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European Affiliate News

UK Scottish Region Affiliate

ISPE UK Scottish Region Affiliate arranged a site visit to Intercell Miomedical Ltd. on 3 November 2009 in Livingston, Scotland. This event gave insight into some of the challenges of successfully moving a small development site into a commercial manufacturer. The event included an introduction to Intercell and its technologies followed by a review of the journey made at the Livingston site in the transition from development to commercial manufacture of a Japanese Encephalitis virus vaccine. This was followed by a tour of the manufacturing facilities.

Speakers for this event included David Venables, Site Director, Intercell Biomedical Ltd, Scotland.

Nordic Affiliate

ISPE Nordic Affiliate hosted, “Use of IT-tools in a GxP environment,” on 20 November 2009 in Copenhagen. This half-day GAMP Forum meeting focused on IT-tools in a GxP environment. The meeting attained a high degree of delegate participation and the presentations were kept short allowing time for questions and discussions.

Topics that were covered during this event included:

  • Trends and regulatory news - round table discussion
  • How automated test tools are managed efficiently - procedures and controls
  • How automated test tools can be used or validation - principles and examples
  • How compliance and control of infrastructure tools are implemented - part 1: procedures and controls
  • How compliance and control of infrastructure tools are implemented - part 2: examples

Speakers for this event included Jesper Hammerstrøm; Michael Herløv Jensen, NNE Pharmaplan; and Hasse Greiner, Novo Nordisk A/S.

ISPE Nordic Affiliate upcoming events include the following:

GAMP Meeting
Date: 11 March 2010
Location: Oslo, Norway
Programme TBD

Water and Steam Including New Baseline Guide
Date: 13 April 2010
Location: Finland
Programme TBD

Italy Affiliate

On 10 December, ISPE Italy Affiliate organised in Milan its end-of-the-year meeting for Members as well as non-members interested in the ISPE activities in Milan, Italy. The evening programme included an overview on the ongoing ISPE activities as well as a recap on the activities of the Italy GAMP Forum, including the best from the workshop “Improving efficiency of Verification phases in GAMP 5 perspective” held in Parma on 14 May 2009. Operational Excellence in Italy was discussed as well, relative to the workshop “Pharma Operational Excellence” held in Milan on 15 October 2009. University Relations was also a topic of discussion, as well as the upcoming 2010 Milan Congress and ISPE/PDA Conference at Pharmintech. The meeting was concluded with a traditional Christmas dinner.

Czech Republic and Slovakia Affiliate

The 7th Annual Conference of the Czech and Slovak ISPE Affiliate was hosted by Hungary on 27-28 November 2009 at the Hotel Gellert, Budapest, Hungary and Teva Hungary, Gödölö. (Hungary has not established their own Affiliate yet, but it participates in the existence and work of the global society.) This notable event included not only a theoretical part consisting of presentations, but a practical part as well: an opportunity for the attendees to visit the TEVA Hungary facility.

Speakers for this event included Lajos Hegedus,Teva Hungary; Jiri Moninec, Affiliate Chairman; Alexandra Kolasinova, Affiliate Committee Member; and Laszló Buzás, Hungarian Pharmaceutical Manufacturers Association.

Germany/Austria/Switzerland (DACH) Affiliate

ISPE DACH Affiliate hosted its third workshop, “GMP and Operator Protection – New Technologies in Powder Filling” on 23 October 2009 at Fellbach and Waiblingen in Germany.

Around 30 participants from pharma industry, engineering companies and suppliers from Germany, Austria and Switzerland updated their knowledge on the latest status of Guidelines/Technical Concepts and Solutions, as well as learned practical manufacturing experiences with those through presentations, discussions and case studies of pharmaceutical users. The event also included a company visit at Bosch Pharma Solids.

Major focus was given to the question of how GMP requirements and operator protection concepts are combined in safe, efficient and economical production solutions for oral solid dosage forms. An update on the latest activities of ISPE regarding the revision of the Baseline® Guide for Oral Solid Dosage Forms added a more general view and gave a perspective on what can be expected from the next revision. Insightful case study presentations including movies of major solutions gave a clear view on today’s concepts. The Q&A session demonstrated a strong interest in this topical subject and the feedback received after the event was very encouraging.

Speakers for this event included Moderator Dr. Frank D. Scholl, Committee Member D/A/CH Affiliate; Dr. Thorsten Schmidt-Bader, MoveproTec, Germany; Dr. Bernd Mümmler, Excella GmbH, Germany; Thomas Cragnolini, Siegfried Ltd, Switzerland; and Dr. Clemens Stief, Pfizer GmbH, Germany.

One participant said, “It has been really worthwhile coming to this event. Good that I participated.”

One of the speakers said, “I am happy that I was able to contribute to this successful event.”


Company visit at Bosch Pharma Solids

 


Attendees at the DACH Affiliate workshop

New Members

In September and October, ISPE welcomed 231 new Members in Europe. Find out who joined!

Flag of Belgium Belgium

Caroline Chardonnet
Erwin Devriendt
Frederique Feront
Matteo Giovinazzi
Jan Glazemakers
Benoit Lefevre
Eric Mairiaux
Francois-Xavier Mariage
Gunther Piepers
Peter Van Dyck
Marc Vanstockem
Freya Wolles

Croatian FlagCroatia

Anita Gojceta-Stajcic
Zeljko Granosa

Cyprus

George Antoniov
Marina Papadopoulou
Anna Paphitou

Flag of Czech Republic Czech Republic

Pavel Basta
Pavel Berger

Flag of Denmark Denmark

Silvija Rako Filipovic
Yasmin Goandal
Britt Hansen
Conni Juhl
Annette Larsen
Annette Laursen
Evamarie Mathiesen
Christian Rasmussen
Joen Svendsen
Eva Villavicencio

Estonian FlagEstonia

Alexey Hudzinsky

Flag of France France

Antoine Alexandre
Nizar Ayed
Anne Bard
Nathalie Bayssat
Didier Boivin
Roger Brandt
Stéphanie Clinquart
Olivier Cochet
Delphine Courade
Chase Duclos-Orsello
Fabrice Escourrou
Doru Felezeu
Etienne Hembert
Thai-Nghia Huynh
Paul Kovach
Anne Marie Le Quere
Herve Leroy
Katell Mignot
Sophie Phelippeau
Jean-Paul Raffault
Peggy Sander
Marie-Pierre Travers
Denis Aytekin Uslu

Flag of Germany Germany

Steffen Diebold
Hartmut Doenges
Martin Folger
Manfred Franck
Torben Frommann
Ute Hagenauer-Hener
Ulrich Heil
Christian Hoesch
Kay Karstadt
Michael Kremp
Jacqueline Kretschmer
Eva Maehlman
John Medina
Martin Melzer
Julia Meyer
Beate Reutter
Bettina Rietz-Wolf
Herbert Schmidt
Heiko Schwarz
Elke Sternberger-Ruetzel
Gerhard Straub
Arno Terhechte
Verena Varadi
Hans Wendebourg
Klaus Zeitler

Flag of Ireland Ireland

Fiona Condron
Mary Deasy
Valerie Dunne
Anita Geoghegan
Michael Howlett
John Hunt
Pauric Kavanagh
Conor Kenny
Diarmuid Mac Coitir
Richard Mackey
Francis Maxwell
Maria O Donovan
Liam Shine
Ciaran Spratt
David Staunton
Tom Varley

Flag of Italy Italy

Marco Annoni
Silvia Armani
Gian Paolo Baranzoni
Guia Bertuzzi
Cristina Mapelli
Luisa Stoppa

Flag of Netherlands Netherlands

Harry Bakker
Nico Castelijn
Ruud Groenewegen
Jochen Niethammer
Rinke Nijland
Tinka Pouw-Kreutzkamp
Sharon Schouten-Tjin A Tsoi
Ernest Van  Bockxmeer
Jan Van Der Kuil
Martin Van Der Meer
Gerrit Van Ringen
Menno Zwart

Flag of Norway Norway

Einar Jonsbu
Elham Kossary
Lilly Margareth Myhra
Bernt Vildalen

Flag of Poland Poland

Wojciech Brdak
Zbigniew Jedynak
Marek Kopczynski
Edyta Sapierzynska
Anita Siewruk

 Portugal

José Paulo Freitas

Romanian FlagRomania

Cringuta Braiescu
Gabriela Ruja

Flag of Spain Spain

Eduardo Alonso Rodriguez
Daniel Alvarez Fuste
Paz Arias Carballo
Luis Arroyo Ballesteros
Ricardo Balaguer Cervantes
Javier Ballesteros Cherp
Xavier Bosch Mestres
Mariano Burgos De La Roca
Juan Carlos Carballo Tejero
Joan Cebrian
Maika Chillon Lorenzo
Xavi Cura Blasi
Roberto De Miguel Garcia
Jordi Fornes Guardia
Xavier Garcia Vaquero
Mercedes Garcia
Jaime Gil Gregorio
Luis Alberto Guerrero
Viktor Hermanson
Eduardo Marquez Navarro
Oscar Marti Magrina
Marc Murillo Cortes
Enric Ortega
Carles Palleja I Solanes
Jordi Pedrerol Jardi
Jaime Perea
Marc Perez Puidengoles
Jordi Pujado
Albert Reines Vila
Marta Rodriguez Gonzalez
Marta Rodriguez
Victor Sanchez-Altura
Lluis Twose Garcon
Genny Vidal

Flag of Sweden Sweden

Peter Aullo
Anneli Bergqvist
Pontus Bergstrand
Johan Englund
Lena Gronberg
Anders Hallstroem
Torbjorn Jalkenas
Karol Lacki
Mikael Meisingseth
Ulla Paulsen

Flag of Switzerland Switzerland

Mario Rafael Bielsa Benet
Joachim Brombach
Johann Burckhardt
Marie de Courten
Mario Dobler
Emilie Drean
Ralph Dröge
Beat Federer
Franck Lehmann
Michael Reitze
Edwin Schiff
Sieghard Schuchmann
Claudio Thomasin
Stefan Wyss

Flag of Turkey Turkey

Sevim Canbulat
Harika Capan
Emine Demiryurek
Figen Ergin
Buket Isik
Duygu Kahraman
Melek Kilic
Burcu Papin
Ioanna Parizyanos Fenerli
Ozgur Sagcan
Cihan Sancaktaroglu
Harika Saral
Mehtap Saydam
Cengiz Serdaroglu
Ayse Tete

Flag of Ukraine Ukraine

Petzo Shotuzma
Oleksiy Sukhomlynov

Flag of United Kingdom United Kingdom

Dave Ainscough
Nick Ashton
Andrew Borthwick
Steven Boyd
Juiliette Brady
Kevin Bruce
Julie Cahill
James Cartwright
Paul Cowcher
Paul Dempsey
Jonathan Golightly
Ian How
Trevor Hutchinson
Alan Jeffery
Shane Jones
Steven Laidler
Geraint Lloyd Evans
Adam Marriott
Dave McCann
Kieran McKeever
James Mitchell
Paul Mitchinson
Ian Morgan
Emma Newman
Ranjinie Ragunathan
Joe Reilly
Neshad Sharma
Dawn Sievwright
Richard Smith
Laura Taylor
Mark Waters
Adrian Waterson

 


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