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Informa
08:30 - 09:00 30 mins
Registration & Coffee
09:00 - 09:10 10 mins
Chair's Introduction to Pharmaceutical Law
09:40 - 10:20 40 mins
Summary of Key EUCJ Decisions
  • Genevieve Michaux - Partner, Mayer Brown
10:20 - 10:40 20 mins
Breaks
Coffee Break
10:40 - 11:10 30 mins
Info
Clinical Trials: What You Need to Know
  • Cristiana Spontoni - Partner, JONES DAY®, Belgium
  • What is a clinical trial?
  • The type of clinical trial and what are they meant for?
  • What are the legal considerations?
11:10 - 11:50 40 mins
Info
The Basics of IP Law for Pharmaceutical Innovations
  • Amanda Simons - Partner, Patent Attorney, J A Kemp
  • Patent Filing and Defence
  • Trademarks and Copyright
11:50 - 12:20 30 mins
An Introduction to Marketing Pharmaceuticals
  • Robert Jenny - Senior Counsel and Director, AMGEN
12:20 - 13:20 60 mins
Breaks
Lunch
13:20 - 14:00 40 mins
Info
The Fundamentals of Marketing Authorisation
  • Anneli Howard - Barrister, Monckton Chambers
  • Defining market authorisation
  • Type of procedures within the EU
  • Timelines of each procedure
  • The pros and cons of the various procedures
14:00 - 14:30 30 mins
Info
SPCs: The Basics
  • Defining market authorisation
  • Procedures within the EU
14:30 - 15:10 40 mins
Info
Getting to Grips with Market Access
  • What are the features?
  • What are the issues?
  • Basics of pricing and reimbursement (i.e.NICE)
  • Legal and ethical considerations
15:10 - 15:50 40 mins
Info
The Fundamentals of Licensing Pharmaceutical Products
  • Laetitia Szaller - Associate General Counsel, UCB
  • Maximising the commercial viability of a pharma patent
    • Pragmatic considerations from an in-house perspective
15:50 - 16:05 15 mins
Breaks
Coffee Break
16:05 - 16:50 45 mins
Info
An Introduction to Competition Law in the Pharmaceutical Sector
  • Why is Competition law so important?
    • Understanding of issues between undertakings (i.e. 101 TEU)
    • Understanding of the concept of dominance (i.e. 102 TEU)
  • When is it a problem?
    • How to spot competition issues (e.g. the AZ case)
    • Strategies involving patents settlements
16:50 - 17:30 40 mins
Info
Orphan Drugs: Regulation and Incentives
  • Sarah Faircliffe - Legal Director, Bird & Bird
  • Orphan drugs designation
  • IP benefits and exclusivity
  • Recent case law

17:30 - 18:00 30 mins
The Generic Life Cycle
18:00 - 18:10 10 mins
Chair’s Closing Remarks and End of Day One
18:15 - 18:45 30 mins
Networking Events
Tour of Downing College
18:45 - 19:00 15 mins
Networking Events
College Bar Opens
19:00 - 20:00 60 mins
Networking Events
Dinner
20:00 - 21:30 90 mins
Networking Events
Pub Quiz
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