In such a highly regulated industry, understanding the key challenges of negotiation and drafting an effective and watertight contract on an international level is a complex topic. It is vital that both legal counsel and commercial executives not only have the key skills and tactics to create a win:win scenario but also the knowledge to ensure any agreement is within the laws and regulations. The alternative is the exposure of the organisation to unnecessary risk and costly disputes.
Who Should Attend:
In-house counsel and legal advisors
Commercial and contract managers
Business development managers
Purchasing and procurement
Patent, IP, trademarks or licensing counsel
Agenda:
Day 1
MODULE 1: INTELLECTUAL PROPERTY ISSUES AFFECTING PHARMACEUTICAL INDUSTRY AGREEMENTS
Intellectual property terms in collaboration and licensing agreements
SPC's - Supplementary Protection Certificates- Securing the full commercial potential of your product
When does R&D infringe patents? Understanding the experimental use and Bolar provisions
Third party IP rights - Freedom to Operate' searches and implications for pharmaceutical industry agreements
MODULE 2: COMMERCIAL AND LEGAL ISSUES AFFECTING PHARMACEUTICAL INDUSTRY AGREEMENTS
Key issues in contract manufacturing agreements
Key issues in co-promotion, co-marketing and distribution agreements
The EMA as a regulator for the pharmaceutical industry
Day 2
Using regulatory processes to define contractual obligations
Key issues in clinical trials and related agreements
MODULE 3: COMPETITION LAW WORKSHOP
Introduction to relevant EU competition law rules
Current competition law issues
MODULE 4: WORKSHOP ON COLLABORATION AND R&D AGREEMENTS
Negotiation of collaboration and licence agreements concerning pharmaceutical product
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