Joel Welch
Associate Director for Science& Biosimilar Strategy, FDA
Joel Welch is the Deputy Office Director for the Office of Product Quality Assessment III in the Office of Pharmaceutical Quality in CDER at the US Food and Drug Administration. The office performs assessment for both small molecule API and the product quality aspects (excluding microbiology) for biological products. He also serves as the Rapporteur for the ICH revision to Q5A(R1) and as the Chair for the Emerging Technology Program. In his time at FDA, he has also served as a Review Chief, Team Leader, Primary Assessor and Regulatory Project Manager. Prior to joining FDA, he spent 6 years in industry supporting late state analytical development of small molecules.