Technology - Implants 2013
Technology - Implants 2013
Technology - Implants 2013
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Markets and regulatory frameworks Thursday May 31 st<br />
8:30 - 9:00 Welcome<br />
9:00 - 13:00 SESSION 1: The orthopaedic implant market and international<br />
opportunities<br />
9:00 Presentation of the implant market and the orthopaedic<br />
contract manufacturing market<br />
• Hip, knee, trauma, spine and orthobiologic products<br />
• Orthopaedic contract manufacturing : forging, casting, machining, finishing,<br />
sintering, coating, MPS<br />
• Economic trends and technological evolution<br />
AVICENNE - Ali Madani - CEO<br />
9:30 - 11:00 ROUND TABLE 1<br />
The new regulatory framework and its effects on the orthopaedic market<br />
ChAIrmAN : ACIdIm - Faraj Abdelnour - President<br />
• Regulatory changes<br />
• The trade unions’ point of view<br />
• The manufacturers’ point of view<br />
• The certification bodies’ point of view<br />
Workshop<br />
1<br />
SPECIAL PURCHASING ISSUES<br />
How to comprehend the Purchaser/Supplier relationship?<br />
14:30 - 16:00 Feedbacks from purchasers and suppliers: selecting<br />
an outsourcing provider and managing the contractual relationship<br />
• Identification of outsourcing providers<br />
• Selection criteria<br />
• Level of commitment<br />
• International contracts<br />
• Multi-year contracts<br />
• Request for proposal<br />
• Sales negotiations<br />
• Sales and logistics clauses<br />
• The Terms and Conditions of Purchase<br />
tLS - Marc Morel - CEO<br />
bIOmEt - Tamara Uricher - Purchasing Manager Biomaterial and Cement<br />
16:00 - 16:30 Break<br />
16:30 - 17:30: Regulatory framework: Ensuring the compliance of<br />
outsourcing providers<br />
• CE marking and FDA standards compliance: which points require extra<br />
vigilance? What can be done to ensure that regulatory changes are adhered to?<br />
• Validating outsourcing providers’ processes - how and by whom? Which<br />
tools and parameters should be introduced to optimise the validation<br />
process?<br />
• Working back up the supply chain to ensure the compliance of outsourcing<br />
providers’ partners<br />
• Allocating compliance-related responsibilities and risks between OEMs and<br />
outsourcing providers<br />
CEISO - Gérard Luzergues - CEO<br />
tLS - Marc Morel - CEO<br />
bIOmEt - Tamara Uricher<br />
Purchasing Manager Biomaterial and Cement<br />
4<br />
A.F.I.d.E.O - Jean-Claude Carbonnier - Deputy Director (European orthopaedic implants manufacturers<br />
importers & distributors association).<br />
ANSm - ex-AFSSAPS –Jean-Claude Ghislain - Medical Devices Evaluation Director<br />
EurOpEAN COmmISSION - Jacqueline Minor - Consumer Affairs Director<br />
LNE/G-mEd - Corinne Delorme - Regulatory Affairs Manager<br />
11:00 - 11:30 Break<br />
11:30 - 13:00 ROUND TABLE 2<br />
What new development opportunities exist on an international level?<br />
ChAIrmAN: AVICENNE - Ali Madani - CEO<br />
• The international migration of medical device innovation hubs<br />
• Emerging countries - what are the real prospects?<br />
- Brazil, India, China: presentation of the markets, their regulatory<br />
frameworks and development examples<br />
- South Korea: what are the new opportunities for orthopaedic firms?<br />
AESCuLAp - Vincent Marie - International Knee Product Director<br />
EmErGO GrOup - David Houot - Consultant Senior<br />
pWC GLObAL hEALthCArE - Brian S. Williams - Global clients & market, Strategy & Innovation<br />
SOLCO bIOmEdICAL - Il Kim - President<br />
13:00 - 14:30 Lunch<br />
14:30 - 17:30 SESSION 2 : Choice of workshops<br />
17:30 Innovation Award<br />
Workshop<br />
2<br />
LAUNCHING A PRODUCT<br />
Overcoming barriers to market entry<br />
ChAIrmAN: AVICENNE - Christophe Pillot - Senior Consultant<br />
14:30 - 15:10 : From the origin to fundings<br />
• How to manage a business plan? Which pitfalls need to be avoided? How<br />
can development and launch costs be minimized?<br />
SYNChrO mEdICAL - Danielo Campani - CEO<br />
• Sourcing funding and applying for specific innovation grants<br />
OSEO - Claude Sabatin - Innovation Manager Rhône<br />
15:15 - 16:15 : Regulatory frameworks<br />
• Developing a preclinical study that provides proof of the concept and esta<br />
blishes how to tackle regulatory constraints<br />
bIOmAtECh - Jean-Pierre Boutrand - Scientific Director<br />
• How optimizing clinical trials?<br />
• Implementing regulatory monitoring<br />
StrAtEGIQuAL - Dr. Fouad Tarabah - Consultant<br />
• Feedbacks: which regulations should be enforced for combination<br />
products?<br />
GrAFtYS - Anthony Le Naour - Regulatory Affairs Manager<br />
16:15 -16:45 Break<br />
16:45 - 17:30: Gaining reimbursement coverage<br />
• Price and reimbursement of implantable medical device in France :<br />
the pathway for medical devices<br />
• CE certification and reimbursement: clinical data for two different objectives<br />
hEALth prOduCt ECONOmIC COmmIttEE - André Tanti - Medical Devices Vice-President<br />
WhItE-tILLEt - Dr. Yves Tillet - Director, Pharmacist
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