Day 1 - Tuesday, September 27, 2016

9:15
Registration and Welcome Coffee
10:00
Opening Remarks from the Chair
10:15
How to Protect and Profit from Big Data: Clinical Trial Data & Research Data
11:00
Practical Implications of the New Clinical Trial Regulation on Disclosure and Data Privacy
12:00
Networking Lunch
1:15

PANEL SESSION

Will There Ever be Harmonisation of Pricing & Reimbursement Across Europe
2:15
Strategies to Achieving Marketing Authorisation for New Drugs
2:45
What Companies Need to Know about the Bolar Exemption
3:30
Coffee Break
3:45
Planning Strategies for Pharmaceutical Companies in Light of the New Medical Device and IVD Regulations
4:30
Impact of the European General Data Protection Regulation
5:00
Chair’s Closing Remarks & End of Day 1

Day 2 - Wednesday, September 28, 2016

8:30
Registration & Morning Refreshments
9:00
Opening Remarks from the Chair
9:15
International Regulatory Requirements: Driving Harmonisation Between the Three Major Regulatory Jurisdictions
10:00
The Impact of Brexit on the Pharmaceutical Industry and Regulatory Requirements
10:30
Coffee Break
10:45
Getting Up to Speed with Accelerated Processes & Pathways
11:30
Strategies for Avoiding Anti-Competitive Conduct
12:15
Networking Lunch
1:15
Understanding the Challenges & Risks of the EU Pharmacovigilance System
2:00
Tackling the Regulatory Challenges of Bringing Biosimilars to Market in the US and EU
2:45
Coffee Break
3:00
Building Strategies for Emerging Markets
3:30
Regulatory Change Management & the Use of Artificial Intelligence (AI)
4:00
Chairman’s Closing Remarks & Conference Ends

Day 1 - Tuesday, September 27, 2016

9:15
Registration and Welcome Coffee
10:00
Opening Remarks from the Chair

Colin Kavanagh
Partner and Head of Life Sciences
Arthur Cox

10:15
How to Protect and Profit from Big Data: Clinical Trial Data & Research Data

Elisabethann Wright
Partner
Hogan Lovells (Brussels)

  • Data Protection Regulation
  • Impact of the new Clinical Trial Regulation
  • Positioning products on the market
  • Use of real world data

11:00
Practical Implications of the New Clinical Trial Regulation on Disclosure and Data Privacy

Ciara Farrell
Associate
Arthur Cox (Ireland)

Professor Sir Michael Rawlins
Chair
The Medicines and Healthcare Products Regulatory Agency (UK)

  • Recent EMA guidance
  • Confidential data transparency
  • Data collection & submission

12:00
Networking Lunch
1:15

PANEL SESSION

Will There Ever be Harmonisation of Pricing & Reimbursement Across Europe

Dr Zubair Hussain
Independent Strategic Regulatory Consultant

Peter L’Ecluse
Partner
Van Bael & Bellis

Dr Katharina Wodarz
Partner
McDermott Will & Emery

Alison Dennis
Partner
Fieldfisher

Adam Plich
Vice President of Pricing & Market Access
Teva Pharmaceuticals (Netherlands)

  • The success of EU Net
  • EU wide pricing system impact
  • HTA obligations
  • Parallel trade of drugs in EU
  • Current practice

2:15
Strategies to Achieving Marketing Authorisation for New Drugs

Dr Christian B Fulda
Partner
Jones Day

  • The strange debates over NAS and do they matter?
  • Is a new application of a known substance a new drug?

2:45
What Companies Need to Know about the Bolar Exemption

Lindsey Kent
European Patent Counsel
Eli Lilly (UK)

Nicola Dagg (United Kingdom)
Partner
Allen & Overy

Jin Ooi
Associate
Allen & Overy (UK)

  • Approach taken by the UK compared to Ireland and the rest of Europe
  • Impact of the Unitary Patent
  • Worldwide perspective

3:30
Coffee Break
3:45
Planning Strategies for Pharmaceutical Companies in Light of the New Medical Device and IVD Regulations

Jackie Mulryne
Associate
Arnold & Porter (UK) LLP

  • Combination products & companion diagnostics
  • Role of the Competent Authorities for Medical Devices (CAMD)
  • Implementing strategies in the transition periods
  • Mhealth/software for medical devices

4:30
Impact of the European General Data Protection Regulation

Paolo Balboni
President
European Privacy Association

  • New principles set forth in the Regulation
  • Main duties and obligations for Controllers and Processors
  • The crucial role of the Data Protection Officer (DPO)
  • Data Protection Impact Assessment (DPIA)
  • Principles of Data Protection by Design and by Default
  • Managing Data Breaches and notifications
  • New data subject’s rights
  • Sanctions and remedies
  • Effective Corporate Data Protection Compliance Programme

5:00
Chair’s Closing Remarks & End of Day 1

Day 2 - Wednesday, September 28, 2016

8:30
Registration & Morning Refreshments
9:00
Opening Remarks from the Chair

Dr Christian B Fulda
Partner
Jones Day

9:15
International Regulatory Requirements: Driving Harmonisation Between the Three Major Regulatory Jurisdictions

Dr Ana Silvia Nita
Group Leader, Global Regulatory Affairs CMC
Roche Pharmaceuticals (Switzerland)

  • Regulatory approval processes
  • Comparison of EMA & FDA guidance
  • Developing a programme that meets US & EU requirements
  • Future approach to clinical requirements

10:00
The Impact of Brexit on the Pharmaceutical Industry and Regulatory Requirements

Peter Bogaert
Partner
Covington & Burling LLP (Brussels)

  • Available options
  • Implications of an EEA-type model on pharma (approvals, exclusivity rights, parallel trade, etc.)
  • Medical devices
  • Practical considerations

10:30
Coffee Break
10:45
Getting Up to Speed with Accelerated Processes & Pathways

Dr Alexander Natz
Secretary General
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) (Belgium)

  • Different regulatory processes
  • Approaches to breakthrough therapies
  • Commercial issues
  • Adaptive licencing, marketing authorisation & exceptional use
  • Unravelling the PRIME initiative
  • Getting products to market
  • EMA’s approach in comparison to standard authorisation pathway

11:30
Strategies for Avoiding Anti-Competitive Conduct

Laetitia Szaller
Associate General Counsel Business Development and Technical Operations
UCB Pharma

Ingrid Vandenborre
Partner
Skadden (Belgium)

  • Analysis of the recent GSK fine
  • Strategies for reducing risks

12:15
Networking Lunch
1:15
Understanding the Challenges & Risks of the EU Pharmacovigilance System

Mario Bertazzoli M.D.
Director, Head of Corporate Drug Safety
Helsinn Healthcare (Switzerland)

  • Quality Management System
  • Premarketing and post marketing drug safety
  • EU Qualified Person for Pharmacovigilance (QPPV)

2:00
Tackling the Regulatory Challenges of Bringing Biosimilars to Market in the US and EU

Cecil Nick
Vice President
PAREXEL Consulting

  • Harmonisation of international requirements
  • Ensuring EMA guidelines are aligned with ICH guidelines

2:45
Coffee Break
3:00
Building Strategies for Emerging Markets

Helen Roberts
Of Counsel, Solicitor
BoneliErede

  • Building strategies for the Emerging Markets
  • The key regulatory challenges in the Emerging Markets

3:30
Regulatory Change Management & the Use of Artificial Intelligence (AI)

Vasilis Tsolis
Director
Cognitiv+ LTD

  • Current volumes
  • AI in compliance
  • Opportunities and pitfalls with AI
  • European regulation monitoring

4:00
Chairman’s Closing Remarks & Conference Ends