The Romanian College of Pharmacists
The Center for Drug Sciences University of Medicine and Pharmacy
Carol Davila Bucharest

announce the organization of
The Sixth Edition of
The International Conference
From Science to Guidance and Practice
online event
21st – 22nd October 2021,
Bucharest, Romania

It has been long since we have had the chance to gather and discuss the latest developments in pharmaceutical sciences, in vitro dissolution and drug release methodologies, compendial chapters, analytical approaches and the design of dosage forms. Even though we wished to be able to organize our annual meeting with physical presence, the organizing committee has decided that it is safer and more feasible to meet online.

As always, we did our best to obtain the confirmation of highly respected scientists to contribute to this year’s edition. It is our hope that, despite the difficulties and limitations of online meetings, we will manage to take full advantage of this opportunity to get together and debate on hot topics in the field of drugs and drug products, continuing our five years tradition of relating and correlating science with regulatory guidance and pharmaceutical practice.

Dr. Vinod P. Shah and Prof. Jean Michel Cardot are our honorable chairmen. We kindly ask you to register using the dedicated web page / enclosed formulary. A confirmation on your intention to participate is needed as soon as possible, so that we can adequately stablish the online platform.

Looking forward to receiving your confirmation,

Our best wishes to you, your family and colleagues,

Keep safe,

The organizing committee.

The conference has been credited by the College of Pharmacists in Romania with 16 EFC Credits

Scientific Committee

Prof. Jean-Michel Cardot

Dr. Vinod P. Shah

Prof. Victor A. Voicu

Prof. Dumitru Lupuleasa

Organizing Committee

Dr. Dalia Simona Miron

Dr. Flavian Stefan Radulescu

M.Sc. Catalin Dumitru Mirica

M.Sc. Andrei Patasanu, MBA

Day 1: October 21, 2021
10:00 Opening ceremony
10:15 Fixing dissolution limits: what are the cases
Prof. Jean-Michel Cardot
Université Clermont Auvergne, France
10:45 In vitro dissolution techniques for poorly soluble drugs and gastrointestinal simulation
Prof. Eric Beyssac
Université Clermont Auvergne, France
11:15 Break
11:30 Small vessel for in vitro dissolutions studies
Prof. Jean-Michel Cardot
Université Clermont Auvergne, France
12:00 Current requirements for in vitro release testing
Dr. Flavian Ștefan Rădulescu, Dr. Dalia Simona Miron
Center for Drug Sciences, University of Medicine and Pharmacy
Carol Davila, Romania
12:30 Lunch break
13:30 The Value of Pharmacopeial Reference Standards: Understanding
Uncertainty, Guard Bands and Risks

Dr. Christian Zeine
United States Pharmacopeia
14:00 How to ensure compliance with the new Ph. Eur. General Chapter 2.1.7.?
Simona Venzin
Head of Service Product Management, Mettler Toledo
14:30 Break
14:45 The newest technologies in climate simulation – contribution to
environmental sustainability

Lothar Maresch
Head of BINDER Academy, BINDER GmbH, Germany
15:15 Ensure Compliance with compendial standards Ph. Eur. General Chapter
2.1.7. and USP 41
Day 2: October 22, 2021
10:15 Rheology for pharmaceutical applications
Philipp Beutler
Application Specialist, Material Characterization, Thermo Fisher Scientific, Germany
10:45 Rheological assessments for Q3 similarity
Dr. Flavian Ștefan Rădulescu, Dr. Dalia Simona Miron
Center for Drug Sciences, University of Medicine and Pharmacy Carol
Davila, Romania
11:15 Break
11:30 Flow through cell as biowaiver tool for special dosage forms
Samir Haddouchi
Managing Director, SPS Pharma Services
12:00 Analytical and preparative SFC – from theoretical potential to
practical benefit

Dr. Björn Thoralf Erxleben
Senior Manager Pharma, Shimadzu Europe
12:30 Lunch break
13:30 Flow-through Cell Dissolution: from APIs to Novel dosage forms
Michel Magnier – Product Manager Dissolution USP 4
Sotax AG, Switzerland
14:00 Changes in change resistant laboratories: the pressure for going

Dr. Christoph Jansen
Technical Key Account Manager, Mettler Toledo, Switzerland
14:30 Break
15:00 Importance of drug release in Complex Generics
Dr. Vinod P. Shah
Pharmaceutical Consultant, USA