IN LIFE SCIENCES LAW
Empowering Women to Lead with Vision and Purpose
11–12 March 2025 • NH Carrefour de L’Europe, Brussels
KEYNOTES
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Georgia Gavriilidou Head of Legal Department European Medicines Agency
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Olga Solomon Director, DirectorateGeneral for Health and Food Safety (DG SANTE) European Commission
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Zoe Kimberly Area Counsel, Europe AbbVie
Arianna Greco Senior Vice President, General Counsel Commercial Alnylam Pharmaceuticals
Aileen Murtagh Senior Director, Legal Counsel Biomarin
Christina Jordan Vice President and Associate General Counsel, International Markets Bristol-Myers Squibb
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FEATURING
Laetitia Szaller General Counsel & Corporate Development Egetis Therapeutics AB
Delphine Marchal Associate Vice President, Assistant General Counsel Eli Lilly & Company
Cristina Alexandrescu Assistant General Counsel GSK Biologicals
Simon Neill Assistant General Counsel Johnson & Johnson
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CO-CHAIRS
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Ilja Morée Head Legal Europe Novartis Innovative Medicines
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Lisa Kinsella Vice President, Associate General Counsel Moderna
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Sonya Rogerson Head Legal Transformation and Real Estate Novartis Operations Novartis
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Ioana Ratescu R&D Legal Head Safety, and International Regulatory Affairs & Development Europe Legal Lead Novartis Pharma AG
Anne Kristine Steen Marke Senior AI & Digital Governance Lead Novo Nordisk
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Anne-Sophie Bricca Deputy General Counsel - Global Compliance Officer Terumo BCT
Olena Goloborodko Director, Corporate Legal Counsel Pfizer
Ingrid Sollerer General Counsel and Chief Compliance Officer Sandoz
Antje-Katrin Weigelt Senior Vice President & General Counsel Europe Teva Pharmaceuticals
Denelle Waynick Johnson Executive Vice President & General Counsel UCB
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Dr. Galit Gonen-Cohen Senior Vice President, Chief IP Officer CSL Welcome Breakfast Sponsor Associate Sponsors Conference Sponsor
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C5 is honored to host the inaugural European Summit for Women Leaders in Life Sciences Law.
This exciting new forum for women life sciences lawyers has been developed with the input and advice of a diverse and esteemed advisory committee comprised leading women counsel and executives for the life sciences industry.
The agenda combines dynamic discussions on the prevalent life sciences legal, regulatory and policy developments, with sessions designed to empower and inspire you.
This is your opportunity to:
ĉ Meet and engage with industry trailblazers
ĉ Gain first-hand insights from key regulators and industry bodies
ĉ Debate substantive legal, regulatory, and policy developments
ĉ Learn how you can increase your prominence in the life sciences sector
ĉ Build relationships with your peers from the biopharmaceutical and medical device sectors
Wherever you are in your professional journey, this event will motivate and enhance your career trajectory.
Space is limited. Do not wait to register. We look forward to welcoming you to Brussels in March.
Sincerely,
Kristy Perkins
Director of Strategic Partnerships & Programming
C5’s European Summit for Women Leaders in Life Sciences Law Reach out with questions: k.perkins@c5-online.com
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Zoe Kimberly Area Counsel, Europe AbbVie United Kingdom
Arianna Greco Senior Vice President, General Counsel Commercial Alnylam Pharmaceuticals Switzerland
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Vice President, International Legal and Compliance Blueprint Medicines Switzerland
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Cristina Alexandrescu Assistant General Counsel
GSK Biologicals Belgium
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Miriam Gundt Partner
Hogan Lovells Germany
TOP 5 REASONS TO ATTEND
Be part of an exciting new annual forum for women leaders in life sciences law
Advance your career with essential leadership strategies and tactics
Engage in dynamic discussions with industry peers and thought leaders from across Europe.
Be inspired and motivated by the first-hand experiences of like-minded women facing similar challenges and opportunities in life sciences law.
Develop your professional network amongst biopharmaceutical and MedTech companies.
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Vice President Law MedTech EMEA Johnson & Johnson Belgium
Cristiana Spontoni Partner, Practice Leader, Health Care & Life Sciences Jones Day Belgium
Olena Goloborodko Director, Corporate Legal Counsel Pfizer Switzerland
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General Counsel and Chief Compliance Officer
Sandoz Switzerland
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Marie Manley Partner, Head of the UK Life Sciences Practice
Sidley Austin LLP United Kingdom
SPEAKER FACULTY
Government
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Olga Solomon
Director, DirectorateGeneral for Health and Food Safety (DG SANTE) European Commission (Belgium)
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Georgia Gavriilidou Head of Legal Department European Medicines Agency (The Netherlands)
Eleanor Charsley Health Tech Sector Specialist Office for Life Sciences (United Kingdom)
Associations
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Jane Lewis Chief Operating Officer and Chief Financial Officer
Association of British HealthTech Industries Ltd. (ABHI)
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Natalie Moll Director General European Federation of Pharmaceutical Industries and Associations (EFPIA) (Belgium)
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Beata Stepniewska Deputy Director General & Head of Regulatory Affairs Medicines for Europe (Belgium)
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Oliver Bisazza Chief Executive Officer MedTech Europe (Belgium)
In-House Counsel
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Zoe Kimberly Area Counsel, Europe AbbVie (United Kingdom)
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Arianna Greco
Senior Vice President, General Counsel
Commercial Alnylam Pharmaceuticals (Switzerland)
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Aileen Murtagh
Senior Director, Legal Counsel
Biomarin (Ireland)
Christina Jordan Vice President and Associate General Counsel, International Markets
Bristol-Myers Squibb (United Kingdom)
Dr. Galit
Gonen-Cohen
Senior Vice President, Chief IP Officer CSL (Switzerland)
Laetitia Szaller
General Counsel & Corporate Development
Egetis Therapeutics AB (Belgium)
Delphine Marchal
Associate Vice President, Assistant General Counsel Eli Lilly & Company (Belgium)
Cristina Alexandrescu
Assistant General Counsel
GSK Biologicals (Belgium)
Caroline Sitbon
Senior Vice President, Legal Affairs IPSEN (France)
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Simon Neill
Assistant General Counsel
Johnson & Johnson (Belgium)
Lisa Kinsella Vice President, Associate General Counsel Moderna (Switzerland)
Sonya Rogerson Head Legal Transformation and Real Estate
Novartis Operations Novartis (United Kingdom)
Ilja Morée
Head Legal Europe
Novartis Innovative Medicines (Switzerland)
Ioana Ratescu
R&D Legal Head Safety, and International Regulatory Affairs & Development Europe
Anne Kristine
Steen Marke
Senior AI & Digital Governance Lead
Novo Nordisk (Denmark)
Olena Goloborodko
Director, Corporate Legal Counsel Pfizer (Switzerland)
Karin Pramburger
Head of IP Polpharma Group (Switzerland)
Kristin Cooklin
Global Group Head of IP Recordati (Switzerland)
Bibianne Bon Chief Legal Officer Recordati (Italy)
Ingrid Sollerer
GC and Chief Compliance Officer Sandoz (Switzerland)
Anne-Sophie Bricca
Deputy General Counsel - Global Compliance Officer Terumo BCT (Belgium)
Antje-Katrin Weigelt
Senior Vice President & General Counsel Europe Teva Pharmaceuticals (The Netherlands)
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Denelle Waynick Johnson
Executive Vice President & General Counsel UCB (Belgium)
Outside Counsel
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Sibel Yilmaz Partner
Covington & Burlington LLP (Belgium)
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Miriam Gundt Partner
Hogan Lovells (Germany)
Cristiana Spontoni Partner, Practice Leader, Health Care & Life Sciences
Jones Day (Belgium)
Koosje Van Lessen Kloeke Partner
Leijnse Artz (The Netherlands)
Georgina Kon Partner
Linklaters LLP (United Kingdom)
Anne-France Moreau Partner
McDermott Will & Emery (France)
Sonsoles Centeno Partner
Pérez-Llorca (Spain)
Marie Manley Partner, Head of UK Life Sciences Practice
Sidley Austin LLP (United Kingdom)
Ingrid Vandenborre Partner
Skadden, Arps, Slate, Meagher & Flom (Belgium)
Economist
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Julia Sabine Wahl Partner
Copenhagen Economics (Belgium)
Recruiters and Consultants
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Marianne Cunnington Vice President Analysis Group (United Kingdom)
Sarah Cowlishaw Partner
Covington & Burling LLP (United Kingdom)
Fiona Adams Managing Shareholder Greenberg Traurig LLP (United Kingdom)
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Lisa Owens
Managing Director, In-House Counsel
Recruiting Major, Lindsey & Africa (United Kingdom)
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Jerry Temko
Managing Director, In-House Counsel
Recruiting
Legal Lead
Novartis Pharma AG (Switzerland)
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Nilda M. Isidro Shareholder Greenberg Traurig LLP (United States)
Major, Lindsey & Africa (United Kingdom)
DAY ONE
Tuesday, 11 March 2025
8:00 Registration Opens Networking Breakfast Sponsored by
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9:00 Co-Chairs Opening Remarks: Advancing Women in Life Sciences Law
To kick-off the inaugural European Women Leaders in Life Sciences Law, the co-chairs will set the tone for the following two days by speaking to the event theme: Empowering Women to Lead with Vision and Purpose
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Dr. Galit Gonen-Cohen Senior Vice President, Chief IP Officer CSL (Switzerland)
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Ilja Morée Head Legal Europe Novartis Innovative Medicines (Switzerland)
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Anne-Sophie Bricca Deputy General Counsel - Global Compliance Officer Terumo BCT (Belgium) KEYNOTE SESSION 9:15 What’s Top of Mind: Priorities for the European
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Olga Solomon Director, Directorate-General for Health and Food Safety (DG SANTE) European Commission (Belgium) Followed by a discussion and reactions from:
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Oliver Bisazza Chief Executive Officer MedTech Europe (Belgium)
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Nathalie Moll Director General European Federation of Pharmaceutical Industries and Associations (EFPIA) (Belgium)
Historically, women's health has been under-researched, leading to disparities in diagnosis, treatment, and care. Learn about work being done by the life sciences industry to address these gaps, achieve greater healthcare equity, and develop solutions that prioritize women’s well-being. This session will cover:
• Generating support to develop medicines for women
• Driving change from the R&D stage in the medical and regulatory environment
• Ensuring equity, equality, and fairness in AI applications in life sciences –tools to prevent bias
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Jane Lewis, BA (Hons) FCMA CGMA Chief Operating Officer and Chief Financial Officer Association of British HealthTech Industries Ltd. (ABHI) (United Kingdom)
Sonya Rogerson Head Legal Transformation and Real Estate Novartis Operations Novartis (United Kingdom)
In this moderated conversation, hear life sciences leaders candidly discuss pivotal moments in their careers and the skills that accelerated their accent to leadership positions.
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Sollerer General Counsel and Chief Compliance Officer Sandoz (Switzerland)
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Adams Managing Shareholder Greenberg Traurig LLP (United Kingdom)
12:30 Networking Lunch
Sponsored by
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13:30 Perspectives on EU Pharmaceutical Legislation Reform: What You Need to Know and the Potential Real-Life Impact on your Business
The proposed EU pharmaceutical legislation reform seeks to address health policy integration across Europe and the accessibility and affordability of medicines. This session will debate the potential impact of the proposed reforms.
• Adapting to the legal and regulatory challenges presented by the Pharma Reform package
» Reduction in regulatory data protection
» Reduction in orphan market exclusivity
• From a legal perspective, how can innovation be preserved?
• Update on Member States’ positioning in response to implications
» Grandfathering of legislation
» Retroactivity
» Transition periods
» Secondary legislation
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Delphine Marchal Associate Vice President, Assistant General Counsel Eli Lilly & Company (Belgium)
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Marie Manley Partner, Head of the UK Life Sciences Practice
Sidley Austin LLP (United Kingdom)
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Beata Stepniewska Deputy Director General & Head of Regulatory Affairs Medicines for Europe (Belgium)
14:15 Assessing the Impact of EU Health Technology Assessment (HTA) Regulation on Market Access
The HTA regulation aims to streamline the approval process by ensuring that new technologies are assessed for their clinical effectiveness, cost-efficiency, and overall value. This session will examine experiences to date in preparing for and complying with the regulation.
• Reviewing market readiness strategies – what implementation challenges were encountered and overcome
• Interdependencies and alignment between the requirements of the HTA Regulation and the obligations stemming from Directive 89/105/EEC (‘Transparency Directive’)
• Examining the type of data needed for a successful JCA report
• What types of additional evidence are being used – how can real world evidence be leveraged?
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Marianne Cunnington Vice President Analysis Group (United Kingdom)
Ioana Ratescu R&D Legal Head Safety, and International Regulatory Affairs & Development Europe Legal Lead Novartis Pharma AG (Switzerland)
• Determining how the regulation is working in practice – is it a system that will be beneficial?
15:00
Networking and Refreshment Break
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Koosje Van Lessen Kloeke Partner
Leijnse Artz (The Netherlands)
Eleanor Charsley Health Tech Sector Specialist Office for Life Sciences (United Kingdom)
15:45 Exploring the Business Implications of the Changing Global IP Landscape for the Life Sciences
IP together with certain regulatory protections are key to incentivising innovation in the biopharmaceutical arena. Understanding these protections as well as the critical role that IP plays in product commercialization is a critical competency for every life sciences lawyer.
This session will review the latest policy developments in the IP landscape in Europe and the rest of the world. The panellists will also provide insights on how these changes impact investment decisions, launch strategies, product life cycle decisions, and generic market entry.
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Julia Sabine Wahl Partner Copenhagen Economics (Denmark)
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Anne-France Moreau Partner McDermott Will & Emery (France)
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Kristin Cooklin
Global Group Head of IP Recordati (Switzerland)
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Moderator: Miriam Gundt Partner Hogan Lovells International LLP (Germany)
16:30 Planning for the Risks of Tomorrow, Today: General Counsel Panel and Town Hall Discussion
Amidst an era of unprecedented technological advancements and innovation, the regulatory, governance, and risk and compliance landscape for life sciences is rapidly evolving.
During this interactive town hall discussion, hear from and engage with GCs from different branches of the life sciences industry on what they are anticipating, and how they are addressing and prioritizing the myriad risks facing their companies.
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Arianna Greco
Senior Vice President, General Counsel
Commercial Alnylam Pharmaceuticals (Switzerland)
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Lisa Kinsella Vice President, Associate General Counsel Moderna (Switzerland)
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Anne-Sophie Bricca Deputy General Counsel - Global Compliance Officer Terumo BCT (Belgium)
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Moderator: Nilda M. Isidro Shareholder Greenberg Traurig LLP (United States)
17:30 Networking Reception
19:00 Dine Arounds (Optional)
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Global Sponsorship Opportunities
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Don’t miss the opportunity to maximise participation or showcase your organisation’s services and talent. For more information please contact us at: SponsorInfo@C5-Online.com
DAY TWO
Wednesday, 12 March
2025
8:15 Co-Chairs Opening Remarks
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Dr. Galit Gonen-Cohen Senior Vice President, Chief IP Officer CSL (Switzerland)
8:30 Breakfast Breakout Sessions
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Ilja Morée Head Legal Europe Novartis Innovative Medicines (Switzerland)
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Anne-Sophie Bricca
Deputy General Counsel
- Global Compliance Officer Terumo BCT (Belgium)
Leverage the shared experiences and collective knowledge of your industry peers during these facilitated roundtable discussions. Attendees will be preassigned to a table for each topic and rotate after 30 minutes.
A: Celebrating Your Success: Embracing the Power of Self Promotion to Benefit You Personally and Professionally
In the life sciences field, where innovation, research and collaboration drive progress, knowing how to strategically showcase your achievements and share your wins is key to building and maintaining a strong professional reputation. This breakout session will address key aspects including:
• Ways to effectively develop your personal brand to guide the way you approach everything and everyone
• Overcoming imposter syndrome and societal conditioning
• Presenting your achievements strategically to build and maintain your professional reputation
• Sharing your wins to motivate and inspire colleagues and industry peers
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Karin Pramburger Head of IP Polpharma Group (Switzerland)
Bibianne Bon Chief Legal Officer Recordati (Italy)
B: Navigating Your Career: Insights into Industry and Legal Talent Trends in the Life Sciences Industry
No matter where you are in your professional journey. it is important to look around the corner for your next role and plan accordingly. In this breakout session, a life sciences legal recruiter will help you chart the way forward, covering the following topical subjects:
• Highlighting legal talent trends in the current market
» Skills in demand
» Diversity and inclusion in HC and senior hiring
• Career development strategies
» Building a personal brand
» Continuous learning and professional development
• Navigating career transitions
» Identifying when to make a change
» Tip for job searching in a competitive market
• Outlining the route to board positions
9:30 Networking and Refreshment Break
10:15 Keynote Presentation
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Georgia Gavriilidou Head of Legal Department European Medicines Agency (The Netherlands)
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Lisa Owens
Managing Director, In-House Counsel Recruiting Major, Lindsey & Africa (United Kingdom)
Jerry Temko
Managing Director, In-House Counsel Recruiting Major, Lindsey & Africa (United Kingdom)
• AI use cases in the life sciences sector
Sciences:
• Challenges of adoption of AI and relevant considerations for pharma and MedTech
• Approach of competent authorities to AI
• Impact of the new EU AI Act on the life sciences industry
• Considerations for establishing a set of legal guidance and quality of oversight for the use of AI
• Key commercial considerations when leveraging AI
» Data governance
» Protecting IP
» Diligence
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Sarah Cowlishaw Partner
Covington & Burling LLP (United Kingdom)
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Georgina Kon Partner
Linklaters LLP (United Kingdom)
The workforce in life sciences often consists of different cultural backgrounds and generations. This session will provide practical information to help leaders appreciate and harness the unique perspective and strengths of team members.
• Understanding the important differences that are part of generational identities
• Identifying the distinct preferences for how different generations receive and process information and what influences their decisions
• Developing techniques to effectively communicate and collaborate with team members from different generations
• Understand emotional perception and expression to influence your team
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Anne Kristine Steen Marke
Senior AI & Digital Governance Lead
Novo Nordisk (Denmark)
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Olena Goloborodko Director, Corporate Legal Counsel Pfizer (Switzerland)
Christina Jordan Vice President and Associate General Counsel, International Markets Bristol-Myers Squibb (United Kingdom)
Cristina Alexandrescu Assistant General Counsel GSK Biologicals (Belgium)
A Case Study
This panel will take you through a hypothetical interactive case study exercise to highlight the changes to product liability regulations that directly impact life sciences companies.
• Navigating the changes to the product liability framework including the burden of proof and latent defects in complex biologics or advanced therapies
• Reviewing the new disclosure requirements and expanded scope for both products covered and damages
• Assessing the risk of increased product liability litigation for novel therapies, personalized medicine and digital health solutions
• Developing litigation strategies to prepare for pan-European class actions and the rise of litigation funders
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Zoe Kimberly Area Counsel, Europe AbbVie (United Kingdom)
Simon Neill Assistant General Counsel Johnson & Johnson (Belgium)
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Cristiana Spontoni Partner, Practice Leader, Health Care & Life Sciences Jones Day (Belgium)
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Sonsoles Centeno Partner Pérez-Llorca (Spain)
14:30 Competition Enforcement in the Pharmaceutical Sector: Lessons Learnt from Dealings with European Commission and the National Competition Authorities
With the growing intensity of antitrust and merger rule enforcement, this session will explore the emerging challenges and key considerations for the life sciences industry as competition law continues to evolve.
• Merger control: Aftermath of the European Court of Justice’s Illumina/Grail Decision
• European Commission Priorities 2024-2029: A new approach to competition policy
15:15 Networking and Refreshment Break
15:45
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Sibel Yilmaz Partner
Covington & Burling LLP (Belgium)
Aileen Murtagh
Senior Director, Legal Counsel Biomarin (Ireland)
Women in Power: Insights into the Highs and Lows of Leadership in Life Sciences
To close out the inaugural Summit, join a frank discussion among a diverse group of women as they share their personal experiences of being leaders in life sciences law. The conversation will focus on the highs and lows and the events that have been the most significant in their professional lives to date. Topics to be discussed include:
• Navigating gender barriers and bias in a male-dominated field
• Leadership styles and approaches – what’s worked, what hasn’t
• Achieving work-life balance in a high-stakes industry
• Career pivots and growth and lessons learnt
• Mentorship and paving the way for the next generation of life sciences women leaders
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General Counsel and Head of Compliance Egetis Therapeutics (Belgium)
Bibianne Bon Chief Legal Officer Recordati (Italy)
Antje-Katrin Weigelt
Senior Vice President & General Counsel Europe Teva Pharmaceuticals (The Netherlands)
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Johnson
Executive Vice President & General Counsel
UCB (Belgium)
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Moderator: Ingrid Vandenborre Partner
Skadden, Arps, Slate, Meagher & Flom LLP (Belgium)
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UPCOMING EVENTS
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