Discover an informative webinar delving into nitrosamine contamination in drug manufacturing and the current scientific and regulatory landscape. Nitrosamines in pharmaceuticals became a topic of special concern when their presence at unacceptable levels in common medicines hit the news in 2018. Drug substance and drug product manufacturers have since been required to conduct risk assessments and, when necessary, perform confirmation tests and recall products to address the risks of nitrosamine contamination and potential genotoxicity.
Over the past five years, developments in process chemistry, analytical technology and regulatory guidances have shaped the state of play for nitrosamine impurities in drug manufacturing. In this webinar, the featured speakers will explore the current scientific and regulatory landscape for nitrosamines, highlighting the current requirements for assessing, controlling and monitoring their presence as contaminants in pharmaceuticals.
Topics in this webinar will include:
- Background on nitrosamines, including factors that increase the risk of contamination in pharmaceuticals
- Recent scientific developments that have enhanced the requirements for risk assessment, testing and mitigation
- Regulatory guidance on assessing the risk of — and identifying the root cause for — potential nitrosamine impurities
- Reporting and notification requirements for nitrosamines in pharmaceuticals
- Recent Food and Drug Administration (FDA) guidance on nitrosamine drug substance-related impurities (NDSRIs) and implementation requirements
Join this webinar to gain insights into nitrosamine contamination in drug manufacturing and the current scientific and regulatory landscape.
Speakers
Dr. Olu Aloba, Vice President, CMC Services, Premier Consulting
Dr. Aloba has more than 25 years of leadership experience in pharmaceutical research and development, pharmaceutical technology, and regulatory strategy. He is a subject matter expert in drug product development, with special expertise in the application of quality-by-design (QbD) to formulation and process development, analytical development, and development strategy. He is a registered pharmacist and holds a US Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.
Dr. Aloba joined Premier Consulting in 2014 and, in his current role, leads Premier Consulting’s Chemistry Manufacturing and Controls (CMC) service offerings focusing on pharmaceutical development strategizing, planning, execution, and documentation in support of drug development programs for Premier Consulting’s clients. He also serves as senior technical advisor on Premier Consulting’s drug, device, and biologics initiatives and is responsible for continuing development of the pharmaceutical quality expertise, knowledgebase, and policy at Premier Consulting.
Before joining Premier Consulting, Dr. Aloba was led the development of specialty pharmaceuticals in various therapeutic categories from concept through regulatory approval. Dr. Aloba is a co-inventor on several pharmaceutical patents and has authored many scientific articles and presented his work at numerous conferences.
Message Presenter
Dr. Marianthi Karakatsani, Director, CMC Development Strategy, Premier Consulting
Dr. Karakatsani has more than 17 years of experience in pharmaceutical research and development, technology transfer, process validation, drug product commercialization, post-commercialization, regulatory CMC submissions and interactions with the Health Authorities. She is a subject matter expert for various types of dosage forms (including drug-device combination products) with expertise in formulation and process development, continuous process improvement (CPI) and overall CMC development strategy.
Dr. Karakatsani joined Premier Consulting in 2019. In her current role, she provides pharmaceutical and regulatory CMC expertise to support drug development programs and post-approval activities. She authors
and reviews regulatory and technical documentation, provides advice on drug product life cycle management activities, performs technical and strategic assessments and gap analyses. She also provides regulatory CMC expertise during meetings with the Health Authorities, for which she serves as CMC lead and authors CMC meeting documents. Dr. Karakatsani expertly supports the preparation of various submissions, such as INDs, NDAs, CTAs, EUAs, MAAs, annual reports, IMPDs, IND amendments and more.
Before joining Camargo, Dr. Karakatsani held various positions in the pharmaceutical industry (brand and generic companies) where she successfully developed and commercialized a variety of dosage forms, both conventional and novel. She was the Scientific Lead for multiple projects from the early drug developmental stages through approval and post-commercialization and had the opportunity to interact with FDA, ANVISA, MHRA and EMA.
Dr. Karakatsani earned a Bachelor of Pharmacy degree from the Aristotle University of Thessaloniki, Greece and a Ph.D. degree in Industrial Pharmaceutics from Long Island University, NY, where she also served as a Teaching Fellow. She is the inventor of several pharmaceutical patents and has authored numerous scientific papers. Some of her work has been presented at scientific conferences.
Message PresenterWho Should Attend?
This webinar will appeal to the senior professionals from pharma, biotech and MedTech companies involved in:
- Regulatory Science and Regulatory Affairs related to drug substance and drug product development and commercialization
- Drug Research and Development
- Synthetic Chemistry
- Manufacturing of drug substances and drug products
- Drug Product Formulation
- Analytical Method Development
- Quality Control
- Quality Assurance
- Nonclinical Research
- Clinical supply
What You Will Learn
Attendees will gain insights into:
- Background on nitrosamines, including factors that increase the risk of contamination in pharmaceuticals
- Recent scientific developments that have enhanced the requirements for risk assessment, testing and mitigation
- Regulatory guidance on assessing the risk of — and identifying the root cause for — potential nitrosamine impurities
- Reporting and notification requirements for nitrosamines in pharmaceuticals
- Recent Food and Drug Administration (FDA) guidance on nitrosamine drug substance-related impurities (NDSRIs) and implementation requirements
Xtalks Partner
Premier Consulting
Premier Consulting is a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.
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