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Informa
08:50 - 09:00 10 mins
Opening remarks from the Chairperson
09:00 - 09:40 40 mins
Stream 1: Intellectual Property
DUAL DIALOGUE: Second medical use patents – lessons learnt from the Actavis v Eli Lilly case
  • Paul Inman - Partner, Gowling WLG, UK
more
  • Examining the UK Supreme Court’s changes in the law of UK patent infringement
  • Implications for freedom-to-operate
  • Other future implications for Europe
  • Compare and contrast UK and German approaches
09:00 - 09:40 40 mins
Stream 2: Regulatory Frameworks
KEYNOTE PRESENTATION: EMA operational preparedness in view of Brexit
  • Sandra Vanlievendael - Head of Long Term and Special Projects Office - EMA Legal Department, EMA, UK
more
09:40 - 10:20 40 mins
Stream 1: Intellectual Property
DUAL DIALOGUE: An update on the structure of Unified Patent Court and implications for industry
  • Brian Cordery - Partner, Bristows LLP, UK
  • Simon Dack - Partner, HOYNG ROKH MONEGIER LLP, The Netherlands
more
  • Update on the structure of the UPC
  • How will Brexit impact the protection of IP?
  • How will the UPC change? How similar will it be?
09:40 - 10:20 40 mins
Stream 2: Regulatory Frameworks
DUAL DIALOGUE: Pharmaceutical marketing: communication with patients and digital media
  • Ilja Morée - Senior Director, Associate GC, Speciality Medicines Europe, Teva Pharmaceuticals Europe BV, The Netherlands
  • Marie Manley - Partner and Head of the Regulatory Practice, Bristows LLP, UK
more
  • How to effectively communicate with patients, including patient focus groups
  • Best practice for use of patient support programmes
  • Optimising pharmaceutical marketing via social media
  • Examining the use of mobile apps and other e-health tools
10:20 - 11:00 40 mins
Morning coffee and networking break
11:00 - 11:50 50 mins
Stream 1: Intellectual Property
DUAL DIALOGUE: Understanding the latest developments in SPCs
  • Marianne Schaffner - Partner, Dechert, France
  • Adrian Spillmann - Head of Corporate Intellectual Property, Valneva, Austria
more
  • Latest status of the EU Commission roadmap for SPCs
  • Examining the current shortcomings of the SPC regulation including regular referrals to the Court of Justice
  • Clarifying the current case law on SPC regulations
  • How will Brexit impact SPCs?
  • Paediatric extensions
11:00 - 11:50 50 mins
Stream 2: Regulatory Frameworks
INTERACTIVE DISCUSSION FORUM: Increasing collaboration between EU Member States for pricing and reimbursement
  • Catherine Longeval - Partner, Van Bael & Bellis, Belgium
  • Koosje van Lessen Kloeke - Partner, Leijnse Artz, The Netherlands
  • Francine Brogyanyi - Partner, DORDA, Austria
more
  • Update on the nature and scope of the BeNeLuxA collaboration including:
    • Information exchanges
    • Horizon scanning activities
    • Joint HTA
    • Joint negotiations
  • Which other countries are considering joining the BeNeLuxA initiative?
  • What are the main challenges and points to consider?
  • Future outlook – could this lead to reshaping of the pricing and reimbursement landscape in Europe?
11:50 - 12:30 40 mins
Stream 1: Intellectual Property
Bifurcation of invalidation and infringement proceedings in German patent litigation – the consequences for litigants
  • Jürgen Dressel - Head Global Patent Litigation Strategy, Novartis Pharma, Germany
more
11:50 - 12:30 40 mins
Stream 2: Regulatory Frameworks
EU Clinical Trials Regulation: preparing for implementation
  • Chris J. Foreman - Senior Director, Legal Affairs, Nordic Sub-Region, Merck Sharp & Dohme (Europe) Inc., Belgium
  • Adela Williams - Partner, Arnold & Porter, UK
more
  • Latest status and extended timelines
  • Examining recent developments in the EU clinical trial portal
  • Practically implementing the CTR – challenges and opportunities
  • What is commercially confidential information?
12:30 - 14:00 90 mins
Networking lunch
14:00 - 14:40 40 mins
Stream 1: Intellectual Property
INTERACTIVE PANEL: Comparing procedures and requirements for preliminary injunctions in different European countries
  • Judith Krens - Partner, Taylor Wessing, The Netherlands
more
  • Approaches for preliminary injunctions within and between different European countries
  • The role of preliminary injunction proceedings in granting a compulsory license for Merck in Germany
  • Other latest case law
14:00 - 14:40 40 mins
Stream 2: Regulatory Frameworks
DUAL DIALOGUE: Off-label use and drug repurposing in the EU: where are we going?
  • Sophie Pelé - National Partner, Dechert LLP, France
  • Elena Cappellaro - Partner, Avvocati Associati Franzosi Dal Negro Setti, Italy
more
  • Opportunities and concerns for off-label use as stated in the Commission's survey
  • Latest case law
  • Overview of local regulations on off-label use
  • Off-label use and reimbursement policies, including Italian and French legislation
  • Next steps?
14:40 - 15:20 40 mins
Stream 1: Intellectual Property
Orphan drugs market exclusivity: exploring regulatory IP rights
  • Harry Kraft - Senior Patent Attorney, Ablynx, Belgium
  • Peter Bogaert - Partner, Covington & Burling LLP, Belgium
more
  • Examining protection strategies available for orphan drugs
  • Latest case law
  • Future outlook
14:40 - 15:20 40 mins
Stream 2: Regulatory Frameworks
The EU Paediatric Regulation: update on the legislative review – industry perspective
  • Victoria Kitcatt - VP & Assistant General Counsel, EU and International Regulatory Law, Pfizer, UK
more
  • Update on the publication of the EU Commission’s final report assessing the impact of the Regulation on public health
  • Future outlook – does the Regulation require amendment?
  • Recent case law
15:20 - 15:50 30 mins
Afternoon tea and networking break
15:50 - 16:30 40 mins
Stream 1: Intellectual Property
Understanding the way in which both EPC law and EU law establish patentability in the field of biotechnology in Europe
  • Rob J. Aerts - Director Intellectual Property, Tigenix SAU, Spain
more
  • Reviewing how the two legal systems interact
  • The systems sometimes collaborate and sometimes go in different directions
  • Discussing how this can result in legal uncertainty for patent applicants and patentees
  • Who determines what is patentable subject-matter and what is not?
15:50 - 16:30 40 mins
Stream 2: Regulatory Frameworks
Designation of orphan medicinal products: issues, challenges and amended regulatory guidance
  • Marie Manley - Partner and Head of the Regulatory Practice, Bristows LLP, UK
more
  • Latest discussions on the concept of “similarity” between products
  • Clarifying the definition of “significant benefit” in the ODR
  • Recent case law and impact on updating the latest guidance
  • Next priorities of the EU Commission
16:30 - 17:10 40 mins
Stream 1: Intellectual Property
Cross border relief and patent infringement – reviewing the latest case law
  • Anja Lunze - Partner, Taylor Wessing, Germany
more
  • Examining the current state of play
  • Lessons for industry
16:30 - 17:10 40 mins
Stream 2: Regulatory Frameworks
Extended Q&A Session: A chance for any remaining questions from the day
17:10 - 17:15 5 mins
Chair's closing remarks and end of conference day
18:15 - 20:15 120 mins
EVENING SEMINAR B: Implementing the European Medical Device Regulation
  • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
  • Céline Bourguignon - Director, Government Affairs EMEA Medical Device & IVDs Department, Johnson & Johnson, Belgium
more

18:15 Registration • 18:30 Start • 20:00 Networking Dinner


Topics to be discussed will include:

  • Setting up a transition program that identifies the gaps and works with the knowns and unknowns, such as:
    • Reclassification of devices (and software specifically)
    • UDI
    • Eudamed
    • Delegated and implementing acts
    • Common specifications
  • Examining the rules on liability and transparency
  • Understanding the increased obligations on economic operators and how to deal with this in your supply chain
08:50 - 09:00

Opening remarks from the Chairperson

Showing of Streams
10:20 - 11:00

Morning coffee and networking break

Showing of Streams
12:30 - 14:00

Networking lunch

Showing of Streams
15:20 - 15:50

Afternoon tea and networking break

Showing of Streams
17:10 - 17:15
Chair's closing remarks and end of conference day

Chair's closing remarks and end of conference day

18:15 - 20:15

EVENING SEMINAR B: Implementing the European Medical Device Regulation

18:15 Registration • 18:30 Start • 20:00 Networking Dinner


Topics to be discussed will include:

  • Setting up a transition program that identifies the gaps and works with the knowns and unknowns, such as:
    • Reclassification of devices (and software specifically)
    • UDI
    • Eudamed
    • Delegated and implementing acts
    • Common specifications
  • Examining the rules on liability and transparency
  • Understanding the increased obligations on economic operators and how to deal with this in your supply chain
  • Erik Vollebregt - Partner, Axon Lawyers, The Netherlands
  • Céline Bourguignon - Director, Government Affairs EMEA Medical Device & IVDs Department, Johnson & Johnson, Belgium
more