Mats Welin Medical Products Agency, Sweden

Mats Welin holds a position as a Senior expert at the Medical Products Agency in Sweden, working with quality assessment of human and veterinary biologics and normative work within this field. He is a pharmacist by training and has been employed at the agency since 1988. Since 1996 he is the Swedish delegate of CHMPs sub group on biologics, the Biologics working party (BWP) and has in addition to assessments of MAAs and scientific advices also been involved in writing of many guidelines and other normative work in the field as well as been involved in EMA-Industry workshops on setting of specifications, QbD, prior knowledge and accelerated procedures. He is an alternate Swedish delegate to the European Pharmacopoeial Commission and have been involved in WHO work, in particular on requirements to post approval changes to human vaccines. He is the EU regulator topic lead in the revision of ICH Q6 on specifications and was also a delegate of the Quality implementation working group (Q-IWG) of the ICH to work with introduction of the Q8-Q10 concepts. He is frequent speaker at conferences on Quality by Design, process validation, setting of specifications and on general aspects in relation to biological medicinal products.