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Dr. Alina Martirosyan
B. Braun Melsungen A... B. Braun Melsungen AG (Germany)
Biocompatibilit... Biocompatibility subject matter expert
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Dr. Alina Martirosyan
B. Braun Melsungen AG (Germany)
Biocompatibility subject matter expert
Dr. Alina Martirosyan is experienced in non-clinical evaluation of medical devices and pharmaceuticals; is a Biocompatibility subject matter expert at B. Braun Melsungen AG (Germany).
As part of the biological risk assessment of medical devices she is planning, coordinating and managing the biocompatibility studies; performs toxicological evaluation and risk assessment of chemical constituents; deals with notified bodies and national agencies.
She holds a PhD degree in Biochemistry, is a European Registered Toxicologist (ERT), Delegate of American Board of Toxicology (DABT), and is acting as an expert in ISO/TC 194 for the 'Biological and clinical evaluation of medical devices'
Erika Udovic
Novartis Novartis
Senior Principa... Senior Principal Scientist
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Erika Udovic
Novartis
Senior Principal Scientist
Erika is currently working as a Senior Principal Scientist at Novartis, with experience in human health hazard and safety evaluations of pharmaceutical impurities, including extractables and leachables.
Her main responsibilities include providing scientific, toxicological, and regulatory support to ensure appropriate risk management.
She conducts safety assessments for various administration routes, using computational and read-across methodologies as needed.
Erika is a member in internal cross-functional teams and committees, as well as external consortiums such as the Safety Working Group within ELSIE.
Previously, she worked as an occupational toxicologist, compiling risk assessment reports for drug substances, intermediates, and raw materials for worker and patient safety purposes.
Erika has a background in Veterinary Medicine and found her passion in Toxicology
Dr Kai Zwingenberger
CSL Behring CSL Behring
Medical Directo... Medical Director Global Quality
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Dr Kai Zwingenberger
CSL Behring
Medical Director Global Quality
Kai is a physician holding postgraduate degrees in tropical medicine, immunology, toxicology and business administration.
During three decades in the pharmaceutical industry his roles spanned R&D, medical affairs, business development and quality.
Supporting quality in CSL Behring Inc Kai authored patient risk assessments including toxicological assessments of extractables/leachables for medical devices and packaging materials used for various routes of administration.
An area of special expertise is the assessment of potential interaction of drug impurities with the immune system including sensitization and immunogenicity of protein biotherapeutics.
Kai lives in Basel, Switzerland.
Dr. Ravi Kiran Kaja
US Pharmacopeia US Pharmacopeia
Senior Principa... Senior Principal Scientist, Complex Generics, Pharmaceutical Science
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Dr. Ravi Kiran Kaja
US Pharmacopeia
Senior Principal Scientist, Complex Generics, Pharmaceutical Science
Dr. Ravi Kiran Kaja is a distinguished researcher and dedicated scientist with a Ph.D. in Analytical Chemistry and over 20 years of experience in Pharmaceutical Analytical Research. His career is fuelled by a steadfast commitment to enhancing patient outcomes through innovative pharmaceutical solutions.
Ravi's expertise spans complex formulation characterization, Extractable & Leachable (E&L) studies, pharmaceutical manufacturing, and science and technology (MS&T) as well as technology transfer. He believes that collaboration and knowledge sharing are key to advancing the industry.
Key Contributions:
- Director of Formulation Analytical at a leading Japanese based company, where he expanded his team and adeptly managed over 200 E&L programs, consistently achieving success in rigorous FDA audits. His leadership fosters mentorship and a culture of excellence.
- Head of Formulation Analytical at a major generic pharmaceutical company, where he was instrumental in developing diverse dosage forms and supporting critical regulatory filings, including NDAs, 505(b)(2)s, and ANDAs. His strategic insights have been pivotal in navigating complex regulatory landscapes.
- Chief Research Scientist at a prominent innovator pharmaceutical company, leading numerous branded product characterization studies, including comprehensive E&L assessments. Ravi thrives on tackling challenging projects that push the boundaries of pharmaceutical science.
- Beyond his professional endeavours, Dr. Kaja is passionate about mentoring young scientists and engaging in community outreach to inspire the next generation of researchers. His unwavering dedication to both his work and the broader scientific community has earned him respect and admiration in the field.
William Bello Ph.D
CHUV | Lausanne univ... CHUV | Lausanne university hospital
Analytical Phar... Analytical Pharmacist | Quality Control Expert
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William Bello Ph.D
CHUV | Lausanne university hospital
Analytical Pharmacist | Quality Control Expert
William Bello is an analytical pharmacist and obtained his PhD degree in Hospital Pharmacy Extractables and Leachables (E&L) within the Pharmacy Department of the Lausanne University Hospital (Switzerland).
He is a quality control specialist as well as an analytical developer of validated analytical methods for stability studies of future compounded drug products in accordance with Pharmacopeial and ICH standards. During his PhD, he has become an expert in the E&L field in hospital pharmacy.
He has installed a quality screening system and a multi-purpose database named DELTA (Database for Extractable and Leachable Trace Assessment) to facilitate the monitoring and semiquantification of non-volatile leachable compounds found in hospital pharmacy-compounded drug products for safety risk assessment.
He evaluated the practice of hospital pharmacy compounding, by assessing the risk of current hospital pharmacy compoundings
Dr. Samuel N. Kikandi, PhD
Sanofi Sanofi
Deputy Director... Deputy Director (Principal Scientist)
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Dr. Samuel N. Kikandi, PhD
Sanofi
Deputy Director (Principal Scientist)
Received PhD in Analytical Chemistry from State University of New York at Binghamton NY, USA.
Have 14 years in the pharmaceutical industry working across multiple functions including biochemistry laboratories.
Currently a Deputy Director- Principal Engineer, leading Material Science and E&L programs at Sanofi Inc.
Participates in industry organizations including ELSIE (Extractables and Leachables Safety Information Exchange) and BioPhorum teams of Experts discussing USP665 and USP661 vs USP661.1/661.2 among other topics.
About The Event (#extractables)
The Global Extractables & Leachables Forum is a leading conference dedicated to addressing the challenges and innovations in the field of extractables and leachables (E&L) in pharmaceuticals, food packaging, and other industries. This forum serves as a platform for industry experts, researchers, regulatory authorities, and professionals to come together to discuss the latest advancements, regulatory requirements, best practices, and emerging trends in E&L studies.
The Global Extractables & Leachables Forum offers a comprehensive program featuring keynote presentations, panel discussions, case studies, workshops, and networking sessions. Participants will have the opportunity to engage with renowned experts, gain valuable insights, and exchange knowledge with peers from around the world.
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35+
Speakers
150+
Attendees
10+
Sponsors
Event Partners
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Leadvent Startup Innovate
Get your solution and product noticed by showcasing your tech products and pitching to a large-scale targeted audience.
There are two ways to participate in Startup Innovate: either as a paid exhibitor or Free marketing partner. As a marketing partner, you will be required to announce the event on your company website, release article about the event, release email marketing campaigns to reach out for potential delegates and send dedicated social media posts on Linkedin , Twitter& other SM handle. Learn more.
EXHIBITOR PLUS
EVENT ORGANIZER
FEATURED COMPANIES
Event Inclusions
PEER ENGAGEMENT
Engage industry peers and share best practices across value chain.
CONTENT AND RECORDINGS
Access to all recordings after the event is over and all presentation slides!
EXHIBITION
Benefit from the exhibition on site, where topic-specific products and services will be displayed!
MEET THE SPEAKERS
During the breaks, the speakers will be available for your individual questions and further discussions.
INDUSTRY INSIGHTS
Gain valuable insights into the latest project developments and opportunities
NETWORKING
Connect with top industry professionals from around the country
Event Details
About the event
Extractables & Leachables (E&L) refer to the study of potential chemical compounds that can migrate from a product, such as a drug delivery systems, packaging, or medical devices, into the environment or directly into the patient. Extractables are chemical compounds that can be extracted from a product under laboratory conditions. Meanwhile, Leachables are compounds that migrate from drug delivery systems, packaging or manufacturing equipment into the drug that is administered to patients
Extractables and leachables examination is continuously growing in importance. Given the current scrutiny paid by governing bodies including the FDA and MHRA, understanding the best practice and guidelines to carry out extractables and leachables studies is imperative in order to eliminate risk and potential development delays.
The Global Extractables & Leachables Forum is a pivotal event in the field, offering two days of intensive discussions, knowledge sharing, and networking opportunities. With a diverse lineup of sessions, attendees will gain valuable insights and practical strategies to address the complex challenges associated with extractables and leachables.
The Global Extractables & Leachables meeting will feature keynote presentations by renowned experts, providing attendees with an overview of the latest regulatory developments, technological advancements, and emerging trends in E&L studies. Panel discussions will delve deeper into specific topics, allowing participants to engage in interactive exchanges with industry leaders and regulatory authorities.
Case studies presented during the forum will offer real-world examples of E&L challenges and solutions, providing valuable lessons learned and best practices for attendees to apply in their own work. Interactive workshops will provide hands-on experience with analytical techniques and methodologies, enabling participants to enhance their skills and capabilities in E&L analysis.
Networking opportunities throughout the forum will allow attendees to connect with peers, exchange ideas, and establish collaborations that can drive innovation and progress in the field. By leveraging the collective expertise and experience of the global E&L community, participants will be better equipped to address current and future challenges in ensuring the safety and quality of pharmaceuticals, food products, and other consumer goods.
The Global Extractables & Leachables Event offers a unique opportunity for industry professionals to come together, share knowledge, and advance the field of E&L studies. By participating in this forum, attendees will gain valuable insights, practical strategies, and networking opportunities that will enable them to address the complex challenges associated with extractables and leachables and contribute to the safety and quality of pharmaceuticals, food products, and other consumer goods on a global scale.
The Extractables and Leachables (E&L) conference is the premier platform for exploring cutting-edge research, regulatory updates, and practical strategies in the E&L field. This hybrid 2 days event will bring together industry leaders, regulatory bodies, and scientific experts to share insights, discuss challenges, and collaborate on innovative solutions.
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At the Leadvent Group conference you can request and organize your appointments by using a matchmaking app. Through the networking tool, each participant can create an individual profile. Guided by categories and keywords, attendees can search, find and approach interesting contacts. There will also be a networking area provided at the event of the conference. Your profile data and the details you provide are visible exclusively for registered participants within the event. You will oversee the information you would like to present and to whom. Our matchmaking app will be activated approximately one month prior to the conference and you will be notified vie e-mail as soon as you can start using the matchmaking App and can then set up your personal profile.
Sales End In
Event Registration For Delegate: Prices and Tickets
ENDUSER
Sale ends on 12-02-2025
Access to Speakers' Presentation
In-person Access to 2 Days Event
Access to Participants List
Networking & Interaction
1-1 Meetings
Q&A sessions
Event Documentation
Mobile & Web App Access
Coffee, Beverages & Snacks
Evening Reception Drinks
Lunch for 2 days
SERVICE PROVIDER
Sale ends on 12-02-2025
Access to Speakers' Presentation
In-person Access to 2 Days Event
Access to Participants List
Networking & Interaction
1-1 Meetings
Q&A sessions
Event Documentation
Mobile & Web App Access
Coffee, Beverages & Snacks
Evening Reception Drinks
Lunch for 2 days
GROUP TICKET - MINIMUM OF 3
Sale ends on 12-02-2025
Access to Speakers' Presentation
In-person Access to 2 Days Event
Access to Participants List
Networking & Interaction
1-1 Meetings
Q&A sessions
Event Documentation
Mobile & Web App Access
Coffee, Beverages & Snacks
Evening Reception Drinks
Lunch for 2 days
VIRTUAL PASS
Sale ends on 02-04-2025
Access to Speakers' Presentation
Virtual Access to 2 Days Event
Virtual Networking & Interaction
Q&A sessions
1-1 Meetings
Event Documentation
Mobile & Web App Access
Event Registration For Sponsor: Prices and Tickets
BRONZE SPONSOR
Sale ends on 12-02-2025
Acknowledgement as a bronze sponsor
2 complimentary in-person tickets
Speaking slot: 30 Minute
Banner Display
Logo on the event website & brochure
¼ page space for company profile or advertisement
Social media acknowledgement and recognition
Promotional material distribution and display
Full access to delegate list
Mobile & Web App (Lead Generation)
EXHIBITOR PREMIUM
Sale ends on 12-02-2025
Acknowledgement as a exhibitor premium
3 complimentary in-person tickets
Banner Display
Logo on the event website & brochure
¼ page space for company profile or advertisement
Social media acknowledgement and recognition
Promotional material distribution and display
Full access to delegate list
Mobile & Web App (Lead Generation)
EXHIBITOR PLUS
Sale ends on 12-02-2025
Acknowledgement as a Exhibitor Plus
2 complimentary in-person tickets
Banner Display
Logo on the event website & brochure
¼ page space for company profile or advertisement
Social media acknowledgement and recognition
Promotional material distribution and display
Full access to delegate list
Mobile & Web App (Lead Generation)
EXHIBITOR
Sale ends on 12-02-2025
Acknowledgement as a Exhibitor
1 complimentary in-person tickets
Banner Display
Logo on the event website & brochure
¼ page space for company profile or advertisement
Social media acknowledgement and recognition
Promotional material distribution and display
Full access to delegate list
Mobile & Web App (Lead Generation)
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Hotel & Venue
We will confirm the venue approximately 3-6 weeks prior to the event date and we will negotiate discounted room rate for conference attendees
Join us in Amsterdam on the 2nd - 3rd April, 2025
Venue:
( TBA ) -
Address:
Amsterdam, Amsterdam
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