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Jun 26, 2014 10:00 AM - Jun 26, 2014 12:00 PM

Online

Variations in the European Union: CMC/Quality Changes

Speakers

Yasmin  de Faria Krim, PharmD, MSc

Yasmin de Faria Krim, PharmD, MSc

CMC working group , Chair, CMC Working Group, DIA Regulatory Affairs Community, France

Yasmin de Faria Krim is an active volunteer at DIA, as chairperson of the CMC working group within the DIA Regulatory Affairs Community. She was the program chair for the last 4 DIA CMC workshops (Washington DC), co-sponsored by AAPS and has also chaired DIA webinars focusing on CMC topics. Yasmin currently works in the consultancy area in Switzerland, and has previously worked in Belgium and the UK, in CMC Regulatory Affairs and European Regulatory Affairs. Yasmin de Faria Krim holds a PharmD and a Master in Regulatory Affairs (International Drug Development and Registration).

Alberto  Ganan Jimenez, PhD

Alberto Ganan Jimenez, PhD

Head of Committees and Quality Assurance, European Medicines Agency, Netherlands

Alberto Ganan Jimenez is a Pharmacist and a Biochemist and holds a PhD on Molecular and Cell Biology from University of Zaragoza (Spain). After working in Pharmaceutical Industry in Business Intelligence positions, Alberto joined the EMA in 2006 as a Product Lead in the Quality of Medicines Office. In 2013, he was appointed Head of Procedures office and since 2022 he is leading the Committees and Quality Assurance Department. This department hosts the secretariat of the Scientific Committees and Working Parties and the Expert panels on Medical devices, provides quality assurance on regulatory and labelling aspects of medicines and is responsible for the procedural management of minor variations and validation of initial MAAs.

Evangelos  Kotzagiorgis, MPharm, MS

Evangelos Kotzagiorgis, MPharm, MS

Pharmaceutical Quality Senior Specialist, Pharmaceutical Quality Office, Human M, EMA, Netherlands

Evangelos is a Qualified Pharmacist and has got an MSc on Pharmaceutical Analysis and Quality Control from the University of Athens, Greece. He has joined the European Medicines Agency (EMA) in 2005. Currently he works as Quality Senior Specialist in the Quality of Medicines Office providing scientific support in the evaluation of new products, and in Scientific Advice requests. Evangelos is also involved in the work of the EMA Quality Working Party and Biologics Working Party and in the development of scientific guidelines. He has previously worked in Industry in R&D and gained experience in pharmaceutical development, manufacturing and quality control.

Pascal  Venneugues

Pascal Venneugues

Quality Specialist, Pharmaceutical Quality Office, European Medicines Agency, Netherlands

Susanne  Winterscheid, PMP

Susanne Winterscheid, PMP

Head of Licensing Division 3, Federal Institute for Drugs and Medical Devices (BfArM), Germany

Susanne Winterscheid is biologist and started at the BfArM in the variation section after a few years of employment in pharmaceutical industry. Since 2005 she was heading the Project Management of a licensing division at BfArM. Since 2008 she is Chair of the Joint CMD working party for variations. In November 2011 she has become the German member of the CMDh. Since June 2015 she is Head of Licensing Division 3 at BfArM.

Presentation -   All Speakers

Presentation - All Speakers

, United States

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