Please note the agenda is subject to change

The page will be updated with further details on the agenda once they are confirmed.


Registration and Coffee


Welcome and Chair’s Introduction

Morning themes: European Transparency, Regulatory & Market Access


Panel Session: Transparency of clinical trial data

  • EMA position on clinical trial and regulatory data
  • Clinical Trial Data – Patient Information Focus
  • Importance of Integrity as well as Transparency
  • Challenges from in-house perspective

Moderated by Helen Roberts


Plenary: Pricing reimbursement update – 2016 EU commission report

  • 2016 EU Commission report
  • Developments in UK & EU HTA
  • Discounts & transparency


Morning Coffee


A choice of two breakout sessions:

A – Biosimilars: Regulatory Developments

  • Update on latest litigation
  • Patent challenges
  • Regulatory approvals
  • Future strategies
  • Sergio Napolitano Director Legal Affairs & Trade Policy, Medicines for Europe
  • Paul England Senior Associate & Professional Support Lawyer , Taylor Wessing
  • Simon Cohen Partner and Heads the International Patents Group, Taylor Wessing

B – Product Liability Claims: Lessons learned from cases

  • Patient rights – status update
  • Class action developments
  • Lessons learned and future strategies
  • Competition – agreements and avoiding pitfalls of anti trust violation



Afternoon themes: Data Privacy, Digital Lifesciences, IP and Competition Law


Panel Session: Privacy management in life sciences

  • Personal data in life sciences and the impact of technology convergence
  • Global landscape and review of the latest/final form of GDPR – implications for accountability, record keeping, patient profiling, data analysis, cross region data movement
  • Within the context of new obligations and risks, how can counsel define and manage compliance?

Moderated by Simon Crossley


A choice of two breakout sessions

C – Collaboration agreements – what are the best jurisdictions to resolve disputes?

D – Understanding competition law and updates

  • Changes in SPCs and Patents
  • Recent, pending and possible future referrals to the CJEU and EFTA Court
  • Reverse payment patent settlements? High-level case law
  • Second medical use patents
  • Competition – agreements and avoiding pitfalls of anti trust violation
  • Cameron Firth Partner - Joint Head of Life Sciences & Healthcare, King & Wood Mallesons


Afternoon Tea


Panel Session: M-health, use of apps, security

  • New apps and legal challenges – case examples
  • The experiments of using patient focus groups
  • How to communicate with patients


Closing comments from chair followed by networking drinks