Mats Welin

Swedish Medical Products Agency

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 with a focus on vaccines and monoclonal antibodies. He is a pharmacist by training and has been employed at the agency since 1988.

Since 1996, he has been the Swedish delegate of CHMPs subgroup on biologics, the Biologics working party (BWP) and chaired the EMA-Industry workshop on making use of prior knowledge in regulatory submissions November 2017. He was also chairing two sessions of the EMA/ FDA workshop on Quality support to PRIME/Breakthrough Therapies in November 2018.

He is also a member of EMEA PAT team dealing with QbD related topics since 2003 as one of the BWP representatives to cover biological aspects in the field He was a delegate of the Quality implementation working group (Q-IWG) of the ICH during its existence 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.