The International Society for Pharmaceutical Engineering (ISPE) announced today that it has named Jean-François Duliere as a European Regulatory Advisor. Effective 1 April 2020, Duliere takes on this role at ISPE with extensive experience in pharmaceutical regulatory compliance and facilities design for biotechnology, oral solid dosage (OSD), and sterile manufacturing.
“Jean-François brings a wealth of knowledge in an array of critical areas of pharmaceutical manufacturing that are especially pertinent during the current COVID-19 pandemic,” said Tim Howard, President and CEO, ISPE. “His addition to the team will strengthen ISPE’s efforts to facilitate industry-wide clarity of new applicable regulations, advising on impacts and resolving towards solutions, and seeking harmonization of regulatory expectations where desired and possible.”
Duliere has more than 20 years’ experience in the pharmaceutical manufacturing industry. He has worked in the areas of quality control, oral solid dosage forms manufacturing (tablets, capsules), packaging, raw materials production from bacteria growth, industrial development, and dual compartments syringes aseptic filling. He is highly experienced in containment issues for high potent active pharmaceutical ingredients (API), mainly in French companies Laboratoires DEBAT and Laboratoires Fournier.
Duliere has been a consultant for the past 20 years with Technip Life Sciences, a leading provider in the design and construction of pharmaceuticals and biotechnologies facilities, as a senior pharmaceutical expert. He oversees early design stage as conceptual design and has been involved with Good Manufacturing Practice (GMP) design reviews and Regulatory Affairs for most pharmaceutical projects, including:
- Sterile facilities in Europe, China, and North Africa
- Oral Solid Dose facilities in Europe and North Africa
- Vaccine facilities in Europe and China
Since becoming a Member of ISPE in 2002, Duliere has been an active volunteer, participating on numerous committees. He is currently the Chair of the ISPE France Affiliate and Chair of the Regulatory Quality Harmonization Europe-Middle East- Africa (RQHC EMEA) Committee. He holds an Industry Pharmacist PhD.
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,500 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland USA, and its operations center in Tampa, Florida USA. Visit ISPE.org for more information.