Betsy P. Fritschel

Betsy Fritschel is Director of Enterprise Regulatory Outreach (ERO) at Johnson & Johnson Enterprise Regulatory Compliance, a corporate group which provides analysis on the emerging external regulatory environment as well as quality and GMP regulatory support to J&J Operating Companies. Betsy joined Johnson & Johnson in 1981 as an analytical chemist, and has extensive pharmaceutical experience in the QC lab, manufacturing site quality, and corporate quality oversight. Betsy is a member of the ISPE Advancing Pharmaceutical Quality Core Team, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) GMP Working Group, the PhRMA Global Quality and Manufacturing Core and the PhRMA Quality Surveillance Core Team. She has represented PhRMA at ICH on several Expert Working Groups (EWGs) and Implementation Working Groups (IWGs) since 1998. These include the IWG for ICH Q11 that developed clarifying Q&A for Starting Material and training materials that are available on the ICH website. She was the PhRMA lead on the IWG that developed clarifying Q&A for ICH Q7 Active Pharmaceutical Ingredient Good Manufacturing Practices that were published in 2015. She was also a member of both the ICH Q7 and Q11 Expert Working Groups that developed these guidance documents.