Clinical Operations in Oncology Trials Europe 2022

22 - 23

November

2022
  • Mövenpick Hotel Zürich-Regensdorf, Zurich, Switzerland
  • Free
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Why attend?

WHAT TO EXPECT FOR 2022

At the Clinical Operations in Oncology Trials Europe event, taking place on the 22nd-23rd November in Zurich, we are pleased to bring together the definitive group of executives responsible for clinical operations in oncology and enhancing the partnership with vendors. There will be expert guidance through a first class conference programme and numerous networking opportunities.

150+

ATTENDEES TO MEET EACH YEAR

35+

EXHIBITORS TO MEET EACH YEAR

20+

SPEAKERS

70+

ATTENDEES AT DIRECTOR + LEVEL

150+

ATTENDEES TO MEET EACH YEAR

35+

EXHIBITORS TO MEET EACH YEAR

20+

SPEAKERS

70+

ATTENDEES AT DIRECTOR + LEVEL

Agenda

  • 22 Nov 2022
  • 23 Nov 2022
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8:15 AM

Registration and Refreshments

8:50 AM

Chair’s Opening Remarks

9 AM

KEYNOTE Unveiling The Importance Of Clinical Trial Diversity For Inclusive Oncology Research And Treatment

  • Investigating ways to adapt to EU regulatory frameworks for clinical trial diversity in oncology
  • Ensuring the participation of diverse set of countries in clinical trials for representative trial findings
  • Identifying different obstacles for inclusive clinical studies in small and big clinical oncology trials
  • Understanding and tackling the scientific skepticism, as well as its potential impact on the diversity of oncology trials

Speakers

Pauline Frank
Patient Engagement And Insights Director, Novartis

9:30 AM

Flexible by Design: Tools to Manage Uncertainty & Complexity in Early Phase Oncology Trials

  • Examine common challenges in early phase oncology trials that can be mitigated with technology tools
  • Explore functionality that can help manage the uncertainty in trial duration, treatment variability and protocol amendments
  • Discuss how an early phase oncology trial case study leveraged IRT functionality to address the protocol complexities

Speakers

Daniela Duffett
Senior Solutions Consultant, Suvoda

10 AM

Discovering The Challenges Of Clinical Trials In Paediatric Oncology

  • When To Approach Regulators: Importance Of Early Interaction With Regulators
  • Understanding The Role Of International Networks: Where Do We Find Investigators?
  • Unveiling The Differences: First In Human vs. First In Child
  • Uncovering Ways To Plan A Study In A Heterogeneous Population
  • Formulation Issues: How Do We Tackle It?
  • Assessing Potential Rewards For Paediatric Regulatory Approval

Speakers

Cesare Spadoni
Founder And Chief Operating Officer, Oncoheroes Biosciences

10:30 AM

Morning Refreshments and Networking

11 AM

Challenging Your Vendor And Understanding Their Mind-Set To Better That Partnership

  • Emphasising the importance of vendor transparency from the start and not over promising, focussing on capabilities
  • Exploring the use of a patient recruitment portal to achieve early or on time study start up
  • Looking at country-specific stats for grass roots vs digital recruitment and planning your digital outreach accordingly
  • Improving the quality of patients through additional vetting to improve your recruitment process

Speakers

Dr. Monika Kouba
Director of Clinical Operations

11:30 AM

Data-Driven Operations and Oversight with elluminate

Operational oversight within outsourced models has become increasingly complex for teams who are tasked with managing trials amid a rapidly changing landscape of partners, technologies, and global regulations. The elluminate Clinical Data Cloud provides one source of truth for clinical and operational data to manage trials across sources. Learn how elluminate delivers:

  • Operational analytics including enrolment, protocol compliance and safety
  • Risk-based analyses and insights with elluminate RBQM
  • Operational knowledge for data-driven development with elluminate CTMS
  • Centralized issue management across roles in operations, data and medical review
  • Sample tracking, data forecasting and site performance insights

Speakers

Achilleas Zaras
Senior Manager, Solution Consulting, eClinical Solutions

12 PM

Proposing a new strategy in oncology clinical development to decrease lead times and trial failures, enabling efficacious and safe drug delivery to patients

  • Use of real world evidence data in clinical trials
  • Endpoints differentiated based on indications and disease stage
  • On going regulatory authorities review to allow early access to novel treatments for patients in need

Speakers

Stefano Ferrara
Director Of Clinical Science, BeiGene

12:30 PM

Lunch and Networking

1:30 PM

Panel Discussion: Patients as Partners: Understanding the Importance of Enhancing Patient Engagement to be a Leader in the Oncology Industry

  • Understanding the effects of patient engagement to achieve faster recruitment and lesser drop-outs in oncology trials
  • Discovering ways to improve communication and understanding patients’ preferences
  • Evaluating patient engagement techniques as a mean of differentiation in competitive oncology markets
  • Exploring developments in patient engagement such as Innovative Medicines Initiative (IMI)’s PREFER initiative

Speakers

Cesare Spadoni
Founder And Chief Operating Officer, Oncoheroes Biosciences
Pauline Frank
Patient Engagement And Insights Director, Novartis
Christine Sturchler
Global Head Patient Engagement, Novartis

2:15 PM

Session Reserved for Event Sponsor: Eclinical Solutions

2:45 PM

Vendor Selection and Management In Clinical Oncology Trials: How To Find the Best Fit for Your Clinical Operations?

  • Discovering various outsourcing models for different clinical oncology trials and biotech firms
  • Discussing key aspect to include in your contract in order to achieve effective oversight
  • Understanding ways to utilize technology and data in Vendor Selection
  • Exploring the implications of user-friendly CRO interfaces in vendor selection

Speakers

Milena Kanova
Vice President Clinical Operations, Palladio Biosciences, Inc., A Centessa Company

3:15 PM

Afternoon Refreshments and Networking

3:45 PM

Panel Discussion: Discovering Methods for Planning and Budgeting Operations in Clinical Oncology Trials to Increase Operational Performance

  • Understanding different ways to design the planning phase efficiently for a clinical oncology trial: lessons learned from Big Pharma
  • Utilizing technology and agile budget planning tools for clinical oncology: the case of ClearTrial
  • Uncovering ways to negotiate a well-planned budget with the study sights to ensure good relationships with vendors

Speakers

Stefano Ferrara
Director Of Clinical Science, BeiGene
Silvio Costanzo
Head Of Clinical Operations, ANAVEON AG
Laura Beni
Head Of Clinical Operations, Cellestia Biotech AG

4:15 PM

Shorten timelines and improve likelihood of approval through intelligent clinical study design

Clinical development is a process fraught with challenges and uncertainty. We believe there are four criteria which, when applied, can reduce both:

  • Understanding the landscape of the disease including current standard of care and approval status of other agents
  • Enhancing efforts for effective patient identification and recruitment using existing genetic data and data generated from perspective patients
  • Evaluating the intended market application strategically
  • Leveraging relationships with KOLs, insights about the regulatory environment, and geographic analysis and reach

Speakers

BOB MILLHAM
President, Clinical Trial Operations, Allucent

4:45 PM

Uncovering Ways To Keep Your Patient At The Heart Of Your Oncology Trial

  • Are pharma companies making assumptions on patient needs and requirements? The importance of including patients’ views in decision-making
  • Assessing patient experience in clinical trials: how can we reduce obstacles for participants?
  • Patients as Research Partners: a collaborative working model

Speakers

Christine Sturchler
Global Head Patient Engagement, Novartis

5:15 PM

Chairman’s Summation and Drinks Reception

8:30 AM

Registration and Refreshments

8:50 AM

Chair’s Opening Remarks

9 AM

Speaker Hosted Roundtables

  • Interactive roundtable sessions offer a unique opportunity to come
  • together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.
  • Each roundtable session lasts for 30 minutes, and delegates may attend up to 2 roundtables.
  • Roundtable 1
  • Evaluating the Concept of E-Consent: Ensuring Operational Efficiency in Oncology Trials by Creating an E-space to Fasten and Optimize patients’ Consent Process
  • Roundtable 2
  • Discussion of Clinical Career Development: Investigating the Importance of Leadership for Successful Clinical Project Management Marianne Keessen, Director of Clinical Operations, Modra Pharmaceuticals
  • Roundtable 3
  • Understanding the New European Central System: Challenges for Submitting Oncology Trials and Ways to Adjust Quickly Cesare Spadoni, Founder and COO, Oncoheroes Biosciences
  • Roundtable 4
  • Discovering the role of Technology and Remote Monitoring for Increased Patient Enrolment for Clinical Oncology Trials: Can Decentralized Trials Enrol More Patient Population from Underrepresented Countries?

Speakers

Dagmar Siebold
Managing Director, Biopath GmbH

10 AM

Morning Refreshments and Networking

10:30 AM

Targeting TACAs – a novel class of tumor-specific antigens: How to de-risk first clinical trials

  • TACAS (Tumor-Associated Carbohydrate Antigens) are a novel class of cancer-specific antigens that drive tumor virulence
  • As they represent 2ndary gene products their expression can hardly be predicted by genetic screening
  • The presentation will address which measures will be taken to de-risk clinical development

Speakers

Peter Sondermann
CEO, Tacalyx GmbH

11 AM

Accelerated performance of complex exploratory patient studies: practical insights from investigational site

  • Unique model of dedicated research clinics in Eastern Europe
  • Strategies for fast patient enrollment and retention
  • Operational tips for flawless study conduct
  • Takeaways after operating under unprecedented circumstances / case studies

Speakers

Dr. Claudia Hesselmann
Founder and CEO, ARENSIA Exploratory Medicine

11:30 AM

Panel Discussion: An investors perspective: Understanding the Investors Motivations for Funding Clinical Trials and Evaluating the Oncology Market

  • Understanding the downturn of Markets in the Oncology Industry and its underlying reasons
  • Exploring the causes of liquidity issues in clinical oncology trials and identifying feasible solutions
  • Discussing the investors’ incentives for fund allocation and value creation in clinical oncology trials

Speakers

Peter Sondermann
CEO, Tacalyx GmbH

12:15 PM

Strategies for successful oncology recurrence trials

This presentation will address successful strategies for oncology recurrence trials including a review of operational and read recommendations to help you improve efficiency and quality for your recurrence studies. The speaker will discuss:

  • Imaging in the context of surveillance;
  • Other procedures for detection of recurrence not discussed;
  • Clinical trials design, including disease-free status;
  • Central imaging evaluation including: establishing disease free status, detection of recurrence and characterization of recurrence; and Operational considerations

Speakers

PAUL VAN MEURS
Director, Medical & Scientific Affairs Oncology, Clario

12:45 PM

Lunch and Networking

1:45 PM

Legal challenges of decentralized clinical trials (EU perspective)

  • First regulatory responses on the management of clinical trials during COVID-19 (FDA, EMA/HMA, local authorities’ approach)
  • Most important aspects of the EU Guidance of management of clinical trials during COVID-19
  • Legal challenges of decentralized clinical trials following COVID-19
  • ACT EU’s (Accelerating Clinical Trials in the EU) planned publication of a recommendation paper governing decentralized clinical trials – multi stakeholder perspectives

Speakers

ESZTER TAKÁCSI-NAGY
Senior Associate, Kinstellar

2:15 PM

From molecule to the clinic: Key points to consider for small biotechs

  • Reviewing key parameters required to enable you to successfully bring an NCE/NBE to the clinic and beyond
  • Considering the science, pharmacology, regulatory advice and marketplace to differentiate your product
  • Identifying key partners, stakeholder needs and management tools to assist in developing your NCE/NBE
  • Creating an effective TPP to increase the likelihood of progressing from bench to bedside

Speakers

Peter Lichtlen
Chief Medical Officer, Numab

2:45 PM

Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

  • Discussing ways to choose the right CRO for small biotech firms outsourcing their operations
  • Tackling the communication issues with large, multi-layered stakeholders Keeping up with technical advances in the field by seeking cost-effective strategies to invest in new technology.
  • Investigating time and cost management approaches to deal with out-of-scope work outsourced to vendors

Speakers

Stefano Ferrara
Director Of Clinical Science, BeiGene
Silvio Costanzo
Head Of Clinical Operations, ANAVEON AG
Kumar Ashesh
CEO, Paras Biopharmaceuticals
Dagmar Siebold
Managing Director, Biopath GmbH

3:15 PM

Chairman’s Summation and Close of Conference

Speakers

Select a speaker to learn more

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Cesare Spadoni
Founder And Chief Operating Officer, Oncoheroes Biosciences

Cesare is co-founder and Chief Operating Officer of Oncoheroes Biosciences Inc., a Boston-based biotech company focused on pediatric oncology drug development. Cesare has more than 20 years of experience in the drug development field, in both scientific and commercial roles. Previously, he held senior positions at AMRI, Aptuit Laurus, ThalesNano and Auxiliis. Cesare started his career as research scientist in a pharmaceutical company (Eisai, London) and in academia (Institute of Enzymology, Budapest).

Following the death of his first daughter Laura to cancer, Cesare set up aPODD Foundation, a London-based charity focused on accelerating paediatric oncology drug development. As aPODD’s chairman he is actively involved on a pro-bono basis in drug repurposing projects, advocacy efforts and research collaborations.

Cesare holds an MSc in Applied Molecular Biology and a PhD in Neurosciences from UCL, University of London, as well as an MBA from the Central European University, Budapest.

Session Details:

Discovering The Challenges Of Clinical Trials In Paediatric Oncology

2022-11-22, 10:00 AM

Session Details:

Panel Discussion: Patients as Partners: Understanding the Importance of Enhancing Patient Engagement to be a Leader in the Oncology Industry

2022-11-22, 1:30 PM

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Yildiray Tanriver
Medical Director, Oncologist, Acik Holding
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Stefano Ferrara
Director Of Clinical Science, BeiGene

Session Details:

Panel Discussion: Discovering Methods for Planning and Budgeting Operations in Clinical Oncology Trials to Increase Operational Performance

2022-11-22, 3:45 PM

Session Details:

Proposing a new strategy in oncology clinical development to decrease lead times and trial failures, enabling efficacious and safe drug delivery to patients

2022-11-22, 12:00 PM

Session Details:

Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

2022-11-23, 2:45 PM

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Sotirios Perdikeas
Global Head Resource Management & Analytics, Strategy, Portfolio & Clinical Operations, Roche
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Silvio Costanzo
Head Of Clinical Operations, ANAVEON AG

Session Details:

Panel Discussion: Discovering Methods for Planning and Budgeting Operations in Clinical Oncology Trials to Increase Operational Performance

2022-11-22, 3:45 PM

Session Details:

Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

2022-11-23, 2:45 PM

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Peter Sondermann
CEO, Tacalyx GmbH

Session Details:

Panel Discussion: An investors perspective: Understanding the Investors Motivations for Funding Clinical Trials and Evaluating the Oncology Market

2022-11-23, 11:30 AM

Session Details:

Targeting TACAs – a novel class of tumor-specific antigens: How to de-risk first clinical trials

2022-11-23, 10:30 AM

View In Agenda
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Peter Lichtlen
Chief Medical Officer, Numab

Session Details:

From molecule to the clinic: Key points to consider for small biotechs

2022-11-23, 2:15 PM

View In Agenda
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Pauline Frank
Patient Engagement And Insights Director, Novartis

Session Details:

KEYNOTE Unveiling The Importance Of Clinical Trial Diversity For Inclusive Oncology Research And Treatment

2022-11-22, 9:00 AM

Session Details:

Panel Discussion: Patients as Partners: Understanding the Importance of Enhancing Patient Engagement to be a Leader in the Oncology Industry

2022-11-22, 1:30 PM

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Milena Kanova
Vice President Clinical Operations, Palladio Biosciences, Inc., A Centessa Company

Session Details:

Vendor Selection and Management In Clinical Oncology Trials: How To Find the Best Fit for Your Clinical Operations?

2022-11-22, 2:45 PM

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Michele Marzola
Co-Founder And CEO, Interceptin Srl
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Matteo Fiorentini
Head Of Oncology Lung Franchise, AstraZeneca
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Marianne Keessen
Modra Pharmaceuticals B.V.
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Laura Beni
Head Of Clinical Operations, Cellestia Biotech AG

Laura Beni has over 15 years’ experience in pharma, CRO and academic setting of which 10+ years in the Clinical Operations. During her career progression she took on more and more responsibilities not solely limited to the Clin Ops.  Currently, she holds the position of Head of Clinical Operations at Cellestia Biotech AG, a privately-owned clinical-stage Biopharma Company located in Basel (Switzerland) whose drug candidate platform is a first-in-class solution targeting orphan cancers.

She is a hospital pharmacist by training and a strong believer that learning is a never-ending process

Session Details:

Panel Discussion: Discovering Methods for Planning and Budgeting Operations in Clinical Oncology Trials to Increase Operational Performance

2022-11-22, 3:45 PM

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Kumar Ashesh
CEO, Paras Biopharmaceuticals

Session Details:

Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

2022-11-23, 2:45 PM

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John McAdory
Head Of Clinical Operations, SillaJan, Inc
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Denis Brkic
Senior Director, Head Of Clinical Operations, Nouscom AG
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Dagmar Siebold
Managing Director, Biopath GmbH

Session Details:

Panel Discussion: Discovering Operational Challenges in Clinical Oncology Trials for Small Biotech Firms and Developing Strategies to Reduce Them:

2022-11-23, 2:45 PM

Session Details:

Speaker Hosted Roundtables

2022-11-23, 9:00 AM

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Christine Sturchler
Global Head Patient Engagement, Novartis

Session Details:

Uncovering Ways To Keep Your Patient At The Heart Of Your Oncology Trial

2022-11-22, 4:45 PM

Session Details:

Panel Discussion: Patients as Partners: Understanding the Importance of Enhancing Patient Engagement to be a Leader in the Oncology Industry

2022-11-22, 1:30 PM

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Dr. Monika Kouba
Director of Clinical Operations

Session Details:

Challenging Your Vendor And Understanding Their Mind-Set To Better That Partnership

2022-11-22, 11:00 AM

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PAUL VAN MEURS
Director, Medical & Scientific Affairs Oncology, Clario

Paul van Meurs, MD, is currently the Director of Medical & Scientific Affairs, Oncology and is responsible for the oversight of Clario’s medical imaging and specialty solutions. Dr. Muers is a qualified MD with more than 20 years of experience in clinical development within the pharmaceutical industry. He has previous experience at BiOrion as their Chief Business Officer as well as Keosys Medical Imaging and Julius Clinical where he was responsible for business development activities. He is also the editor of the Dutch Textbook of Pharmaceutical Medicine (Published 2014).

Session Details:

Strategies for successful oncology recurrence trials

2022-11-23, 12:15 PM

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Dr. Claudia Hesselmann
Founder and CEO, ARENSIA Exploratory Medicine

Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

Session Details:

Accelerated performance of complex exploratory patient studies: practical insights from investigational site

2022-11-23, 11:00 AM

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BOB MILLHAM
President, Clinical Trial Operations, Allucent

Bob Millham is currently President of Clinical Trial Operations, at Allucent, a global provider of comprehensive drug development solutions. He has more than 20 years of leadership experience across global pharmaceutical, biotech and contract research organizations. Throughout his career he has spearheaded scientific teams, clinical development programs and operations worldwide to drive the success of cancer therapeutics. Highlights of Bob’s career include:

a 17-year career at Pfizer, leading and contributing to the development of compounds against multiple indications of cancer, including lung, breast, colorectal and ovarian.
overseeing drug development activities and opening a pivotal phase 3 clinical trial in metastatic breast cancer while COO of Odonate Therapeutics.
leading the Oncology Center of Excellence, as well as clinical trial management initiatives for a variety of biotech and pharmaceutical clients as senior vice president at Syneos Health.
while in position as vice president of strategic alliances for Caris Life Sciences, growing and developing the organization’s Precision Oncology Alliance network
Bob has authored and co-authored multiple peer-reviewed articles, abstracts, and presentations. He earned a master’s degree in pharmaceutical medicine from Hibernia College in Dublin, Ireland, as well as a master’s degree in microbiology from the University of New Hampshire. He holds a bachelor’s degree in biology from Middlebury College.

Session Details:

Shorten timelines and improve likelihood of approval through intelligent clinical study design

2022-11-22, 4:15 PM

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Daniela Duffett
Senior Solutions Consultant, Suvoda

As Director of Services Delivery, Ben oversees services delivery out of Suvoda’s Bucharest office. Ben has over 11 years of experience in the software industry, holding a variety of positions in professional services, global operations, and business development. He has consulted with Fortune 2000 clients across a variety of industries on how to best leverage technology to solve mission-critical business challenges.

 

Session Details:

Flexible by Design: Tools to Manage Uncertainty & Complexity in Early Phase Oncology Trials

2022-11-22, 9:30 AM

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Achilleas Zaras
Senior Manager, Solution Consulting, eClinical Solutions

Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions.

Session Details:

Data-Driven Operations and Oversight with elluminate

2022-11-22, 11:30 AM

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ESZTER TAKÁCSI-NAGY
Senior Associate, Kinstellar

Eszter Takácsi-Nagy is a Senior Associate in the Budapest office focusing on life sciences and healthcare matters. Her expertise includes in-depth knowledge of the pharmaceutical, biotechnological, healthcare and medical devices sectors and the related regulatory environment. Eszter also regularly advises on competition and state aid matters, and has leveraged that experience to deliver a broader and deeper service offering to the firm’s life sciences clients. She has advised domestic and international clients on licensing, compliance, enforcement as well as sector related M&A.

Session Details:

Legal challenges of decentralized clinical trials (EU perspective)

2022-11-23, 1:45 PM

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Plan Your Visit

Venue

Mövenpick Hotel Zürich-Regensdorf

Mövenpick Hotel Zürich-Regensdorf, Zurich, Switzerland Im Zentrum, Zürich, Switzerland, 8105

Accommodation

Mövenpick Hotel Zürich-Regensdorf, Zurich, Switzerland

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SPONSORSHIP ENQUIRIES

Conor Taylor

+44 (0)20 7936 6870

SPEAKING OPPORTUNITIES

Ruth Atterbury

Portfolio Manager

MARKETING ENQUIRIES

Katie Giorgadze

Marketing Manager

SPONSORSHIP ENQUIRIES

To enquire about sponsorship opportunities for the conference, please contact:

Conor Taylor

 


+44 (0)20 7936 6870

SPEAKER ENQUIRES

The program for the event is underway. Please get in touch with the program director if you would like to be part of the program

Ruth Atterbury

Portfolio Manager