Inaugural European Summit for Women Leaders in Life Sciences Law - WEB

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Empowering Women to Lead with Vision and Purpose

11–12 March 2025 • NH Carrefour de L’Europe, Brussels

KEYNOTE

Georgia Gavriilidou Head of Legal Department European Medicines Agency

Zoe Kimberly Area Counsel, Europe AbbVie

Arianna Greco Senior Vice President, General Counsel Commercial Alnylam Pharmaceuticals

Christina Jordan Vice President and Associate General Counsel, International Markets Bristol-Myers Squibb

Laetitia Szaller General Counsel & Corporate Development Egetis Therapeutics AB

CO-CHAIRS

Ilja Morée Head Legal Europe Novartis Innovative Medicines

Anne-Sophie Bricca Deputy General CounselGlobal Compliance Officer Terumo BCT

FEATURING

Delphine Marchal Associate Vice President, Assistant General Counsel Eli Lilly & Company

Cristina Alexandrescu Assistant General Counsel GSK Biologicals

Caroline Sitbon Senior Vice President, Legal Affairs IPSEN

Simon Neill Assistant General Counsel Johnson & Johnson

Lisa Kinsella Vice President, Associate General Counsel Moderna

Ioana Ratescu Head of Legal Regulatory Europe & Development France & Iberia Novartis Pharma AG

Anne Kristine Steen Marke Senior Ethics and Privacy Counsel Novo Nordisk

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

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

Zoe Kimberly Area Counsel, Europe AbbVie United Kingdom

Arianna Greco Senior Vice President, General Counsel Commercial Alnylam Pharmaceuticals Switzerland

Vice President, International Legal and Compliance Blueprint Medicines Switzerland

Cristina Alexandrescu Assistant General Counsel

GSK Biologicals Belgium

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.

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

General Counsel and Chief Compliance Officer

Sandoz Switzerland

Marie Manley Partner, Head of the UK Life Sciences Practice

Sidley Austin LLP United Kingdom

Sabrina Ballet
Ana Garcia Bello
Ingrid Sollerer

SPEAKER FACULTY

Government

Anna Vernet

Acting Head of Unit, Antitrust: Pharma and Health Services European Commission (Belgium)

Georgia Gavriilidou Head of Legal Department European Medicines Agency (The Netherlands)

Heather Hobson Head of Regulation and Access Office for Life Sciences (United Kingdom)

Associations

Jane Lewis Chief Operating Officer and Chief Financial Officer

Association of British HealthTech Industries Ltd. (ABHI)

Natalie Moll Director General European Federation of Pharmaceutical Industries and Associations (EFPIA) (Belgium)

Beata Stepniewska Deputy Director General & Head of Regulatory Affairs

Medicines for Europe (Belgium)

In-House Counsel

Zoe Kimberly Area Counsel, Europe AbbVie (United Kingdom)

Arianna Greco

Senior Vice President, General Counsel Commercial Alnylam Pharmaceuticals (Switzerland)

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)

Simon Neill

Assistant General Counsel

Johnson & Johnson (Belgium)

Lisa Kinsella Vice President, Associate General Counsel Moderna (Switzerland)

Ilja Morée

Head Legal Europe

Novartis Innovative Medicines (Switzerland)

Ioana Ratescu Head of Legal

Regulatory Europe & Development France & Iberia

Novartis Pharma AG (Switzerland)

Anne Kristine Steen Marke

Senior Ethics and Privacy Counsel

Novo Nordisk (Denmark)

Olena Goloborodko

Director, Corporate Legal Counsel Pfizer (Switzerland)

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)

Denelle Waynick Johnson Executive Vice President & General Counsel UCB (Belgium)

Outside Counsel

Sibel Yilmaz Partner Covington & Burlington LLP (Belgium)

Sarah Cowlishaw Partner Covington & Burling LLP (United Kingdom)

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)

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

Julia Sabine Wahl Partner

Copenhagen Economics (Belgium)

Recruiters and Consultants

Marianne Cunnington Vice President Analysis Group (United Kingdom)

Fiona Adams Managing Shareholder Greenberg Traurig LLP (United Kingdom)

Nilda M. Isidro Shareholder Greenberg Traurig LLP (United States)

Lisa Owens

Managing Director, In-House Counsel Recruiting Major, Lindsey & Africa (United Kingdom)

DAY ONE

Tuesday, 11 March 2025

8:00 Registration and Networking Breakfast

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

Dr. Galit Gonen-Cohen

Senior Vice President, Chief IP Officer CSL (Switzerland)

KEYNOTE SESSION

Ilja Morée Head Legal Europe

Novartis Innovative Medicines (Switzerland)

Anne-Sophie Bricca Deputy General Counsel

- Global Compliance Officer Terumo BCT (Belgium)

9:15 What’s Top of Mind: Priorities for the European Life Sciences Sector

European Commission representative to be confirmed

Nathalie Moll Director General European Federation of Pharmaceutical Industries and Associations (EFPIA) (Belgium)

10:15 Networking and Refreshment Break

10:45 Correcting Health Inequality Through Life Sciences: Developing Innovative Health Care Solutions for Women

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

Jane Lewis, BA (Hons) FCMA CGMA Chief Operating Officer and Chief Financial Officer Association of British HealthTech Industries Ltd. (ABHI) (United Kingdom)

(Additional speakers to be confirmed)

• Ensuring equity, equality, and fairness in AI applications in life sciences – tools to prevent bias

11:45 Tales from

the Trenches: Working Your Way Up to Succeed on a Global Level

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.

Caroline Sitbon Senior Vice President, Legal Affairs IPSEN (France)

Ingrid Sollerer General Counsel and Chief Compliance Officer Sandoz (Switzerland)

Moderator: Fiona Adams Managing Shareholder

Greenberg Traurig LLP (United Kingdom)

12:30 Networking Lunch

Sponsored by

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

Delphine Marchal Associate Vice President, Assistant General Counsel Eli Lilly & Company (Belgium)

Marie Manley Partner, Head of the UK Life Sciences Practice

Sidley Austin LLP (United Kingdom)

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

Marianne Cunnington Vice President Analysis Group (United Kingdom)

Ioana Ratescu Head of Legal Regulatory Europe & Development France & Iberia Novartis Pharma AG (Switzerland)

• What types of additional evidence are being used – how can real world evidence be leveraged?

• Determining how the regulation is working in practice – is it a system that will be beneficial?

15:00

Networking and Refreshment Break

Koosje Van Lessen Kloeke Partner

Leijnse Artz (The Netherlands)

Heather Hobson Head of Regulation and Access Office for Life Sciences (United Kingdom)

DAY ONE | Tuesday, 11 March

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.

Julia Sabine Wahl Partner

Copenhagen Economics (Denmark)

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.

Arianna Greco Senior Vice President, General Counsel Commercial Alnylam Pharmaceuticals (Switzerland)

Lisa Kinsella Vice President, Associate General Counsel Moderna (Switzerland)

Anne-Sophie Bricca Deputy General Counsel - Global Compliance Officer

Terumo BCT (Belgium)

Moderator: Nilda M. Isidro

Shareholder Greenberg Traurig LLP (United States)

17:30 Networking Reception

19:00 Dine Arounds (Optional)

With conferences in the United States, Canada, Latin America and Europe, the C5 Group of Companies: American Conference Institute, Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

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

Dr. Galit

8:30 Breakfast Breakout Sessions

Ilja

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

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

Georgia Gavriilidou Head of Legal Department European Medicines Agency (The Netherlands)

Lisa Owens Managing Director, In-House Counsel Recruiting Major, Lindsey & Africa (United Kingdom)

• AI use cases in the life sciences sector

• 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

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

Sarah Cowlishaw Partner

Covington & Burling LLP (United Kingdom)

Anne Kristine Steen Marke

Senior Ethics and Privacy Counsel Novo Nordisk (Denmark)

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)

Life Sciences – 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

Zoe Kimberly Area Counsel, Europe AbbVie (United Kingdom)

Simon Neill Assistant General Counsel

Johnson & Johnson (Belgium)

Cristiana Spontoni Partner, Practice Leader, Health Care & Life Sciences

Jones Day (Belgium)

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

Sibel Yilmaz Partner

Covington & Burling LLP (Belgium)

15:45 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

Szaller General Counsel and Head of Compliance Egetis Therapeutics (Belgium)

Anna Vernet Acting Head of Unit, Antitrust: Pharma and Health Services European Commission (Belgium)

Antje-Katrin Weigelt Senior Vice President & General Counsel Europe Teva Pharmaceuticals (The Netherlands)

Denelle Waynick Johnson

Executive Vice President & General Counsel

UCB (Belgium)

Moderator: Ingrid Vandenborre Partner

Skadden, Arps, Slate, Meagher & Flom LLP (Belgium)

16:45 Closing Remarks from Co-Chairs

17:00 Close of Conference

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For over 40 years, C5 Group has provided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities. Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

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Media Partner

UPCOMING EVENTS

19–20 March 2025 | Seaport Hotel, Boston, MA
19–20 May 2025 | New York Bar Association, New York, NY
25–26 March 2025 | NH Collection Brussels Grand Sablon, Brussels
21–22 May 2025 | Radisson Blu Hotel, Amsterdam
29–30 April 2025 | The Altman building, New York, NY
19–20 June 2025 | Boston, MA
30–31 July 2025 | Boston University, Boston, MA

NH Carrefour de L'Europe

Rue Marche aux Herbes - Grasmarkt Straat, 110, 1000 Brussels, Belgium

C5 Communications is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote "C5 COMMUNICATIONS 100325".

Please note that the guest room block cut-off date is 3 February 2025 After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Book with confidence!

Register and pay to lock in your early rate and be eligible for a full refund until 25 February 2025. If you are unable to attend for any reason, you will have the following options: y A full credit note for you, or a colleague to attend another event.

y A full refund.

All cancellations and changes must be submitted to Registration@C5-Online.com by 25 February 2025.

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