March 15-16, 2023 | Milan, Italy & Online (CET) | #VLgenotoxic

Sheraton Milan Malpensa Airport Hotel & Conference Centre | Malpensa Terminal 1, S.S, 336 | 21010 Ferno VA, Italy
CONFERENCE & EXPO

Key Practical Learning Points:

• Critical considerations on compliant implementation of ICH M7 and Q3D
• Assessment and control of DNA reactive (mutagenic) N-nitrosamines
impurities to limit potential carcinogenic risk
• Uncertainties, misalignment, investigations, observations, and experiences
related to nitrosamine
• New frontiers in techniques, technologies and partnerships in genotoxic
impurities identification, monitoring, and control
• Recent developments in risk assessment and recommendations on the
safety qualification of impurities
• Ongoing advancements on the potential gaps affecting impurities
identifying and control
• Genotoxic impurities CMC regulatory requirements, pitfalls, and
expectations in the field
• Efficient strategies to assess, test, and control impurities in
pharmaceutical products, drug substances/APIs, and excipients
• Evaluation of extractables and leachables (E&L) for genotoxic potential
• Analytical, regulatory, and toxicology achievements and prospects
for compliant mutagenic and elemental impurities identification,
monitoring, and control

Moderator
Dr. Raphael Nudelman, IL Dr. Susanne Glowienke, CH
Senior Director of Impurity Expert, R&D Director, Preclinical Safety
Operations Novartis Pharma AG
Teva Pharmaceutical Industries Ltd.
Dr. Andrew Teasdale, UK
Irene Cecchini, IT
Senior Principal Scientist / Head of Impurity
Senior Principal Scientist
Management & CMC Strategy
Healthcare Business of Merck
AstraZeneca

Dr. Carla Landolfi, IT

Dr. Paulo Eliandro da Silva Junior, BR
European Registered Toxicologist (ERT) /
Technical and Regulatory Director
CEO - Toxicology Risk Assessor
Integra Consultancy
ToxHub

Dr. Rodney Parsons, US Dr. Aloka Srinivasan, US

Executive Director, Chemical Development Principal and Managing Partner
Bristol Myers Squibb RAAHA LLC

Dr. Dana Lena Budde, DE

Dr. Joerg Schlingemann, DE
Scientist Biocompatibility Testing
Director, Principal Expert Quality Control
Product Development Bioreactor
Systems
Characterisation
Merck Healthcare KGaA
Sartorius Stedim Biotech GmbH
Dr. George Johnson, UK
Marina Couva, CY
Associate Professor
QPPV
Institute of Life Science at Swansea
Medochemie Ltd
University

Dr. Arianna Bassan, IT Dr. Markus Obkircher, DE

Principal Consultant Director, Research & Development
Innovatune Merck Life Science

Dr. Michael Burns, UK Dr. Karl Abele, CH

Principal Research Scientist – Mirabilis Lead Principal Scientist for HRAM-LC/GC/MS
Lhasa Limited Solvias AG

Partners & Sponsors

2023 Vonlanthen Group of Companies. All Rights Reserved.

March 15-16, 2023 | Milan, Italy & Online (CET) | #VLgenotoxic

Introduction
The recall of Valsartan has proved a critical need of a rational risk
assessment strategy for potential nitrosamines in pharmaceutical
products.
At the #VLgenotoxic 2023,, along with focussing on the
N-nitrosamines, we will explore the most important aspects
around the detecting and reporting of genotoxic impurities,
current investigations and regulatory, toxicological, analytical,
pharmaceutical relevant prospects related to GTIs, as well
as recent advances and further development and future
considerations towards the different types of impurities present
in drugs.
Join the keynote presentations and case studies, participate
in the interactive panel discussions and Q&As, visit exhibitions,
and extend partnership opportunities while learning about
the advanced strategies and perspectives in the landscape of
impurities and E&L at the 7th Impurities: Genotoxic, Nitrosamine
& Beyond conference on March 15--16,, 2023..

Who Should Attend 

Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:

Analytical Science Extractables & Leachables (E&L) Microscopy Quality by Design (QbD)
Active Pharmaceutical Genetic Toxicology Mutagenic Impurities Quality Control
Ingredient (API) Development Genotoxic Impurities (GTIs) Mutagenicity Regulatory
Assay Development Genotoxicity N-Nitrosamine Toxicology
Carcinogens Good Manufacturing Practices Organic Synthesis Validation
Chemistry (Analytical, Organic, (GMP) Permitted Daily Exposure Quantitative Structure-
Medicinal, Protein) Good Laboratory Practice (GLP) (PDEs) Activity Relationships (QSAR)
Drug Safety Impurities Purification
Elemental Impurities In Silico Quality Assurance

2023 Vonlanthen Group of Companies. All Rights Reserved.

March 15-16, 2023 | Milan, Italy & Online (CET) | #VLgenotoxic

Partners & Sponsors

Innovatune is a science- and technology-based company providing consultancy services for the
hazard assessment of chemicals mainly focusing on human health. The services make the most of
in silico methods, which aim at predicting toxicity from the molecular structure of chemicals. Hazard
assessment of chemicals builds on the combination of information from different sources in an
efficient and informed way; when available, standardised protocols are followed to integrate relevant
data (in vitro, in vivo, human) with adequate in silico predictions. Innovatune is committed in advancing
the use of new approach methodologies and, in particular, in silico approaches in regulatory contexts.

Selvita is a preclinical Contract Research Organisation providing multidisciplinary support in resolving

the unique challenges of research within the areas of drug discovery and drug development
studies. Selvita was established in 2007 and currently employs over 1,000 professionals, of which
over 40% hold a PhD degree. The company research sites are located in Krakow (HQ) and Poznan,
Poland, as well as Zagreb, Croatia.
Selvita provides state-of-the-art analytical services supporting pharmaceutical and biopharmaceutical
companies at various stages of drug development and CMC processes by providing contract
laboratory services for testing. We have a diverse analytical instrumentation and expertise portfolio,
allowing us to meet varied demands, including testing of starting materials, drug substances,
intermediates, and final products of small and large molecules. Selvita complies with GMP and GLP
requirements to meet the highest industry standards.

Lhasa Limited is a Leeds-based not-for-profit organisation. At Lhasa, we are driven by our purpose:
To enable informed decision-making on chemical safety. In line with this purpose, we create forward-
thinking software solutions, which have been solving real-world chemical safety assessment
problems for almost 40 years. Our technology is designed by scientists, for scientists, in collaboration
with industry stakeholders and regulators. We are committed to enabling scientists to make better
predictions on the safety of drugs, chemicals, and cosmetics by using existing data better and
developing computer-aided reasoning and information systems for the advancement of science.

Solvias is a world leader in contract research, development, and manufacturing (CRO/CDMO). We

provide integrated analytical services and solutions to the pharmaceutical, biotech, and medical
device industries. Our comprehensive analytical testing portfolio integrates a broad range of
capabilities spanning all stages of drug discovery, development, and commercial release for better
and safer products.

Cleanchem Laboratories is an independent reliable R&D based Custom Research and Manufacturing
company (CRO/CRAMS) delivering its numerous leading Products and Services to Pharmaceutical,
Chemical, Clinical, Speciality Chemical, Biotech and allied industries. Since 8 Yrs of dedicated service
to the industry consist of world class R&D Infrastructure of 20,000 Sq.Ft area located in Mumbai.
All the research laboratories are equipped with ultramodern instrument and equipment facility.
Well versed team of around 100 scientists including PhD’s and PG’s are involved in development
of innovative products and services with low cost manufacturing taking an account of Environment
concern. Custom Synthesis Services, Ready stock Library of 4000+ Impurities & other products.
Pioneer in Development of Nitrosamines & NDSRI Standards in India. Ready stock Inventory of more
than 300+ Nitrosamine and NDSRI standards. 

2023 Vonlanthen Group of Companies. All Rights Reserved.

 Schedule
DAY 1 | March 15, 2023 | MILAN, ITALY & ONLINE (CET) | #VLgenotoxic

08:30 Registration and Welcome Coffee/Networking/Exhibition Break

09:00 Opening by Moderator | Dr. Raphael Nudelman, IL | Teva Pharmaceutical Industries Ltd.

Recent updates on nitrosamines: Areas of uncertainty and misalignment *

• Quality-related issues – Can we reduce levels of nitrosamines through CMC control alone?
• Safety issues – The relationship between safety challenges and what can and cannot be addressed from a CMC perspective; why
09:10 18ng is a disaster
• Regulatory issues – What is the current regulatory position? What is clear and, more importantly, what is not, and the impact of ambiguity
Dr. Andrew Teasdale, UK | Senior Principal Scientist | Head of Impurity Management & CMC Strategy | AstraZeneca

09:50 SPEED NETWORKING

Understanding the landscape of potential small and drug-substance-related nitrosamines in pharmaceuticals

• Using large datasets of existing drug substances, can we evaluate the true scale of challenges associated with NDSRIs?
10:20 • Examining the trends in potential formation, what lessons we can learn from them?
• Considering the risks posed by nitrosamines that could be formed, can future work be prioritised?
Dr. Michael Burns, UK | Principal Research Scientist – Mirabilis Lead | Lhasa Limited

10:50 NETWORKING / COFFEE / EXHIBITION BREAK

Nitrosamine risk assessment strategy for pharma and biologics

• Introduction - risk assessment workflow
• Potential sources of nitrosamine in the manufacturing process and risk evaluation criteria
11:20 • Risk assessment strategy for biotech products: Application of a bottom-up approach
• Key factors to be evaluated for the risk analysis
• Applicability examples, outcomes, and critical points
Irene Cecchini, IT | Senior Principal Scientist | Healthcare Business of Merck

Nitrosamines in pharmaceuticals
• NDMA in metformin products
11:55 • Analytical challenges
• Case studies of NDSRIs
Dr. Joerg Schlingemann, DE | Director, Principal Expert Quality Control Systems | Merck Healthcare KGaA

High-throughput cell-painting assay to assess E&L genotoxicity

• The mode of action of E&L on cells is difficult to investigate
12:30 • An unbiased high throughput screening (cell painting) with a human U2OS cell line was used to study 45 different compounds
• Comparison of the read-outs with a reference library allows prediction of the mode of action of E&L on cells
Dr. Dana Lena Budde, DE | Scientist Biocompatibility Testing | Product Development Bioreactor Characterization | Sartorius Stedim Biotech GmbH

13:00 BUSINESS LUNCH

14:00 NETWORKING / COFFEE / EXHIBITION BREAK

Genotoxicity evaluation of a valsartan-related complex N-nitroso-impurity/safety assesment *

• Genotoxicity assessment of a complex N-nitrosamine
14:20 • Structural considerations
• Ames test and in-vivo transgenic rodent assay to address mutagenicity
Dr. Susanne Glowienke, CH | Director, Preclinical Safety | Novartis Pharma AG

SPONSORSHIP SPEAKING SLOT

Defining AI limits of N-nitrosamines based on structure activity relationship (SAR) analysis

15:00 • SAR analysis workflow for data-poor nitrosamines
• Local and global similarity
• Potency categories and read-across
Dr. Arianna Bassan, IT | Principal Consultant | Innovatune

*Presentation is expected to be virtual

2023 Vonlanthen Group of Companies. All Rights Reserved.

 Schedule
DAY 1 | March 15, 2023 | MILAN, ITALY & ONLINE (CET) | #VLgenotoxic

SPONSORSHIP SPEAKING SLOT

Trace analysis of N-nitrosylated APIs in a GMP environment

• Detection of high ppm levels of NDMA in Valsartan in our labs immediately raised high
concerns of the involved manufacturers
• The maximal N-nitrosamines dosage of 18 ng/day is applied
• As one of the main CROs in this area, we developed over 60 validation SOPs for small
15:25 N-nitrosamines (NDMA, NDEA, etc.), which were formed in customers’ DPs by reactions of
small, residual amines with nitrosylating excipients
• In the last two years, focus has been shifted to the nitrosylation of API itself, which very often
occurs during the tableting procedure
• Reaction is caused by the interaction of amino-functions in the API with nitrite ions, typically
present in the excipients starch, cellulose, etc.
Dr. Karl Abele, CH | Principal Scientist for HRAM-LC/GC/MS | Solvias AG

15:55 NETWORKING / COFFEE / EXHIBITION BREAK

Current developments related to nitrosamines and strategies for control of nitrosamine in pharmaceuticals *
• Gaps in communications between different regulatory agencies
• NDSRIs and the related challenges; are they all carcinogenic?
16:25 • Dilemma with acceptable intakes; what makes a good surrogate?
• Challenges with analytical methods; is mass spec the only solution?
• Challenges of reformulation using nitrite scavengers; what about IID?
Dr. Aloka Srinivasan, US | Principal and Managing Partner | RAAHA LLC

End-to-end nitrosamine assessment and control

17:05
Dr. Rodney Parsons, US | Executive Director, Chemical Development | Bristol Myers Squibb

17:45 Q&A/PANEL DISCUSSION (All Speakers of the Day Are Invited) & MODERATOR’S CLOSING REMARKS

18:15 NETWORKING / EXHIBITION BREAK

18:30 BUSINESS DINNER - in the SHERATON MILAN MALPENSA AIRPORT HOTEL’S RESTAURANT (All participants are invited)

Are you searching for a partnership based

on scientific excellence and world-class quality?
Solvias provides integrated analytical services and solutions to the pharmaceutical,
biotech and medical device industries. Our comprehensive analytical testing
portfolio integrates a broad range of capabilities spanning all stages of drug
discovery, development and commercial release for better and safer products.

Visit solvias.com for

more information.

*Presentation is expected to be virtual

2023 Vonlanthen Group of Companies. All Rights Reserved.

 Schedule
DAY 2 | March 16, 2023 | MILAN, ITALY & ONLINE (CET) | #VLgenotoxic

08:30 Registration and Welcome Coffee / Networking / Exhibition Break

09:00 Opening by Moderator | Dr. Raphael Nudelman, IL | Teva Pharmaceutical Industries Ltd.

Nitrosamines in APIs – Quantitation according to USP General Chapter <1469> and beyond
• Nitrosamine testing according to USP monograph
• Expanding the scope beyond USP materials
09:05 • Certification of relevant reference standards
• API nitrosamine derivatives
Dr. Markus Obkircher, CH | Director, Research & Development | Merck Life Science

Setting limits for NDSRIs

09:40
Dr. Raphael Nudelman, IL | Senior Director of Impurity Expert, R&D Operations | Teva Pharmaceutical Industries Ltd.

Setting limits for novel N-nitrosamines in active pharmaceutical ingredients

10:20 • State-of-the-art strategies and approaches for assessing acceptable intakes
Dr. Carla Landolfi, IT | European Registered Toxicologist (ERT) | CEO - Toxicology Risk Assessor | ToxHub

11:00 NETWORKING / COFFEE / EXHIBITION BREAK

Risk assessment of nitrosamines

11:30
Dr. George Johnson, UK | Associate Professor | Institute of Life Science at Swansea University

Considerations around NDMA in ranitidine

12:10
Marina Couva, CY | QPPV | Medochemie Ltd

Understanding the chemistry and risk of forming nitrosamines in drug products: From key starting material synthesis through
drug product manufacturing and product stability
12:35 • Evaluation of the chemical environment of drugs to assess the formation of mutagenic impurities and determine strategies to
measure their risk
Dr. Paulo Eliandro da Silva Junior, BR | Technical and Regulatory Director | Integra Consultancy

13:10 Q&A/PANEL DISCUSSION (All Speakers of the Day Are Invited) & MODERATOR’S CLOSING REMARKS

13:40 BUSINESS LUNCH

Upcoming Events
EXTRACTABLES
4th Extractables & Leachables Summit and LEACHABLES
May 10-11, 2023 | Vienna, Austria | #VLEnL

Drug/Device
5th Drug-Device Combinations & Sustainability Conference Combination & Sustainability
September 27-28, 2023 | Düsseldorf, Germany | #VLDDCP Annual Conference

2023 Vonlanthen Group of Companies. All Rights Reserved.

 Speakers Biographies
March 15-16, 2023 | MILAN, ITALY & ONLINE (CET) | #VLgenotoxic

Dr. Raphael Nudelman, IL | Senior Director of Impurity Expert, R&D Operations | Teva Pharmaceutical Industries Ltd.
Raphael Nudelman holds a master’s of pharmaceutical sciences from the Hebrew University of Jerusalem and a PhD in organic chemistry from the Weizmann Institute of
Science in Rehovot, Israel. He held research fellow positions in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, USA, and at the Duke University Medical
Center, North Carolina, USA. He has been with Teva Pharmaceutical Industries in Israel since 2003 and has held research positions in the medicinal chemistry department
and the patent department. Since 2010, he has been the head of chemical and computational toxicology in Teva’s non-clinical safety department. From 2011-16, Raphael also
served as the president of the medicinal chemistry section of the Israel Chemical Society.

Dr. Susanne Glowienke, CH | Director, Preclinical Safety | Novartis Pharma AG

Dr. Susanne Glowienke graduated from the University of Stuttgart-Hohenheim, Germany, in food chemistry/technology. She then undertook research in the area of analytical
chemistry and obtained her PhD degree from the faculty of food technology (cereal chemistry) in 1997 at the same university. In 2000, she joined Novartis in Basel, Switzerland,
as a postdoc in the area of Q(SAR) for toxicological endpoints. Susanne was working as a lab head for bacterial mutagenesis in genetic toxicology, preclinical safety, and is
responsible for the QSAR predictions and impurity/excipient assessments at Novartis. Currently, Susanne is a director in preclinical safety at Novartis, Basel, Switzerland. She
held several positions at Novartis, including positions in genetic toxicology and QSAR modelling. She is currently head of the impurity safety group and as such responsible for
contaminant issues including nitrosamines. Susanne is part of and has led a number of industry expert groups within DruSafe IQ (US), European Federation of Pharmaceutical
Industries and Associations (EFPIA), the Extractables and Leachables Safety Information Exchange (ELSIE), and several data sharing initiatives.

Dr. Andrew Teasdale, UK | Senior Principal Scientist | Head of Impurity Management & CMC Strategy | AstraZeneca
Andrew Teasdale, PhD, is a senior principal scientist in impurity management and external advocacy at AstraZeneca. Andrew has over 20 years’ experience in the
pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role, he chairs AstraZeneca’s impurity advisory group. Andrew
has published over 30 papers relating to genotoxic impurities and other impurity-related matters and has been a speaker at many international conferences. He has also led a
number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation
of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI), and the Extractables and Leachables Safety Information Exchange (ELSIE).
Andrew led the recent development of the ICH M7 addendum table from an industry perspective and was the inventor of the purge tool concept, Mirabilis™. He also published
a book addressing genotoxic impurities, ‘Genotoxic Impurities Strategies for Identification and Control,’ (Wiley and Son) and is soon to publish as editor a book focussed on
practical implementation of ICH quality guidelines.

Irene Cecchini, IT | Senior Principal Scientist | Healthcare Business of Merck

Irene Cecchini works as a principal scientist in Merck Biotech’s product development division based in Guidonia Site, close to Rome, Italy. She graduated in analytical chemistry
at the University of Rome in 2003, and in the same year joined Serono as an analytical methods development junior researcher. In the following years she developed her
expertise, particularly in extractables and leachables (E&L), elemental impurities (EI), and sub-visible particles (SbVP). In 2016 she was appointed lab manager of the E&L
group, where she managed E&L studies on the final biotech products containers, as well as for manufacturing processes components (single-use systems) and coordinated
analytical investigations linked to manufacturing processes issues. Since 2019, she has been a principal scientist in the impurity analytics unit of analytical development biotech
department dealing with chemical and biological process impurities. In this role she contributes to building up strategies for her department’s core business, especially looking
for cross-functional synergies. She is a member of ELSIE and BPOG industry consortia for E&L topics. She recently joined EFPIA and PhRMA working groups as a Merck
representative expert following the development of the new ICH Q3E.

Dr. George Johnson, UK | Associate Professor | Institute of Life Science at Swansea University
George Johnson is an associate professor of genetic toxicology at Swansea University. He has expertise in the quantitative use of genetic toxicity data for hazard and risk
assessment purposes and has an interest in high content and multiplex in-vitro test systems. He currently has active roles in the HESI-GTTC, IWGT 2022, COM and EEMGS-
EXCOM, and carries out teaching, research, and consultancy at Swansea.

Dr. Carla Landolfi, IT | European Registered Toxicologist (ERT) | CEO - Toxicology Risk Assessor | ToxHub
Dr. Carla Landolfi graduated in chemistry and pharmaceutical technology from Rome University. She has more than 20 years of experience in the toxicology field gained in the
pharmaceutical industry, 10 of them as manager to the toxicology group. She’s the main or co-author of several papers and posters, has published in peer-reviewed journals,
and she’s an invited speaker at international conferences as well as the founding editor of archives of clinical toxicology. In 2020, she founded the ToxHub, a consultancy
company specialised in toxicological risk assessment and regulatory toxicology.

Dr. Paulo Eliandro da Silva Junior, BR | Technical and Regulatory Director | Integra Consultancy
Dr. Paulo Eliandro da Silva Junior is a pharmacist-biochemist (USP) with a master’s and PhD in medicinal chemistry, synthesis and drug discovery (FCFRP-USP, University of East
Anglia – UEA, UK; Johannes Gutenberg University of Mainz – JGU, Germany). His experience in the pharmaceutical industry started in 2013 as a trainee at Novartis (Horsham,
UK) in the global discovery chemistry department, and after that Paulo worked mainly in the regulatory affairs department with a focus on drug master file (DMF), quality
audits, mutagenic impurities, purge factor calculations, and control of nitrosamines on his own consulting company, Integra Consultancy and BIND, a company that works with
synthesis and characterisation of analytical standards, such as degradation product, azides, and nitrosamines.

Dr. Arianna Bassan, IT | Principal Consultant | Innovatune

Arianna Bassan is a chemist with long-term expertise in toxicology. She graduated from the University of Padova (Italy) and she earned her PhD in chemical physics at the
department of physics of Stockholm University (Sweden). She had worked several years in international environments including Stockholm University, MSD/Merck&Co., and
the European Commission. Her main interest lies in the use of computational toxicology for human health hazard assessment. She also led several different scientific projects
with focus on data management (e.g., development of the EFSA’s hazard database known now as OpenFoodTox, and management of pre-clinical data for pharma) and data
curation. She is currently principal consultant in Innovatune, where she is also partner in the firm. She provides integrated toxicology services making the most of (Q)SAR and
read-across methodologies for different applications including regulatory submissions (e.g. ICH M7) and product development. She is engaged in numerous activities aiming
at standardising industrial and regulatory applications of computational toxicology. She is currently involved in different projects such as the update of the EFSA pesticides
genotoxicity database and the EMA-funded research project MutaMind (led by Fraunhofer ITEM) that aims at shedding light on the mutagenicity of different classes of
nitrosamines to distinguish highly potent from less potent carcinogens.

Dr. Dana Lena Budde, DE | Scientist Biocompatibility Testing | Product Development Bioreactor Characterization | Sartorius Stedim Biotech GmbH
Dr. Dana Budde graduated in biotechnology from Bielefeld University. She works at Sartorius Stedim Biotech as the technical lead for in-house biocompatibility testing. Her
work focusses on in-vitro cell compatibility assessment of single-use material and the cytotoxicity of extractables and leachables. Her work highlights the importance of
leachables evaluation in the context of cell and gene therapy, publishing her research in several peer-reviewed journals.

2023 Vonlanthen Group of Companies. All Rights Reserved.

 Speakers Biographies
March 15-16, 2023 | MILAN, ITALY & ONLINE (CET) | #VLgenotoxic

Dr. Rodney Parsons, US | Executive Director, Chemical Development | Bristol Myers Squibb
Dr. Rodney Parsons earned his bachelor’s degree in chemistry in 1986 from Trinity College and then received his PhD in 1992 from the University of Vermont under the
guidance of Professor Martin E. Kuehne. His doctoral studies were focussed on the development of novel routes for the construction of indole alkaloids. He then carried
out postdoctoral studies in organic chemistry with Professor Clayton H. Heathcock at the University of California at Berkeley. In 1994 he became a research scientist at
Dupont-Merck Pharmaceutical Co., where he eventually rose to the rank of director. In 2001, after the acquisition of the DuPont Pharmaceuticals Co., he joined Bristol-Myers
Squibb, where he is currently an executive director in the chemical process development department. He has been involved with drug development programs in a number
of therapeutic areas including virology, cardiovascular, oncology, and metabolic diseases. His research interests include pharmaceutical process R&D, asymmetric synthesis,
heterocyclic chemistry, and natural products total synthesis. He has been the BMS Mutagenic Impurity Assessment Committee (MIAC) chair since 2006. On the MIAC he leads
an R&D-wide committee to establish control strategies for mutagenic impurities and align BMS internal practices with the evolving health authority regulations. Most recently
he has led the end-to-end nitrosamine assessment and control process for the organisation. He has published over 40 papers and multiple patents in these areas.

Dr. Aloka Srinivasan, US | Principal and Managing Partner | RAAHA LLC

Aloka Srinivasan, PhD, is the principal and managing partner of RAAHA LLC (www.raahallc.com) and brings more than two decades of experience in the pharmaceutical
industry, including nine years of progressive experience with the US FDA in the office of generic drugs, Lupin Pharmaceuticals, Lachman Consultants, and PAREXEL
International. She provides strategic guidance to the pharmaceutical industry on regulatory and chemistry, manufacturing, and controls (CMC) for drug products and drug
substances at all stages of development and for all types of regulatory submissions. Aloka has supported the development of several new drugs and generics during her
tenure in PAREXEL and Lachman from the CMC and regulatory perspective. She has worked closely with the industry and FDA related to development and approval of several
complex 505(b)(2) applications as well as complex generic applications. She spearheaded the foundation of a division in FDA related to review of drug master files (DMF)
for drug substances under GDUFA and played a pivotal role in writing the FDA Guidance for Industry: Initial Completeness Assessments for Type II API DMFs Under GDUFA
and a QbR document for drugs substance, which is part of FDA Mapp. 5015.10. She was one of the main authors of the QbR-QOS (Question-based Review-Quality Overall
Summary) for ANDAs, which is the current basis of review of generis at CDER/FDA. Aloka is one of the world class experts in the area of nitrosamine impurities based on her
research background and has been supporting the industry in addressing these carcinogenic impurities in the drugs. Aloka received her PhD from the University of Missouri
(USA) under Dr. Richard N. Loeppky of nitrosamine fame. Her thesis was titled “A study of putative intermediates involved in the activation of beta-oxidized nitrosamines and
nitrosation of N-substituted aziridines”. Aloka also spent seven years as a scientist at the National Cancer Institute, working for Dr. Larry K. Keefer, researching on nitrosamines
in potential nitric oxide donor drugs.

Marina Couva, CY | QPPV | Medochemie Ltd

Marina Couva has a lot of experience in the pharmaceutical industry in the fields of both quality and safety. She is a pharmacy graduate, a registered pharmacist in Cyprus,
and also holds a master’s degree in management. She has served in a number of positions in Medochemie Ltd, a generics pharmaceutical company with headquarters in
Lemesos (Limassol), Cyprus. She is a qualified person and currently holds the role of the QPPV, as well as the position of group quality senior manager, responsible for GDP.
Her experience spreads across many issues relating to GxP compliance, combining quality and safety.

Dr. Markus Obkircher, CH | Director, Research & Development | Merck Life Science
Markus Obkircher is director of R&D, heading Merck’s reference materials and proficiency testing division with teams in the US and Switzerland. He is responsible for the in-
house development of new analytical standards and certified reference materials under ISO/IEC 17025 and ISO 17034 double accreditation. Prior to this position he was R&D
manager in Buchs, Switzerland, with a strong focus on synthesis, characterisation, and certification of reference materials. He joined Merck/Sigma-Aldrich eight years ago after
heading the development unit for a custom API manufacturer. He completed his post-doctoral studies at Harvard in Boston, USA, and his PhD thesis in Basel, Switzerland, and
further holds an executive MBA degree from the University of Zurich.

Dr. Joerg Schlingemann, DE | Director, Principal Expert Quality Control Systems | Merck Healthcare KGaA
Joerg Schlingemann is a director and principal expert for quality control systems within Merck KGaA’s/EMD Serono’s healthcare quality unit. He studied molecular biology in
Uppsala and Heidelberg, where he completed a doctorate degree at the German Cancer Research Center in 2005. He has 14 years of experience in the pharmaceutical industry
from various roles within quality control and quality assurance. Since late 2019, Joerg has been leading EMD Serono’s analytical activities for N-nitrosamines, based on which
he has authored or co-authored several scientific publications dealing with analytical challenges, NDMA in metformin, nitrite in excipients and the prevalence of NDSRIs. Joerg
is an advocate of scientific collaboration, data sharing and expressive visualisation of data. He is married and has three children.

Dr. Michael Burns, UK | Principal Research Scientist – Mirabilis Lead | Lhasa Limited
Michael Burns joined Lhasa Limited in 2015 as part of the Mirabilis project, aiding the research and curation of knowledge relevant to understanding the potential for purging
of mutagenic impurities from drug substance syntheses. In 2017, Michael took over leadership of the scientific development of Mirabilis, working closely with leading members
of the purge calculation community to develop both Mirabilis and the broader purge concept. More recently, Michael has been involved with a number of projects focussing on
the ongoing nitrosamine challenges facing the pharma industry. As part of this work Michael has been working with academic institutions and industry bodies, such as the IQ
consortium and USP, to find collaborative approaches to both understanding and subsequently addressing nitrosamine issues related to drug quality.

Dr. Karl Abele, CH | Principal Scientist for HRAM-LC/GC/MS | Solvias AG

Karl Abele studied organic chemistry with a PhD in 1988 and has been using hyphenated GC/MS and LC/MS quadrupole systems since 1985. He worked for three main MS
manufacturers as an application chemist or product manager from 1990-08, using quadrupoles, triple quadrupoles, ion traps, and time-of-flight instruments. In 2010, he joined
Solvias AG, a Swiss contract research organisation with > 800 FTEs today, located in Switzerland, France, and in the USA. Karl has been leading the Solvias E&L team in Switzerland
since 2010, and established HRAM-LC/MS/MS systems (Q-Exactive Orbitrap and Exploris MS) and HRAM-GC/MS (Exploris MS) as main tool for impurity ID and quantification at
trace level. Today, the team has in total six Orbitrap systems qualified for GMP and is validating up to 50 trace analysis methods per year for a wide range of pharma manufacturers.

2023 Vonlanthen Group of Companies. All Rights Reserved.