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Key Sessions

Isabelle Chatelier

INTERACTIVE DISCUSSION FORUM New Data Protection Regulations and GDPR for Clinical Research

DG Justice and Consumers, European Commission, Belgium

May 23
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08:00 - 08:50

Conference Registration

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Showing of Streams
10:20 - 10:50

Networking Break

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Showing of Streams
12:10 - 13:40

Networking Lunch

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Showing of Streams
08:00 - 08:50 50 mins
Conference Registration
08:50 - 09:00 10 mins
Stream 1: Data Privacy and Healthcare Compliance
Introduction from Chairperson
08:50 - 09:00 10 mins
Stream 2: Licensing and Collaboration
Introduction from Chairperson
09:00 - 09:30 30 mins
Info
Stream 1: Data Privacy and Healthcare Compliance
Uncovering the Tensions Surrounding GDPR and Clinical Trials
  • William Long - Partner, Sidley Austin LLP, UK
  • Understanding and evaluating the different legal grounds for processing personal data: experience in practice
  • Examining questions around the qualification of data controller and data processor
  • Exceptions and challenges for secondary use and scientific research
  • Managing data subject rights in clinical trials
09:30 - 10:20 50 mins
Info
Stream 1: Data Privacy and Healthcare Compliance
INTERACTIVE DISCUSSION FORUM New Data Protection Regulations and GDPR for Clinical Research
  • Isabelle Chatelier - Legal and Policy Officer, DG Justice and Consumers, European Commission, Belgium
  • William Long - Partner, Sidley Austin LLP, UK
  • Stefano Marino - Head of Legal Department and Acting DPO, European Medicines Agency, The Netherlands
  • Alejandro Gené - Chief Privacy Counsel, Legal Advisor, Celgene, Switzerland
  • EMA perspective: new regulation on Data Protection applicable to EU institutions and bodies
  • Practical challenges for the pharmaceutical industry: varying approach to the legal basis for processing data
  • Data protection authorities approach and focus: identifying the challenges and opportunities
  • Health Authorities view on the application of GDPR for clinical trials
09:40 - 10:20 40 mins
Info
Stream 2: Licensing and Collaboration
DUAL DIALOGUE Roundup of Commercial Litigation from the Pharmaceutical Sector: Lessons Learnt
  • Patrick Duxbury - Partner, Intellectual Property, Gowling WLG, UK
  • Examining litigation across global commercial transactions: examining key areas of contention
  • Lessons learnt: rundown of the top pitfalls to avoid during commercial transitions
10:20 - 10:50 30 mins
Networking Break
10:50 - 11:30 40 mins
Info
Stream 1: Data Privacy and Healthcare Compliance
Data Privacy and Risk Management as a Business Enabler in the Pharmaceutical Industry
  • Maria Chiara Atzori - Head of Data Privacy Corporate Legal, Novartis International AG, Switzerland
  • Understand GDPR risk approach
  • Using GDPR as an opportunity to transform life science operations
  • Practical insight into how privacy can enable the strategy of a pharmaceutical business
  • Comparing the privacy risk-based approach of a global multinational to a small to medium size pharmaceutical organisation
10:50 - 11:30 40 mins
Info
Stream 2: Licensing and Collaboration
DUAL DIALOGUE Examining Agreements for Multi-Partner Collaboration
  • Veronika Bednar - Senior Director, Head of Corporate & Commercial, EMEA Legal, Astellas Pharma Europe, UK
  • Marie Fillon - National Partner, Partner, Dechert LLP, France
  • Aligning interests: how do you structure a deal to ensure all interests align?
  • Multiparty collaborations: format, structure, financial and sub-licence implications
  • Practical guidance and pitfalls to avoid when trying to align multi-party interests
11:30 - 12:10 40 mins
Info
Stream 1: Data Privacy and Healthcare Compliance
DUAL DIALOGUE Effective Compliance: Benchmarking Whistleblowing and Anti-Bribery Programmes
  • Nicolai Behr - Partner, Baker & McKenzie LLP, Germany
  • Overview of current whistleblowing protection in the EU and the proposal for EU Whistle-blower Protection Directive
  • Reviewing anti-bribery regulations across Europe: lessons learnt from recent cases
  • Best practice and benchmarking advice for implementing a successful compliance program
  • Examining competition law considerations around whistleblowing
11:30 - 12:10 40 mins
Info
Stream 2: Licensing and Collaboration
DUAL DIALOGUE The Rise of Digital and Pharmaceutical Collaborative Models
  • Claire Solk - Senior Legal Counsel, AstraZeneca, UK
  • Adam McArthur - Assistant General Counsel, Corporate, AstraZeneca, UK
  • Examining the growth and opportunities of digital health
  • Exploring partnering models and deals structures
  • Practical guidance: managing partnerships, aligning diverse partner interests and culture and solving IP right challenges
12:10 - 13:40 90 mins
Networking Lunch
13:40 - 14:20 40 mins
Info
Stream 1: Data Privacy and Healthcare Compliance
CASE STUDY Harmony Project: Anonymisation, Cross Border Compliance and Big Data
  • Fabian Dorra - Legal Counsel, Bayer AG, Germany
  • Maintaining compliance with national data protection laws and GDPR
  • Insight into legal frameworks: how to share highly sensitive patient data amongst multiple partners
  • Practical approach to safeguarding big data and anonymisation for big data analysis
13:40 - 14:40 60 mins
Info
Stream 2: Licensing and Collaboration
INTERACTIVE DISCUSSION FORUM Key Factors in Making your Collaboration a Success
  • Sally Shorthose - Partner, Bird & Bird LLP, UK
  • Laetitia Szaller - Associate General Counsel, UCB SA, Belgium
  • Alex Nesbitt - Senior Director and General Counsel, Corporate & Transactions, Teva Pharmaceuticals Europe BV, The Netherlands
  • Evaluating different strategies and models for collaboration
  • What are partners looking for? Key driver’s strategic partners and investors
  • Where’s the value? Assessing your value across your assets, know-how and IP
  • What are the key aspects of an effective due diligence process
  • Getting due diligence right: starting the process early and taking a multi-functional approach
14:20 - 14:50 30 mins
Info
Stream 1: Data Privacy and Healthcare Compliance
Speaking, Panellist, Moderators and Webinar Opportunities

Join one of the session outlined on the agenda or suggest a topic of your choice (subject to approval by Knect365).

  • Healthcare Compliance
  • Data Privacy

Please contact linda.cole@knect365.com, Tel +44 (0) 20 7017 6631 if you are interested in participating as a speaker, panellist, moderator or hosting webinar.

14:40 - 15:20 40 mins
Info
Stream 2: Licensing and Collaboration
DUAL DIALOGUE Competition Law Considerations in Structuring Business Development Collaborations
  • Kyriakos Fountoukakos - Partner, Herbert Smith Freehills LLP, Belgium
  • Chris Verleye - Assistant General Counsel, Johnson & Johnson, Belgium
  • Antitrust implications of licencing and collaboration deals
  • Understanding the thresholds and conditions for triggering block exemptions
  • Practical guidance on how to define a 'relevant' market and the definition of potential collaborators and competitors
  • Beyond just collaboration: M&A and full-function joint ventures. Innovation competition and acquisition of start-ups and biotech
14:50 - 15:20 30 mins
Stream 1: Data Privacy and Healthcare Compliance
Networking Break
15:20 - 16:00 40 mins
Info
Stream 1: Data Privacy and Healthcare Compliance
DUAL DIALOGUE Collaboration and Compliance with HCPs
  • Cristiana Spontoni - Partner, JONES DAY LLP, Belgium
  • Alice Cabrio - Compliance Officer, Roche Italy (Pharma & Dia), Italy
  • Review of regulations and codes of conduct for transparency and collaborating with HCPs
  • Self-regulation vs. regulations: analysing the compliance gaps
  • Strategies for creating and maintaining successful HCP collaborations
  • Compensating healthcare professionals: establishing a fair market value

15:20 - 15:50 30 mins
Stream 2: Licensing and Collaboration
Networking Break
15:50 - 16:20 30 mins
Info
Stream 2: Licensing and Collaboration
Expert Tax Advice: Tax Regimes for Innovation and Considerations when Structuring Deals
  • Tax planning for collaboration and licencing agreements
  • Examining financial components of licencing agreements and their tax implications
  • Transfer pricing: intragroup and arm’s length arrangements
  • Comparison of tax regimes for innovation across Europe

Please contact linda.cole@knect365.com, Tel +44 (0) 20 7017 6631 if you are interested in participating as a speaker, panellist, moderator or hosting webinar.

16:00 - 16:40 40 mins
Info
Stream 1: Data Privacy and Healthcare Compliance
DUAL DIALOGUE Mitigating Risk whilst Optimising Patient Interactions
  • Fausto Massimino - Director Legal, Compliance and Governance, Roche SpA, Italy
  • Annabelle Bruyndonckx - Counsel, Simmons & Simmons LLP, Belgium
  • Latest developments, regulations, codes related to patient interactions
  • Walking the fine line: optimising interactions in a highly regulated environment
  • Best practice for patient support programmes
16:20 - 17:00 40 mins
Info
Stream 2: Licensing and Collaboration
DUAL DIALOGUE Implementing Effective Termination Provisions in Agreements
  • Frank Landolt - Chief Counsel Legal & IP, Confo Therapeutics, Belgium
  • Paola Sangiovanni - Partner, Gitti and Partners Studio Legale Associato, Italy
  • The importance of early focus on termination and consequences of early termination
  • Best practice advice on handling conflict in licencing negotiations: termination clauses, identifying what you can claim and when damages need to be paid
  • Settling disputes: common pitfalls to avoid and best practice advice
16:40 - 16:45 5 mins
Stream 1: Data Privacy and Healthcare Compliance
Chair’s Closing Remarks
16:45 - 16:50 5 mins
Stream 1: Data Privacy and Healthcare Compliance
Close of Data Privacy and Compliance Day
17:00 - 17:05 5 mins
Stream 2: Licensing and Collaboration
Chairperson’s Closing Remarks
17:05 - 17:10 5 mins
Stream 2: Licensing and Collaboration
Close of Conference