- Central European Biotechnology Portal
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2nd Annual Pharma Law Convention this time in Prague!

Publish date: 2013-01-18

2nd edition of Pharma Law Convention organized in partnership with The Association of Innovative Pharmaceutical Industry is held in Prague, Czech Republic on 13-14 of March 2013. Its mission is to bring pharmaceutical industry of Central and Eastern Europe together with experts from European regulatory and legal fields.

Tags: czech republic , events , pharma

As a know-how exchange and open discussion platform 2nd annual Pharma Law Convention is divided into two days. The first day consists of two parts about transparency and compliance, and competition laws, while the second one will be fully devoted to  parallel trades in context of EU.

Detailed program of 2nd Annual Pharma Law Convention from their site:

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

Further information available on:


Jacek Plewka


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