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3RD ANNUAL GENOTOXIC IMPURITIES SUMMIT: BEYOND NITROSAMINES

Two days of expert insights and high-impact networking with leading toxicologists, regulatory specialists, and pharmaceutical innovators.This is your opportunity to advance your career, stay ahead of evolving regulations like ICH M7, and deepen your expertise in genotoxic risk assessment and impurity control.

berlin

October 1-2, 2025

Get the full event program

REGISTER NOW

Featuring industry leaders in genotoxic impurity control and pharmaceutical safety.

About the conference

Offline
Online

join your way!

event date

October 1-2

Genotoxic Impurities Summit 2025:
The Transformation of Pharmaceutical Safety Through Science and Regulation

The 3rd Annual Genotoxic Impurities Summit is a premier event uniting experts from pharmaceutical companies, regulatory agencies, and toxicology research.
Focusing on critical topics such as nitrosamines control, ICH M7 updates, DNA-reactive impurities, and advanced genotoxic risk assessment strategies, this summit is the ideal platform for professionals aiming to stay ahead in impurity management and enhance pharmaceutical safety standards.

Berlin

Event location

OUR SPONSORS

If you are interested in becoming a partner or sponsor, please feel free to contact us.

get the full conference program and a discount on early booking

All materials

By filling out the form, you accept the terms of the "Privacy Policy"

Request the full program and a personalized consultation to learn more about the benefits of participation

What’s in it for you as an attendee?

Networking opportunities

with key stakeholders from pharma, biotech, and regulatory bodies

for managing genotoxic impurities across the drug development lifecycle

Hands-on strategies

into nitrosamines, ICH M7, and the latest regulatory expectations

Cutting-edge insights

We provide the knowledge, networking, and innovation to drive your professional evolution in the pharma sector

«Business Conference Facilitation» is more than just an event organizer

Request your discount

€250
off

brief schedule

KEY POINTS

2 days

from 8:00 AM

OCTOBER 1-2, 2025

berlin

Technological Advancements: Exploration of innovative techniques for identifying, monitoring, and controlling genotoxic impurities

Risk Assessment Advancement: Progression in risk assessment practices and guidance for impurity qualification

Regulatory Navigation: Understanding CMC regulations and industry expectations for genotoxic impurities

Comprehensive Control: Assessment, testing, and control of impurities across pharmaceutical products, drug substances, and excipients

Gap Identification: Addressing potential gaps impacting the control of mutagenic impurities

Compliance Maintenance: Critical factors for adhering to ICH M7 and Q3D guidelines.

Carcinogenic Risk Mitigation: Effective control strategies for DNA-reactive N-nitrosamine impurities.

Strategy Alignment: Navigating uncertainties and aligning strategies for nitrosamine management

WANT TO SEE FULL AGENDA

Can’t Make It to Berlin? Join Us Online!

Join Our Live Q&A Sessions

Join live Q&A sessions to explore challenges, share perspectives, and gain insider knowledge from top speakers.

Get full access to expert sessions in real time – learn directly from industry leaders, discover breakthrough innovations, and stay ahead with the latest trends in plastic recycling.

Watch Live Presentations in Real Time

Register for Online Access

Join online

Attend the conference from anywhere in the world and gain insights from global experts, access live sessions, join interactive Q&As, and receive post-event materials—all without leaving your desk.

Learn more about the event and select your preferred participation package

Online & Offline

By filling out the form, you accept the terms of the "Privacy Policy"

Contact Us to Enhance Your Conference Experience with Expert Guidance.

Meet Our Speakers

Preclinical Evaluation

Medical Devices

Toxicological Risk

Crystal D’Silva

Associate Director, Preclinical Toxicology | Preclinical Sciences, Strategy, Innovation |

PRINCIPAL RESEARCH SCIENTIST

DR. MICHAEL BURNS

Mutagenic Risk

Small Molecule APIs

Purging Calculations

Department Head

Pharmaceutical Consultant and Toxicologist

Drug Substance Lead

B. Braun Melsungen AG

Biologics Manufacturing

CEO ProtonAction

Technical and Regulatory Director

Group Leader Com & Projects AC

Rok Grahek

Ilaria Coccoglioniti

Florian Huber

Alina Martirosyan, PhD, ERT, DABT

Wilmer A. Sanjuan

Lucas Maciel Mauriz Marques

Paulo Eliandro da Silva Junior

Tim Averbeck

Impurity Profiling

Nitrosamine Risk Assessment

Drug Substance Development

Biocompatibility Studies

Nitrosamine Analysis

LC-MS/MS Method Development

Pharmaceutical Quality Control

Analytical Standards Synthesis

Drug Substance Characterization

Extractables & Leachables Analysis

NDSRI

Chemical Risk Assessment

LC-MS / GC-MS Analytics

Toxicological Evaluation (ICH Q3D / PDE)

Chemical Research

Regulatory Liaison (ISO / NB)

Analytical Development

Pharmaceutical QA/QC

ICH M7 Compliance

Thierry Beltran

ICH-M7 Compliance Coordinator within PDP Scientific Excellence

Senior Market Development Manager Pharma/CRO

Nando Sanchez

Risk Management

Pharmaceutical Development

Market Strategy

Nitrosamine Analysis

Pharmaceutical Quality Control

Chromatography & Mass Spectrometry

Mr Nathanael Page

Associate Scientific Director

Become a Sponsor or Partner of the Genotoxic Impurities Summit

WHY SPONSOR

LET'S CHOOSE YOUR CUSTUMIZED PACKAGE

Showcase your expertise and align your brand with the industry’s leading event focused on the latest advancements in genotoxic impurities, nitrosamine mitigation, and regulatory strategy.
As a sponsor or partner, you'll gain:

Targeted exposure to decision-makers from pharma, biotech, and regulatory bodies
Opportunities to present, exhibit, or host a session
Strategic brand visibility before, during, and after the event

+100 Attendees

+12 Speakers

confirmed participation

we are expecting

Experts from 50+ top pharmaceutical companies
80% of attendees are senior-level professionals (Manager, Director, VP, or C-suite)
Representatives from regulatory bodies, R&D, toxicology, analytical chemistry, and QA/QC
94% of past attendees rated the summit as “highly relevant and applicable to their daily work”

We offer tailored sponsorship options to match your goals—whether it’s speaking, branding, exhibiting, or hosting networking sessions.

📩 Contact us at general@bcf-events.com or call +420 214 214 720 to discuss your ideal package.