1. This year marks 30 years since the inception of C5 Group.
It is time to match our brand with the dynamic strides we have made.C5Business Information in a Global Context
a C5 Group Company
Register Now | +44 (0) 20 7878 6888 | C5-Online.com/PharmaReg
a C5 Group Company
Business Information in a Global Context
EU Pharmaceutical
Regulatory Law
27th
-28th
September 2016 | Grange Tower Bridge Hotel | London
Minimising Risks in the Pharmaceutical Sector by Ensuring Regulatory Compliance
Professor
Sir Michael Rawlins
Chair
The Medicines &
Healthcare Products
Regulatory Agency
(UK)
Mario Bertazzoli M.D.
Director, Head of
Corporate Drug Safety
Helsinn Healthcare
Lindsey Kent
European Patent
Counsel
Eli Lilly
Laetitia Szaller
Associate General
Counsel
UCB Pharma
(Belgium)
Dr. Ana Silvia Nita
Group Leader, Global
Regulatory Affairs CMC
Roche Pharmaceuticals
(Switzerland)
Sponsored by:
Media Partners:

2. 14:15
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?
14:45
What Companies Need to Know about
the Bolar Exemption
• Approach taken by the UK compared to Ireland and the rest of Europe
• Impact of the Unitary Patent
• Worldwide perspective
Lindsey Kent
European Patent Counsel
Eli Lilly (UK)
Nicola Dagg
Partner
Allen & Overy (UK)
15:30 Coffee Break
15:45
Planning Strategies in Light of the
New Medical Device & IVD Regulations
• Combination products & companion diagnostics
• Role of the Competent Authorities for Medical Devices (CAMD)
• Implementing strategies in the transition periods
• Mhealth/software for medical devices
Jackie Mulryne
Associate
Arnold & Porter (UK) LLP
16:30
Impact of the European General
Data Protection Regulation
• 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
Paolo Balboni
President
European Privacy Association
17:00
Chair’s Closing Remarks & End of Day 1
Conference Day One
27th
September 2016
9:15 Registration & 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
• Data Protection Regulation
• Impact of the new Clinical Trial Regulation
• Positioning products on the market
• Use of real world data
Elisabethann Wright
Partner
Hogan Lovells (Brussels)
11:00
Practical Implications of the New Clinical Trial
Regulation on Disclosure and Data Privacy
• Recent EMA guidance
• Confidential data transparency
• Data collection & submission
Professor Sir Michael Rawlins
Chair
The Medicines and Healthcare Products
Regulatory Agency
Ciara Farrell
Associate
Arthur Cox
12:00 Networking Lunch
13:30
Will There Ever be Harmonisation
of Pricing & Reimbursement Across Europe
• The success of EU Net
• EU wide pricing system impact
• HTA obligations
• Parallel trade of drugs in EU
• Current practice
Dr Zubair Hussain
Independent Strategic Regulatory Consultant
Peter L’Ecluse
Partner
Van Bael & Bellis
Alison Dennis
Partner
Fieldfisher
Dr. Stephan Rau
Rechtsanwalt
McDermott Will & Emery Rechtsanwälte
Steuerberater LLP
PANELSESSION
GLOBAL SPONSORSHIP OPPORTUNITIES
C5 works closely with sponsors to create the perfect business
development solution catered exclusively to the needs of any
practice group, business line or corporation.
To find out how to position your firm as an industry leader
by sponsoring this event, please contact Chris Murphy on
+44 (0)20 7878 6955 or email c.murphy@c5-online.com
Join the Conversation @C5Live #PharmaReg

3. ©C5, 2016
a C5 Group Company
Register Now | +44 (0) 20 7878 6888 | C5-Online.com/PharmaReg
a C5 Group Company
Business Information in a Global Context
Conference Day Two
28th
September 2016
8:30 Registration & Morning Refreshments
9:00
Opening Remarks from the Chair
Dr Christian B Fulda
Partner
Jones Day
9:15
Tackling the Regulatory Challenges of Bringing
Biosimilars to Market in the US and EU
• Regulatory approval processes
• Comparison of EMA & FDA guidance
• Developing a programme that meets US & EU requirements
• Future approach to clinical requirements
Cecil Nick
Vice President
PAREXEL Consulting
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
• 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
Dr Alexander Natz
Secretary General
European Confederation of Pharmaceutical
Entrepreneurs (EUCOPE)
11:30
Strategies for Avoiding Anti-Competitive Conduct
• Analysis of the recent GSK fine
• Strategies for reducing risks
Laetitia Szaller
Associate General Counsel
Business Development and Technical Operations
UCB Pharma
Ingrid Vandenborre
Partner
Skadden (Brussels)
12:15 Networking Lunch
13:45
Understanding the Challenges & Risks
of the EU Pharmacovigilance System
• Quality Management System
• Premarketing and post marketing drug safety
• EU Qualified Person
for Pharmacovigilance (QPPV)
Mario Bertazzoli M.D
Director, Head of Corporate Drug Safety
Helsinn Healthcare
14:15
International Regulatory Requirements: Driving
Harmonisation Between the Three Major Regulatory
Jurisdictions
• Harmonisation of international requirements
• Ensuring EMA guidelines are aligned with ICH guidelines
Dr Ana Silvia Nita
Group Leader, Global Regulatory Affairs CMC
Roche Pharmaceuticals (Switzerland)
15:00 Coffee Break
15:15
Understanding the Rising Importance of the
Emerging Markets
• Building strategies for the Emerging Markets
• The key regulatory challenges in the Emerging Markets
16:00
Regulatory Change Management & the
Use of Artificial Intelligence (AI)
• Current volumes
• AI in compliance
• Opportunities and pitfalls with AI
• European regulation monitoring
Vasilis Tsolis
Director
Cognitiv+ LTD
16:30
Chairman’s Closing Remarks & Conference Ends
Arthur Cox is one
of Ireland’s leading
corporate law firms with
staff of over 700 in offices in Dublin, Belfast, London, New York and
Silicon Valley. A market leader in the provision of legal services to
the Life Sciences industry, combining legal skill with solid industry
knowledge, our multi-disciplinary practice group represents many of
Ireland and the world’s major pharmaceutical and medical devices
companies.
Sponsored by:

4. This year marks 30 years since the inception of C5 Group.
It is time to match our brand with the dynamic strides we have made.C5Business Information in a Global Context
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Venue Information at a Glance
Date: 27th-28th September 2016
Time: 9:15–17:00
Venue: Grange Tower Bridge Hotel
Address: 45 Prescot St, London, E1 8GP, UK
Telephone: +44 (0)20 7959 5000
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EU Pharmaceutical Regulatory Law
27th
-28th
September 2016 | Grange Tower Bridge Hotel | London
Minimising Risks in the Pharmaceutical Sector by Ensuring Regulatory Compliance