Name: Nitrosamine Impurities Forum Americas
Start: 28/09/2021 02:00 PM +00:00
End: 29/09/2021 10:00 PM +00:00

Waters Corporation, the premium brand in the analytical instruments industry, creates business advantages for laboratory-dependent organizations by delivering practical and sustainable scientific innovation to enable significant advancements in healthcare delivery, environmental management, food safety, and water quality worldwide. Bringing keen understanding and deep experience to those responsible for laboratory infrastructure and performance, Waters helps customers make profound discoveries, optimize laboratory operations, deliver product performance, and ensure regulatory compliance. Pioneering a connected portfolio of separations and analytical science, laboratory informatics, mass spectrometry, as well as thermal analysis, Waters&rsquo; technology breakthroughs and laboratory solutions provide an enduring platform for customer success

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&middot; &nbsp; &nbsp; &nbsp; &nbsp; Small alkyl nitrosamines vs "complex" nitrosamines
&middot; &nbsp; &nbsp; &nbsp; &nbsp; Is read-across feasible for "complex" nitrosamines?
&middot; &nbsp; &nbsp; &nbsp; &nbsp; De-risking of "complex" nitrosamines
&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; o &nbsp; sAre all nitrosamines part of the CoC?
&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; o &nbsp; MW adjustment of AIs

Dr. Raphael Nudelman

The Complexity of Nitrosamines for the Generics Industry

&middot;&nbsp; &nbsp;Development of a systematic risk-based approach
&middot;&nbsp; &nbsp;Key factors and the development of a decision tree
&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; - AP&nbsp;
&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; - Drug Product

Dr. George Johnson

Nitrosamine Impurities – How to Conduct an Actual Risk Assessment?

The regulators earlier investigations led to industry-wide recalls of valsartan and other &ldquo;sartan&rdquo; (losartan, irbesartan) angiotensin II receptor blockers (ARBs). More recently, the nitrosamine impurities findings have been extended to ranitidine, nizatidine, and metformin, leading to recalls of these drug products. This presentation will highlight how API and drug product manufacturers consider the ways nitrosamines form and evaluate the risk for nitrosamine contamination or formation in their products, prioritizing evaluation of APIs and drug products based on factors such as maximum daily dose, duration of treatment, therapeutic indication, and number of patients treated &amp; evaluate synthetic route including regulatory starting materials and solvents

Dr. Christopber Borths

How to deal with Nitrosamine Impurities in API?

Nitrosamines as low-level contaminants have been a regulatory concern for pharmaceuticals, where risk assessments have been required for all drugs on the market. &nbsp;Zero exposure to nitrosamines is impossible to prove, and nitrosamines are ubiquitous in water, food, tobacco smoke, and endogenously created in the body. &nbsp;Therefore, the safety of nitrosamines is critical to their assessment. &nbsp;Nitrosamines are a Cohort of Concern (COC) class of carcinogens and thus more potent than a mutagenic compound under ICH M7. &nbsp;Regulatory guidelines have been developed to address the limits for nitrosamine impurities. &nbsp;This session will discuss some of the existing guidelines, and the current research used to advance the safety of impurities.&nbsp;

Dr. Joel Bercu

Understanding the Safety Assessment of Nitrosamines

- What is acceptable by regulators while conducting risk assessment?
- Identify challenges in assessing risk in Raw Materials, API, Drug products &amp; Packaging Materials
- How to calculate acceptable intake limit which is set by regulatory authorities?
- How to choose suitable analytical methods to meet the acceptance intake limit?
- 3-Step Approach to implement Risk Assessment with real case examples with lessons learned during the process

Agenda

Speakers15 Speakers

Dr. Ganapathy Mohan

Dr. Aloka Srinivasan

Dr. Maria Augusta Carvalho Rodrigues

Dr. Steven Baertschi

Mr. Nadim Mira

Dr. Ron Kelly

Mr. Justin Moser

Dr. Raphael Nudelman

Dr. George Johnson

Dr. Christopber Borths

Dr. Joel Bercu

Dr. Gopala Krishna

Dr. Rodney Parsons

Dr. Nayrton Flavio Moura Rocha

Ranjith Paul

Booth3 Booth

Waters

CPhI Conferences

Informa Markets in India

Agenda

Speakers.css-1f6omqm{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#5d5d5d;font-family:'Poppins',sans-serif;margin-left:0.8rem;}15 Speakers

Dr. Ganapathy Mohan

Dr. Aloka Srinivasan

Dr. Maria Augusta Carvalho Rodrigues

Dr. Steven Baertschi

Mr. Nadim Mira

Dr. Ron Kelly

Mr. Justin Moser

Dr. Raphael Nudelman

Dr. George Johnson

Dr. Christopber Borths

Dr. Joel Bercu

Dr. Gopala Krishna

Dr. Rodney Parsons

Dr. Nayrton Flavio Moura Rocha

Ranjith Paul

Booth.css-7303n9{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#5d5d5d;font-family:'Poppins',sans-serif;color:#FFFFFF;margin-left:0.8rem;font-weight:400;}3 Booth

Waters

CPhI Conferences

Informa Markets in India

Speakers15 Speakers

Booth3 Booth