University of Medicine and Pharmacy Carol Davila Bucharest
Invited speakers who confirmed their contribution at
The 7th Edition of the International Conference From Science to Guidance and Practice
Courtyard by Marriott Bucharest Floreasca
Boulevard, Bulevardul Dimitrie Pompeiu 2 A,
Bucharest 020337, Romania,
October 13th-14th, 2022
Scientific Program, Day 1
In vitro dissolution / drug release methodologies and physicochemical testing
Compendia Regulatory Science
Pharmaceutical software
| Day 1 October 13th, 2022 | Topic | 09:00-09:30 | Registration of participants | |
| 09:30-09:45 | Opening Ceremony | |||
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#09:45-10:15 | #Dr.Vinod P. Shah Pharmaceutical consultant Ph.D, FAAPS, FFIP United States of America |
#Regulatory update: Biowaiver and Beyond | |
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#10:15-10:45 | #Prof.Jean-Michel Cardot Pharm D, Ph. D. Consultant for SAS Borvo France |
#EMA News in dissolution 2020-2022 | |
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#10:45-11:15 | #Prof.Jean-Michel Cardot Pharm D, Ph. D. Consultant for SAS Borvo France |
#In vitro tests for locally applied locally acting drugs in the Gastro Intestinal Tract | |
| 11:15-11:30 | Coffee break | |||
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#11:30-12:00 | #Dr.Vinod P. Shah Pharmaceutical consultant Ph.D, FAAPS, FFIP United States of America |
#What is new in Complex Generics? | |
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#12:00-12:30 | #Samir Haddouchi Managing Director SOTAX Pharma Services France |
#In vitro release testing for non-conventional dosage forms | |
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#12:30-13:00 | #Dr.Herbert Schmidt Technical Officer, Health Products Policy and Standards World Health Organization Geneva Switzerland |
#The WHO International Pharmacopoeia, Focus, Processes, Response to COVID-19 and Collaboration with other Pharmacopoeias | |
| 13:00-14:00 | Lunch break | |||
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#14:00-14:30 | #Dr.Christian Zeine Ph.D, Senior Manager, Scientific Affairs EMEA United States Pharmacopoeia Switzerland |
#Impurities in Drug Substances/Products – Global Guidances and USP Perspective | |
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#14:30-15:00 | #Samir Haddouchi Managing Director SOTAX Pharma Services France |
#Qualification of USP1/2 dissolution instruments | |
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#15:00-15:30 | #Dr.Flavian Ștefan Rădulescu Center for Drug Sciences UMFCD Bucharest Romania |
#In vitro release testing for topical semisolids. Current requirements and future developments | |
| 15:30-15:45 | Coffee break | |||
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#15:45-16:30 | #Dr. Kimmo Leppänena Sales Manager, AutoChem Mettler-Toledo GmbH Switzerland |
#Real-Time Particle Size Dynamics of Tablet Dissolution | |
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#16:30-17:00 | #Dr.Larisa Wu Associate Director for Science and Communication ONPD/OPQ/CDER/US-FDA United States of America |
#Modernizing Assessment and Submission in the Age of Digitalization | |
Scientific Program, Day 2
| Day 2 October 14th, 2022 | Topic | 09:30 | Start of the second day | |
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#09:30-10:00 | #Dipl.-Biol. Lothar Maresch BINDER Academy BINDER GmbH Germany |
#ICH stability requirements and stability testing equipment for pharmaceutical products | |
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#10:00-10:30 | #René Fässler Product Manager, Dissolution Testing (USP 1,2,5,6) Sotax AG Switzerland |
#Data integrity for dissolution testing in a Client/Server environment | |
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#10:30-11:00 | #Gunnar Danielson Head of Global Software Solutions and LabX Consultancy Mettler Toledo International Switzerland |
#Data Integrity and Workflow Efficiency: the business benefit of digital transformation | |
| 11:00-11:15 | Coffee break | |||
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#11:15-11:45 | #Michele Martiradonna Business Area Manager Industrial and Product Inspection Mettler Toledo Sales International Switzerland |
#Ensure consistent quality, data integrity and traceability through automated formulation solutions | |
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#11:45-12:15 | #David Grant Global Product Manager PURELAB ELGA LabWater United Kingdom |
#PURELAB® Pharma Compliance | |
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#12:15-12:45 | #Miguel Avanzini Cofounder BenchTech GmbH Spain |
#Open labs and flexible furniture: SmartLab concept by BenchTech GmbH | |
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#12:45-13:15 | #Philipp Beutler Application Specialist, Material Characterization Thermo Fisher Scientific Germany |
#Rheology of pharmaceutical products – from formulation over production to application | |
| 13:15-13:30 | Panel discussion. Closing ceremony | |||