Please note the agenda is subject to change
The page will be updated with further details on the agenda once they are confirmed.
09:00
Registration and Coffee
Morning themes: European Transparency, Regulatory & Market Access
09:35
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
- Gautier Pereira Senior Legal Manager, GSK
- Aleksandar Rusanov Legal Adviser, Legal Department in the European Medicines Agency
- Rhianon Ebsworth Senior Corporate Counsel, Novo Nordisk
10:35
Plenary: Pricing reimbursement update – 2016 EU commission report
- 2016 EU Commission report
- Developments in UK & EU HTA
- Discounts & transparency
- Helen Roberts – Chairperson Of Counsel, Bonelli Erede
10:55
Morning Coffee
11:30
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
- Tom Spencer Senior Counsel, GSK
- Cécile Derycke Co-Head of Global Life Sciences Litigation Arbitration & Employment, Hogan Lovells
- Matthew Felwick Counsel, Hogan Lovells
12:20
Lunch
Afternoon themes: Data Privacy, Digital Lifesciences, IP and Competition Law
13:20
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
- Funke Abimbola FRSA General Counsel & Company Secretary, Roche UK
- Ian Inman Group Manager Policy Delivery – Advice & Guidance, ICO
- Paula Barrett Partner, Eversheds
- Simon Crossley Partner, Eversheds
- Maria Chiara Atzori Head Data Privacy CH, Novartis International
14:20
A choice of two breakout sessions
C – Collaboration agreements – what are the best jurisdictions to resolve disputes?
- Suzanne Smith Chief Legal Officer & Company Secretary, Abcam
- Sally Shorthose Partner, Bird & Bird LLP
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
15:10
Afternoon Tea
15:40
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
- Victoria Hordern Senior Associate, Hogan Lovells
- Andrew Skipper Partner, Hogan Lovells
- Christian Di Mauro Partner, Hogan Lovells
- Professor Robert S. H. Istepanian BSc., MSc., PhD, FIET, SeniorMIEEE Visiting Professor and Academic, Department of Electrical and Electronic Engineering, Imperial, College, London
16:30