Seminar Nr. 16448
|Non-ECA/APIC Members:||EUR 1596,--|
|ECA Members:||EUR 1516,--|
|EU GMP Inspectorates:||EUR 1260,--|
|APIC Members:||EUR 1436,--|
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Tel.: 06221 / 84 44 0 E-Mail: email@example.com
Hélène Bruguera, EDQM France
Maria Filancia, EMA, United Kingdom
Rainer Gnibl, EU-GMP Inspector, Germany
Landry Le Chevanton, DSM, Switzerland
David Cockburn, formerly European Medicines Agency (EMA)
Marieke van Dalen, Aspen Oss B.V., The Netherlands
Joerg Gampfer, Hovione, Portugal
Markus Goese, F. Hoffmann-La Roche, Switzerland
Oksana Golycheva, Janssen Pharmaceutica, USA
René van Herpen, Aspen Oss B.V., The Netherlands
Martijn Klop, Synthon, The Netherlands
Danny de Scheemaecker, Janssen Pharmaceutica, Belgium
Michael Toward ,Johnson Matthey MacFarlan Smith, United Kingdom
Dieter Vanderlinden, Ajinomoto OmniChem, Belgium
Francois Vandeweyer, Janssen Pharmaceutica, Belgium
Guy Villax, Hovione, Portugal
The APIC/CEFIC Conference on Active Pharmaceutical Ingredients is Europe’s leading event. Many major stakeholders from Authorities and the Industry are each year joining this Conference. Speakers from EMA, EDQM, National Authorities, from Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.
The GMP Conference, of which the final part is a Joint GMP & RA session, provides updates from recent authorities’ initiatives, activities and interpretations related to GMP compliance of API manufacturing. Hear from industry speakers their approaches and best practices on compliance related to the various existing and emerging aspects of API GMP.
The conference will be opened by a presentation about FDA latest initiatives in 2018 with special focus on the EU-US-MRA followed by a presentation about current findings from EU-GMP inspections at EU- & Asian API-manufacturers. The following lectures are dedicated to the Brexit and the consequences for the API industry, the latest development of the EU-US-MRA, the current regulatory landscape in Canada and Data Integrity aspects in the API production area.
In the Joint GMP and the Regulatory Affairs part of the conference you will get to know what authorities can do about drug shortages, the latest requirements for API registrations in Eastern Europe an update on ANVISA’s international cooperation and on EDQM’s activities and initiatives. Furthermore you will hear presentations about the EU ASMF assessment worksharing, Industry point of view of the ICH Q12 guideline and recent developments regarding API regulations in China. The conference will be rounded off by a presentation about the way towards global harmonization of regulatory requirements.
The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to practical experiences with API filings in Emerging Countries, risk based audits of regulatory starting materials, statistical approaches to process validation, ICH Q3D consequences for APIs, Drug Substance control strategies and aspects of fraud in the supply chain of APIs and raw materials.
The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.