On March 26-27, 2015, the European Generic Medicines Association (EGA) will host its 11th Legal Affairs Forum in Brussels, Belgium. The Forum will focus particularly on:

  • EGA 2020: Where Are the Latest Trends Leading this Sector?

A panel discussion will take place between general counsels of EGA member companies. The themes that will be discussed include the opportunities and threats that the sector is going to face in the next five years in light of the latest developments in the industry.

  • Export Exception During the Supplementary Protection Certificate (SPC)

The EGA will further explore, together with the European Commission, the legal angles of the proposal to manufacture in European Union (EU) for export to non-EU countries during the SPC period. The SPC export exception proposal has the aim to stimulate pharmaceutical production in Europe, insource thousands of highly skilled jobs, manufacturing science and know-how, and give the European generic and biosimilar medicine industries a boost for global leadership.

  • Interplay Between Intellectual Property (IP) and Regulatory Protections

The conference will address a series of topics of regulatory nature that have an IP relevance, from second medical use patents to orphan drug exclusivities, from the issues around the “sunset clause” to the situation regarding the “Bolar” clause and the European Medicines Agency (EMA) policy on clinical trials transparency. A panel debate involving industry experts and the head of the legal department of the EMA will follow.

  • Latest Developments in EU and Global Patent Litigations–Their Impact on the European Industry

The conference will also address the main developments in patent litigations in the EU and worldwide with a particular attention to the impacts on the European industry. Particular focus will be also placed on biosimilar medicines.

When registering for the event, please indicate that you heard about the Legal Affairs Forum from FDA Life.

FDA Life is proud to be a media sponsor of the 11th Legal Affairs Forum. We look forward to seeing you there!