| SSPA
2010 PROGRAM
Sunday,
June 13, 2010
16:00
- 18:00 Registration
18:00 - 18:30 Welcome and Opening Ceremony
18:30 - 19:30 Opening Lecture: From Discovery
to Clinical: Integrated Approaches to Drug Development, Dr
Giovanni Gaviraghi, Siena Biotech (Italy)
19:30 - 20:30 Welcome party
Monday,
June 14, 2010
09.00
- 9:15 Opening of SSPA 2010.
I
SESSION – PHYSICAL PROPERTIES CHARACTERIZATION DURING PHARMACEUTICAL
PRODUCT DEVELOPMENT
09.30
- 10.30 DS and DP characterization across
product development. Dr Brigida Allieri
- GSK (Italy)
10.30 - 11.30 Polymorphism assessment.
Prof. Dario Braga - University of Bologna (Italy)
11:30 - 11:45 Coffee-break
11:45 - 12:45 Spectroscopical methods toward
physical properties characterization. Dr
Hervé Lucas
- Kaiser
Optical Systems (France)
12:45
- 14:00 Lunch
14:00
- 15.45 Ph.D. thesis dissertations.
15:45 - 16:00 Coffee break
16:00 - 18.00 TUTORIAL on forced
degradation and stability studies. Dr Marina Galvani
- GSK (Italy)
Tuesday,
June 15, 2010:
II
SESSION – PREFORMULATION AND FORMULATION
09:00 - 10:00 Drug delivery overview.
Dr Sara Nicoli - University of Parma (Italy)
10:00 - 11:00 Formulation in preclinical studies.
Dr Geert Verreck - Janssen Pharmaceutica (Belgium)
11:00 - 11:15 Coffee break
11.15 - 12.15 Active pharmaceutical ingredient
and choice of formulation principle: Biopharmaceutical considerations.
Prof. Werner Weitschies - University of Greifswald
(Germany)
12.15 - 13.15 Understand, formulate and manufacture
dosage forms. Dr Massimo Bresciani - GSK
(Italy)
13:15
- 14:00 Lunch
III
SESSION – ANALYTICAL QUALITY BY DESIGN (QbD)
14:00
- 15:00 Combining Quality by Design (QbD)
and Process Analytical Technology (PAT): understand and improve
pharmaceutical processes. Dr Dirk Lochmann - Merck-Serono
(Germany)
15:00 - 16:00 QbD: Regulatory requirements
and expectations. Dr Fiona Bird - GSK Ware
(UK)
16:00 - 16:15 Coffee break
16:15 - 18:15 TUTORIAL on multivariate
analysis. Dr Marianna Machin - Novartis
Pharma AG (Switzerland)
Wednesday,
June 16, 2010
IV
SESSION – METHOD VALIDATION
9:00
- 10:30 Objective of validation, documentation
and regulatory bodies, validation and quality assurance (QA) - traceability.
Dr Serge Rudaz - University of Geneva/University
of Lausanne (Switzerland) and Dr Eric Rozet - University
of Liège (Belgium)
10:30 - 10:45 Coffee break
10:45 - 12:30 Terminology and definition.
Practical guidelines for method validation.
12:30
- 13:30 Lunch
13:30
- 15.00 TUTORIAL on validation
and data treatment, examples, software demonstration. Dr
Serge Rudaz - University of Geneva/University of Lausanne
(Switzerland) and Dr Eric Rozet - University of
Liège (Belgium)
15:00 - 16:30 TUTORIALS on experimental
design, examples, software demonstration. Dr Sandra
Furlanetto - University of Florence (Italy)
16:30
- 16:45 Closing remarks
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