Switzerland A3P Forum

Combination Products

Location

Aquatis Hotel Lausanne

Date

May 28th

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Format

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Combined products are therapeutic and diagnostic products combining drugs, devices and / or biological products. With the production of new targeted drugs that are mainly sterile products, regulators expect to receive a large number of combined products for review. Given that the combined products include components that would normally be regulated by different types of regulatory bodies, NBE manufacturers are facing new challenges in all aspects of product development and management, including preclinical testing. , clinical investigations, marketing applications, manufacturing and quality control, and subsequently approval of changes after approval. Come share with us your combined product process validation experience, the preparation of your file, the different channels used to comply with the new FDA regulations applicable since April 2019.

Official language of conferences: English
No simultaneous translation of conferences

Thursday, May 28, 2020

Program not finalized. The order of the conferences is given for information purposes, subject to modification. Program not finalized. The order of the conferences is given for information purposes, subject to modification.
Welcome of participants
09:00
Introduction and beginning of conferences
Vincent GRIFFOUL - A3P SWITZERLAND
09:30
Combination products regulatory news and challenges: sharing on NBOs experience
Isabelle MINGAM - UCB FARCHIM
09:45
Combined Medical Devices: Biological and Toxicological Risk Assessment
Abdess NAJI - MATERIALS & HEALTH
10:15
Coffee break - visit of the exhibition
10:45
Design control in the frame of combination products: Applying theory in reality
Frédérique NOSETTI & Hervé SOUKIASSIAN - BECTON DICKINSON
11:30
Lunch - visit of the exhibition
12:30
Biocompatibility Testing of Combination Products: focus on E&L studies
Elodie SAUDRAIS - EUROFINS
14:00
Development of new combined products: design space, design of experiment, etc ...
David ROE - NOVARTIS
14:30
Coffee break - visit of the exhibition
15:00
The Drug & Delivery Device Co-Development Journey - Diary, Challenges and Key Milestones in the new EU regulatory environment
Marielle FOURNIER - VOISIN CONSULTING
15:30
Title to come
Speaker to confirm
16:00
Discussions and conclusion
16:30
Cocktail aperitif
17:00

You wish to reserve a stand, please fill out our online form

Exhibitor form

Plan of the exhibition

CompanyNo. StandCompanyNo. Stand
1 ALPS AUTOMATION5
CONFARMA2 OPTIMA PHARMA6
SOFAST37
4 B BRAUN MEDICAL8

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 140 × 60 cm, 2 chairs and 1 electrical connection (2kw ) without protection circuit breaker.
  • 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 (500 € HT)
  • Registration

  • Participant information

  • Billing information

  • A3P communications

  • Terms and conditions

  • This field is only used for validation purposes and should remain unchanged.

Contact

Depending on your requirements and preferences, you can contact Nina Chatré:

Phone: +33 7 58 68 94 49
Fax: +33 (0)4 37 28 30 60
E-mail : nchatre@a3pservices.com
Mail: A3P, 30 rue Pré-Gaudry - Lyon 69007

Accessibility

Hotel reservation

Aquatis Hotel

Bern Road 148
CH-1010 Lausanne
+41 21 654 24 24