A3P Switzerland Congress
Annex1 GMP Eu
Lieu
Mövenpick Hôtel Lausanne
Date
March, 11&12
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FORMAT
Conferences, Partners Workshops, Exhibition
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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
NOVATEK - SIEMENS - SOURCIN - SYNEXIN
11:30
Lunch on the exhibition
12:30
Partner workshops
NOVATEK - SIEMENS - SOURCIN - SYNEXIN
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
HDM - Efficient technologies for cost-effective ZAC decontamination in the Pharmaceutical & Life sciences industries
Didier MARTINEZ - BIO15PHARMA & MERCK
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
NOVATEK - SIEMENS - SOURCIN - SYNEXIN
11:00
Lunch on the exhibition
12:00
Partner workshops
NOVATEK - SIEMENS - SOURCIN - SYNEXIN
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
Roger HOLENSTEIN - OPTAPHARM<
16:00
End of the day
16:30
Tuesday, March 11
Session 1
Boosting Training and Production with AR and Micro-Videos
SOURCIN
Discover how augmented reality and micro-videos can transform training and production processes to improve consistency, increase quality, and enable self-guided learning. Michael Mödler, Head of Training, Operational Excellence and Strategic Projects at Lonza Biologics Operations Visp, will showcase example on forward-thinking approach. Explore how our solution provides real-time, hands-free guidance. This hands-on session includes a practical demonstration of AR integration to enrich your training and production capabilities, even in closed systems and for everyday tasks such as gowning and cleaning.
Workshop 1
Bridging the Divide: Holistic Contamination Control Through Real & Digital Convergence
SIEMENS
Workshop 2
Methodology for bringing a conventional line into compliance with Annex 1: 3D design, analysis of practices, Mock-up, on-site construction, and qualification
SYNEXIN
Workshop 3
Next-Generation Pharma Data Management: Leveraging digitalization, automation, and data modeling for EU GMP Annex 1 Compliance
NOVATEK
Explore " Next-Generation Pharma Data Management: Leveraging digitalization, automation, and data modeling for EU GMP Annex 1 Compliance " in this workshop. Learn how to define and refine user requirements, while integrating cutting-edge technologies like Novatek LIMS, automation, integration, and IoT to optimize data integrity, traceability, and productivity. Gain practical insights into building scalable, compliant systems that meet current and future regulatory requirements.
Workshop 4
Session 2
Boosting Training and Production with AR and Micro-Videos
SOURCIN
Discover how augmented reality and micro-videos can transform training and production processes to improve consistency, increase quality, and enable self-guided learning. Michael Mödler, Head of Training, Operational Excellence and Strategic Projects at Lonza Biologics Operations Visp, will showcase example on forward-thinking approach. Explore how our solution provides real-time, hands-free guidance. This hands-on session includes a practical demonstration of AR integration to enrich your training and production capabilities, even in closed systems and for everyday tasks such as gowning and cleaning.
Workshop 1
Bridging the Divide: Holistic Contamination Control Through Real & Digital Convergence
SIEMENS
Workshop 2
Case study (follow-up to Workshop 1): Introduction and distribution of materials in RABS: focus on maintaining Sterility Assurance.
SYNEXIN
Workshop 3
Next-Generation Pharma Data Management: Leveraging digitalization, automation, and data modeling for EU GMP Annex 1 Compliance
NOVATEK
Explore " Next-Generation Pharma Data Management: Leveraging digitalization, automation, and data modeling for EU GMP Annex 1 Compliance " in this workshop. Learn how to define and refine user requirements, while integrating cutting-edge technologies like Novatek LIMS, automation, integration, and IoT to optimize data integrity, traceability, and productivity. Gain practical insights into building scalable, compliant systems that meet current and future regulatory requirements.
Workshop 4
Wednesday, March 12
Session 3
Future of biopharma: Compliance, mixed Reality and AI
SOURCIN
Dive into the future of biopharma with the latest advancements in mixed reality and AI, exploring their applications for compliance, visual inspections, cleaning, … This session fosters open discussions and shares insights into the technologies shaping the industry. To inspire actionable ideas, we’ll discuss compelling biopharma use cases, including interactive demonstrations of hands-on solutions.
Workshop 1
Bridging the Divide: Holistic Contamination Control Through Real & Digital Convergence
SIEMENS
Workshop 2
Methodology for bringing a conventional line into compliance with Annex 1: 3D design, analysis of practices, Mock-up, on-site construction, and qualification
SYNEXIN
Workshop 3
Next-Generation Pharma Data Management: Leveraging digitalization, automation, and data modeling for EU GMP Annex 1 Compliance
NOVATEK
Explore " Next-Generation Pharma Data Management: Leveraging digitalization, automation, and data modeling for EU GMP Annex 1 Compliance " in this workshop. Learn how to define and refine user requirements, while integrating cutting-edge technologies like Novatek LIMS, automation, integration, and IoT to optimize data integrity, traceability, and productivity. Gain practical insights into building scalable, compliant systems that meet current and future regulatory requirements.
Workshop 4
Session 4
Future of biopharma: Compliance, mixed Reality and AI
SOURCIN
Dive into the future of biopharma with the latest advancements in mixed reality and AI, exploring their applications for compliance, visual inspections, cleaning, … This session fosters open discussions and shares insights into the technologies shaping the industry. To inspire actionable ideas, we’ll discuss compelling biopharma use cases, including interactive demonstrations of hands-on solutions.
Workshop 1
Bridging the Divide: Holistic Contamination Control Through Real & Digital Convergence
SIEMENS
Workshop 2
Case study (follow-up to Workshop 1): Introduction and distribution of materials in RABS: focus on maintaining Sterility Assurance.
SYNEXIN
Workshop 3
Next-Generation Pharma Data Management: Leveraging digitalization, automation, and data modeling for EU GMP Annex 1 Compliance
NOVATEK
Explore " Next-Generation Pharma Data Management: Leveraging digitalization, automation, and data modeling for EU GMP Annex 1 Compliance " in this workshop. Learn how to define and refine user requirements, while integrating cutting-edge technologies like Novatek LIMS, automation, integration, and IoT to optimize data integrity, traceability, and productivity. Gain practical insights into building scalable, compliant systems that meet current and future regulatory requirements.
Workshop 4
Map of the exhibition
| Société | N° Stand | Société | N° Stand | |
| PHARMAMEDIA DR.MÜLLER | 1 | SYMBIOSE ENVIRONNEMENT | 11 | |
| PHARMTEC | 2 | JCE BIOTECHNOLOGY | 12 | |
| SYNEXIN | 3 | SIEMENS | 13 | |
| STERIS | 4 | PACOSPHARM | 14 | |
| SALAMANDERU | 4a | ACTEMIUM | 15 | |
| BECKMAN COULTER | 4b | GETINGE | 16 | |
| SOURCIN | 5 | NOVATEK | 17 | |
| BD LIFE SCIENCES | 6 | LAPORTE EURO | 18 | |
| EREA | 7 | ACD SWISS | 19 | |
| DEVEA | 8 | ELIS CLEANROOM | 20 | |
| ASSOCIATES OF CAPE COD | 9 | ICARE | 21 | |
| AM INSTRUMENTS | 10 | SOLIDFOG | 22 |
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
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
Code promo hôtel :
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Ajouter dans la case « Special rates » le code « MOV1 » dans la partie « Preferential code » et appuyer sur « Submit »
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