Under the high auspices of the President of the Republic of Croatia, Prof. dr. Ivo Josipović
25 – 26 October, 2013
Esplanade Zagreb Hotel, Zagreb, Croatia
www.zicps2013.com
Final programme
October
Registration
08:00 – 09:00
Registration at Esplanade Zagreb Hotel
Welcome addresses and opening remarks
09:00 – 09:30
Keynote Lecture
The potential outcomes for new concepts in drug discovery and development towards better and safer medicines
9:30 – 10:10
Leslie Z. Benet
University of California, San Francisco, CA, USA
Moderators: Meindert Danhof, EUFEPS & Vinod P. Shah, FIP SIG on Regulatory Sciences
Session I
Towards better and safe medicines
10:10 – 12:10
Session Leaders:
Daan J.A. Crommelin, Utrecht University, Utrecht, The Netherlands
Hans H. Linden, EUFEPS, Stockholm, Sweden
10:10 – 10:40
Vinod P. Shah
FIP SIG on Regulatory Sciences (Chair), AAPS (Former president), North Potomac, MD, USA
10:40 – 11:10
Mike Hardman
IMI JU EMTRAIN Project Coordinator, AstraZeneca R&D Science Policy, Macclesfield, Cheshire, United Kingdom
Q&A
11:50 – 12:10
Coffee/Tea
Session II
Implementation of regulatory sciences leads to better quality of medicines
12:40 – 14:00
Session Leaders:
Vinod P. Shah, FIP SIG on Regulatory Sciences (Chair), AAPS (Former president), North Potomac, MD, USA
Mike Hardman, IMI JU EMTRAIN Project Coordinator, AstraZeneca R&D Science Policy, Macclesfield, Cheshire, United Kingdom
12:40 – 13:10
Sabine Brosch
Business Lead, EudraVigilance and International Standardisation in PhV, European Medicines Agency, European Union, United Kingdom
Q&A
13:40 – 14:00
Lunch
14:00 – 15:00
Poster Session
Session III
Safety from molecule to medicine’s use – Academia and pharmaceutical industry perspectives
15:00 -17:50
Session Leaders:
Lennart Dencker, EUFEPS, Uppsala University, Uppsala, Sweden
Milena Jadrijević-Mladar Takač, EUFEPS, CPhS, University of Zagreb, Croatia
15:00 – 15:30
Meindert Danhof
Leiden University, Leiden Academic Center for Drug Research, Division of Pharmacology, Einsteinweg 55, P.O. Box 9502, 2300 RA Leiden, the Netherlands
Q&A
17:30 – 17:50
Coffee/Tea
18:15 – 19:45
Jaap van Harten
Elsevier BV, Amsterdam, The Netherlands
More
Banquet Dinner/Pharmaceutical Ball – Pharmaceutical scientists gathering together with paractitioners
21:00
At The Emerald Ballroom, Esplanade Zagreb Hotel
Session IV
Through education and networking in sciences towards better and safe medicines and patients’ wellbeing
08:30 – 10:50
Session Leaders:
Leslie Z. Benet, University of California, San Francisco, CA, USA
Meindert Danhof, EUFEPS, Leiden Amsterdam Center for Drug Research (LACDR), Leiden, The Netherlands
09:00 – 09:30
Clive G. Wilson
EUFEPS, University of Strathclyde, Glasgow, Scotland, United Kingdom
Q&A
10:30 – 10:50
Coffee/Tea
Session V
Regulatory perspectives on bioequivalence and biosimilarity of medicines
11:30 – 13:30
Session Leaders:
Kamal K. Midha, FIP, Saskatoon, SK, Canada
Clive G. Wilson, EUFEPS, University of Strathclyde, Glasgow, Scotland, United Kingdom
11:30 – 12:00
A. Atilla Hincal
IDE Information Center Education and Consultancy Ltd Co, Ankara/İstanbul, Turkey
12:00 – 12:30
Vinod P. Shah
FIP SIG Regulatory Sciences (Chair), AAPS (Former president), North Potomac, MD, USA
13:00 – 13:30
Daan J.A. Crommelin
Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, UIPS, Utrecht, The Netherlands
Lunch
14:00 – 15:00
Poster Session
Session VI
National regulatory approaches versus international trends
15:00 – 17:20
Session Leaders:
A. Atilla Hincal, IDE Information Center Education and Consultancy Ltd Co, Ankara/İstanbul, Turkey
Imre Klebovich, Semmelweis University, Budapest, Hungary
15:30 – 16:00
Carla M. Caramella
Department of Drug Sciences – University of Pavia-I, Pavia, Italy
Closing ceremony
Moderator: Vinod P. Shah, FIP SIG on Regulatory Sciences
Closing ceremony lecture
The faith of pharmaceutical sciences in the frame of regulatory sciences advancements
Concluding remarks
17:50 – 18:00
