Learn more about the latest developments
on pharmaceutical excipients and discuss
with experts from across the value chain.
Learn more about the latest developments
on pharmaceutical excipients and discuss
with experts from across the value chain.
| Programme subject to change | ||
| 9:00 | Opening Remarks | |
| Frithjof Holtz, Merck / Chair, IPEC Europe | ||
| MORNING SESSION | ||
| 9:10 | Updates from the EDQM and the European Pharmacopoeia | |
| Petra Doerr, EDQM | ||
| 9:50 | Novel Excipients – the need, regulatory challenge and FDA Pilot Review program | |
| Nigel Langley, BASF USA | ||
| 10:30 | Coffee Break | |
| 11:00 | Comparison of Pharmaceutical Excipients and Food Ingredient Requirements | |
| Matthias Rheinheimer, Merck | ||
| 11:40 | Co-processed excipients: Regulatory environment in Europe | |
| Christian Becker, BASF and Darek Lewin, JRS Pharma | ||
| 12:20 | Q&A – Morning session | |
| 12:35 | Lunch Break | |
| AFTERNOON SESSION | ||
| 13:30 | How to Ensure Pharmaceutical Product Success through Excipient QbD Efforts | |
| Mohammad Qadir, IFF | ||
| 14:10 | Lipid Excipients in mRNA delivery | |
| Lars Albermann, Merck | ||
| 15:00 | Coffee Break | |
| 15:30 | Stability understanding of excipients for solid-based biopharmaceutical products | |
| Wouter Hinrichs, University of Groningen | ||
| 16:10 | A regulatory update on Titanium Dioxide | |
| Kevin Hughes, Colorcon | ||
| 16:40 | Q&A – Afternoon session | |
| 16:55 | Closing Remarks | |
| Frithjof Holtz, Merck / Chair, IPEC Europe | ||
Frithjof Holtz is a biologist and has been working for almost 30 years with Merck KGaA, Darmstadt, Germany, having many years of experience in quality assurance and regulatory affairs. Besides experience in chemical manufacturing (excipients/APIs) he has also working experience in quality assurance for drug products (sterile/non-sterile). Furthermore, he is now working for almost 15 years in Regulatory Affairs (CMC) for pharmaceutical starting materials. Currently he is responsible for the coordination of the advocacy & surveillance activities of Merck Life Science.
Dr. Petra Doerr (pharm. D; PhD) is the Director of the European Directorate for the Quality of Medicines and HealthCare (EDQM), since October 2021. Following the first ten years in the medical products industry, working in international regulatory affairs, she joined Swissmedic, Swiss Agency for Therapeutic Products, in October 2004 as the Head of International Affairs. In 2007, she became a member of the management board and from 2014 to 2019, she served as Head of Communication & Networking and Deputy Executive Director. From July 2019 to October 2020, she provided consultancy services to the WHO, and then joined that WHO as the Head of Unit Regulation and Safety in November 2020.
Nigel Langley is the current Chair of IPEC-Americas (2022-2024) and Global Technology Director, BASF Pharma Solutions. Dr. Langley has contributed to more than 100 scientific publications and received the IPEC Foundation Award for Industry Research Achievements in Excipient Technology in 2018. He has been included on the Medicine Maker Power List for small molecules in 2020, 2021 & 2022.
Dr. Matthias Rheinheimer works as Senior Consultant – Food Quality & Regulatory Compliance at the Life Science business of Merck KGaA, Darmstadt, in the Regulatory Management team. As an expert for pharma and food materials, he is working on various projects in product development and maintenance, marketing initiatives, customer service, quality, and supplier qualification.
Christian Becker studied pharmacy at the Ruprecht-Karls-University in Heidelberg, Germany.
He joined BASF in 2004 and gained a global expert function in Regulatory Affairs with a focus on Novel Excipients and co-processed excipients.
Darek Lewin graduated in “Technology of Renewable Raw Materials” in 2001 at the University of Applied Sciences Hannover. In 2003, he was employed as the Project Manager for “Microencapsulation of Probiotic Bacteria” at J. Rettenmaier & Söhne GmbH & Co KG, Rosenberg, Germany, a world-wide, dynamic leader in the fiber industry. JRS provides with their fiber products solutions for various applications and chemical processes for almost every field of daily life, i.e. for pharmaceutical and food applications, or for 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 GmbH & Co KG. JRS Pharma is currently the biggest producer of Microcrystalline Cellulose worldwide. Additionally, JRS Pharma serves the pharmaceutical industry with a family of high functional solid excipients. Since 2007, Darek Lewin is the Head of Quality for the JRS Group with production plants in Europe, USA, India, China and Mexico.
Mohammad Qadir holds a degree in Pharmacy, a Master’s in Pharmaceutical Analysis and a PhD in Drug Delivery and Formulation Design.
Dr. Qadir has over 14 years of experience in the pharmaceutical industry and academia, particularly in formulation design and delivery of various dosage forms. His focused areas and expertise are in controlled, sustained, delayed and pulsatile delivery. He mostly worked in R&D and possess extensive experience in drug product and combined device development from proof of concept to clinical trials. He previously worked with multinational companies within the UK and abroad. In his current role he is actively involved in new product development, application development work and multivariate analysis.
Originally a molecular biologist, for the last 14 years Lars Albermann has been working in several regulatory positions in pharmaceutical industry as well as contributing to a number of industry associations. Currently, he is responsible for a team of regulatory experts in Merck Life Science Regulatory Management working on regulatory topics mainly related to APIs and excipients.
After a PhD at the University of Twente (The Netherlands), Dr. Hinrichs obtained a post-doc at the University of Twente and the Utrecht University. Dr. Hinrichs is a Senior researcher/lecturer at the Department of Pharmaceutical Technology and Biopharmacy at the University of Groningen. His research interests include: stabilization of biopharmaceuticals by spray drying and (spray) freeze drying, alternative dosage forms for dry/stabilized biopharmaceuticals and strategies to improve dissolution behaviour of lipophilic drugs.
Kevin Hughes has been with Colorcon for over 15 years where he has been the Technical Expert in film coating, immediate release excipients and extended release excipients. Now Regulatory Affairs and Quality Assurance Manager for Colorcon, he is responsible for the EMEA region, providing regulatory support to customers in both the pharmaceutical and food industries, monitoring any regulatory changes, industry initiatives and is closely involved with the IPEC Quality and Regulatory Affairs Committee. Mr. Hughes is also responsible for Quality at the Dartford site, and hosting of all customer and certification audits as well as conducting supplier audits as an IRCA qualified Lead Auditor.