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.
| 9:00 | Opening Remarks | ||
| Amina Faham, IFF / Chair, IPEC Europe | |||
| MORNING SESSION Moderated by Frank Milek, Hedinger | |||
| 9:10 | Updates from the EDQM and the European Pharmacopoeia | ||
| Petra Doerr, EDQM | |||
| 9:50 | Establishment of standard system for pharmaceutical excipients: from ChP 2020 to further | ||
| Jiasheng Tu, China Pharmaceutical University | |||
| 10:30 | Coffee Break | ||
| 11:00 | USP’s Iterative approach to Excipients Standards Development and its application to novel excipients | ||
| Catherine Sheehan, US Pharmacopeia (USP) | |||
| 11:40 | Application of EXCiPACT Certification Scheme to Pharmaceutical Auxiliary Materials(PAMs) | ||
| Iain Moore, CRODA / immediate past President, EXCiPACT | |||
| 12:20 | Success through Excipient QbD Efforts – Your recipe for success | ||
| Mohammad Qadir, IFF | |||
| 13:00 | Lunch Break | ||
| PANEL SESSION Moderated by Adrian Bone, IPEC Europe | |||
| 14:00 | Sustainability and Excipients | ||
| Geertrui Haest, Cargill – Robert Williams, AstraZeneca – Petra Doerr, EDQM – Catherine Sheehan, USP | |||
| AFTERNOON SESSION Moderated by Mahmud Yunis, BIOGRUND | |||
| 15:00 | Developability Classification System (DCS): Enabling an Optimized Approach for Formulation of Poorly Soluble Molecules | ||
| Markus Lubda, Merck KGaA | |||
| 15:40 | Coffee Break | ||
| 16:00 | Pre-competitive data sharing to support ICH Q3D risk assessments | ||
| Grace Kocks, LHASA Limited | |||
| 16:40 | Nitrite & Nitrate and Nitrosamines in excipients and mitigation strategies – an Excipient supplier’s view | ||
| Rodrigo Arias, DFE Pharma | |||
| 17:20 | Q&A session | ||
| Mahmud Yunis, BIOGRUND and Frank Milek, Hedinger | |||
| 17:40 | Closing Remarks | ||
| Amina Faham, IFF / Chair, IPEC Europe | |||
Programme subject to change.
In order of appearance.
Amina is a highly effective senior leader with several years of experience in leadership, generating business growth thru technology expertise and creating value for customers utilizing business acumen. Amina earned a Ph.D. degree in Pharmaceutical Sciences from school of Pharmacy, University de la Mediterranean France. She has over 15 years of Healthcare industry experience and have worked for several pharmaceutical and chemical companies. Amina offers an array of skills in customer-centric cultures, logical problem solving, and cross-functional collaboration, team leadership, strengthening competitive position, business development and talent acquisition. Since 2022, Amina is Vice-President, Global Research & Development Pharma Solutions for International Flavors & Fragrances (IFF).
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.
Jiasheng Tu is the professor of pharmaceutics of China Pharmaceutical University, a supervisor of doctorate students. Dr. Tu has also served as the chair of CHP pharmaceutical excipient committee, an expert committee member of CHP, an expert committee member of pharmaceutical excipient of USP. Dr. Tu graduated from Beijing Medical University. He was awarded Ph.D. of pharmaceutics in China Pharmaceutical University at 1992 and did postdoctoral researches in University of the Pacific, CA, during 2001-2003.
Dr. Sheehan is currently the Senior Director of Growth Programs, Foods and Excipients under the Global Science and Standards Division at the United States Pharmacopeia (USP), Rockville, MD. In her current role, she supports USP’s mission and priority initiatives for strengthening the global supply of quality medicines and foods. Her responsibilities also include partnering through USP’s Stakeholder Engagement Model to improve awareness and advocating for adoption of new and up-to-date quality standards and related programs around the globe.
Dr Iain Moore is the Global Head of Quality Assurance at Croda International. He has contributed to the publication of European and US National Standards, many IPEC Guides and papers, and the EFfCI GMP Guide for Cosmetic Ingredients. He is the current chair of the EFFCI GMP Committee and is the immediate past President of the Board of EXCIPACT asbl.
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.
Adrian Bone is the Executive Secretary of the IPEC Federation. He graduated in Pharmacy from the University of London in 1979. Thereafter, he pursued a career of 35 years in the pharmaceutical industry working primarily in Quality assurance in several international roles. He also served as Chair of IPEC Europe for two terms and is currently the Senior Advisor for IPEC Europe.
Geertrui Haest is Scientific & Regulatory Affairs Manager EMEA at Cargill. Cargill has a broad range of products supplied to the pharmaceutical industry, both as excipients or active pharmaceutical ingredients.
She has more than three decades of experience in product development, application support to customers and regulatory support for EMEA markets.
Geertrui is an expert member of the carbohydrate working party of the EDQM and as such she is involved in the development of carbohydrate product monographs in the Ph. Eur.
As a member of IPEC Europe’s Quality and Regulatory Affairs working group, she is part of the team compiling IPEC’s new Sustainability chapter for the IPEC Excipient Information Package Guide.
Robert Williams is Director of Sustainability in AstraZeneca’s ONEProcurement team, working with the global supply chain to deliver AZ Sustainability goals
Lead on reducing Scope 3 emissions towards Net Zero, driving Responsible Supply Chain and supporting the Power of Diversity to inspire innovation
Focus on developing high performing supply chains to deliver truly sustainable business growth. Co-lead for PSCI Decarbonization Topic Team; lecturer in energy procurement for the Energy Institute; member of Durham University’s Energy & Industry Board (DEI).
Dr. Mahmud Yunis has been working for over 15 years at BIOGRUND in several positions. In his current function as Technical Director, he is responsible for preparing and implementing global strategic regulatory plan for BIOGRUND products and the strategic development of the Quality, Production and R&D department. He has a PhD degree in Analytical Chemistry from University of Muenster, Germany. Before joining BIOGRUND he worked for a consulting company on the area of GxP procedures and processes for five years.
Markus Lubda holds a PhD in Bio/Chemistry from the Technical University of Darmstadt, Germany and is by academical education a Biomolecular Engineer. He is responsible for the strategic development and positioning of an excipient portfolio for oral solid dosage form applications. Thereby the focus is to enhance solubility and bioavailability of the most challenging APIs with specifically engineered excipients.
Grace Kocks is a Principal Application Scientist in Lhasa Limited’s Applied Sciences Team. She joined Lhasa in 2013 as a Scientist, after achieving her BSc at the University of Leeds in Biomedical Science. She has continued to build on Lhasa’s strong reputation for facilitating data sharing and is proud to co-chair two industry data sharing consortiums. The first aims to aid ICH Q3D elemental impurities excipient risk assessments, and the most recent focuses on sharing excipient nitrites levels to aid compiling nitrosamine risk assessments.
Rodrigo Arias holds a degree on industrial and process engineering, a master’s in international business and diplomas on pharmaceutical production processes, high speed tableting, and international logistics. He worked at Novartis manufacturing site in the engineering projects and maintenance department. At DFE Pharma, since 2010, he has had several responsibilities in Latin America and EMEA regions, always with focus on tech support and quality-based sales. He has joined key tasks such as QbD training for global distribution network and business development for 3D printing and Dry Powder Inhalation. Since 2020 a permanent member of the GDP committee at IPEC Europe.