IPEC Europe is the association that brings together producers, distributors and users of pharmaceuticals excipients. IPEC Europe counts 71 full members, 4 associate members and 5 co-opted members.
Mr. Frithjof Holtz is a biologist and has been working for almost 30 years with Merck KGaA, Darmstadt, Germany, having a long year 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. Frank Milek is an industrial pharmacist and has been working in pharmaceutical excipients industry for more than 15 years, specialised in the field of supply chain and distribution. He is registered QP according to EU regulation and responsible at Aug. Hedinger GmbH & Co. KG for Quality, Regulatory Affairs and GMP.
Frank is currently the Chair of the GTDP Committee in FECC (European Association of Chemical Distributors) and an active member of the EXCiPACT project.
Karine Roth is a Pharmacist and has more than 20 years of experience within Pharmaceutical Industry.
She is currently working with Novartis as Global Head Quality Cell & Gene Therapy (C>) Network; her role includes Quality oversight for development, commercialization and manufacturing of C> therapies for all Novartis assets. Previously she used to lead different quality organization looking at Technical development of Biologics, QA Oversight of suppliers and parenteral contract manufacturers.
Prior Novartis, she has worked for Eli Lilly in several management position in Regulatory, Quality Assurance and Operational Excellence.
Amina earned a Ph.D. degree in Pharmaceutical Sciences from School of Pharmacy, University de la Mediterranée France. Amina has over 15 years of pharma industry experience and strong knowledge on regulatory affairs support of submissions and on-going regulatory compliance for product development process.
She joined DOW Europe in Switzerland in 2011, as a pharmaceutical application specialist to drive and support the pharma business growth in Europe Middle East and Africa, and then moved into a global leadership role in Pharma R&D organization. One of Amina’s main responsibilities is to use her pharmaceutical technical expertise to closely connect to the innovation needs of the pharmaceutical industry.
Liz Meehan is a material scientist with a PhD from City University, London and more than 30 years experience in material characterisation.
She has worked in the pharmaceutical industry for 10 years, in the Pharmaceutical Development department of AstraZeneca, specialising in the field of excipient characterisation, relating excipient properties to functionality in dosage form design. More generally her activities include excipient risk assessment/mitigation for the development of robust pharmaceutical formulations.
Dr. Mahmud Yunis has been working for 13 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.
Karsten Diehl is a biotechnologist and has been working for more than 20 years in the regulated pharmaceutical and health care environmental.
He joined BASF SE Ludwigshafen, Germany in 2011 and is part of the BASF Pharma Solutions global quality department. Karsten has experience in manufacturing pharmaceutical ingredients, contract manufacture handling, supply chain and distribution as well as general Quality- and GMP-Compliance topics.
Prior BASF SE, he has worked for Procter & Gamble within several quality position in Quality Assurance and Operational Excellence.
Kevin 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.
Kevin is now Regulatory Affairs and Quality Assurance Manager for Colorcon and 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. Kevin 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.
Prior to Colorcon, Kevin spent 5 years at Boots Healthcare Development, where he was Team Leader developing solid oral dosage forms for Boots Pharmacies. Kevin graduated with from Nottingham University in 1994. He has been involved in the pharmaceutical industry for 20 years.