Conference Overview

For the transformation of starting material into the product is needed API synthesis, which involves multiple reaction steps, including reagents, intermediates, catalysts, solvents and others. As a result, low levels of by-products may appear in API as impurities. This impurity may have toxicity, incl. carcinogenicity and genotoxicity, what may cause mutations, potentially leading to cancer. Due to this fact and focusing on ensuring safety of public health is critical to identify, monitor, analyse and control genotoxic impurities and strive to their minimum level. This has led to the crucial need in the development and improvement of analytical methods.

The Genotoxic Impurities in Pharmaceuticals Summit 2021 is focusing on overcoming challenges and barriers, sharing knowledge, strategies, best techniques and new methodologies in GTI predictions, analysis and control during the drug development process, overview and practical implementation of GTI guidelines and regulations (ICH M7 and ICH Q3D), risk assessment, exposure limits calculation and predictions' empowerment through in silico.

The featured talks on:

Meeting the challenge of trace analysis of N-nitrosamines -The impact for the pharmaceutical industry.
Risk Assessment of Nitrosamines in Pharmaceuticals: Not All Nitrosamines are Highly Potent.
Development of a Drug Product workflow for Nitrosamine Risk Assessments.
Quantitative Analysis of In Vivo Mutagenicity Dose-Response Data for Risk Assessment and Regulatory Decision-making: A Case Study of Alkylnitrosamines.
Setting limits for nitrosamines that lack carcinogenicity data.
Analytical Solutions for the Detection and Quantification of Nitrosamines Using Separations and Mass Spectrometry.
3 general suggestions for assessing positive response in genetic tox.
Assessment of potential mutagenic degradation products.
Handling mutagenic extractable and leachable compounds released from devices.

Who You Will Meet

By Seniority Level

C-Level, Presidents, Chairs, Members of the Board & VPs
Directors, & Heads
Leaders & Managers
Fellows, Principals & Scientists
Toxicologists & Chemists
Advisors, Coordinators, Auditors & Consultants
Other Professionals, Experts & Specialists

By Division

ADME
Analytical Chemistry
Analytical Development
Analytical R&D
Analytical Science
Analytical Science & Technology
Analytical Sciences
API
Biocompatibility
Chemical Toxicology
CMC
Compound Safety
Computational Toxicology
Data Sciences & Artificial Intelligence
Drug Development
Drug Safety
Drug Safety Research & Evaluation
Genetic Toxicology
Genetics & Mutagenesis
Genotoxicity
GMP
GTIs
Impurities
In Silico Toxicology
Metabolism
Mutagenicity
Pharmaceutical Sciences
Pharmacokinetics
Pharmacology
Pharmacovigilance
Process Chemistry
Process Development
QbD
Quality Assurance & Operations
Quality Control
Regulatory Affairs & Compliance
Research & Development
Risks Assessment
Small Molecules
Toxicology
Toxicology Discovery
Validation

By Company Type

Pharmaceuticals
Biotechnology
CRO
CMO
Technologies & software providers
Equipment providers
Regulatory agencies
NOP
Other

By Region

Central and Eastern Europe
North America
Middle East and Africa
Asia-Pacific
Other

Conference Programme

Day One - Thursday 15, July 2021

Tentative Schedule:

Central European Summer Time (CEST, Prague, UTC/GMT +2 hours)

12:00

12:20

12:30 Meeting the challenge of trace analysis of N-nitrosamines -The impact for the pharmaceutical industry.

The history of the N-nitrosamine challenge.
How has Industry met this challenge?
What are the practical measures needed to provide ultra-trace N-nitrosamine data?

Mark Harrison,
Principal Analyst, AstraZeneca, Sheffield, United Kingdom

13:00

13:10 Speed Networking

13:40 Risk Assessment of Nitrosamines in Pharmaceuticals: Not All Nitrosamines are Highly Potent.

Commercial product nitrosamine risk assessment using nitrosamine structural groupings
Read-across approach developed to minimize compound-specific risk assessments and analytical testing
Case example compound-specific risk assessment

Michelle Kenyon,
Associate research fellow in Drug Safety, Pfizer Global Research and Development, USA

14:10

14:20

14:30 Development of a Drug Product workflow for Nitrosamine Risk Assessments.

Development of a cross industry aligned approach to the nitrosamine risk assessment of drug products
GSK experiences of using this workflow to perform drug product risk assessments
Shared experiences relating to regulatory submissions

Mike Urquhart,
Scientific Director, GlaxoSmithKline, Stevenage, United Kingdom

15:00

15:10 Quantitative Analysis of In Vivo Mutagenicity Dose-Response Data for Risk Assessment and Regulatory Decision-making: A Case Study of Alkylnitrosamines.

Use of genetic toxicity data for assessing alkylnitrosamines
Mechanism of action, and dose response characterisation for noteworthy alkylnitrosamines
Risk assessment opportunities for specific alkylnitrosamines using these approaches

Dr. George Johnson,
Associate Professor in the Institute of Life Science, Swansea University, United Kingdom

15:40

15:50 Setting limits for nitrosamines that lack carcinogenicity data.

Raphael Nudelman, Ph.D., ERT,
Director of Chemical & Computational Toxicology, Teva Pharmaceuticals, Israel

16:20

16:30

16:40 Analytical Solutions for the Detection and Quantification of Nitrosamines Using Separations and Mass Spectrometry.

The analytical methodology applied for genotoxic impurity analysis needs to provide an appropriate level of sensitivity to meet the required detection limits and demonstrate good accuracy, precision, and reproducibility. In this work, we present robust analytical approaches for the detection and quantification of nitrosamine impurities using UV, MS and HRMS techniques. The performance and sensitivity of these methodologies are demonstrated by analyzing several nitrosamine impurities in drug substances and drug product formulations.

Margaret Maziarz,
Principal Scientist, Scientific Operations, Waters Corporation, Milford, MA, USA

17:10

17:20 PANEL DISCUSSION: 3 general suggestions for assessing positive response.

Pairwise comparison to concurrent control.
Dose-related trend assessment.
Biological relevance (within the historical bounds).

Dan Roberts,
Genetic Toxicologist and Flow Cytometrist, Charles River Laboratories, USA

18:20

Day Two - Friday 16, July 2021

Tentative Schedule:

Central European Summer Time (CEST, Prague, UTC/GMT +2 hours)

12:00

12:20

12:30 Case Study #1 AVAILABLE

13:00

13:10 Case Study #2 AVAILABLE

13:40

13:50

14:00 Assessment of potential mutagenic degradation products.

Expectations on degradation products
Approaches for assessing degradation products
Analytical strategies

Tom van Wijk,
Principal Scientist, Analytical Science and Technology Team lead Pharmaceutical analysis, Abbott Healthcare Products B.V., Weesp, The Netherlands

14:30

14:40 To Be Announced.

Carla Landolfi, ERT,
European Registered Toxicologist (ERT) R&D, Head of WEP Toxicology - Preclinical Development, Angelini, Pomezia, Italy

15:10

15:20 Reserved for Intertek

15:50

16:00

16:10 Handling mutagenic extractable and leachable compounds released from devices.

Ron Brown
Owner and Principal Toxicologist, Risk Science Consortium, LLC, USA

16:40

16:50 Case Study #7 AVAILABLE

17:20

17:30 Closing remarks and end of summit

Registration Form

To register to the summit as a Delegate, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com.

*Please note, all participation packages, contains complete conference materials distribution after the event (Slides, list of participants, stream and video recording). You don't need to order an additional "Documentation Packages".

ONLINE Participation:

Available until
15 July 2021

Individual ticket

With live event recording

€295

2-Days Summit

Available until
15 July 2021

Group ticket 2-3

With live event recording

*per person

€215

2-Days Summit

Available until
15 July 2021

Group ticket 4+

With live event recording

*per person

€145

2-Days Summit

Available until
15 July 2021

15 July

1st Day

With live event recording

€195

1-Day Summit

Available until
15 July 2021

16 July

2nd Day

With live event recording

€195

1-Day Summit

Registration Form

To register to the summit as a Delegate, Exhibitor or Sponsor, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com.

Online Sponsorship:

Available until
15 July 2021

Speaker

Sponsorship Package

€995

1 pass included

Additional pass: €195

Session: 20 minutes

Logo and URL placement

Social media recognition

2-Days Summit

Available until
15 July 2021

Partner

Sponsorship Package

€1,295

2 passes included

Additional pass: €145

Session: 30 minutes

Logo and URL placement

Social media recognition

Colour advert in agenda: 1/2 page

Promotional materials distribution

Link to Landing page

2-Days Summit

Available until
15 July 2021

Gold

Sponsorship Package

€1,695

3 passes included

Additional pass: €95

Session: 40 minutes

Logo and URL placement

Social media recognition

Colour advert in agenda: 1 page

Promotional materials distribution

Link to Landing page

Link to Virtual Exhibition page

Keynote presentation: 15 minutes

Chairing of Day 1 or 2

2-Days Summit

Buy Document Form

€395 - Documentation Package, includes complete conference materials.
Post-event presentations with video recording, slide decks, a list of participants, and other promotional materials.
*The presentation content is subject to speaker’s companies approval for distribution.

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