Objective

This annual conference will bring legal practitioners working with the pharmaceutical sector up-to-date on the latest relevant regulatory developments, legislative initiatives and case law.

A particular focus will be on implications for the sector of recent EU activities in the fields of competition and patent law and of pharmaceutical law, in particular the ongoing EU initiatives on early and equal access to medicines.

Key topics

• Competition law and patent law
• Consequences of the recent CJEU case Genentech v Hoescht (C-567/14) on non-exclusive licence agreements
• Impact of recent competition law decisions in the US and in Europe
• Outcome of recent CJEU and national decisions on patent term extensions for pharmaceutical products

Early and equal access to medicines in the EU

• Ongoing strategy for EU cooperation on Health Technology Assessment
• Recent initiatives from the EMA on early access to medicines: STAMP, PRIME, adaptive pathways, joint scientific advice

EU pharmaceutical law round-up

• Update on recent activities of the European Commission
• Adoption of the EU reform on medical devices and in-vitro diagnostics
• Result of the public consultation on the concept of similarity for orphan designations
• Impact of Brexit in the pharmaceutical sector
• Implementation of the General Data Protection Regulation in the pharmaceutical sector

Who should attend?

In-house counsel, lawyers in private practice, lawyers in national ministries and authorities dealing with regulation of the sector.

Weblink:

https://www.era.int/cgi-bin/cms?_SID=13cd9ed755f0fd474aae90131fe6582569a006f300521009411002&;_sprache=en&_bereich=artikel&_aktion=detail&idartikel=126284