|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.