The Future of

Bio/Pharmaceutical Analysis

Online Summit 2024

Now On-Demand

Speakers

20 June

Speakers

Archana Bahuguna

Archana Bahuguna

Regulatory Compliance SME, Founding Expert Member and Nitrosamine Exchange Ambassador

Dr. Archana Bahuguna is a Professional with a career spanning over two decades in Pharmaceutical companies – Unichem, Zydus Cadila, Merck KGaA, Pfizer, Accutest, KPMG, Raptakos Brett.

She has extensive Global experience in leading Analytical R&D teams supporting development programmes (Phase 1 to Phase 3) for drug substances and drug products for diverse portfolios of NCEs and Generics and Quality Control teams supporting commercialization of drug substances and drug products.

She has led cross-site, cross-functional teams contributing to successful Development programmes, Technology Transfers, Regulatory Inspections, Registration and Commercialization of drug substances and drug products across geographies comprising US, EMEA, APAC & Latam.

Her core competencies are in the area of Laboratory Sciences and Regulatory Compliances with specialization in Analytical Method Development & Analytical Method validations for drug substances and drug products, Analysis of drugs from biological fluids for Bioequivalence/Bioavailability studies, Analysis of Herbal drugs. She has led several Regulatory Inspections in her Professional assignments as an Analytical & Quality Control SME.

She has served secondments at Pfizer’s Global European R&D Headquarters at Sandwich, Kent, UK & Pfizer’s Global Manufacturing sites at Michigan in US, Ascoli Piceno in Italy. She has also been a part of collaborations in Brazil.

Dr. Bahuguna,

  • Is a Lean Six Sigma Green Belt certified by Quality Council of India, Ministry of Commerce & Trade, Govt of India.
  • Contributes as an Expert in the EWGs of the Indian Pharmacopoeia under the aegis of Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Govt of India.
  • Member of Analytical, Microbiology Quality Control Working Group of European Compliance Academy.
  • Contributes as a Founding Expert Member & Nitrosamine Exchange Ambassador in USP’s Nitrosamine Exchange Community.
  • Life Member of Chromatographic Society of India
  • Contributes as an active Member of Midwest Compendial Discussion Group
  • Contributes as a Speaker in Webinars, Symposia in various Industry, Academia forums.

 

Dr. Bahuguna is associated with Academics and serves as:

  • Member on Board of Studies of Department of Chemistry at SIES College of Arts, Science & Commerce, Mumbai. (Empowered Autonomous)
  • Visiting faculty at SIES Institute of Chromatography and Spectroscopy, Navi Mumbai.

 

Dr. Bahuguna obtained her Ph.D. in Analytical Chemistry from University of Mumbai with specialization in Pharmaceutical Analysis & a Master’s in Organic Chemistry from University of Mumbai (University Gold medalist)

She has been the recipient of numerous Awards during her Academics and has also been recognized for her Professional contributions, a few among them include:

  • Featured amongst Asia GCC Iconic Women Leaders and is the recipient of Asia GCC Iconic Women Leader Award in Pharmaceutical Quality Control.
  • Women Super Achiever Award for Excellence & Leadership in Pharmaceutical Quality Control.
  • Most Trusted Women Leader Award in Pharmaceutical Quality Control for Excellence & Leadership in Pharmaceutical Quality Control.
  • Dr. K.A. Hamied’s Chemistry Prize for securing highest number of marks at the M.Sc. degree exam (Sponsored by Cipla Ltd.)
Ellutia logo
Panel

10.30 – 12.00 am CET

Nitrosamine contamination

Is it still an issue today?

Almost six years after N-nitrosodimethylamine (NDMA) contamination was first identified, the toxic short alkyl chain N-nitrosamine issue appears on the way to resolution. In contrast, N-Nitrosamine drug substance-related impurities (NDSRIs) are still a burgeoning issue with many new NDSRIs being reported on a weekly basis. This session will:

  • Review the latest guidelines on nitrosamine risk evaluation and risk assessment
  • Explore analytical techniques for determination of nitrosamine impurities
  • Discuss the path to international regulatory harmonisation.
Varun Ahuja with Syngene logo

Varun Ahuja

Head-Toxicology, Safety Assessment
Syngene International Ltd

Jonathan Angove with Ellutia logo

Jonathan Angove

Senior Applications Chemist
Ellutia

Ivana Gusić with Teva logo

Ivana Gusić

Senior Manager, Nitrosamine Testing and Analytical Technologies
TEVA Pharmaceuticals

Ingrid Hegbom Ekman with Cambrex logo

Ingrid Hegbom Ekman

Director of R&D
Cambrex

Malcolm Ross with Novartis logo

Malcolm Ross

Analytical Specialist - External and Member of Nitrosamine Task Force
Novartis

Archana Bahuguna

Moderator: Archana Bahuguna

Regulatory Compliance SME, Founding Expert Member and Nitrosamine Exchange Ambassador