A3P 2024 Congress
EU GMP Annex 1 / Patient risk management ICH Q9(R1) / Digitalization
Venue
Espace Bellevue, Biarritz (France)
Format
Conferences, workshops, exhibition
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The 35th edition of the A3P 2024 Annual International Congress will take place on October 8, 9 and 10, 2024. Like every year, it brings together the entire profession to discuss the major challenges facing the pharmaceutical industry.
This year’s program is based on Annex 1 feedback, patient risk management according to ICH Q9(R1) and digitalization. It features conferences with the participation of health authorities, workshops, as well as an exhibition with over 120 exhibitors.
Once again this year, the 3-day event will provide a major forum for exchanges and opportunities to strengthen relationships between pharmaceutical industry experts.
We look forward to welcoming you, to share with you these moments of technical and scientific discussion and exchanges that are always highly professional, in a convivial atmosphere that is year after year the hallmark of the event and its reputation.
Simultaneous translation of conferences : French <-> English
Tuesday, October 08th
Wednesday, October 09th
Our guests, Alexandre Laridan, TULIPE's Director of Operations, and Anne Carpentier, the association's Head Pharmacist, will share their experiences and challenges in the rapid distribution of medicines to crisis zones such as Ukraine, Gaza and Chad. Together, we will discuss the added value for participating companies, the rigorous selection of partner NGOs, and TULIPE's future prospects, including the innovation of new health kits and the organisation of volunteer days.
This interactive conference will be a unique opportunity to hear inspiring testimonials on the real impact of solidarity and humanitarian aid, to understand the logistical and regulatory challenges, and to discover how everyone can contribute to these philanthropic actions. Don't miss this opportunity to find out more about their projects, which are making a significant difference to the lives of patients around the world.
Thursday, October 10th
What is a “Workshop” at the A3P International Congress?
- Over the course of a day, participants exchange ideas, work and debate on a technical or regulatory theme presented by facilitators.
- The aim of the workshops is to raise awareness and explore theoretical or practical concepts in greater depth, using case studies that participants must deal with in sub-groups, in order to propose solutions in the form of conclusions, drawn up with the help of the expert facilitators.
- The workshop group is made up of an A3P representative (or moderator) from the A3P board, two facilitators chosen for their recognized skills, and participants (industrialists and suppliers) who register by name.
- Registration for the A3P 2024 Congress entitles you to take part in one of the 19 workshops to be presented this year (subject to availability).
- The list of workshops is available below. Click on the workshop title to find out more about its content.
During this workshop, these expectations will be deeply assessed and discussed based on practical short case studies. Recommendations and risk assessment elements will be shared for further enrichment.
Feel free to come with your examples/case studies !
This workshop is intended for everyone, intermediate to experienced level, and should allow participants to analyze and discuss the critical aspects of the aseptic process, to consider various cases in real situation.
Under realistic conditions, the workshop will lead the participants to consider the Annex 1 expectations, the interpretation from authorities and will provide suggestions and examples for a good control program.
In order to guarantee the effectiveness and efficiency of a cleaning process on the installations concerned, one of the first steps is process development. This step is essential in order to optimize the critical process parameters as accurately as possible, so as to guarantee the effectiveness and quality control of the cleaning process, while taking into account economic and environmental issues.
Another important objective of this development phase is to establish the impact of variations in critical parameters on cleaning efficiency. This output data will be used to guide the design of cleaning equipment and justify the associated qualification and validation effort.
- Sanitary design (stainless steel, minimum speed, Reynolds, loop design, etc.).
- Preventive management (recording and interpretation of critical parameters, monitoring, disinfection, maintenance, etc.)
- Curative management: what treatment, when to trigger it, etc.
Content:
- 1. Introduction / Roundtable ==> sharing among trainees
- 2. Theoretical contributions illustrated by practical and varied feedback
- Feedback from facilitators and participants on operational field experiences
- 3. Application via a serious game - experimenting with performance improvements
- Technical, organizational, methodological
- 4. Consolidation of lessons learned from the exercise through a focused sequence on the mindset, methodology, and especially the Lean tools
- Making learners aware of the exercise's teachings
- Transposing the key points into a takeaway memo
Specific features of this workshop:
- Serious game
- Participants' contributions prepared in advance
- Memo summarizing key points for effective practice upon return to their company
Hazard Identification
Formality
Subjectivity
Risk Based decsion making
This will be supported as by cultural excellence.
Following a presentation of the general principles that guide the conduct of investigations, participants will study three cases of proven or suspected microbiological non-compliance and the means of investigation available to us to document them in a robust and scientific manner. It will be necessary to define their exact status (proven/unproven), to explain the source, the cause and their impact in order to implement the appropriate corrective and preventive actions where necessary. In particular, we will consider the case of a "non-compliant BioBurden" analysis, a case of a possibly non-compliant PSA and finally a case of a possibly non-compliant sterility test, taken from real industrial situations. The aim will be to identify appropriate strategies for these three types of case and to develop a relevant approach to investigating OOS in microbiology.
Four themes will be addressed during the day:
- Air: filtration, cleanrooms, airborne disinfection, clothing
- Liquids: water production and distribution, filtration and SUS (Single-Use Systems)
- Production equipment: filling lines, isolator and RABS (Restricted Access Barrier System), autoclave
- Quality: laboratory equipment, Qualification/Validation, services and consulting
Objectives of air handling in CAZs
Principles of air handling system design
Class, pressure and temperature zoning
Heat and air balance
Creation of a PID
Equipment definition
Integrating energy savings into ZAC design
Roles and objectives of digitizing an air handling system (Automation, BMS, remote supervision, Smart System, associated maintenance, etc.)
Conclusion on the links/correlation between digitizing HVAC systems and associated energy savings
- Risk benefits: how to argue for a retro QbD approach? feedback
- Setting up QbD retro: What data do I need? How can it be used?
- Steps to follow, Pitfalls to avoid
- Continuous Process Verification (CPV)
- The aim of the workshop is to consider the various possible options, to select one for each group and to define the various stages, with their advantages and disadvantages, up to the implementation of the retro QbD.
Exhibition Plan
Full exhibition
Companies | n°stand |
ABC TRANSFER | O14 |
ADVANCED INSTRUMENTS | KO4 |
AEROMETRIK | O6 |
AKTEHOM | F19 |
ALBHADES | R10BIS |
AMSONIC – HAMO | R23 |
ASEPTIC TECHNOLOGIES | K5 |
ASSOCIATES OF CAPE COD | O36 / O37 |
ATRYON | O13 |
AVN | K2 |
BATIMPRO CHARRIER | R12 |
BAUSCH+STRÖBEL | R7 |
BD | K16 |
BECKMAN COULTER FRANCE | O22 |
BIOMERIEUX | O43 / O44 |
BIOPHARMA TECHNOLOGIES FRANCE | O38 |
BWT | O42 |
CAP INGELEC | K15 |
CARSO LSEHL | R9 |
CATALENT | B1 |
CCIT | K6 |
CHARGEPOINT TECHNOLOGY | O10 |
CHARLES RIVER | R26 |
CHRISTEYNS | F4 |
CONFORMAT | O2 |
CONTEC | O9 |
COPHACLEAN | O48 |
CYTIVA | O16 / O34 |
DEVEA | R22 |
ECOLAB | O32 / O33 |
ELIS CLEANROOM | O24 / O26 |
ELLAB FRANCE | K4 |
ELSCOLAB | KO1 |
ENDRESS+HAUSER | R30 |
EREA PHARMA | R29 |
EUROFINS BPT | F15 / F15BIS |
GASPOROX | O11 |
GETINGE FRANCE | B2 |
GETINGE LA CALHENE | K19 |
GIVE & TECH | O3 / O4 / O5 |
GOMETROLOGIE | K14 |
GROUPE ICARE | F12 |
HEX + SAFYR | F1 |
HOF SONDERANLAGENBAU | O50 |
HONEYWELL – HPS | K17 |
ILC DOVER | F10 |
IMA FRANCE | F16 |
INITIAL | O30 |
INTERSCIENCE | O1 |
INTERTEK FRANCE | O27 |
IWT BY TECNIPLAST | O42BIS |
JBT BOURSIER | O21 |
JCE BIOTECHNOLOGY | O51 / O52 |
KÖRBER PHARMA | O19 |
LABORATOIRE HUCKERT’S INTERNATIONAL | R10 |
LAPORTE EURO | R27 |
LONZA COLOGNE | O45 |
LSB – LA SALLE BLANCHE | R32 |
MARCHESINI GROUP | F7 |
MERCK | F13 / F14 |
MESALABS | R4 |
MGA TECHNOLOGIES | O28 |
NEOCERAM | K8 |
NIKKA DENSOK | KO3 |
NOVATEK INTERNATIONAL | R20 |
OPTIMA PHARMA | O46 |
OXY’PHARM – SANIVAP | R25 |
PARKER HANNIFIN | R5 |
PARTICLE MEASURING SYSTEMS | K18 |
PEMFLOW – TECHNOFILTRES | O41 |
PFEIFFER VACUUM | O7 |
PHARM-ALLIANCE | F6 |
PHARM’ADIS | R21 |
PHARMAPLAN | R24 |
PHARMASEP | O47 |
PHARMTEC | O17 |
PIERCAN | R15 |
PMT FRANCE | O23 |
PQE GROUP | KO5 |
PROMEPLA | K9 |
PROSYS GROUP | B4 |
RAUMEDIC | K7 |
REALCO | R14 |
ROMACO FRANCE | F11 |
ROMMELAG | R8 |
RT2i | K1 |
SALAMANDERU | F9 |
SCHOTT PHARMA | O20 |
SCHREINER MEDIPHARM | O49 |
SCHÜLKE FRANCE | O29 |
SGD PHARMA | K12 |
SGS HEALTH SCIENCE | R28 |
SHERPAPHARMA | K3 |
SIDJI | O8 |
SKAN | F3 |
SOFAST | F2 |
SOLIDFOG TECHNOLOGIES | R31 |
SOURCIN | O12 |
SPC GROUP | K11 |
STÄUBLI | O40 |
STAXS | F8 |
STERILINE | O18 |
STERIS | R16 / R17 / R18 / R19 |
SWAN | R3 |
SYMBIOSE ENVIRONNEMENT | F17 / F18 |
SYNEXIN | O25 / R1 |
SYNTEGON TECHNOLOGY | O39 |
TECHNIP ENERGIES | R6 |
TECHNOCHIM | R13 |
TEG | B3 |
TELSTAR | O31 |
TEMPRIS | KO2 |
TERANGA GROUPE | O15 / O35 |
TERUMO PHARMACEUTICALS | K10 |
THERAXEL | R11 |
VALTRIA | F5 |
VEOLIA WATER TECHNOLOGIES | R2 |
WARANET SOLUTIONS | K13 |
WILCO | R7. |
Registration form
A3P International Congress
Once you have completed this form, you will receive a copy by email
Registration fee :
Until September 8 : 1300€ excl. VAT (VAT 20%) + A3P Membership required (additional costs to be expected if you are not yet a member).
From September 9 : 1430€ excl. VAT (TVA 20%) + Membership required (additional costs to be expected if you are not yet a member).
To request a quote, please complete the form and select the “quote” option in the payment information section
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/adhesion/
Contact
Depending on your requirements and preferences, please contact Natalina SEMEDO :
Phone : +33 (0)4 37 28 30 40
Email : nsemedo@a3pservices.com
Shuttles : Airport or SNCF station <-> Casino Bellevue
Shuttles will be available:
- Monday 7 October from 10:30 am to 11pm
- Tuesday 8 October from 9h30 am to 10:30 am
- Thursday 10 October from 9 am to 11 am and 12 am to 5 pm
No need to book, the shuttles make several round trips at these times.
Venue
Hotel reservations
The Tourisme Basque has blocked rooms in several of the city’s hotels especially for you, to ensure maximum availability and attractive rates.
Several types of hotels and budgets are available. You’ll find the list below.
Booking platform of Tourisme Basque : Click here
Hôtels ** | |
Hôtel Les Alizés | |
Hôtels *** | |
Hôtel Akena | Hôtel Oxo |
Hôtels **** | |
Hôtel Gran Tonic | Hôtel Florida |
Hôtels ***** | |
Hôtel Sofitel |