Annual Conference on EU Law in the Pharmaceutical Sector 2019

Date: 21 February 2019

Time: 09:15

Duration: 2 days

Location: Brussels, Belgium

Cost: € 890,00

Organiser: Academy of European Law

Web Link: https://www.era.int/?128326&en

Description:

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.

KEY TOPICS

- Competition law: Recent rulings from the CJEU and ongoing European Commission cases on pay for delay, off-label use and more;
- Patent law: SPC manufacturing waiver, specific mechanism for parallel imports;
- Data exclusivity: Revised EU definition of similar orphan designations, impact of recent General Court rulings on significant benefit;
- Emerging legal issues linked to new technologies and Digital Health: 3-D printing and artificial intelligence, medical data, data sharing and “personalised medicines”;
- EU pharmaceutical law round-up: Recent developments on pricing and access to medicines, HTA post 2020, Brexit “preparedness”.

SPEAKERS

- Rainer Becker, Head of Unit, DG COMP, European Commission, Brussels;
- Peter Bogaert, Partner, Covington & Burling, Brussels;
- Martin Fitzgerald, Deputy Director General, GIRP (European Healthcare Distribution Association), Brussels;
- Edith Frénoy, Director, Market Access/HTA, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels;
- Emmanuelle Huck, Programme/Policy Officer, DG CNECT, European Commission, Brussels;
- Catherine Longeval, Partner, Van Bael & Bellis, Brussels;
- Lokke Moerel, Professor, University of Tilburg, Senior Of Counsel, Morrison & Foerster, Berlin;
- Ingo Müller, Lawyer, Kohlpharma, Merzig;
- Alexander Natz, Secretary General, EUCOPE, Brussels;
- Jörg Plessl, Director, EU Affiliates, Regulatory Affairs, Norgine, Wettenberg;
- Christian Tillmanns, Partner, Meisterernst Rechstanwälte, Munich.