ISPE Brings International Expertise to Senior Vice President, Global Regulatory Affairs Position

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Dr. Theodora Kourti will join ISPE as the new Senior Vice President, Global Regulatory Affairs.

Theodora Kourti, PhD

We are pleased to have such a high-caliber professional joining the ISPE team. Theodora brings a wealth of technical knowledge and an incredible international reputation from the continuous manufacturing arena.

ISPE—the International Society for Pharmaceutical Engineering announced today that Dr. Theodora Kourti will join the Society as the new Senior Vice President, Global Regulatory Affairs. Dr. Kourti brings technical expertise in key pharmaceutical topics such as Quality by Design (QbD), Process Analytical Technology, Continuous Manufacturing, and Lifecycle Management as well as significant international regulatory experience. Dr. Kourti has had strong and collaborative interactions with international regulatory agencies and has served as a subject matter expert for both FDA and EMA.

“We are pleased to have such a high-caliber professional joining the ISPE team. Theodora brings a wealth of technical knowledge and an incredible international reputation from the continuous manufacturing arena,” said John Bournas, President and CEO of ISPE. Bournas added, “She will be a critical part of our global regulatory efforts and help us continue the robust and ongoing dialogue ISPE has with the international agencies and national competent authorities.”

Before joining ISPE Dr. Theodora Kourti served as Senior Technical Director at GlaxoSmithKline, Global Manufacturing & Supply at the New Product Introduction Centre of Excellence where she has had significant regulatory interactions with FDA, EMA, Japan and other markets with regard to QbD product filing and lifecycle support. She has earned a stellar reputation in the Pharmaceutical Community for her technical competence, innovation and ability to explain regulatory requirements within a scientific framework. She has co-authored papers with FDA and EMA, organized and co-chaired numerous scientific sessions with FDA and EMA at international Pharmaceutical Conferences and has been an invited speaker to many key meetings dealing with leading edge topics. Dr. Kourti has been a significant contributor in many ISPE initiatives notably the PQLI guides, PAT community of practice, and continuous manufacturing. She has interacted with all facets of ISPE including Generics, Excipient Manufacturers, Equipment and Instrument Manufacturers, Biopharmaceuticals and Consumer Healthcare.

“Thepharmaceutical industry and the regulatory agencies have a common goal: fast, efficacious and safe delivery of drugs to patients. We live in era where enormous strides are being made by both sides to improve the ways they deliver on this goal. Innovative ways of producing drugs like continuous manufacturing with real time release, breakthrough therapy designations, avoiding supply chain interruptions, and maintaining process robustness are examples of these efforts. In order to make these initiatives a reality, and at the same time deliver affordable drugs, industry needs new skill sets, tools, education, training and support so that it achieves a realistic return on investment. ISPE has been playing a key role in these efforts and I am excited to join the organization,” said Dr. Kourti. And added, “Close collaboration, dialogue and scientific exchange between industry and the regulatory authorities at the international level facilitates and speeds up these efforts and spearheads new initiatives. All facets of the pharmaceutical industry, from excipient providers, equipment and instrument suppliers to drug developers and manufacturers have a role to play in achieving this common goal. As SVP, Global Regulatory Affairs, I intend to work closely with all facets of the industry and the regulatory agencies in these exciting times, and I am looking forward to the challenges ahead.”

Dr. Kourti will take on her role at ISPE on 5 October 2015, and will immediately participate in fall conferences to include Process Validation, 6 - 7 October 2015 in Silver Spring, MD and ISPE’s Annual Meeting, 8 – 11 November 2015 in Philadelphia, PA (http://www.ispe.org/annualmeeting).

Dr. Kourti earned her PhD in Chemical Engineering from McMaster University in Canada and a Diploma of Engineering (Chemical) from Aristotle University in Greece.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and 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 in Tampa, Florida, USA. Visit http://www.ISPE.org for more information.

For more information contact:
Maria Robertson
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE) Tel: +1-813-960-2105, ext. 207
Email: mrobertson(at)ispe(dot)org
http://www.ISPE.org

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Maria Robertson
ISPE
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