Science Seminar Details

Date	Monday September 22, 2014 8.20 AM - 5.30 PM
Cost	Free
Location	Dom Pedro Hotel Lisbon Portugal
Contact	Isabel Pina ipina@hovione.com

Science Seminar Agenda

Time	Presentation & Speaker
08:20	Registration
08:50	Opening Remarks Guy Villax, Hovione
09:00	One Idea: Four Products Wendell Wierenga
09:50	Challenges in Oral Deliver Mark Saunders, Kuecept
10:30	Coffee Break
11:00	Challenges in Inhalation Delivery: DPI Eunice Costa, Hovione
11:40	Drug Delivery of Poorly Soluble Oral Drugs Geert Verreck, JnJ
12:20	Drug Delivery of Biopharmaceuticals Robert Forbes, University of Bradford
13:00	Lunch
	QbD in Practice – Hovione’s experience
14:30	Adapting a Quality System to allow for a QbD filing José Ascensão, Hovione - New definitions for old words - Batch records with undefined process parameters - Getting operators to execute a process where parameters are multivariate and not individually specified
14:50	PAT, Quality Metrics and key Technical Aspects Nuno Matos, Hovione - Gathering data to understand the process - Using models to predict, to scale-up to, to understand - Lessons learnt
15:10	What Regulators do differently in a QbD filing Luísa Paulo, Hovione - What’s different in the reviewers’ questions - Why do reviewers attend the inspection - What is focused on during an inspection
15:30	QbD Pay-back Filipe Gaspar, Hovione - A case-study: Cost of a QbD filing, savings in time and API from using mathematical models Does QbD gets us to 6 Sigma
15:50	Coffee Break
16:15	Round Table: what has QbD shown us Moderated by Filipe Gaspar, Hovione
17:15	Final Remarks Guy Villax, Hovione
17:30	End

For more information: US: call 609-918-2600, email us or visit www.hovione.com | Europe and rest of the world: call +351 219 829 450, email us or visit www.hovione.com