Romanian AcademySection of Medical Sciences

announce the organization of

the Third Edition of The International Conference

“From Science to Guidance and Practice”September 28-29, 2017

Ramada Bucharest Parc Hotel - Terra Grand Ballroom

Scientific committee

Dr. Vinod P. Shah

Pharmaceutical consultant, USA

Prof. Jean-Michel Cardot

Université Clermont Auvergne, France

Dr. Johannes Krämer

Phast GmbH, Germany

Local organizing committee

Dr. Dalia Simona MironDr. Flavian Ștefan Rădulescu

Dr. Dragoș Florian CiolanM.Sc. Cătălin Dumitru Mirică

Prof. Victor A. Voicu Prof. Dumitru Lupuleasa

Prof. Andrei Valentin Medvedovici Prof. Doina Drăgănescu

Chairmen

Dr. Vinod P. ShahProf. Jean-Michel Cardot

Prof. Victor A. VoicuProf. Dumitru Lupuleasa

IDU AG N CO ET AE NC

DN

E PI RC AS C

TM IO CR EF

INTERNATIONALCONFERENCE

3rd edition

University of Medicine and Pharmacy “Carol Davila” Bucharest - Center for Drug Sciences

Romanian Society forPharmaceutical Sciences

Prof. Dumitru Lupuleasa

Romanian Society of Pharmaceutical Sciences

Dr. Erika Stippler

USP, Dosage Form Performance Laboratory, USA

Dr. Samir Haddouchi

Managing Director, SPS Pharma Services

Organized by the Romanian Society for Pharmaceutical Science, University of Medicine and Pharmacy “Carol Davila” Bucharest, the Romanian Academy, Section of Medical Science and O.F. Systems, the first editions of the International Conference “From Science to Guidance and Practice” were favorably received and attended by more than 250 representatives of medical and pharmaceutical scientists, from Romania and abroad.

Following the last editions’s success and considering the continuously increasing applications of in vitro tests in drug development, this year's edition will be focused on the newest methodologies for manufacturing and content of drugs and drugs products.

The conference has been credited by the Romanian College of Pharmacists with 24 EFC credits.

PERFORMANCE MATTERSO.F. Systems

Day 1: September 28, 2017

08:30 - 09:30 Registration of participants

09:00 - 09:30 Opening ceremony

09:30 - 10:00 1. BCS and Biowaivers: Regulatory update Dr. Vinod P. Shah, Pharmaceutical Consultant, USA

10:00 - 10:30 2. Linking QC-Methodology with Biowaivers Dr. Johannes Krämer, Phast GmbH, Germany

10:30 - 11:00 Coffee break

11:00-11:30 3. BCS and Biowaivers: Regulatory update Dr. Vinod P. Shah, Pharmaceutical Consultant, USA

11:30-12:00 4. USP Compendial Dissolution / Drug Release testing - Overview and Updates Dr. Erika Stippler, USP, Dosage Form Performance Laboratory,USA

12:00-12:30 5. Dissolution as a tool for API characterization Dr. Samir Haddouchi, Managing Director, SPS Pharma Services

12:30-13:00 Q&A session

13:00-14:00 Lunch

14:00-14:30 6. Title to be confirmed Prof. Andrei Valentin Medvedovici, University of Bucharest, Romania

14:30-15:00 7. The role of in vitro drug release in Q3 assessment for topical semisolids Dr. Dalia Simona Miron, Prof. Victor A. Voicu, University of Medicine and Pharmacy “Carol Davila” Bucharest & Romanian Academy, Romania

15:00-15:30 8. ELEARNBCS, a collaborative platform for academia and industry Dr. Flavian Rădulescu, Prof. Dumitru Lupuleasa, University of Medicine and Pharmacy “Carol Davila” Bucharest, Romania

15:30-16:00 9. EMA reflection paper on dissolution, status after 1 year Prof. Jean-Michel Cardot, Université Clermont Auvergne, France

16:00-16:15 Q&A session

16:15-16:30 Coffee break

16:30-17:30 Hands-on session

20:00 O.F. System’s PARTY LAB

Day 2: September 29, 2017

09:00 - 09:30 1. New EMA Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development Prof. Jean-Michel Cardot, Université Clermont Auvergne, France

09:30 - 10:00 2. Chemical inhalation risk & safety solutions Julie Prianon, Deputy Director European Sales, Erlab

10:00 - 10:30 3. Processing of pharmaceutical polymers – solutions from Thermo Scientific for HME and TSG applications Dr. Eng. Ansgar Frendel, Senior Channel Manager, Materials and Structural Analysis | Material Characterization Thermo Fisher Scientific

10:30-11:00 Coffee break

11:00-11:30 4. Data Integrity. LabX solution for automated data integrity Wojciech Czerwiński, Global Software Solutions Specialist, Mettler-Toledo

11:30-12:00 5. LabVantage Pharma, reduce cost and improve lab efficiency using GAMP 5 guidelines Vitale Ambrosini, Director, Southern Europe & International Partners, LABVANTAGE SOLUTIONS Ltd.

12:00-12:30 6. Implementing automation for dissolution Dr. Samir Haddouchi, Managing Director, SPS Pharma Services

12:30- 13:00 Q&A session

13:00 - 14:00 Lunch

14:00 - 16:00 7. Are We On Track? – a short Workshop about Serialization John Eicholtz, Market Manager, Mettler-Toledo Vision Inspection - PCE

Title: __________ Family name: _______________ First name: ____________________ (the name and title you provide will be printed on your badge)

Institution: ____________________________________________________________

Address:______________________________________________________________

Postal/ZIP code: ___________, City: ______________, Country: _________________

Telephone: _____________________, E-mail: ________________________________

Please confirm your presence at the Conference Yes No

Please confirm your presence at the O.F. Systems’s PARTY LAB!

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Participants will register at catalina.urs@ofsystems.ro

Conference location: Ramada Bucharest Parc Hotel, Bd. Poligrafiei, nr. 3-5, sector 1 - Bucuresti

Registration form

NE FACE PLACERE SA VA INVITAM LA

O.F. Systems’s

CELEBRATING 25 YEARS OF PERFORMANCE!

JOI, 28 SEPTEMBRIE - ORA 20:00TAPO LOUNGE

STRADA OLTETULUI, NR. 30, SECTOR 2, BUCURESTI

Va rugam sa confirmati prezenta la adresa de email: catalina.urs@ofsystems.ro