| 08h30 |
Welcome |
| 09h30 |
SESSION 1: The orthopaedic implant market and international opportunities |
| 09h30 |
ROUND TABLE 1: The orthopaedic market by implant type
• Presentation of the implant market and the orthopaedic contract manufacturing market
• The international knee implant market: market overview and emerging needs
• The spinal implant market: the different players and the role of innovation
• The hip implant market and current technological progress
• Feedback: The implant market seen through the eyes of an end-user |
| 11h00 |
Break |
| 11h30 |
ROUND TABLE 2: What new development opportunities exist on an international level?
• What new opportunities exist in the USA? General presentation of the market and its regulatory framework
• Emerging countries - what are the real prospects?
- Brazil, India, China: presentation of the markets, their regulatory frameworks, and development examples
- South Korea: what are the new opportunities for orthopaedic firms? |
| 11h30 |
Lunch |
| 14h30 |
SESSION 2: Choice of workshops |
| 14h30 |
WORKSHOP 1 (FOR PROCUREMENT PROFESSIONALS ONLY): the Purchasing Manager’s challenges
Selecting an outsourcing provider and establishing the level of commitment
- Identifying outsourcing providers on a European and global level
- Choosing outsourcing providers. Which selection criteria should be used?
- Outsourcing providers’ hierarchy pyramid: What level of relationship and commitment should you choose? To what extent should the outsourcing provider be involved in the development process?
- Adapting the contract to mirror the level of commitment the outsourcing provider has been offered. How and when should a multi-year contract be chosen?
• Managing the contractual relationship
- Dealing with the challenges of sales negotiation
- Which sales and logistics clauses should be included in the sales contract?
- The Terms and Conditions of Purchase: which points require extra vigilance?
- Ensuring the contract is fulfilled. Adapting the contract (adding new clauses, including technological developments)
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Break |
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Regulatory framework: Ensuring the compliance of outsourcing providers
- CE marking and FDA standards compliance: which points require extra vigilance? What can be done to ensure that regulatory changes are adhered to?
- Validating outsourcing providers’ processes – how and by whom? Which tools and parameters should be introduced to optimise the validation process?
- Working back up the supply chain to ensure the compliance of outsourcing providers’ partners
- Allocating compliance-related responsibilities and risks between OEMs and outsourcing providers |
| 14h30 |
WORKSHOP 2: Launching a product: overcoming barriers to market entry
• Understanding end users’ needs
• Putting together a Business Plan for a new product
- Assessing the product’s risks and opportunities
- Which pitfalls need to be avoided? How can development and launch costs be minimized?
- Sourcing funding and applying for specific innovation grants
• Incorporating regulatory constraints
- Clinical testing: What help is available?
- Enforcing regulations:
2012: Incorporating the new European regulations
Which regulations should be enforced for combination products?
Implementing regulatory monitoring
- Preparing for compliance inspections, handling the inspection visit and implementing corrective measures
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| 16:00 |
Break |
| 16:30 |
Gaining reimbursement coverage
- The reimbursement of implants on an international scale: what are the differences between countries?
- Spotlight on France: What are the latest developments regarding device reimbursement?
- How to anticipate reimbursement reviews
- Considering reimbursement coverage issues during the R&D phase. Optimizing the device reimbursement application process
- Incorporating possible future product changes in the existing reimbursement framework
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