Congress A3P Switzerland

Annex1

Lieu

Mövenpick Hôtel Lausanne

Date

March, 11&12

Save The Date !

FORMAT

Conferences, Partners Workshops, Exhibition

Partager

The A3P Switzerland congress in March 2025 will delve into the interpretation and application of the new Annex 1 in Switzerland, with a focus on sharing practical insights and experiences from the industry. Since the publication of Annex 1 Manufacture of Sterile Medicinal Products and its implementation on August 23 with PICs PE 009-17, the pharmaceutical and biotechnology sectors have been faced significant changes in process design, aseptic practices and contamination control requirements. This forum will provide a unique opportunity to discuss Swissmedic’s interpretation of these new requirements and to examine the strategies and challenges encountered by industry leaders in their implementation efforts. Participants will gain insight into compliance expectations and innovative approaches to meet the stringent standards now required for the manufacture of sterile and low microbial load medicinal products.

Official language of conferences : English

Tuesday, March 11

Welcome participants
08:30
GIC presentation
GIC member Community of practice
09:00
Annex 1 requirements for APS and Operator Qualification with insight from Swissmedic Q&A
Gesine KAISER - CSL BEHRING & Benjamin DELIS - BACCINEX
09:30
Aseptic process simulation - campaign and intervention strategy
Lucile LIEGARD - LABORATOIRES CDM LAVOISIER & Benoit FRANQUIN - CSL BEHRING
10:00
Coffee break on the exhibition
10:30
Partner workshops
11:30
Lunch on the exhibition
12:30
Partner workshops
14:00
Navigating challenges of Annex 1 Implementation in Biotech DS: Gowning, Smoke Tests, and Laminar Flow Classification
Valerie SAUTHIER & Maria SILVA - MERCK
15:00
Annex 1 Requirements: Multi-Site Implementation and Local CCS Insights for Low Bioburden Bio DS manufacturing sites
Raha JUILLERAT & Gilles TRIMBORN UCB
15:30
Coffee break on the exhibition
16:00
Title to be defined
16:30
Strategic Adaptation of Annex 1: Enhancing Contamination Control for Low Bioburden Biologics
Assaf LEVI - LONZA
17:00
Cocktail on the exhibition
17:30
End of the day
19:30

Wednesday, March 12

Welcome participants
08:30
Ambiguity in cleanroom requalification testing
Victor METTLER - TAKEDA
09:00
Environmental Monitoring (focus sur le Non Viable)
Béatrice FOURNIE - ASPEN PHARMA & Thomas PEREZ - SANOFI
09:30
Coffee break on the exhibition
10:00
Partner workshops
11:00
Lunch on the exhibition
12:00
Partner workshops
13:30
Implementation of a quality risk approach for APS interventions
Cindy GOBAUT & Alexis BILLARD - BRACCO
14:30
Coffee break on the exhibition
15:00
Challenges of regulatory aspects ​on cleaning and bio-decontamination processes: inspection feedback
Lauriane ZUCHUAT - CORDEN PHARMA & Pierre DEVAUX - THERAXEL
15:30
Overcoming challenges in Annex 1 compliance: A step phased approach for small manufacturers with outdated equipment to ensure product quality during compliance transition period
16:00
End of the day
16:30

Our partners

Titre atelier 1
Animateur 1
Modérateur 1
Description 1
Atelier 1
Titre atelier 2
Animateur 1 & Animateur 2
Modérateur 1
Description 2
Atelier 2
Titre atelier 3
Animateur 1 & Animateur 2
Modérateur 1 & Modérateur 2
Description 3
Atelier 3

Registration form will be available soon

For all inquiries, please contact Victoria PALOMBI vpalombi@a3pservices.com

Map of the exhibition

SociétéN° StandSociétéN° Stand
PHARMAMEDIA DR.MÜLLER1SYMBIOSE ENVIRONNEMENT11
PHARMTEC2JCE BIOTECHNOLOGY12
SYNEXIN3SIEMENS13
STERIS4PACOSPHARM14
4aACTEMIUM15
BECKMAN COULTER4b16
SOURCIN 5NOVATEK17
BD LIFE SCIENCES6LAPORTE EURO18
EREA7ACD SWISS19
DEVEA8ELIS CLEANROOM20
ASSOCIATES OF CAPE COD9ICARE21
AM INSTRUMENTS10SOLIDFOG22

Services included with the Table Top

  • A dedicated exhibition space where you can set up your products and communication tools: umbrella stand, roll-up, display, product, etc. Basic equipment including a 180×80 cm table, 2 chairs and 1 electrical connection (2kw) without circuit breaker
  • Breaks and meals as indicated in the program
  • Unlimited WiFi
  • A badge giving you free access to the entire technical and scientific program
  • List of event participants
MONTAGE TABLETOP 3x2 01

Registration fee: 1 240€excluding VAT (20% VAT) + A3P membership required* *additional costs to be expected if you are not yet a member.
To find out if you are a member, please contact us.
For prices, please see: https://www.a3p.org/en/membership/

Contact

You can contact Victoria PALOMBI :

Téléphone :+337 58 68 94 49
Email : vpalombi@a3pservices.com
Courrier : A3P, 30 rue Pré-Gaudry – Lyon 69007

Accessibilité