Annex1 - Drug substances/Drug product

Impact of the new version of annex1 on drug substance and drug processes

Place

LAUSANNE

Date

March, 16

Format

Conferences, round table, exhibition

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The intent of Annex 1 is to provide guidelines for the manufacturing of sterile products but not only! The new Annex 1 suggests that certain principles and guidance can be used to support the manufacture of other products that are not necessarily sterile, such as certain liquids, creams, ointments and biological intermediates….  The interpretation and implementation of this new Annex 1 will be discussed with our experts in contamination control strategy, drug substance and drug product manufacturing, microbiological and particles monitoring and aseptic process simulation at the next A3P forum to be held at l’Aquatis in Lausanne on March 16. 2023.

Agenda and conference program in progress…

Official language of the conference: English
🎧 No simultaneous translation

Thursday, March 16

Welcome of the participants
08:30
Introduction conference
09:15
Title to be confirmed 
Pierre DEVAUX & Julien TRIQUET, A3P Annex 1 Common Interest Group
09:30
Interpretation of Annex 1 for ATPMs : Implementation of Contamination Control Strategy for clinical manufacturing of AAVs (Adeno-Associated Virus).
Paul FIORIO, BAYER
10:00
Coffee break on the exhibition
10:30
Annex 1 Implementation Global Strategy: Main common impacts and key implementations plans.
Christophe HAENTZLER, GSK
11:15
CCS deployment ou EM control strategy versus annex 1
Barbara MOSER & Gesine KAISER, CSL BEHRING
11:45
Lunch and coffee break
12:15
Key Current Considerations, Trends and Challenges linked to Aseptic Process Simulations (APS)
Isabelle HOENEN, LILLY
14:45
Case Study - Impact of Annex 1 on Takeda Neuchatel APS program
Jules MOUSSATOFF, TAKEDA & Yves MOINARD, HUMANIM
14:45
Coffee break on the exhibition
15:15
Impact of revised Annex 1 from a supplier perspective: sterilizing grade filtration, PUPSIT and single-use systems
Lionnel LUEGINBUEHL & Philippe STURCHLER, PALL
14:45
ROUND TABLE
A3P Annex 1 Common Interest Group
16:15
End of the event
17:30

Exhibition map

< The exhibition is now fully booked >

CieBooth NrCieBooth Nr
JCE BIOTECHNOLOGY1EREA7
RAPID MICRO BIOSYSTEMS2LAPORTE EURO8
BACCINEX3TERANGA GROUP9
HEX GROUP4LABORATOIRES ICARE10
SKAN5SYMBIOSE ENVIRONNEMENT11
BORER CHEMIE6STERIS12
  • A dedicated exhibition space on which you can install your products and communication tools: umbrella stand, roll-up, display, product, … A basic equipment including a table 180×80 cm, 2 chairs and 1 electrical connection.
  • Coffee breaks and lunch indicated in the program
  • Unlimited Wifi
  • A badge that gives you free access to the entire technical and scientific program
  • Possibility to register an additional person (600€ excl. VAT)

Exhibitor Form

A3P Switzerland Forum

The exhibition is now fully booked

Registration Form

A3P Switzerland Forum

Once this form is completed, you will receive a copy by email

Registration fee: 600€ HT + A3P membership required (additional costs to be expected if you are not yet a member).
To know if you are a member, please contact us.
To know the rates, please refer to the Membership section of the website.

Contact

You can contact Nina Chatré :

Phone : +33 7 58 68 94 49
Email : nchatre@a3pservices.com
Address: A3P, 30 rue Pré-Gaudry – Lyon 69007 (France)

On-Site : Aquatis Hotel, Route de Berne 148, CH-1010 Lausanne (switzeraldn)

Access

Hotel reservation

Aquatis Hotel
Route de Berne 148, CH-1010 Lausanne (Switzerland)
Phone : +41 21 654 24 24
Email : info@aquatis-hotel.ch