A3P

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OPHRDC

4 5 & July 2017
Lyon, France
Conferences, Workshops, Exhibition

The pharmaceutical industry as a whole, and especially biotechnology companies, for different reasons, are turning to outsourcing for the development or the provision of their products on the market. The A3P with its network, connects actors of this activity (suppliers and contractors) to review the problems encountered, whether technical order, regulation or cultural.

The 2 days program has been designed to offer a good balance between lectures delivered by opinion leaders, workshops led by a tandem of users and providers, and an exhibition providers. All in an atmosphere conducive to trade.

 

REGISTRATION
Fees
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EXHIBITION

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PROGRAM - 4 and 5 2017 July
Espace Tête d'Or, 103 boulevard of the Battle of Stalingrad, 69100 Villeurbanne (Lyon)

   
  CONFERENCES
July 4
09: 00 - 12: 30
 

Outsourcing and contracting: industrial strategy, challenges and associated risks
Sonia Kasperowicz - GSK & Jacques Navellou - Axys Network

Responsabilities of the contract giver and concrete example with a vaccine
Pierre Lauer - Sanofi Pasteur

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Strategy for the development of an innovative parental drug product containing two MABs. Keys to success in an outsourced challenging project
Alain Sainsot - Amatsi Group

Outsourcing analyzes, facing a high-growth market, the development of a site. Feedback from a site transfer, 800 people, 10000m², realized in 6 weeks
Adrien Puissegur & Yassine Bouhid - Carso Group

Operational excellence and regulatory compliance: 2 key objectives
Marc Maury - Unither Pharmaceutical & Paul Beyou - SGS

Control of the quality of the products by the subcontractors through the quality contract established according to the FDA guidance Of November 2016
Nathalie Parisot - Celgene

   
           
  WORKSHOPS
July 4
14: 00 - 18: 30

1 Workshop: Contract manufacturing / processing contract: what difference?
The key points of negotiation in a subcontracting manufacturing:
-the capacity / volume commitments,
-l'exclusivité / alternative sources
-l'approvisionnement raw materials
-The product delivery terms
-The compliances caused by the manufacturer / contract manufacturer
-The responsibility of the manufacturer / contract manufacturer and its insurance coverage
-the intellectual / industrial property orbiting manufacturing
-The change of control clauses
-The anti-corruption clauses and non-compete clauses
Emmanuelle De Schepper & Jean-Marc Grosperrin - Dentons

2 Workshop: Crisis management in the context of a production in a CMO
Crisis management is a key topic in the pharmaceutical industry because of the expected level of traceability and responsiveness.The context of the sub-traintance brings an obvious additional complexity by adding an additional player in this exercise.
Transparency and a relationship of mutual trust are essential when dealing with a crisis. In this workshop we will see how to build an organization and a relationship that can manage a crisis in the most effective and positive way possible. We will see the key points to be anticipated and highlight the expectations of the authorities.
Julien Triquet - GSK & Patrick Rousseau - Aspen

gb3 Workshop: How onboarding our customers in serialization program?
Serialization is one of the most important and complex challenges that the pharmaceutical industry is currently facing with deadlines on November 2017 for the US and February 2019 for the EU. Choosing the right solution for the first step of the process is the first step. Eg: how to adapt our internal organization with external demands? Which functions do we have to integrate? How can the team work together to be efficient? ...
This is what we offer you to work on - having the chance to have both CDMO's and MAH around a table.
Patrick Barillot & Staffan Widengren - Recipharm

gb4 workshop: Important Aspects BFS CMO:
What are The Reasons / benefits for outsourcing BFS products?
What are the significant aspects to accomplish achieve smooth product transfer?
What Responsibilities shoulds / must be shared and what are the consequences for the Contract Giver?
Martin Haerer & Christoph Bohn -Rommelag CMO

   
             
  DINNER
4 July -
18:45
  Cocktail and dinner at the "Terrasses du Parc"    
           
  CONFERENCES
July 5
09: 00 - 14: 30
 

Production of IMPs - Feedback from a non-pharmaceutical sponsor
Marianne Perdrijat - DBV & Nicolas Le Rudulier - Creapharm

Contract manufacturing organizations : which level of oversigh ?
Jihaine-Najah Baud & David Da Cunha - Roche

gbRecovering the GMP certification partner after the acquisition of a manufacturing site by a CMO
Cristina Velasco - Rovi Contract Manufacturing

What a journey from the Big Pharma to the CMO
Jean-Yves Sarciaux - Galien LPS

The role of the depository in the pharmaceutical industry
Luc Pradeau - Alloga

Cold Chain Logistics : Outstanding cold chain management based on an owned network, high quality standards and qualified packaging
Sébastien Pradal - World Courier

Challenges of creating a BU dedicated to the CDMO within Servier
Gwenaël Servant - Servier CDMO

How to succeed a pharma manufacturing site divestiture ? Key success factors / Feedback
Ludovic Mathieu - In Altum Consulting & Roland Blondel

   
           
  ROUND TABLE 
July 5
15: 00 - 17: 30
 

Key success factors for outsourcing operation,
Ask your questions to our experts

   

Contact :
Victoria Palombi
04 37 28 30 53
This e-mail address is protected against spambots. You need JavaScript enabled to view it.

 

 

 

Nearby Hotels

Crowne Plaza Lyon****

International City
22 quai Charles de Gaulle, Lyon 69006

T. 04 78 17 86 86


The Marriott Hotel ****

International City
70 quai Charles de Gaulle, Lyon 69006
T. 04 78 17 50 50


Hotel Mercure ****

7 place Charles Hernu, Villeurbanne 69100
T. 04 72 44 46 46


Hotel B & B Lyon Caluire Cité Internationale
148-150 Grande Rue de St Clair, Caluire-et-Cuire 69300
T. 
08 92 68 70 76

Résidence hôtelière Temporim Lyon Cité Internationale****
35, Quai Charles de Gaulle Lyon 69006
T. 04 37 47 57 67 


Nearby parking

Parking the Espace Tête d'Or

Accessible to participants

33 St. Louis Guérin
69100 Villeurbanne