In order to mark the 20th anniversary of Pharmaceutical Engineering in Portugal, Dr. Ajaz S. Hussain (President of the National Institute for Pharmaceutical Technology & Education – NIPTE, Minneapolis, Minnesota, USA) will give a lecture entitled “Leadership for 21st Century Pharmaceuticals”, on 9th October 2019, at 3 p.m.
Dr. Hussain is the father of FDA’s Process Analytical Technology (PAT) Initiative and one of the people who in 2001 promoted cGMPs for the 21st Century which resulted in the creation of Quality by Design, Risk-based ICH Guides. Pharmaceutical Development & Manufacturing, Lifecycle Management – mentioned in ICH Q8, Q9, Q11 and Q12 in 2019. This set of initiatives and documents is at the heart of the scientific field called Pharmaceutical Engineering.
It is a unique opportunity to gain insight into the forces that have shaped the profound transformations in the way the pharmaceutical industry develops, produces and manages from a life-cycle perspective the medicines and therapies that are on the market today.
It is still very relevant to remember the article he wrote in 2005 and which inspired the current model of the 2nd cycle of studies at The Technical and The Faculty of Pharmacy University of Lisbon, in Pharmaceutical Engineering (MEFARM). In his article a parallel is made between the paradigms of Chemical Engineering and the absence of these same checkpoints in the time course of Pharmaceutical Technology until the end of the twentieth century.”
Dr. Ajaz S. Hussain has more than 30 years of distinguished career in biopharmaceuticals in different capacities at academic Institutions, federal regulatory agencies including FDA (1995-2005) and pharmaceutical industry (2005-2013) in the US and EU. Major positions held by him include Deputy Director, Office of Pharmaceutical Science, US FDA and served under the Senior Biomedical Research Service (SBRS – a track under the Public Health Service Act). Among his most memorable peer recognitions are – FDA Scientific Achievement Awards, Fellow status in the American Association of Pharmaceutical Scientists and in the Swiss Society of Pharmaceutical Sciences, the Industrial Pharmacy Medal (International Pharmaceutical Federation); Scientific Achievement – Regulatory Science Award (AAPS); the Dr. M. Venkateswarlu Memorial Lecture Award (Indian Pharmaceutical Association), among several other awards and public recognitions.
Venue: Amphitheatre QA02.4, floor -2, South Tower.