Pharma Law Convention 2013 brings pharmaceutical industry public and private sector together with regulatory and legal European experts. Established as a know-how exchange and open discussion platform, the program will address the rapidly developing legal regulations in the CEE pharmaceutical sector, through subjects such as parallel trade, transparency and compliance.
Program - Day 1
1) Compliance – Transparency
- Miscellaneous legal interpretations of EFPIA Ethical Codex.
- Extraterritorial reach of Sunshine Act and UK Bribery Act to CEE countries
- Challenges of enforcing transparency rules and laws in CEE - recent actions
- Regional compliance regulations - Pending legislation
- Effect of emerging global legislation and regulatory enforcement on corruption prevention and anti-bribery
- Transparency on Pharma sector spending. The way ahead - voluntary or enforced by law
- Similarities and differences between regulatory development in US and Europe
- Developing culture of ethics and compliance in the CEE Pharma sector - effectiveness of compliance programs
2) Competition
- Compatibility of Early-Entry-Contracts with Competition Law
- Evergreening and the challenges to the competition rules
- Compatibility of Patent Settlements with Competition Law
- "Pay-for-delay" settlement agreements.
- Approach to market definition in pharmaceuticals cases - constructing market dominance
- Competition concerns over co-marketing and co-promotion agreements
- Vertical relationship between manufacturers and distributers
- Bonus Schemes
- Non-price competition between suppliers
Program - Day 2
3) Parallel trade
- Complete legal framework analysis of parallel trade in EU
- Parallel trade in context of EU
- Quantification and trends
- Typical export/import countries
- Characteristic of portfolio
- Specific trade aspects of parallel trade in Pharma distribution chains
- Parallel trade from manufacturer point of view & prediction of development
For further informatin and registration, please visit:
http://www.lawconvention.eu