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Pharma

Excipients: Science, Quality & Safety Live Event

  • 7th October 2020
  • Webex flag Webex
  • ONLINE

Hosted by the experts in GMP/GDP, Excipients: science, quality & safety LIVE event will provide an opportunity for pharmaceutical, nutraceutical, and excipient manufacturers, and excipient distributors to participate in the interactive discussion on the recent practice and expectations in the field.

Learn more about the development of novel excipients, and meeting quality, and regulatory / CMC requirements in the area.

The brochure contains the additional info and key insights of the live event.

Read more

About the Excipients: Science, Quality & Safety Event

Inactive ingredients, excipients, are vital in the manufacturing of biopharmaceuticals and in the formulation of small molecule and biopharmaceutical products, for a drug to be safe and effective.   

Control of excipient manufacturing and distribution is now considered a key priority. Therefore, the appropriate GMP and GDP requirements should be met. The corresponding risk control and mitigation strategies to be established, to guarantee the quality and safety, for novel excipients and delivery systems as well.   

Some ingredients used as pharmaceutical excipients have applications in dietary supplements or food ingredient markets. Although there might be an overlap in quality management systems and material specifications/requirements, many differences remain. 

Excipients: science, quality & safety LIVE webinar on 7 October 2020, delivered by the professionals in the industry, will bring an interactive approach to:  

  • learn from subject-specific case studies
  • exchange expert knowledge and expectations 
  • get guidance and professional advice, addressing critical aspects in R&D innovations
  • clarify regulatory / CMC guidelines

Join virtually an interactive discussion and practical presentations, exploring industry experience and critical aspects, including recent regulations standards, testing strategy, and recommendations to establish purity, identity and quality, meeting formulation challenges, and supplier qualification issues.  

Learn from the industry experts, since it is becoming the key to guaranteeing a high-quality nutritional product or medication.  

After the event, you will receive a digital certificate of attendance.   

Who should attend 

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

  • Analytical Chemistry 
  • Biologics 
  • Clinical Testing 
  • CMC (Chemistry, Manufacturing, and Controls) 
  • Drug Delivery 
  • Ingredients 
  • Formulation 
  • Generics 
  • Good Distribution Practice (GDP) 
  • Good Laboratories Practice (GLP 
  • Good Manufacturing Practice (GMP) 
  • Laboratory Services 
  • Lifecycle Management 
  • Manufacturing 
  • Market Authorisation 
  • Marketing 
  • Packaging 
  • Processing 
  • Product Management 
  • Product Development 
  • Purchasing 
  • Quality Assurance (QA) 
  • Quality by Design (QbD) 
  • Quality Control (QC) 
  • Raw Materials 
  • Research & Development 
  • Regulatory  
  • Risk Management 
  • Sales 
  • Scale-up 
  • Science 
  • Supply Chain 
  • Toxicology 

KEY PRACTICAL LEARNING POINTS

  • Advancing excipients science, research, and innovations
  • Applying regulatory standards and leveraging authorities' expectations 
  • Establishing an appropriate risk control and mitigation strategy
  • Meeting requirements for GMP-compliant manufacturing

Darek Lewin, DE

Head of Quality

JRS Group

Darek graduated in “Technology of Renewable Raw Materials” in 2001 at the University of Applied Sciences Hannover. In 2003, he was employed as Project Manager for “Microencapsulation of Probiotic Bacteria” at J.Rettenmaier & Söhne GmbH & Co KG, Rosenberg, Germany a worldwide, dynamic leader in the fiber industry. JRS provides its fiber products solutions for various applications and chemical processes for almost every field of daily life, i.e., for pharmaceutical and food applications, or technical and industrial use.   

From 2004 to 2006, he was responsible as the Food and Feed Safety Manager and then as Corporate Quality Manager for JRS Pharma. JRS Pharma is a leading manufacturer of excipients. It offers a complete portfolio of solutions for the global health science industry with high functionality excipients, binders, disintegrants, lubricants, and functional fillers thickeners, stabilizers, carriers, and coatings.  

Since 2007, Darek is the Head of Quality for the JRS Group with production plants in Europe, the USA, India, China, and Mexico.

Dr. Christian Trendelenburg, CH

Associate Director

Novartis Institutes for Biomedical Research 

Christian-Friedrich Trendelenburg is a senior toxicologist in Preclinical Safety (PCS) at the Novartis Institutes for Biomedical Research (NIBR) in Basel/Switzerland. He is a scientific expert for the safety evaluation of impurities, extractables/leachables, and excipients, with a major focus on the safety evaluation of pharmaceutical products for children. As a Preclinical Safety project leader in the Neuroscience and Global Health therapeutic areas, he represents PCS in global project teams to support drug development by summarizing, evaluating, and interpreting nonclinical safety aspects. He graduated in biochemistry from the University of Kaiserslautern/Germany and has a PhD (Dr. rer. nat.) in Toxicology. Christian has a strong background in all areas of safety sciences, including agrochemical, food, chemical (home & personal care), and pharmaceutical products. He is a EUROTOX-certified toxicologist and member of the German and Swiss toxicological societies (DGPT & SST). 

Dr. John C. Shelley, US

Schrödinger Fellow

Schrödinger, LLC 

John earned an MSc from the University of Waterloo in theoretical chemistry and a PhD from the University of Pennsylvania in computational chemistry. Following post-doctoral research in computational chemistry at the University of British Columbia, he worked for Procter & Gamble studying surfactants' structures in solution. For the last 18 years, John has worked for Schrödinger, LLC, as a scientific software developer and a research scientist, managing several products, including the Materials Science Coarse-Grained product. 

Dr. Matthias Knarr, DE

T&I Synthesis & Characterization

DuPont Nutrition & Health - Pharma Excipients 

Dr. Matthias Knarr studied chemistry at the University of Hamburg and holds a Ph.D. from the Institute for Technical & Macromolecular Chemistry. He has been working for Dow since 2005 at the Bomlitz R&D Center in Germany. Matthias Knarr leads the lab for the pressurized synthesis of new cellulose ethers as well as the labs for the applied material characteristics for many years and he is now focusing his work on the development of new methods for improved characterization of the portfolio products and formulations containing those. Additionally, he supports various R&D projects with the focus of the development of new cellulose ether products according to the specific market needs and to tailor their performance based on structure-property relationships. 

Matthias Knarr authored 10 journal publications in e.g. Carbohydrate Polymers, Food Hydrocolloids, or Macromolecular Symposium; (co-) authored/presented more than 50 presentations on international events and holds more than > 60  US + EP &  JP granted patents.  

Besides this, he is also a certified Six Sigma Black Belt. 

Dr. Liliana Miinea, US

Technology Manager

Lubrizol Life Science Health 

Nick DiFranco, US

Market Manager – Long-Acting Drug Delivery

Lubrizol Life Science Health 

TBA

Shilpa Mistry-Patel, UK

Head of Pharma, UK & Ireland

Chemlink Specialities Ltd
(Harke Pharma)

Shilpa Mistry has completed her studies at De Montfort University in BSc Pharmaceutical and cosmetic sciences. Then she went to work for Elan Pharmaceuticals in Athlone, Ireland for two years as a formulation scientist working on solid dosage forms. Shilpa has then moved in working closely with excipients and has 17 years’ experience working within cellulose derivatives.

Darek Lewin, DE

Head of Quality

JRS Group

Dr. Christian Trendelenburg, CH

Associate Director

Novartis Institutes for Biomedical Research 

Dr. John C. Shelley, US

Schrödinger Fellow

Schrödinger, LLC 

Dr. Matthias Knarr, DE

T&I Synthesis & Characterization

DuPont Nutrition & Health - Pharma Excipients 

Dr. Liliana Miinea, US

Technology Manager

Lubrizol Life Science Health 

Nick DiFranco, US

Market Manager – Long-Acting Drug Delivery

Lubrizol Life Science Health 

Shilpa Mistry-Patel, UK

Head of Pharma, UK & Ireland

Chemlink Specialities Ltd
(Harke Pharma)

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What our
participants
are saying

“It is a great opportunity to connect with colleagues, share our experience and process with, and learn from our colleagues about their experience and process.” 

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Frank Liu

Head of Product Characterization and Risk Assessment (PCARA) Drug Safety Research and Evaluation (DSRE), R&D at Takeda

“Thanks a lot, to all the team and Vonlanthen organization which made this summit a real success.” 

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Simone Carrara

E&L Laboratory Manager at Eurofins Biopharma Product Testing Italy

“I absolutely enjoyed the meeting with such a focused topic.” 

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Brinda Mahadevan

Director, Global Pre-clinical Development at Abbott Laboratories