A3P Congress South Africa 2024

EU GMP Annex 1 / Patient risk management ICHQ9(R1) / Digitalization

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Venue

Century City Conference Centre, Cape Town (SA)

Date

8, 9 & 10 October

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Format

Conferences, workshops and exhibition

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Program

Simultaneous translation of the conferences: French <-> English

Tuesday, October 08th

Welcome of the participants
08:00 am
A word from the president
Jacques NAVELLOU - A3P
08:50
Introductory conference - Integrating environmental issues into the pharmaceutical industry
Julien TRIQUET - CSL BEHRING & Samah RINGA - VEOLIA & Antoine TOUSSAINT - GSK
09:00
Introduction to the "Digitalization" session
Jean-Louis JOUVE - COETIC
09:25
"Factory of the Future": from strategy to execution
Pierre DORIGNAUX - TAKEDA
09:30
Digital transformation, driving simplification in the control laboratory
Olivier ANTOINE & Helene LAGNEAUX - SANOFI EVF
10:00
Coffee break on the exhibition
10:30
Good Manufacturing Practices supported by digital transformation - Feedback
Vincent BIGEARD & Xavier NOLLEVEAUX - VIRBAC
11:30
Digitalization modeling of aeraulic flow in design phases and benchmark
Rodolphe HENRIETTE - NOVO NORDISK
11:50
How can multi-stage experimental designs integrating several sources of knowledge be designed to speed up the development of bio-processes?
Julien DE CROM - UCB et Thomas CORNET - DNALYTICS
12:10
Q&A session
Vincent BIGEARD & Xavier NOLLEVEAUX - VIRBAC / Rodolphe HENRIETTE - NOVO NORDISK / Julien DE CROM et Thomas CORNET - UCB
12:30
Lunch
13:00
Introduction to the "ICH Q9(R1) Patient Risk Management" session
Pierre ANDRE - LEO PHARMA & Christophe MEUNIER - AKTEHOM
14:55
ICH Q9(R1) Implementation Quality Risk Management
Jean-François DULIERE - ISPE
15:00
Veterinary drug inspection and risk management
Maryline BUGGIN-DAUBIE - ANSES / ANMV
15:30
Coffee break on the exhibition
16:00
A look back on the "ICH Q9(R1) Experience: where are we now?" survey
Pierre ANDRE - LEO PHARMA & Christophe MEUNIER - AKTEHOM
17:00
Challenges and benefits of risk based approaches for standardization and simplification
Cécile FEUILLET - SANOFI
17:30
How can risk management be adapted to the technical and human environment? Specific work needs to be done to manage and control subjectivity.
Sonia LASSURE - SERVIER & Camille LANDRIEU - AKTEHOM
18:00
End of day 1
06:30 pm

Wednesday, October 09th

Workshop sessions / Training
The aim of the workshops is to raise awareness or to deepen theoretical or practical notions with the help of case studies that the participants must deal with during a workshop in order to propose solutions in the form of conclusions, written with the help of the expert facilitators.
During one day, the participants will exchange, work and debate around a technical or regulatory theme.
Registering for the Congress allows you to participate in one workshop
08:00 am
The workshops will be available soon.
    Workshop
    Cofee break
    10:00 am
    Continuation of the first part of the workshop
    10:30 am
    Lunch cocktail
    12:00 am
    Second part of the workshop
    01:30 pm
    Cofee break
    03:00 pm
    Continuation of the second part of the workshop
    03:30 pm
    End of the day 2
    05:00 pm

    Thursday, October 10th

    Welcome of the participants
    07:30 am
    Introduction to the "EU Annex 1" session
    Julien TRIQUET - CSL BEHRING & Nicolas BOURGEOIS - SANOFI
    08:25
    Introduction: EU Annex1 in the regulatory environment: positioning and perspectives of various health authorities
    Antoine AKAR - HUMANIM LIFE SCIENCES et Eric HURTUBISE - V3IE
    08:30
    Reflections and tools for implementing a APS strategy
    Benoit FRANQUIN - CSL BEHRING & Jérôme WEISZ - NOVO NORDISK & Nicolas BOURGEOIS - SANOFI
    09:00
    News on Annex 1 and reading of A3P Congress topics by ANSM: APS, CCS, Working height
    Lu-Jie FERRE - ANSM
    09:30
    Coffee break on the exhibition
    10:30
    From proof of the absence of residual air in steam processes to the bio-decontamination of isolators and RABS by gaseous hydrogen peroxide (VH2O2) processes
    Emna SLAMA - SYNEXIN & Dominique WEILL - DOWELI
    11:15
    What are the challenges facing the industry in the face of the new Annex 1 requirements for the lyophilization process?
    Benoit MOREAU - GSK & Dominique SIERAKOWSKI - DS ASEPTIC COMPLIANCE
    11:45
    Continuous particulate monitoring in compliance to Annex 1 - Rethinking and consolidating fundamentals from design to operation
    Béatrice FOURNIE - ASPEN NOTRE DAME DE BONDEVILLE & Thomas PEREZ - SANOFI
    12:15
    Closing of the 2024 Congress
    12:45 am

    Workshops

    Define a robust aseptic process simulation (APS) strategy to combine high-quality sterile drugs with appropriate industrial effort.
    Laurent MERLI - AUNERIPHARM
    Moderator coming soon
    During the workshop, the following topics will be addressed: Current regulations including new version of EU Annex 1, Exhaustive review of requirements in terms of process and hold-times. Aseptic process simulation effort depending on: Technologies: RABS vs. isolators, Pharmaceutical forms: liquid vs lyophilized products, Primary components: pre-filled syringes vs. vials, Understand the worst-case and bracketing approach, Processes and operators (re)qualification. To fully understand the concepts of APS, a case study will be submitted to attendees. The context of the case study is a new product introduction in a Contract Manufacturing Organization (CMO) having different technologies and pharmaceutical forms. The exercise will determine if additional APS is needed to introduce the new sterile product in the facility and, due to the new EU Annex 1 release, if any gaps need to be solved.
    Atelier 1
    Risk Management in Material Transfer According to Annex 1
    Sascha ROTHER - BASAN SA
    Moderator coming soon
    In this case study, participants will focus on the complexities of material transfer in a pharmaceutical manufacturing facility, specifically within the context of the recently updated Annex 1. The goal is to conduct a comprehensive risk assessment that identifies potential contamination points during the material transfer process. The case study will simulate real-world scenarios where participants must apply Annex 1 principles to propose effective mitigation strategies and ensure compliance with stringent regulatory standards.
    Atelier 2
    Annex 1 Implementation and Challenge in the Pharmaceutical Industry
    Daniel KELLNER-STEINMETZ - VEOLIA WATER TECHNOLOGIES & SOLUTIONS AUSTRIA
    Moderator coming soon
    This workshop will be an industry collaborative discussion focusing on the implementation of technology for Contamination Control Strategies (CCS) in the pharmaceutical industry. We will explore the following topics:
  • Current state of Annex 1 implementation in South Africa
  • Challenges in implementing CCS and its advantages
  • Identifying process risks and creating an FMEA (Failure Mode and Effect Analysis)
  • Selecting the right technology to mitigate and achieve risk control
  • Validation requirements for such technology
  • Data handling and the advantages of data analytics in a world of digital automation

    • The learning objectives of this workshop are to:
  • Critically review current process and quality control strategies
  • Understand and motivate participants to implement better and simplified process steps and quality control strategies

    • Agenda:
  • Introduction and overview of Annex 1 and CCS
  • Case studies of successful Annex 1 implementation in South Africa and globally
  • Discussion of the role of data analytics in CCS and its impact on the industry
  • Best practices for selecting and implementing CCS technology
  • Group discussions and interactive activities to reinforce learning
    • Atelier 3

    Exhibition

    Map of the exhibition

    PLAN Congress Cap Cod A3p 24
    SociétéN° StandSociétéN° Stand
    BASAN SOUTH AFRICA1ESCO TECHNOLOGIES6
    CHEMETRIX EXPORT (PTY) LIMITED27
    3AUNERIPHARM8
    49
    510

    Services included with the Table Top stand

    • A dedicated exhibition space on which you can install your products and
      communication tools: umbrella stand, roll-up, display stand… delimited by a
      structure with back partitions and returns.
    • A basic equipment including a table 180 x 80 cm, 2 chairs and 1 electrical
      connection (16A, 300 kw) without circuit breaker, a row of 2 spotlights, the
      loan of a Nespresso coffee machine with pods.
    • Breaks and meals as indicated in the programme
    • Unlimited Wifi
    • A badge that gives you free access to the entire technical and scientific
      programme
    • The list of participants to the event
    • Possibility to register an additional person at the special “accompanying
      person” rate (590€ excl. VAT)
    • MONTAGE TABLETOP
    • Table Top A3P

    Book a Table-top

    Table-top rate (A3P membership is compulsory and up to date on the date of the event):  3600€ excl. VAT

    I am already an A3P member and I book a table top A3P member and I book a table top – A3P Congress South Africa 2024 – Cape Town.

    To know if you are a member, please contact us.
    To know the rates, please refer to the Membership section of the website: https://www.a3p.org/en/membership/

    Registration

    Practical information

    Contact

    Téléphone : +33 (0)4 37 28 30 40
    Email : info@a3pservices.com; arauturier@a3pservices.com
    Courrier : A3P, 30 rue Pré-Gaudry – Lyon 69007

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