Name: Extractables & Leachables Europe 2021
Start: 17/11/2021 04:15 AM +00:00
End: 18/11/2021 10:00 PM +00:00

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&amp;D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec&rsquo;s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,600 collaborators from over 30 countries to improve the health of those in need &ndash; and to realize the vision that "every drug can be made and every disease can be treated."

WuXi AppTec Medical Device Testing

SCIEX delivers solutions for the precision detection and quantification of molecules, empowering our customers to protect and advance the wellness and safety of all. We have led the field of mass spectrometry for 50 years. From the launch of the first ever commercially successful triple quadrupole in 1981, we have developed groundbreaking technologies and solutions that influence life-changing research and outcomes.
Today, as part of the Danaher family of global life science and technology innovators, we continue to pioneer robust solutions in mass spectrometry and capillary electrophoresis. Our customers are able to quickly respond to environmental hazards, better understand biomarkers relevant to disease, improve patient care in the clinic, bring relevant drugs to market faster and keep food healthier and safer.
That&rsquo;s why thousands of life science experts around the world choose SCIEX to get the answers they can trust to better inform critical decisions that positively impact lives.&nbsp;

SCIEX

Solvias is a world leader in contract research, development and manufacturing. With headquarters near Basel, Switzerland, over 700 highly qualified employees take pride in delivering innovative analytical solutions that enable our customers in the pharmaceutical, biotech, medical device and cosmetic industries to bring safer and better products to market faster.

Solvias

Nelson Labs is the leading global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies.
Based in Belgium, Nelson Labs Europe is a Center of Excellence providing premium Extractables &amp; Leachables testing services to the pharmaceutical and medical device industries.

Nelson Labs

PPD&reg; Laboratories combines high-quality scientific expertise with industry-leading technologies supported by a commitment to exceptional quality. Our customers benefit from comprehensive lab services spanning bioanalytical, biomarkers, central lab, GMP and vaccine sciences. Our laboratory services accelerate pharmaceutical development for small molecules and biologics, allowing customers to make faster decisions about their compounds.

At this conference we work hand in hand with the RIC|Group.&nbsp;
On site you will be attended at the booth of the RIC|Group and online by the GERSTEL colleagues in Muelheim an der Ruhr.
Our Goal is to provide science and industry with high quality, technically advanced analytical systems that offer:
<ul>
<li>previously unattainable detection limits</li>
<li>automation and improved productivity</li>
<li>modular design focused on the needs of the customer&nbsp;</li>
<li>accurate and reproducible results</li>
<li>highest standards of design quality</li>
<li>environmentally responsible technologies</li>
</ul>
To cultivate close relationships with our customers enabling us to understand their needs and to provide solutions that help them be more successful.
To provide comprehensive application support and timely first class service using the latest logistics and communication technologies.
 Our dynamic team is always ready to meet the welcome challenges we constantly face, both from our steadily growing business and in the field of chemical analysis

GERSTEL

Whether you are evaluating pharmaceutical manufacturing equipment (such as single-use systems), container closure systems, delivery devices, or other medical devices, Eurofins companies offer a broad range of services to support extractables and leachables testing. With over 20 years of experience and more than 60 scientists dedicated to E&amp;L testing, we conduct hundreds of controlled extraction studies each year, along with the associated leachables stability studies.
We offer a variety of controlled extraction techniques to generate an extractable profile that will best match the intended use of the components being evaluated. In addition, we conduct simulated and real-time leachables studies to evaluate the presence of leachable compounds in the drug product. Our toxicologists can then evaluate the E&amp;L data to determine the impact to patient safety. If needed, we can use our extensive experience to successfully develop and validate fully GMP-compliant methods to monitor leachables in your drug product or intermediates.

Eurofins BioPharma Product Testing Italy

Smithers helps medical device and pharmaceutical product manufacturers bring innovative and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA.
Our experienced team will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO.
We can assist throughout your medical device product development.
Services include:
Extractables and leachables studies Device physical and functional testing Device verification and validation Product and packaging durability, integrity and stability testing Material selection, property characterisation, life prediction Failure analysis

Smithers

SGS enables the medical and health innovators to deliver life-changing solutions in the quickest, safest and most efficient way. Our E&amp;L centers of excellence in Europe, North America and Asia-Pacific offer a wide range of testing solutions to satisfy both local and global demands.&nbsp;

SGS Institut Fresenius GmbH

Day One - Welcome from Smithers

08:50 Chair's opening remarks 09:00 What's hot in E&amp;L? Latest feedback from Smithers' E&amp;L series in US, China and Europe 09:30 Panel discussion: Addressing the key knowledge gaps - what is the availability and status of guidance to address them? 10:00 Similarities and differences between chemical characterisation of medical devices and medicinal products 10:30 Going beyond the ISO 10993-18

Dr. Andrew Feilden

Carsten Worsøe

Michael Creese

Paolo Pescio

Jason Creasey

Thomas Egert

Alicja Sobańtka, PhD

Cheryl Stults

Day One: Session 1 - E&L Hot Topics & Session 2 - E&L for Medical Devices

Networking Break - Head to the Networking Lounge, visit our virtual Exhibition or attend one-to-one video meetings!

11:45 Chemical characterisation of medical devices - from a Notified Body perspective 12:15 Extractables and leachables journey for medical devices - planning for uncertainty, including regulatory and market considerations 12:45 Panel: Adapting to the new reality of chemical characterisation of devices 
&nbsp;

Dr. Christina Reufsteck

Sandi Schaible

Day One: Session 2 - E&L for Medical Devices

Networking Lunch - Head to the Networking Lounge, visit our virtual Exhibition or attend one-to-one video meetings!

14:00 Physics-based exposure models for medical device leachables 14:30 Extractables goes in-silico: The Extractables Management and Calculation Tool ExSim 15:00 The future role of Mass Transport Modelling in support of chemical safety risk assessments &nbsp; &nbsp;

Armin Hauk

David M. Saylor, Ph.D.

Day One: Session 3: Modelling of E&Ls

Day One: Session 3: Modelling of E&Ls (Part 2)

16:30 Development of non-mutagenic TTC values for parenteral L&amp;E substances: An ELSIE initiative 17:00 Framework for sensitisation assessment of extractables and leachables in pharmaceuticals 17:30 Panel discussion: Emerging toxicological issues for the safety assessment of E&amp;L compounds 18:15 Chair's day one summary and closing remarks

Agenda

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Carsten Worsøe

Michael Creese

Dr. Andrew Feilden

Paolo Pescio

Dr. Christina Reufsteck

Sandi Schaible

Thomas Egert

David M. Saylor, Ph.D.

Armin Hauk

Thomas Broschard

Patricia Parris

Dr. Bettine Boltres

Diane Paskiet

Ron Brown

Robert Malick

Dr. Martin Wåhlander

Petra Booij

Marine Lepoutre

Etienne Michel

Jason Creasey

Heike Schäfer-Grebe

Ulli Hohenester

Alicja Sobańtka, PhD

Christopher Houston

Bekhzod Djurakholov

Cheryl Stults

Ernst Bouvin

Gwen Manach

Ward D’Autry

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;}9 Booth