COURSE DESCRIPTION
OVERVIEW
You are responsible for developing or executing an outsourcing strategy for your company, but Contract Manufacturing Organizations (CMOs) aren’t calling you back – or worse yet, the clock is ticking and you are struggling to even find the right CMO for your drug development and/or manufacturing. What’s more, there is an overwhelming amount of material on outsourcing across the internet, but where do you start looking? How do you vet vendors? Where do you find the time? If initiating a relationship with a new CMO is not something you do every day, how do you know where go, what information to share or how much budget? What compliance and/or regulatory issues come into play?
LEARNING OBJECTIVES
This interactive, 90-minute webinar will take you step-by-step through the outsourcing process and highlight the best practices and common pitfalls along the way, giving real world examples to illustrate how to procure a CMO that fits your strategy and specific needs. These steps will include:
- Outsourcing Strategy Development
- Developing Selection Criteria and Pre-Requisites
- Anatomy of RFI’s, RFP’s and Technical Packages
- Conducting Searches
- Executing CDA’s
- Competitive Bidding and Proposal Assessment
- Conducting Site Visits
- Term Sheet Development
- Master Agreement Negotiation and Execution
- Project Initiation
At the end of the session, you will have the insight and tools to help you coordinate and control the transaction, understand the costs, and assure that the selected CMOs meet your specific needs.
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