A3P ICH Q12
Accelerate innovation and changes, Facilitate lifecycle management, Reduce Regulatory Burden, Strengthen Quality Assurance

Place

Mercure Lyon Center Perrache Hotel

Date

19 September 2019

Save the date !

Format

Conferences, Exhibition, Round Table

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The late publication 2017 of the draft version of the ICH Q12 guide post-approval change management led several laboratories and interest groups to work for several months to interpret the text and provide feedback to ICH prior to release of the final version.

In anticipation of this final publication by the ICH (Step 4 planned in November 2019), the GIC A3P ICH Q12 offers you a day dedicated to the interpretation of this guideline, the challenges and opportunities it raises and offers you to share together its comments on the text.

Representatives of the regulatory authorities will be present during this day which will be held around conferences, an exhibition and a round table.

Official language of conferences: French
Simultaneous translation of conferences: French <-> English

Thursday September 19

Welcome of participants
08:30
Reminder of the guideline, return of the work of the GIC A3P ICH Q12
Members of GIC A3P ICH Q12
09:00
ICH Q12: the evaluation point of view
Jean-Louis ROBERT
09:45
Coffee break - visit of the exhibition
10:30
ICH Q12 the point of view of the inspection of the ANSM
ANSM intervention
11:30
Applying QbD for biological products - LFB Experience
Laurent SIRET - LFB
12:00
Lunch - visit of the exhibition
12:30
First steps taken towards "ICH Q12" (New Veterinary Records)
Viviane NERON DE SURGY - VETOQUINOL
14:00
ICHQ12 Implementation of an Industry Perspective with a Focus on Established Conditions (Application to vaccines)
Mihai BILANIN - GSK BIOLOGICALS
14:30
Feedback from FDA pilot program on Established Conditions
Nadia BEAUDOUX - LILLY France
15:00
Coffee break - visit of the exhibition
15:30
Round table
16:00
End of the event
17h00

You wish to reserve a stand, please consult our exhibitor file

Booking form

Plan of the exhibition

SociétéN° Stand
 CARSO-LSEHL1

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, product, ... A basic endowment including table 180 × 80 cm, 2 chairs and 1 electrical connection (2kw ) without a circuit breaker, the loan of a Nespresso coffee machine with pods
  • Breaks and meals indicated in the program
  • Unlimited WiFi
  • A badge that allows you free access to the entire technical and scientific program
  • List of participants in the event
  • Ability to register an additional person at the special rate "accompanying" (500 € HT)

You wish to reserve a stand, please consult our exhibitor file

Booking form

Registration form
A3P Lyophilization - 2 & 3 October 2017 in Lyon

At the end of this form you will receive a copy of your registration.

Registration







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Contact

According to your requirements and your preferences, you can contact Victoria PALOMBI:

Phone: + 33 (0) 4 37 28 30 53 // + 33 (0) 6 65 37 51 37
Fax: +33 (0)4 37 28 30 60
E-mail : vpalombi@a3pservices.com
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007

Accessibility

Hotel reservation

Mercure Hotel - Lyon Château Perrache
12 Course of Verdun Rambaud,
69002 Lyon
Tel: 04 72 77 15 00


Hotel Ibis - Lyon Center Perrache

28 Cours de Verdun Perrache,
69002 Lyon
Tel: 04 78 37 56 55

Hotel Campanile - Lyon Perrache
17 Place Carnot,
69002 Lyon
Tel: 04 78 37 48 47


Kyriad Hotel - Lyon Perrache
26 Cours de Verdun Perrache,
69002 Lyon
Tel: 04 78 71 17 47

Hotel des Savoies
80 Rue de la Charité,
69002 Lyon
Tel: 04 78 37 66 94