Course No 15880
|Non-ECA/APIC Members:||EUR 1680,--|
|ECA Members:||EUR 1596,--|
|EU GMP Inspectorates:||EUR 1260,--|
|APIC Members:||EUR 1512,--|
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Hugo Bonar, HPRA, Ireland
Hélène Bruguera, EDQM France
Sven-Erik Hillver, MPA, Sweden
Anabela Marcal, EMA, United Kingdom
Keith McDonald, MHRA, United Kingdom
Christina Meissner, AGES, Austria
Jean-Louis Robert, Chairman of the EMA QWP, United Kingdom
Marieke van Dalen, Aspen Oss B.V., The Netherlands
Manuel Figueiredo, Hovione, Portugal
Betsy Fritschel, Johnson & Johnson, USA
Valérie Guilbaut, Novacyl, France
Patrick Lefèvre, PCAS, France
Martijn Klop, Synthon, The Netherlands
Moheb Nasr, GSK, USA
Mechthild Sander, Alfred E. Tiefenbacher, Germany
Michael Toward, Johnson Matthey MacFarlan Smith, United Kingdom
Francois Vandeweyer, Janssen Pharmaceutica, Belgium
Hilde Vanneste, Janssen Pharmaceutica, Belgium
Victoria Waddington, United Kingdom
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 FDA, 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 industry’s experiences with Quality Metrics followed by a presentation about the current status of the FDA/EMA Mutual reliance initiative. The following lectures are dedicated to the Regulatory Starting Materials, APIC’s revised GDP How to do Guide, industry’s experiences with continuous processing and counterfeiting APIs.
In the Joint GMP and the Regulatory Affairs part of the conference you will get an update on EDQM’s activities and hear presentations about the ICH Q11 Q&A from a health authority perspective, the current status of ICH Q12 and its benefit from the regulator’s and industry’s perspective, the QWP’s point of view regarding ICH Q3D, API variations and generic industry’s experience, FDA’s Division of Lifecycle APIs assessment of DMFs and case studies on post approval changes.
The specific GMP and Regulatory Affairs topics to be discussed in the Parallel Sessions will relate to practical experiences with ASMF assessment/worksharing, APIC’s revised Quality Agreement Guideline and Template and practical experiences with non EU/US authorities inspections. Further topics are dedicated to data integrity issues in the analytical environment and how to prevent them, APICs experience with supporting documentation for API filings in Emerging Countries and GMP requirements for biotech vs. biological APIs.
The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.