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ERA: Annual Conference on EU Law in the Pharmaceutical Sector 2019
Event Description
- Competition and intellectual property law
- Medical data and innovative technologies
- Access to medicines in the context of Brexit
On 21 November 2018, the Court of Justice of the European Union adopted its awaited Lucentis / Avastin decision (CJEU, case C-29/17) . This new judgement on the reimbursement of medicinal products used off-label has a major impact for the pharmaceutical sector.
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”
Networking
This conference is a great opportunity to meet and network with speakers and participants from whole Europe.
Who should attend?
In-house counsel, lawyers in private practice, lawyers in national ministries and authorities dealing with regulation of the sector
Online registration and programme
Languages: English
Organiser: Academy of European Law (ERA), Florence Hartmann-Vareilles
Event number: 219R05
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
Laura Whiting, Counsel, Freshfields Bruckhaus Deringer, London