ISPE Announces Leaders from FDA, EMA, WHO, & AEMPS at Annual European Conference

ISPE announced six regulatory speakers for the 2022 ISPE Europe Annual Conference, taking place 25–27 April 2022 in Madrid, Spain and virtually. The programme will feature a keynote address by Maria Jesus Lamas Diaz and two regulatory panel discussions with regulators across the globe. The first panel discussion will centre around sustainability, Annex 1 implementation and good engineering practice, and the second panel will discuss digital transformation.

Confirmed Regulatory Speakers:

Brendan Cuddy
Lead Scientific Officer

Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020 and is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG).

Rick Friedman
Deputy Director, Office of Manufacturing Quality

Richard L. Friedman is the Deputy Director, Science and Regulatory Policy, Office of Manufacturing and Product Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). In this position, he is responsible for oversight of case review relating to drug manufacturing quality to assure scientific and risk-based decisions. This position includes review of regulatory action recommendations regarding inspections and manufacturing site acceptability and promoting sound regulatory policy development.

Maria Jesus Lamas Diaz
AEMPS (Spanish Agency of Medicines and Healthcare Products)

María Jesús Lamas Díaz has been the director of the Spanish Agency for Medicines and Medical Devices (AEMPS, by its acronym in Spanish) since 2018 and, as such, is responsible for its direction, management and coordination of actions. She is also a member of the coordinating group of the Head of Medicine Agencies (HMA) and of the Management Board of the European Medicines Agency (EMA). She represents Spain on the Steering Board of the European Vaccine Strategy led by the European Commission.

Manuel Ibarra Lorente
Head of Pharmaceutical Inspection & Enforcement Department
AEMPS (Spanish Agency of Medicines and Healthcare Products)

Manuel Ibarra Lorente has served at AEMPS in this position since July 2019. Prior to being the Head of Pharmaceutical Inspection & Enforcement, he served at AEMPS as a GMP Inspector since 2005.

Dimitrios Catsoulacos
Technical Officer - Expert Inspector

Dimitrios Catsoulacos has served as the Technical Officer at WHO since 2017. Prior to his position at WHO, he has served at U.N. – UNICEF, the National Organization for Medicines EOF – Greece, and at the European Medicines Agency.

Carmelo Rosa, PsyD
Director, Division of Drug Quality I

Carmelo Rosa has a B.S., M.S., Psy.D. His background is in biology and chemistry and holds a doctoral degree as a Clinical Psychologist. He has been with FDA for over 27 years. He is one of two Division Directors responsible for the review of all Official Action Indicated (OAI) inspection reports related to drug manufacturing facilities that may result in a regulatory action.

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