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ICHQ3D Elemental Impurities
8 months before the go live. Are you ready for the implementation?

4th May 2017, Bern

The guidance is applicable since June 2016 for New products and will be effective in December 2017 for all the products.During the day, Risk analysis to manage the control of elemental impurities in the product will be presented Integrating the products / process knowledge.
Shop floors experiences will be detailed aussi to Illustrate the different Approaches Applied qui peut être to be in compliance with this new guidance.

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REGISTRATION (attendees)
 

A3P Switzerland Program
Novotel Bern Expo -Guisanplatz 4, 3014 CH-Bern (Switzerland)

  Thursday, May 4 2017th
08.30 Welcome of the participants at the Novotel Bern Expo
09.00 Introduction
Vincent Griffoul - Switzerland A3P President
09.10 Operational Implementation of ICH Q3D - Proposed Analytical Methods
Elise Gallais - SGS
09.50

Implementation Strategy of ICH guideline Q3D for a long term parenteral sustained release formulation

Marco Salvagni - DEBIOPHARM
10.30 Coffee Break at the Exhibition Area
11.00

Feedback from a Biotech industry is Q3D ICH Implementation

Aurélie Duclos - VIFOR PHARMA
11.40

How to Implement ICH Q3D - Defining a Risk-Assessment Strategy for Elemental Impurities

Elizabeth Moreau, LABORATORIES BOUCHARA-RECORDATI
12.30 Lunch

14.00

ICH Q3D - Implementation, a control strategy in Biotech - Feedback of the "drug product" solution used to monitor Elemental Impurities based approach of the Risk Assessment
Sylvain Plagellat - MERCK

14.40

Elemental Impurities testimony of implementation by a contract manufacturing organization
Jean-Marc Libersa - FAREVA

15.20

ROUND TABLE

All speakers and participants
16.00 Departure for the visit of CSL Behring
  CSL Behring AG - a company of the CSL Behring group based in the USA - more employees than 1,400 people at ict facility in Bern.

They apply Their know-how and dedication to Developing, manufacturing and distributing high-quality biotherapeutics made from human plasma.
CSL Behring's products, immunoglobulin for the treatment of immunodeficiency's and disturbances of immune function, an Anti-D immunoglobulin for the prevention of haemolytic diseases in the newborn, an intravenous immunoglobulin for Preventing cytomegalovirus disease associated with solid organ transplantation, and albumin used in emergency treatment and intensive care, are distributed worldwide.
Since 1949 CSL Behring AG has-been Located in the Wankdorf district of Bern, next to the Stade de Suisse stadium.
16.15

19.00
  • Welcome of the participants
  • Compagny Presentation
  • Visit
  • Question & Answer
  • Aperitif & Discussion
csl behring bern
19.30 Dinner at the Novotel

 

 Exhibitors list
 COMPANY NAME
ANTON PAAR SWITZERLAND 
 AMSONIC
ASSOCIATE OF CAPE COD
JAG JAKOB AG PROZESSTECHNIK
QUALITY SERVICE
 SCHÜLKE & Mayr

Contact: Nina CHATRE - Email. This e-mail address is protected against spambots. You need JavaScript enabled to view it. - Tel. + 41 27 509 37 28

 

 

Download the Hotel list recommendations

Novotel Bern Expo ****
Am Guisanplatz 2 - 3014 CH-Bern

Holiday inn Westside ****
Riedbachstrasse 96 - 3027 CH-Bern

Sorell Ador ****
Laupenstrasse 15 - 3001 CH-Bern

Ambassador Hotel ****
Seftigenstrasse 99 - 3007 CH-Bern

Best Western HOTELBERN****
Zeughausgasse 9 - 3011 CH-Bern

Hotel Sternen Muri****
Thunstrasse 80 - 3074 CH-Bern-Muri

Hotel Kreuz***
Zeughausgasse 41 - 3000 CH-Bern

Hotel Schweizerhof Bern*****
Bahnhofplatz 11 - 3001 CH-Bern