7th Annual Outsourcing in Clinical Trials DACH 2024

Providing a specific platform for the clinical trials community in the DACH region to develop innovative clinical operations and outsourcing strategies.

29 - 30

October

2024
  • Hyatt Regency Zurich Airport The Circle, Zurich, Switzerland
  • Ticketed
  • Why attend?
  • Agenda
  • OCT Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Why partner?
  • Contact Us
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Why attend?

WHAT TO EXPECT FOR 2024?

Join pharma and biotech experts to discuss new trends and opportunities and learn how they optimize their clinical operations enabling you to stay ahead of the game. Find the right solution providers to partner with, allowing you to accelerate your trial timelines.

200+

Attendees

40+

Speakers

20+

Exhibitors

200+

Attendees

40+

Speakers

20+

Exhibitors

See What It's All About

Agenda

  • 29 Oct 2024
  • 30 Oct 2024
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Streams

Stream one

Clinical Operations

Stream two

Innovation & Technology

10:30 AM

Morning refreshments and networking

11 AM

INTERACTIVE SESSION The future of clinical trials: leveraging AI & emerging technologies

Get ready to actively participate and share your insights in this engaging, hands-on session
  • Upskilling and collaboration journey - how to stay on top of all emerging technologies
  • Use cases - where to begin and what is being done to integrate new technologies into clinical trials
  • Forward looking- what are the most promising ground-breaking technological advancements and innovations such as in silicon clinical trials?

Speakers

Eric Hajjar
Former Associate Director, Global Medical Research Operations, Biogen

11:30 AM

Breaking down barriers: the key role of localization in enhancing diversity in clinical trials

• Urgency vs. Diversity: the pressure for rapid trial results often leads to the exclusion of some diverse populations, in part due to the extensive localization efforts required
• Impact of localization: avoiding translation work can sideline certain participant groups, highlighting the need for improved translation strategies from sponsors, eCOA providers and translation vendors to enhance trial inclusivity
• Proactive solutions: adopting automation, integrating localization into technology development, and streamlining workflows for translation are essential for making clinical trials more inclusive and diverse

Speakers

Jonathan Norman
Director, Localization Services, YPrime

12 PM

Integrating digital health technologies in clinical trials

• Improving recruitment and adherence with digital tools
• Streamlining and securing data analysis with digital platforms
• Ensuring compliance with digital documentation and reporting

 

Speakers

Jade Sternberg
Digital Health Lead, Digital Switzerland

12:30 PM

Digital Display Labels (DDL’s) – Relabelling the Clinical Trial Landscape

  • Digital Display LabelsIntroducing DDLs for primary and secondary Clinical Trial packaging
  • Transformational & Innovative technology providing real-time supply chain advantages - benefits in integrated operations,  packaging optimisation, quality, regulatory, and clinical operations efficiencies
  • Secure digital connectivity -  enabling enhanced  supply chain capabilities and efficiencies with new clinical supply packaging opportunities and reducing risk of clinical supply on critical registration path

Speakers

Brian Sheridan
Vice President Global Adherence & Clinicals, Smurfit Westrock
Martina Marauli
Director Clinical Supply Innovation, MSD International Business GmbH, Lucerne

12:45 PM

15-minute Tech Spotlight

Session reserved for event sponsor

Speakers

Prof. Dr. med. Andreas Trojan
Co-Founder and CMO, Mobile Health AG, Medical Oncologist and Leading Physician, Breast Center Zürichsee

1 PM

Lunch and networking

2 PM

Innovative thinking for increasing patient diversity and inclusion in clinical trials

• Increasing diversity in clinical trial patient recruitment
• Understanding why diversity in clinical trials is important for trial outcomes
• Exploring how to advance medicine through increased diversity

Speakers

Francine Metelo
Lead Workstream Ethnicity and Culture DEICE Europe, Pfizer
Josue Mfopou Kunjom
Director Clinical Operations, Pfizer

2:30 PM

Session reserved for event sponsor

3 PM

Fostering a culture of quality in clinical research: a catalyst for innovation

• Is there any area where quality is more paramount than in clinical research?
• Are the traditional quality management tools and metrics the right approach?
• Exploring what embeds quality deep in the clinical research culture

Speakers

Effie Pournara
Senior Global Medical Director, Novartis

3:30 PM

Afternoon refreshments and networking

4 PM

FIRESIDE CHAT Exploring the benefit of integrative IT applications in clinical trials for small biopharma companies

  • Discuss the importance of the concept of a "single source of truth"
  • How can we improve Data integrity and Accuracy?
  • What can we do to strengthen Regulatory Compliance and Auditability in a scientific driven environment?

Speakers

Anke Müller
Associate Director / Team Lead Clinical Operations, AiCuris Anti-infective Cures AG

4:30 PM

PANEL DISCUSSION Exploring the transition of innovation & technological advancements in clinical trials

• Are we making the most of technology & innovation in the clinical trial space?
• How are these tools being utilized efficiently?
• The importance of exploring ethical considerations
• Examining the relationship between innovation, creativity, and regulations
• What’s next?

Moderator
Effie Pournara, Senior Global Medical Director, Novartis

Speakers

Josue Mfopou Kunjom
Director Clinical Operations, Pfizer
Effie Pournara
Senior Global Medical Director, Novartis
Eva Herrmann-Keiner
Senior Clinical Operations Manager, Neurimmune

8 AM

Registration and refreshments

8:40 AM

Chairperson’s opening remarks

9 AM

Navigating ICH GCP V3 regulatory requirements: updates and best practices

• Understanding the latest changes in ICH GCP V3 regulatory requirements in a user-friendly manner
• Implementing effective compliance measures to ensure alignment with evolving regulatory expectations
• Identifying key challenges and ways to overcome them

 

 

Speakers

Nicolas Le Bec
Director, Therapeutic Area Quality Lead, Global R&D Quality, Bristol Myers Squibb

9:30 AM

Session reserved for Medidata

10 AM

Session reserved for 1MED

10:30 AM

Morning refreshments and networking Sponsored by Aixial

11 AM

PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

• Identify the key challenges that make DACH region less attractive for clinical trials
• Strategies to make the region more appealing for global trials, focusing on speeding up processes, reducing costs, and leveraging technology for efficiency and inclusivity
• Discuss the consequences of low participation in clinical trial
• Present strategies to streamline administrative processes and reduce bureaucracy
• Explore methods to enhance patient recruitment and retention

Panelists

Cornelia Baumgartner, Clinical Operations Lead, T-CURX
Ina Meyer, Study & Site Operations Country Lead Switzerland, Global Clinical Operations, Novartis
Andrea Sauerland, Senior Director Clinical Operations, Endotronix
Nicolas Schneider, Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

Speakers

Cornelia Baumgartner
Head of Clinical Operations, T-CURX
Ina Meyer
Study & Site Operations (SSO) Country Manager Switzerland, Novartis
Andrea Sauerland
Senior Vice President Clinical Operations, Endotronix
Dr. Nicolas Schneider
Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

11:30 AM

Session reserved event sponsor

12 PM

Aspects to contemplate when selecting a CRO for rare disease trials

  • • Does possessing therapeutic expertise remain imperative in choosing a CRO for a rare disease inquiry?
    • Evaluating the advantages of niche specialized CROs versus expansive multinational CROs
    • Extra hurdles in the CRO selection procedure arise when addressing ultra-rare diseases, where CROs may lack familiarity with the condition
    • Discussing the merits and drawbacks of engaging a comprehensive service CRO for your rare disease examination versus collaborating with various vendors across the study

Speakers

Christoph Gasteyger
Executive Director, Global Program Team Lead Hematology/Nephrology, Alexion

12:30 PM

Session reserved for event sponsor

1 PM

Lunch and networking

2 PM

Q&A session What do venture capitalists look for in startups? Unveiling the main criteria for investment

Speakers

Nadiia Wyttenbach
Managing Director, Growth Equity, Redalpine

2:30 PM

Session reserved for event sponsor

3 PM

Developing the first treatment for my own ultra-rare disease – lessons learned

• Meaningful involvement of patients in the study design phase to reflect their needs and improve trial execution
• Ethical aspects of trial designs in ultra-rare diseases
• Partnering with patient advocacy groups to foster meaningful relationships
• Experiences and lessons learned from being a patient representative in regulatory approval and HTA proceedings

Speakers

Dr. Jasmin Barman-Aksözen
Research Investigator, Lecturer and Rare Disease Patient Advocate, University of Zurich

3:30 PM

Afternoon refreshments and networking

4 PM

Key considerations and strategic steps to ensure successful and timely execution when planning your first clinical trial as a start-up company

• Understanding the timeline from the initial idea to the first patient enrolment
• Assembling a powerful team within your company
• Creating a realistic project plan and budget
• Gaining a thorough understanding of the regulatory and competitive landscape
• Carefully considering the design of your trial, patient availability, the number of patients needed, and the number of sites/countries involved
• Choosing the right partners, including CROs, vendors, and sites

Speakers

Cornelia Baumgartner
Head of Clinical Operations, T-CURX

4:30 PM

PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process

• Emphasizing the importance of defining clear communication channels, expectations, and escalation procedures among CROs, sponsors, and sites to ensure transparency and accountability throughout the trial
• Highlighting the benefits of leveraging communication technologies such as centralized platforms and project management tools to facilitate real-time information sharing and collaboration among stakeholders
• Providing training and resources to enhance communication skills and promote effective teamwork across all levels

Speakers

Christoph Gasteyger
Executive Director, Global Program Team Lead Hematology/Nephrology, Alexion
Monika Gawlowicz
MD Investigator, Pratia
Judit Magos
Clinical Operations Manager, Viatris

5:15 PM

Chairperson’s closing remarks

DRINKS RECEPTION

8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

9 AM

PANEL DISCUSSION The clinical trial landscape for small to mid-sized biopharma in the DACH region

• New regulations and guidance around clinical trials in the DACH region: how will this impact you?
• Staff turnover and layoffs: handling changes in the industry in order to ensure success
• Navigating the constantly evolving vendor and CRO landscape as a small to mid sized sponsor company
• An overview of technology and innovation in the clinical trial industry: what’s working and what isn’t?

Speakers

Clare Price
Clinical Operations Leader, CDR-Li

9:45 AM

Session reserved for event sponsor

10:15 AM

FIRESIDE CHAT Ensuring adequate sponsor oversight of clinical trials when outsourced to clinical contract research organisations

• Ensuring that KPIs are informative and meaningful.
• Assessing overall project risk and appropriate surveillance tactics
• Consolidating your overall management strategy that can be coordinated with CRO SOPs
• Documentation of Sponsor oversight activities throughout the study

Speakers

Judit Magos
Clinical Operations Manager, Viatris

10:45 AM

Morning refreshments and networking

11:15 AM

Understanding pharmacovigilance in clinical trials DACH

  • Mechanism of pharmacovigilance of medicinal products and drug devices in clinical trials in the DACH region
  • Assessment of regulations and responsibilities of key stakeholders
  • Interplay between the health authorities and vendors and challenges related to pharmacovigilance

Speakers

Joan D’souza
Contact Person for Pharmacovigilance for Swissmedic and BfArM

11:45 AM

FIRESIDE CHAT Enhancing site accessibility and collaboration in clinical trials to reduce burden on sites

• Understanding the resource constraints faced by trial sites and the impact on their accessibility and participation in clinical studies
• Promoting flexibility in data management by accommodating both paper and electronic platforms based on site preferences, ensuring smoother integration and reduced burden on site staff
• Encouraging open communication with sites to understand their specific needs and preferences

Speakers

Ina Meyer
Study & Site Operations (SSO) Country Manager Switzerland, Novartis

12:15 PM

Setting up Clinical Operations in a Startup/Biotech Environment: An agile approach to turn a corner

·       Introducing Clinical Operations and GCP in a new Start-up / Biotech environment

·       Focusing on the key components to successfully, and within budget, run a study from scratch

·       Overcome the challenges of a small team inhouse and efficiently perform the oversight

Speakers

Georgios Sarantis
Senior Clinical Trial Manager, Granite Bio

12:45 PM

Lunch and networking

1:45 PM

Artificial Intelligence in Pharma

  • Generative AI roadmap and latest developments
  • Business impact and use cases
  • Risks, limitations, and other considerations
  • Recommendations

 

Speakers

Beyza Karakoy
Analyst,​ Strategic Intelligence​, GlobalData

2:15 PM

Session Reserved for Event Sponsor

2:45 PM

Financial oversight of clinical studies and development to optimize cost savings

• Creating a cost optimized study set-up to work more effectively
• Reviewing selection processes and negotiations with your vendor
• Management and closure of study budget

Speakers

Clare Price
Clinical Operations Leader, CDR-Li

3:15 PM

Afternoon refreshments and networking

4 PM

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

During the roundtable discussion session, the conference hall will be divided into two ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
Exploring ways to involve patients in clinical trials to advance patient recruitment and retention with regulatory considerations
Dr. Jasmin Barman-Aksözen, Research Investigator, Lecturer and Rare Disease Patient Advocate, University of Zurich

ROUNDTABLE 2
How can we be more efficient in clinical operations with less resources?
Nicolas Schneider, Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

ROUNDTBALE 3
Aligning clinical teams with supply teams earlier to improve processes and output
Jasmin Hellwig, Associate Director Vendor Relationship Management, MSD

Speakers

Jasmin Hellwig
Associate Director Vendor Relationship Management, MSD
Dr. Nicolas Schneider
Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München
Dr. Jasmin Barman-Aksözen
Research Investigator, Lecturer and Rare Disease Patient Advocate, University of Zurich

END OF CONFERENCE

5 PM

Chairperson’s closing remarks

Speakers

Select a speaker to learn more

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Cornelia Baumgartner
Head of Clinical Operations, T-CURX

Session Details:

PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

2024-10-29, 11:00 AM

Session Details:

Key considerations and strategic steps to ensure successful and timely execution when planning your first clinical trial as a start-up company

2024-10-29, 4:00 PM

View In Agenda
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Christoph Gasteyger
Executive Director, Global Program Team Lead Hematology/Nephrology, Alexion

Session Details:

PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process

2024-10-29, 4:30 PM

Session Details:

Aspects to contemplate when selecting a CRO for rare disease trials

2024-10-29, 12:00 PM

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Nadiia Wyttenbach
Managing Director, Growth Equity, Redalpine

Session Details:

Q&A session What do venture capitalists look for in startups? Unveiling the main criteria for investment

2024-10-29, 2:00 PM

View In Agenda
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Monika Gawlowicz
MD Investigator, Pratia

Session Details:

PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process

2024-10-29, 4:30 PM

View In Agenda
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Dr. Jasmin Barman-Aksözen
Research Investigator, Lecturer and Rare Disease Patient Advocate, University of Zurich

Session Details:

Developing the first treatment for my own ultra-rare disease – lessons learned

2024-10-29, 3:00 PM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-30, 4:00 PM

View In Agenda
Next speaker
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Ina Meyer
Study & Site Operations (SSO) Country Manager Switzerland, Novartis

Session Details:

PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

2024-10-29, 11:00 AM

Session Details:

FIRESIDE CHAT Enhancing site accessibility and collaboration in clinical trials to reduce burden on sites

2024-10-30, 11:45 AM

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Andrea Sauerland
Senior Vice President Clinical Operations, Endotronix

Session Details:

PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

2024-10-29, 11:00 AM

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Dr. Nicolas Schneider
Director Clinical Operations and Alliance Management, ITM Isotopen Technologien München

Session Details:

PANEL DISCUSSION Revitalizing clinical trials in the DACH region: overcoming challenges and enhancing attractiveness

2024-10-29, 11:00 AM

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-30, 4:00 PM

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Next speaker
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Effie Pournara
Senior Global Medical Director, Novartis

Session Details:

Fostering a culture of quality in clinical research: a catalyst for innovation

2024-10-29, 3:00 PM

Session Details:

PANEL DISCUSSION Exploring the transition of innovation & technological advancements in clinical trials

2024-10-29, 4:30 PM

View In Agenda
Next speaker
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Judit Magos
Clinical Operations Manager, Viatris

Clinical trial expert with 12 years of international experience in both CRO and Sponsor roles, spanning from feasibility to trial reporting across Phase I-IV studies. Highly adept at supervising cross-functional teams in dynamic and fast-paced environments. Recognized as a decisive and trusted team member with an analytical and proactive approach, specializing in various therapeutic areas, including oncology and rare diseases.

Session Details:

PANEL DISCUSSION Enhancing communication between CROs, sponsors and clinical trial sites for an efficient work process

2024-10-29, 4:30 PM

Session Details:

FIRESIDE CHAT Ensuring adequate sponsor oversight of clinical trials when outsourced to clinical contract research organisations

2024-10-30, 10:15 AM

View In Agenda
Next speaker
Back
Clare Price
Clinical Operations Leader, CDR-Li

Session Details:

PANEL DISCUSSION The clinical trial landscape for small to mid-sized biopharma in the DACH region

2024-10-30, 9:00 AM

Session Details:

Financial oversight of clinical studies and development to optimize cost savings

2024-10-30, 2:45 PM

View In Agenda
Next speaker
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Jade Sternberg
Digital Health Lead, Digital Switzerland

Session Details:

Integrating digital health technologies in clinical trials

2024-10-29, 12:00 PM

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Martina Marauli
Director Clinical Supply Innovation, MSD International Business GmbH, Lucerne

Martina holds a Master's in Pharmaceutical Science from Karl-Franzens-University Graz, Austria. Her certifications include Lean Six Sigma Green Belt, St. Gallen Management Institute Business Strategy, and the London Business School programs re. Accelerated Development as well as the Innovation Through Design Thinking.

Over her 25-year career, she's taken on multifaceted roles at Fresenius Kabi, Roche, and MSD, spanning divisions across Research, Manufacturing, Commercial and Global Support Functions. She developed drug products to market and pioneered a novel single-use auto-injection device platform for sterile dosage forms. Beyond product development, Martina has been leading business process streamlining, strategic development, and organizational integration. Her achievements include establishing the global MSD Innovation and Development Hub in Zurich, founding the global MSD Center of Excellence for Comparator Blinding, innovating an early phase biologics supply chain, amplifying Enterprise Strategy Office projects as a Design Thinking Facilitator and enhancing the Global Market Access forecasting methodology. Currently she is creating innovative solutions for clinical supply operations, clinical sites, and leading digitalization as well as people innovation endeavors; she is leading the MSD Digital Display Labeling (DDL) project as well as co-leading the cross-industry DDL Community of Practice.

Session Details:

Digital Display Labels (DDL’s) – Relabelling the Clinical Trial Landscape

2024-10-29, 12:30 PM

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Brian Sheridan
Vice President Global Adherence & Clinicals, Smurfit Westrock

Brian joined, the then WestRock, in 2018 as Vice President Global Adherence & Clinicals - the business unit focused on providing Adherence focused, patient centric and Child Resistant Senior Friendly (CR-SF) packaging & service solutions to the Pharmaceutical, Biotech & Clinical Trial industries.

Having majored in marketing, business studies and finance Brians key expertise has been developing packaging solutions supplied to these key markets. Holding a wide range of increasingly elevated positions within companies such as Cardinal Health, Catalent and across several other packaging entities, Brian has gained invaluable insights and a thorough understanding of the demanding requirements, operating systems and ethos of the various market sectors that Smurfit Westrock support today.

Within the last number of years Brian's focus, together with his globally based team, has been to strategically develop a bespoke, best in class global supply infrastructure within the Smurfit Westrock specialized field of Adherence, Clinical Trial and SMART digital & electronic platforms. These cutting-edge solutions encompass electronically enhanced SMART measure and monitor packaging solutions, such as Cere®Pak, together with developing the vision and capabilities of Cere®Screen Digital Display Labels within the Clinical Trial Supplies arena..

Session Details:

Digital Display Labels (DDL’s) – Relabelling the Clinical Trial Landscape

2024-10-29, 12:30 PM

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Josue Mfopou Kunjom
Director Clinical Operations, Pfizer

Session Details:

Innovative thinking for increasing patient diversity and inclusion in clinical trials

2024-10-29, 2:00 PM

Session Details:

PANEL DISCUSSION Exploring the transition of innovation & technological advancements in clinical trials

2024-10-29, 4:30 PM

View In Agenda
Next speaker
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Francine Metelo
Lead Workstream Ethnicity and Culture DEICE Europe, Pfizer

Session Details:

Innovative thinking for increasing patient diversity and inclusion in clinical trials

2024-10-29, 2:00 PM

View In Agenda
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Nicolas Le Bec
Director, Therapeutic Area Quality Lead, Global R&D Quality, Bristol Myers Squibb

Session Details:

Navigating ICH GCP V3 regulatory requirements: updates and best practices

2024-10-29, 9:00 AM

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Beyza Karakoy
Analyst,​ Strategic Intelligence​, GlobalData

Beyza Karakoy is an Analyst in GlobalData’s Strategic Intelligence team, having joined in September 2021. She authors and manages a portfolio of reports, contributing to the analysis of technologies across various sectors, notably financial services and sport. Her areas of expertise include tech regulation, data privacy, legal tech, and AI. Prior to joining GlobalData, Beyza completed her LLM Master of Laws at the London School of Economics and Political Science.

Session Details:

Artificial Intelligence in Pharma

2024-10-30, 1:45 PM

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Jasmin Hellwig
Associate Director Vendor Relationship Management, MSD

Jasmin Hellwig graduated from the Applied Institute of Science in Muttenz, Switzerland, 2005 in Chemistry and joined Inovalab AG the same year as Study Director. In her various roles, including Business Development, Deputy of the General Management and Deputy of Test Facility Management, she enjoyed facilitating success by supporting processes, which meet high quality and business need. Since 2010 Jasmin is part of the Global Clinical Supplies department of MSD, former Schering Plough. She started as Project Lead coordinating packaging of clinical supplies and supporting integration projects. In September 2014, Jasmin joined the Comparator Sourcing and Planning group, supporting Clinical Trials by purchasing comparators on time from various sources. Since 2020, she fosters the Relationship Management group.

Besides various hobbies she cultivates, particularly horses and singing, she graduated as MSc in Management from the Lorange Business School, Zurich, Switzerland, in 2015.

 

Session Details:

PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

2024-10-30, 4:00 PM

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Joan D’souza
Contact Person for Pharmacovigilance for Swissmedic and BfArM

Joan D’souza's treatment experience includes oncology, dermatology, pain management, infectious disorders, vaccines, drug-device combinations, neurology, cardiovascular gastroenterology, respiratory, orphan diseases, rare diseases, and diabetes.

Joan currently is active in several ISoP special interest groups, including Risk communication (secretary), Medical devices, Geriatric pharmacovigilance, Vaccination, Medication error, and Ecopharmacovigilance. Joan has actively participated in the Pharmacovigilance and Medical devices special interest groups of the European Medical Writers Association. She has frequently written for the ISoP Drug Safety Journal and the European Medical Writers Association Journal. She is also a member of PIPA, UK and RQA, UK. She was also the past-president of ISOP Switzerland and Austria Chapter. She is currently pursuing a Masters in Pharmacovigilance and Pharmacoepidemiology at Eu2P and preparing for her PhD in drug- device combination regulations at the University of Strasbourg.

Joan is a lawyer (JD licensed to practice law in Minnesota, US) and a physician. She earned a Dean's List designation for academic performance after completing a post-baccalaureate clinical research program at the University of Cincinnati in the US. Joan also obtained an advanced diploma in pharmacovigilance with software training. She also runs a non-profit women’s association called VinspireU, that helps women to settle overseas. Joan resides in Switzerland and has a supportive husband and two beautiful girls. During her free time, she likes singing, playing piano, or hiking with her family.

Session Details:

Understanding pharmacovigilance in clinical trials DACH

2024-10-30, 11:15 AM

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Jonathan Norman
Director, Localization Services, YPrime

With 7 years of experience in localising paper and electronic COAs, Jonathan today leads translation and questionnaire licensing strategies for YPrime. He develops innovative approaches to ensure quality and accuracy in translated clinical trial materials, focusing on reducing translation burdens and increasing trial diversity. Throughout his career, Jonathan has progressed from Project Manager to Director roles in linguistic validation and quality assurance. He's a trusted SME in localisation best practices, maintaining strong relationships with eCOA providers, pharma sponsors, and copyright holders across the clinical research industry

Session Details:

Breaking down barriers: the key role of localization in enhancing diversity in clinical trials

2024-10-29, 11:30 AM

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Eric Hajjar
Former Associate Director, Global Medical Research Operations, Biogen

Session Details:

INTERACTIVE SESSION The future of clinical trials: leveraging AI & emerging technologies

2024-10-29, 11:00 AM

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Anke Müller
Associate Director / Team Lead Clinical Operations, AiCuris Anti-infective Cures AG

Over the last 25 years, my career has evolved in various roles and I have held senior positions in the pharma/biotech industry and with international CROs. Comprehensive knowledge and experience in Clinical Operations, experience from First in Human up until late stage. Global experience, understanding the nuances of operating in a diverse environment. Strong leadership skills, with experience in a managerial role. Medical background and advanced IT skills in Trial Management Systems, EDC and e-TMF

My aim is to make the people who report to me feel that they are a valued member of a successful team, doing meaningful work in an environment of trust.

Session Details:

FIRESIDE CHAT Exploring the benefit of integrative IT applications in clinical trials for small biopharma companies

2024-10-29, 4:00 PM

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Eva Herrmann-Keiner
Senior Clinical Operations Manager, Neurimmune

Session Details:

PANEL DISCUSSION Exploring the transition of innovation & technological advancements in clinical trials

2024-10-29, 4:30 PM

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OCT Advisory Board

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Rosalie Filling
Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

 

Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

 

Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

 

Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

 

Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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Kathleen Cohen
Vice President, Clinical Development, Marinus Pharmaceuticals

Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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THOMAS M TREMBLAY
Vice President Of Clinical Development, Trefoil Therapeutics, Inc

Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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Behtash Bahador
Director, Health Literacy, CISCRP

Behtash Bahador is the Director of Health Literacy at the non-profit organization CISCRP, and holds a Master of Science in Health Communication from the Tufts University School of Medicine. Since 2014, he has collaborated with a range of stakeholder groups to establish and implement patient- and public-centric initiatives across the life-cycle of drug and treatment development. This has included supporting the development of regulatory and cross-disciplinary best practice guidelines, operationalizing key elements of evidence-based public health programing into research engagement activities, and always keeping the needs of patients, participants and the public at the forefront of his work.

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Hyatt Regency Zurich Airport The Circle

The Circle 41 Kloten 8058 Switzerland

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Partnership Opportunities

We work with you to design a bespoke package to meet your business needs, where you could:

  • Demonstrate your expertise on the agenda – have the attention of the entire audience. For greatest impact, why not position your talk before a networking break and immediately conduct follow up conversations with highly engaged attendees
  • Showcase your business and its services at an exhibition booth, which provides a perfect meeting place for prospective new clients
    Present the value proposition of your offering over your competitors, in front of an audience of active, engaged potential customers
  • Speak with key decision makers as part of our intimate, interactive roundtable style workshop sessions with over 8 hours allowed for networking

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  • 200+ attendees each year
  • 80% attendees C-suite level

 

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WHAT TO EXPECT FOR 2023

Join pharma and biotech experts to discuss new trends and opportunities and learn how they optimize their clinical operations enabling you to stay ahead of the game.

 

Find the right solution providers to partner with, allowing you to accelerate your trial timelines.

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SPONSORSHIP ENQUIRIES

Alex Purnell

Senior Sponsorship Manager

+44 204540 7786

SPEAKER ENQUIRIES

Ralitsa Pashkuleva

Conference Producer

MARKETING ENQUIRIES

Moona Popal

Marketing Manager

DELEGATE ENQUIRIES

Sunny Saikia

VIP Delegate Manager

SPONSORSHIP ENQUIRIES

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

Alex Purnell

Senior Sponsorship Manager


+44 204540 7786

SPEAKER ENQUIRIES

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

Ralitsa Pashkuleva

Conference Producer