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2nd Extractables and Leachables Live Event

  • 9th June 2021
  • Zoom flag Zoom
  • ONLINE

In the course of this 2nd E&L Live Event, we will explore the guideline updates, analytical testing innovations, and the impact of Extractables and Leachables (E&L) on biologics safety.

Let's address the current E&L challenges with experienced pharmaceutical professionals who will share their in-depth knowledge on various topics. Learn how to manage your E&L strategy and analyze testing techniques.

This event will provide a broad outlook and guidance on E&L including:

  • Latest technological developments
  • Regulatory landscape and requirements for E&L studies
  • E&L guidance on medical devices
  • Toxicological risk assessment of E&L
  • Biomanufacturing
Read more

About the Extractables and Leachables Event

In the course of this 2nd E&L Live Event, we will explore the guideline updates, analytical testing innovations, and the impact of Extractables and Leachables (E&L) on biologics safety.

Let’s address the current E&L challenges with experienced pharmaceutical professionals who will share their in-depth knowledge on various topics.

Join us on Wednesday, June 9th, 2021, at 12:00 p.m., and learn how to manage your E&L strategy and analyze testing techniques. 

We are bringing you seven live presentations on how to manage the E&L challenges and meet regulatory requirements. Led by subject-matter experts, who will cover exciting topics that are gaining increased attention in the industry with an emphasis on understanding the best practices for an effective and efficient E&L analytical testing innovations and impact on biologics safety.

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Principal Scientists, Chemists, Engineers and Fellows specializing in:

  • Bioprocessing
  • Container Development
  • CMC
  • Device Engineering
  • Extractables and Leachables/E&L
  • Formulation
  • Materials Science
  • Materials Selection
  • Manufacturing Science and Technology
  • Medical Devices
  • Parenterals
  • Packaging and Labelling
  • Product and Process Development
  • Pharmaceutical Analysis
  • QA/QC
  • Regulatory Affairs
  • Safety Assessments
  • Standardization
  • Testing
  • Toxicology

Industry

  • Pharmaceuticals
  • Biotechnology
  • Medical Devices

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

Key Practical Learning Points

  • Latest technological developments
  • Regulatory landscape and requirements for E&L studies
  • E&L guidance on medical devices
  • Toxicological risk assessment of E&L
  • Biomanufacturing

Dr. Simone Biel, DE

Senior Regulatory Consultant

Merck KGaA

Simone is a Regulatory Expert at Merck Life Science and provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on Single-Use Technology (SUT). Over the last years, Simone supported biopharmaceutical drug manufacturer’s implementation of SUT in their manufacturing process.

With her deep understanding of SUT market needs and industry trends, she acts as a subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in Microbiology. 

Dr. Reinhard Stidl, AT

Senior Toxicologist

Safetree Consulting e.U.

Dr. Reinhard Stidl is Managing Director of the independent consultancy office Safetree Consulting e.U., founded in 2018. Reinhard holds a Master in Chemistry (University of Vienna, 2002), a PhD in Chemistry (University of Vienna, 2007), a Master of Advanced Studies Toxicology (Medical University of Vienna, 2007) and is EUROTOX registered toxicologist (ERT) since 2011. Before working as a consultant, he gained more than 10 years of experience as a Toxicological Risk Assessor and team leader at Baxter, Baxalta, and Shire, where his last assignment was Associate Director Toxicological Risk Assessments.

 Dr. Stidl is an internationally known expert in chemical safety assessment in the context of pharmaceuticals since 2010, with a strong focus on extractables and leachables (E&L). During the assignments in the pharmaceutical industry, he was responsible for the global design and refinement of the global safety assessment strategy within Baxter, Baxalta, and Shire. Today, he provides his expertise to clients around the world, assisting in making pharmaceutical and medical products safe for patients.

DR. ANDREAS NIXDORF, DE

Business Development Manager

SGS Life Science Services

Andreas studied organic chemistry at the University of Bielefeld in Germany, with the main focus on mass spectrometry and computational chemistry. Since the date of his Ph.D./doctorate in 1997, he worked in different scientific and managerial positions, ranging from the head of a laboratory to GMP QA site manager in the Life Science industry, prior to proceeding with his carrier at SGS in 2007. From 2007 to 2010, he was responsible for project management and regulatory consultancy at the customer service Pharma at SGS Institute Fresenius GmbH. Andreas introduced Extractables & Leachables testing services for both medical devices and pharmaceutical applications at SGS in 2008 and got his current position as a business development manager in 2010. 

Andreas applies technical and regulatory knowledge, scientific experience, and expert judgment to address a broad range of difficult problems. He troubleshoots and directs the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships with clients from the pharmaceutical and medical industry. 

With over 25 years’ experience in the Life Science segment, he is a frequent speaker at events and international conferences (PDA, A3P, ECA, VDI, BioInnovation, CPHI, Smithers RAPRA, IQPC, Vonlanthen Group, Chinese Medical Device Association, Dipartimento di Scienze del Farmaco in Pavia and others) in the fields of Medical Devices, Single Use Systems and Finished Packaging safety evaluation. Companies in regulatory-controlled industries are challenged by ongoing regulatory systems. Changes must be set in practice, and cross-functional teams with different functional expertise must be organized to work toward a common goal. Andreas wants to motivate experts from the Life Industry or organizations to work together to realize or achieve a better and effective cross-departmental collaboration to improve regulatory requirements for safety testing of plastic materials that are used to produce the medical product.

Mike Ludlow, UK

Science Lead, Analytical & Material Sciences

LGC

Mike has over 25 years of experience as an analytical chemist specializing in the characterization of pharmaceutical drug products, storage devices, and delivery systems. He joined LGC in 1998 as part of a multi-disciplinary chromatography and spectroscopy function and has played a key role in establishing the current E&L testing services within LGC’s Drug Development Solutions Group. Mike is a regular contributor to events concerning E&L and traces impurity analysis.

Ron Brown, US

Owner and Principal Toxicologist

Risk Science Consortium

Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and provides support for companies developing New Approach Methods (NAMs) that can serve as alternatives to animals models for toxicity testing. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is a founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis. 

Dr. Elizabeth Martin, UK

Strategic Impurities Toxicology Lead / Regulatory Safety Centre of Excellence

AstraZeneca

Dr. Elizabeth Martin is a European Registered Toxicologist and gained her Ph.D. at the University of Wales, Swansea. She joined the Medical Research Council Toxicology Unit in 1992 and led a research group focused on assessing the importance and consequences of DNA damage and the use of DNA adducts as markers for predicting carcinogenic risk. Dr. Martin joined AstraZeneca as a Genetic Toxicologist in 2001; in 2008 moved into a role as a Project Toxicologist and began supporting all projects with the safety assessment of impurities and Extractables & Leachables. Currently based in Cambridge, UK, Dr. Martin is a late-stage Project Toxicologist and the Strategic Impurities Toxicology Lead. 

Dr. Tino Otte, CH

Head of Sales and Consulting

Intertek (Schweiz) AG

Dr. Tino Otte is the Head of Sales and Consulting at Intertek in Switzerland. He joined the company in 2016. Tino is specialized in Extractables & Leachables Studies, Impurity Characterization, and Method Development. Tino has more than 13 years of experience in Analytical Chemistry, Pharmaceuticals, and Polymer Characterization. He holds a degree in Polymer-Chemistry from the University of Halle/Saale and a Ph.D. from the Darmstadt Technical University, where he graduated in 2010. Prior to joining Intertek, he worked at different CROs and Laboratory Instrument Manufacturers in Switzerland and Germany.

Dr. Simone Biel, DE

Senior Regulatory Consultant

Merck KGaA

Dr. Reinhard Stidl, AT

Senior Toxicologist

Safetree Consulting e.U.

DR. ANDREAS NIXDORF, DE

Business Development Manager

SGS Life Science Services

Mike Ludlow, UK

Science Lead, Analytical & Material Sciences

LGC

Ron Brown, US

Owner and Principal Toxicologist

Risk Science Consortium

Dr. Elizabeth Martin, UK

Strategic Impurities Toxicology Lead / Regulatory Safety Centre of Excellence

AstraZeneca

Dr. Tino Otte, CH

Head of Sales and Consulting

Intertek (Schweiz) AG

BROCHURE 

Request the 2nd Extractables and Leachables Event brochure and find out the latest topics and ideas that will be shared.

Request

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What our
participants
are saying

I absolutely enjoyed the meeting with such a focused topic.

 

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Brinda Mahadevan

Director, Global Pre-clinical Development at Abbott Laboratories

Well organized and thoroughly enjoyed event. All presentations were excellent, and the online format well executed.

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PAST

Attendee

Thanks a lot for all your organization which made this summit a real success.

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Simone Carrara

E&L Laboratory Manager at Eurofins Biopharma Product Testing Italy