guided Pharmacy students for their dissertation work. In her own words, she is the combination of a Scientist & an Artist. Apart from being a good technical writer, her Ghazals, Poems & Articles have been published in Books, Magazines & Newspapers. Her 1st Collections of Ghazals has been published in Dec 2020, named “ Shafaq Ke Aas Paas”. She also like to paint, to read & to organise events.

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. 

Sonia Sehra have overall 19 years of experience in core regulatory affairs. Her initial experience started with new submissions and post approval life cycle management including variations applications & renewals of WHO, South Africa, rest of Africa, South East Asia, China, Russia and CIS markets in Ranbaxy laboratories limited, Gurgaon, India ( now known as Sun Pharmaceuticals limited). She worked for different dosage forms like solid orals, solutions, suspensions, semi-solid dosage forms. Currently she is working with Mylan since last 9 years, and current profile includes post approval life cycle management of European markets, Australia, New Zealand, Japan and China markets. Responsible for life cycle management of more than 5000 MAs. Involved in facilitation of smooth launch of approved products. actively participated in various regulatory inspections. 

Dr. Sachin Pandey is an Analytical Chromatographer who joined Thermo Fisher Scientific in 2015 and carries a rich experience of more than 20 years, post-PhD in the field of analytical techniques including Mass Spectrometry, HPLC, GPC-SEC, Sample prep, GC, etc. Currently he is working as a Team Leader of Centre of Excellence, Lab leading a team of application scientists responsible for development of analytical methods and trouble shootings for Pharma, Bio-Pharma, Chemical industries. Prior joining to this industry, he was working as a LC-MS Application Specialist & Group leader for bio-analytical & Clinical diagnostic research & development.

Gaurav Kulkarni with around 18 years of rich industrial experience working on Mass Spectrometry and Analytical techniques. Gaurav Kulkarni got his Master’s from M.S University Baroda. Gaurav has previously worked with companies like Sunpharma, Eurofins Advinus and Biocon Ltd leading teams of scientist in area of analysis and characterization of Therapeutics Peptides, Complex generics and semi synthetic molecules. Gaurav Kulkarni has gained experience in multiple scientific domains like API Analytical development, Preclinical Drug development, Drug Metabolism/Pharmacokinetics and BA/BE analysis for Clinical studies. At Agilent Gaurav Kulkarni is the Product portfolio Manager for LCMS, GCMS and Automation solutions ranging from single quadrupole MS to state of art High Resolution Mass Spectrometers and also automation solution for sample preparation and high throughput Mass spectrometers.

Mr. Dheeraj Handique has been associated with Shimadzu India Pvt. Ltd. since 2008 and brings over 22 years of experience in the analytical instrumentation industry. At Shimadzu, he leads pre-sales and post-sales application support for GC and GCMS/MS technologies across the pharmaceutical, chemical, food safety, and flavour & fragrance sectors. His expertise includes method development, validation, troubleshooting, and complete system configuration involving advanced accessories such as Headspace (HS), Thermal Desorption (TD), and Pyrolyzer systems.
Mr. Handique has authored and presented around 30 posters at international conferences and is recognized for his hands-on experience in sample preparation and analysis using cutting-edge GC and GCMS/MS technologies. A passionate educator, he frequently delivers lectures and workshops on Gas Chromatography, Mass Spectrometry, Headspace, and Thermal Desorption techniques at national scientific forums.