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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

× Download Final programme in PDF DOWNLOAD

× Download Final programme and Book of Abstracts in PDF DOWNLOAD

Final programme

October

Registration

08:00 – 09:00

Registration at Esplanade Zagreb Hotel

25Oct

Welcome addresses and opening remarks

09:00 – 09:30

25Oct

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

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25Oct

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
 

Concerns and hopes for better medicines and their safety

10:10 – 10:40
Vinod P. Shah

FIP SIG on Regulatory Sciences (Chair), AAPS (Former president), North Potomac, MD, USA

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25Oct

Revolutionising biomedical research education and training in Europe – Experiences, achievements, obstacles and perspectives

10:40 – 11:10
Mike Hardman

IMI JU EMTRAIN Project Coordinator, AstraZeneca R&D Science Policy, Macclesfield, Cheshire, United Kingdom

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25Oct

Harmonizing pharmaceutical science, practice and education towards global health

11:10 -11:50
Kamal K. Midha

FIP Immediate Past President, Saskatoon, SK, Canada

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25Oct

Q&A

11:50 – 12:10

25Oct

Coffee/Tea

25Oct

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

 

European Medicines Agency – regulatory perspectives on the safety of medicines

12:40 – 13:10
Sabine Brosch

Business Lead, EudraVigilance and International Standardisation in PhV, European Medicines Agency, European Union, United Kingdom

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25Oct

Research misconduct and publishing ethics

13:10 – 13:40
Jaap van Harten

Elsevier BV, Amsterdam, The Netherlands

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25Oct

Q&A

13:40 – 14:00

25Oct

Lunch

14:00 – 15:00

25Oct

Poster Session

25Oct

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

 

Systems pharmacology – towards the prediction of efficacy and safety

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

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25Oct

Safety on a molecular level

15:30 16:00
Andreas Link

University of Greifswald, Germany

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25Oct

Avoiding interaction between drugs – Industrial versus academic perspectives

16:00 – 16:30
Imre Klebovich

Semmelweis University, Budapest, Hungary

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25Oct

Forty years of academic biopharmaceutical sciences and Its impact on drug development

16:30 – 17:00
Leslie Z. Benet

University of California, San Francisco, CA, USA

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25Oct

Bridging the gap between industry and academia in achievement of scientific goals and safety of medicines

17:00 – 17:30
Eva Maria Muchitsch

EUFEPS, Baxter, Vienna, Austria

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25Oct

Q&A

17:30 – 17:50

25Oct

Coffee/Tea

25Oct

Elsevier Seminar

How to write great papers: from title to references, from submission to publication

18:15 – 19:45
Jaap van Harten

Elsevier BV, Amsterdam, The Netherlands
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25Oct

Banquet Dinner/Pharmaceutical Ball – Pharmaceutical scientists gathering together with paractitioners

21:00

At The Emerald Ballroom, Esplanade Zagreb Hotel

25Oct

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
 

Improved sciences education and training: Systems approach and collaboration

08:30 – 09:00
Hans H. Linden

EUFEPS Senate, Leader European Projects, Stockholm, Sweden

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26Oct

New education and training technologies

09:00 – 09:30
Clive G. Wilson

EUFEPS, University of Strathclyde, Glasgow, Scotland, United Kingdom

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26Oct

Standards of doctoral training as a way to build evidence based knowledge about medicines

09:30 – 10:00
Zdravko Lackovic

ORPHEUS, University of Zagreb, Zagreb, Croatia

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26Oct

Networking of EUFEPS contributes to pharmaceutical sciences advancements

10:00 – 10:30
Lennart Dencker

EUFEPS, University of Uppsala, Uppsala, Sweden

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26Oct

Q&A

10:30 – 10:50

26Oct

Coffee/Tea

26Oct

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

 

Impact of bioequivalence studies on the progresses of pharmaceutical sciences over past 35 years

11:30 – 12:00
A. Atilla Hincal

IDE Information Center Education and Consultancy Ltd Co, Ankara/İstanbul, Turkey

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26Oct

US-FDA Perspectives on bioequivalence regulations – Challenges in meeting bioequivalence requirements

12:00 – 12:30
Vinod P. Shah

FIP SIG Regulatory Sciences (Chair), AAPS (Former president), North Potomac, MD, USA

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26Oct

EMA Perspectives in BE regulations

12:30 – 13:00
José A. G. Morais

University of Lisbon, Lisbon, Portugal

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26Oct

‘Biosimilarity’, an evolving paradigm for biologicals and non-biological complex drugs

13:00 – 13:30
Daan J.A. Crommelin

Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, UIPS, Utrecht, The Netherlands

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26Oct

Q&A

13:30 – 13:50

26Oct

Lunch

14:00 – 15:00

26Oct

Poster Session

26Oct

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

 

Croatian regulatory approaches in the EMA strategic frame

15:00 – 15:30
Viola Macolic Sarinic

HALMED, Zagreb, Croatia

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26Oct

Novel technologies for controlled drug delivery: Balancing innovation with regulatory compliance

15:30 – 16:00
Carla M. Caramella

Department of Drug Sciences – University of Pavia-I, Pavia, Italy

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26Oct

Developmental risk management plan – A living document

16:00 – 16:30
Vid Stanulović

Aprova- an Alten Company, Boulogne-Billancourt Cedex – France

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26Oct

There are no borders for sciences nor for medicines market – Medicines safety is an imperative for health

16:30 – 17:00
Milena Jadrijevic-Mladar Takac

EUFEPS, University of Zagreb, Croatia

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26Oct

Q&A

17:00 – 17:20

26Oct

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

17:20 – 17:50
Rogério Gaspar

University of Lisbon, Lisbon, Portugal

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26Oct

Concluding remarks

17:50 – 18:00

26Oct