A3P Switzerland Forum

Combination Products

Location

Aquatis Hotel Lausanne

Date

6 October 2020

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Combination products are therapeutic and diagnosis products combining drugs, devices and/or biological products. With the manufacture of new targeted drugs which are mostly sterile products, regulators are expecting to receive a great number of combination products to review. Given that combination products are comprised of components that would usually be regulated by various types of regulatory bodies, NBE manufacturers are facing new challenges on all aspects of products development and management, including preclinical tests, clinical investigations, marketing applications, manufacturing and quality control, and then after approval of changes. Come and share you experience of with us process validation of combination products, the preparation of your file, the various ways to be in compliance with the new FDA regulation, which is applicable since April 2019.

Official language of confrrences: English
No simultaneous translation

Tuesday 6 October 2020

Programme subjected to modification due to the change of date (postponement due to the Covid-19 health situation). Our speakers are currently confirming their presence.
Reception of participants
9:00 a.m.
Introduction and beginning of conferences
Vincent GRIFFOUL - A3P SWITZERLAND
9:30 a.m.
Combination products regulatory news and challenges: sharing on NBOs experience
Isabelle MINGAM - UCB FARCHIM
9:45 a.m.
Combined Medical Devices: Biological and Toxicological Risk Assessment
Abdess NAJI - MATIERES & SANTE
10:15 a.m.
Coffee break - Visit of the exhibition
10:45 a.m.
Design control in the frame of combination products: Applying theory in reality
Frédérique NOSETTI & Vincent HERIN - BECTON DICKINSON
11:30 a.m.
Lunch break - Visit of the exhibition
12:30 p.m.
Biocompatibility Testing of Combination Products: focus on E&L studies
Elodie SAUDRAIS - EUROFINS
2:00 p.m.
Development of new combined products: design space, design of experiment, etc...
David ROE - NOVARTIS
2:30 p.m.
Coffee break - Visit of the exhibition
3:00 p.m.
The Drug & Delivery Device Co-Development Journey - Diary, Challenges and Key Milestones in the new EU regulatory environment
Marielle FOURNIER - VOISIN CONSULTING
3:30 p.m.
Title to be confirmed
Speaker to be confirmed
4:00 p.m.
Discussion and Conclusion
4:30 p.m.
Aperitif cocktail
5:00 p.m.

Sold out exhibition.

Exhibition map

Company Stand NumberCompanyStand Number
 GROUPE JBT1 OPTIMA PHARMA6
 CONFARMA2 STRATEGIE SANTE7
 SOFAST3 B BRAUN MEDICAL8
 EUROFINS MEDICAL DEVICE TESTING4 STERIS9
ALPS AUTOMATION5ELLAB10

Services included with the stand

  • A dedicated exhibition area on which you can install your communication products and tools: umbrella stand, roll-up, display, products, etc. …A basic equipment including a 140×60 cm, 2 chaises et 1 raccordement électrique(2kw) table, 2 chairs and 1 electrical connection (2kw) without a protective circuit breaker.
  • Breaks and meals listed in the programme
  • Unlimited Wifi
  • A badge that allows you free access to the entire technical and scientific programme
  • The list of the event participants
  • Possibility to register an additional person at the special “accompanying” rate (500 € ex-taxes)
  • Registration

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  • Billing Information

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Contact us

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

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

Accessibility

Hotel reservation

Hôtel Aquatis

Route de Berne 148
CH-1010 Lausanne
+41 21 654 24 24