Hosted by recognisable experts in GMP/GDP as well as research and innovation, the Excipients: Science, Quality & Safety Online Summit will provide an opportunity for pharmaceutical, nutraceutical, and excipient manufacturers, users and distributors to participate in an interactive discussion on the recent practices and expectations in the field.
Learn about the recent developments of novel excipients while meeting quality and regulatory/CMC requirements.
The brochure contains the additional info and key insights of the live event.Read more
The need for innovation in excipients innovation is stronger than ever before.
Selecting the appropriate inactive ingredients (excipients) to support the design of pharmaceutical formulation is a critical stage in the drug manufacturing process, and it can help decrease high development costs.
Control of excipient manufacturing and distribution, and meeting the appropriate GMP and GDP requirements, has become crucial. In order to guarantee the quality and safety of novel excipients and delivery systems, the corresponding risk control and mitigation strategies must be created in order to meet acceptance criteria. The regulatory constraints, including the lack of the established approval pathways, are continuing to be a problem in accelerating of excipients innovation.
While some ingredients are used as pharmaceutical excipients, a variety of them have applications as well in cosmetics and food industries. Although there might be an overlap in quality management systems and material specifications/requirements, many differences remain.
The excipients manufacturers, distributors, and users, as well as authorities, regulators, and other stakeholders, should intensively collaborate in order to boost excipients research and innovation and to bring to market safe and high-quality novel excipients.
The Excipients: Science, Quality & Safety Online (virtual spin-off of the 2nd annual summit) on 23 November 2021, delivered by professionals in the industry, will bring a LIVE and interactive approach to:
Join virtually for an interactive discussion and informative presentations, exploring industry experience and critical aspects, including recent regulations standards, testing strategy, and recommendations to establish purity, identity and quality, ways to meet formulation challenges, and supplier qualification issues.
After the event, you will receive a digital certificate of attendance.
Chief Executives, Vice Presidents, Directors, Heads, Leaders, and Managers specialising in:
DuPont Nutrition & Health - Pharma Excipients
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. Iain Moore is the global head of quality assurance at Croda International, a supplier of many types of high purity excipients. He has held a range of QA roles in Croda for over 25 years, including implementing ISO and GMP standards and hosting two regulatory inspections to API GMPs.
He has contributed to the publication of both European and US national standards, the famous IPEC-PQG GMP Guide for Pharmaceutical Excipients and the EFfCI GMP Guide for Cosmetic Ingredients. He was instrumental in the team that took the IPEC-PQG GMP Guide and converted it to the EXCiPACT Certification Scheme for Pharmaceutical Excipients.
He is the current chair of the EFFCI GMP committee and is the current president of the board of EXCiPACT asbl.
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 21 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.
Sunil Kumar Nataraj is a pharmaceutical professional with 12 years of international leadership for excipient new product development, testing, scale-up, and managing projects with on-the ground experience of driving formulation projects through internal/external stakeholders in USA, Germany, Netherlands, and India. Sunil held three roles within DFE Pharma across Germany, USA, and Netherlands in the capacity of technical manager from 2017-21. Sunil also held two roles within SPI Pharma, the most recent being technical manager for Asia from 2012-17 before moving to DFE Pharma in Germany. Sunil's research work includes twin-screw granulation for continuous manufacturing with Leistritz and publishing an industry awareness article on setting science and risk-based excipient specification.
Sunil is currently a freelance consultant helping customers by offering scientific affairs and excipient solutions for small molecule drug development from pre-formulation screening and ommercialisation to helping with managing post-approval changes.
David R. Schoneker is currently the president and owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specialising in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food, and related industries. The firm provides expert advice for difficult problems, GMP and supplier qualification auditing services, and training on excipient and food/color additive regulatory, quality, and supply chain concerns.
Prior to August 2019, David was the global regulatory director – strategic relationships at Colorcon, Inc. From 1995-2018 he was director of global regulatory affairs. Prior to 1995 he was director of quality assurance and quality control, where he coordinated all quality activities for Colorcon North America.
David has been active in many professional organisations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC, and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organisations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Consumer Health Products Association (CHPA), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN), and the Institute of Food Technologists (IFT).
He was the chairman of IPEC-Americas from 2007-09 and is currently a member of the executive committee. He is now serving as the vice chair for science and regulatory policy, where he is actively involved with the development of regulatory, safety, excipient GMP, and supplier qualification-related guidelines to improve excipient acceptability, safety, and global supply chain security. David also co-chairs IPEC’s QbD/product development committee, composition committee, and IID working group. He also is a member of the board of directors of the IPEC Foundation. He is the global expansion coordinator for the IPEC Federation, and has been critically involved in the development of many of the IPEC groups and partnerships around the world.
In January 2020, David became an adjunct professor at the Temple University School of Pharmacy, where he teaches in the RA/QA masters program. He teaches the following courses: Regulation of Dietary Supplements and Functional Foods; Global Excipient Regulations.
Alvaro Goyanes is the co-founder and development director at FabRx, the first company focussed on developing 3D-printing technology for fabrication of personalised medicines and medical devices. He is also an honorary lecturer at University College London - School of Pharmacy (UK) and a part-time lecturer at the Faculty of Pharmacy - University of Santiago de Compostela (Spain). Alvaro is one of the first researchers to evaluate the opportunities of 3D printing using new 3D-printing technologies to manufacture oral dosage forms and medical devices. Alvaro has published more than 60 articles. He was listed amongst the world's most highly influential researchers in 2019 and 2020 by Web of Science and he is a recognised world expert in 3D printing of medicines with more than 100 communications to international conferences. He holds a PhD in pharmaceutics from the University of Santiago de Compostela (Spain) and he worked for three years as a registered pharmacist, thus having first-hand knowledge of the needs in terms of medicines in the pharmacy community.
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.
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 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.
DuPont Nutrition & Health - Pharma Excipients
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Thank you very much for the efforts made by you and your team to ensure the delivery of a high quality, interactive webinar.
Novel excipients are creating the significant hurdles for drug formulators. Thank you for such a great opportunity to learn more on the subject of excipients.
Thank you for accelerating the excipient innovation and qualification process through this professionally organized conference with the key experts in the area of excipients.