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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 also detailed to illustrate the different approaches which can be applied to be in compliance with this new guidance.

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REGISTRATION (attendees)
 

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

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

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

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

Feedback from a Biotech industry on ICH Q3D Implementation

Aurélie Duclos - VIFOR PHARMA
11.40

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

Elisabeth Moreau, LABORATOIRES 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 of the Risk Assessment approach
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 – employs more than 1,400 people at its 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, immunoglobulins 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 & Discussions
csl behring bern
19.30   Dinner at the Novotel 

 

 Exhibitors list
 COMPANY NAME
 ANTON PAAR SWITZERLAND 
 AMSONIC
 ASSOCIATES OF CAPE COD
 JAG JAKOB AG PROZESSTECHNIK
 QUALITY ASSISTANCE
 SCHÜLKE & MAYR

Contact : Nina CHATRE - Email. Cette adresse e-mail est protégée contre les robots spammeurs. Vous devez activer le JavaScript pour la visualiser. - Tel. +41 27 509 37 28

 

 

Download the Hotel recommendations list

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

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

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

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

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

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

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

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