Quality by Design (QbD) in Pharmaceutical Development

Poul Bertelsen
Poul Bertelsen

Poul Bertelsen

PhD (Pharm), Principal Pharmaceutical Expert,
Honorary Associate Professor at Copenhagen University

LEO Pharma
Industriparken 32
DK-2750 Ballerup

Email: pntdk(@)leo-pharma.com

Poul Bertelsen is a Principal Pharmaceitical Expert at Leo Pharma. Additionally he is an Honorary Associate Professor at the Faculty of Health and Medical Sciences (University of Copenhagen). He received his PhD from the Royal Danish School of Pharmacy in 1987 and started his career in the medicinal industry in the pharmaceutical development department of the company Alfred Benzon which was later bought by Nycomed now Takeda.

Poul is a member of Pharmacy Sub-Committee under the Pharmacopoeia Commission and he is a co-leader of the module dealing with Quality of Drug Substance and Drug Product at Medicademy.

Poul has worked with development of drug products for 29 years including both lab scale and commercial scale and both oral, parenteral and nasal routes of administration. He is author or co-author of 17 papers, 12 granted patents and has done numerous presentations in EU and US within the field of pharmaceutical development and manufacture of drug products. Poul has worked with QbD in Takeda for about 8 years with special emphasis on DoE and Quality Risk Analysis and is at present leading the implementation of QbD in the global CMC group in Takeda.