More information to come soon.

Speakers will include:

Kevin Pay Chief Executive, TOPRA, United Kingdom

Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Research, United States of America

Paula Loekemeijer Chief Executive, MEB, the Netherlands

Session Leaders:

Sabine Haubenreisser Principal Scientific Administrator - Stakeholders and Communication EMA, Germany

Roelie Marinus Senior Policy Advisor MEB, the Netherlands

 

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

In recent years, we have witnessed a growing complexity in the clinical research environment and increasing fragmentation across Europe's clinical trials landscape, despite the implementation of the Clinical Trials Regulation.

Complex and inconsistent requirements across Europe, unnecessary red tape, and slow uptake of novel approaches are widening the gap between Europe and other regions while hindering innovation.

In this session, we will bring together representatives from regulators, ethics committees, industry, and patient organisations to reflect on the current situation and identify areas where action is needed the most, to re-establish an attractive and highly competitive European clinical research ecosystem; one that supports faster, smarter, and more patient-centric trials.

Session Leaders:

Katarina Nedog Associate Director, EFPIA, Belgium

Maren Koban Director, Global Regulatory and Scientific Policy, Merck Group, Germany

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

Until a few years ago the trending hashtags were blockchain, real world evidence, and accelerated pathways. Soon after, Parallel advice and HTA Bodies, and Payors came to the fore, suddenly out of nowhere the world was hit with Generative AI. 

Let’s face it, the healthcare industry never had issues in keeping up with the times and health agencies are no different. Both FDA and EMA have issued guidance relating to the use of AI in 2023. This year the Agencies have also started implementing generative AI in-house. 

This session aims to shed light on the Agencies’ approach to balancing the need for swift access to groundbreaking treatments with the imperative of ensuring public safety. By fostering an open exchange of ideas, the chat will provide insights into the agencies’ current initiatives, their future directions, and the broader implications for public health policy and practice.

Join us for a compelling conversation that promises to deepen our understanding of the complexities at the intersection of healthcare innovation and regulation, and to envision the future of public health in a rapidly evolving landscape.

Session Leaders:

Sabine Haubenreisser Principal Scientific Administrator - Stakeholders and Communication EMA, Germany

Francesca Buttigieg Director of Regulatory Affairs PTC Therapeutics, Switzerland

 

Electronic Product Information (ePI) holds critical medicinal product information available to patients and healthcare providers almost in real time. Discover current state and factors needed for EU implementation and the overview of the EMA/HMA ePI Pilot Project.

Session Leaders:

Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Research, United States of America

Katja Pečjak MTOPRA Director BD, Sales and Marketing, Industry Subject Matter Expert in EMA/HMA ePI Pilot Project, Billev Pharma East, Slovenia

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

 

More information to come soon.
 

Speakers will include:

Kevin Pay Chief Executive, TOPRA United Kingdom

Michael Kipping Director, Medical Technologies EMEAA, United Kingdom

Aman Khera FTOPRA Vice President, Regulatory Science, Strategy and Innovation Worldwide Clinical Trials, Canada

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

 

Speakers will include:

Kevin Pay Chief Executive, TOPRA United Kingdom

Margareth Jorvid FTOPRA CEO, Regulatory Affairs & Quality Assurance Methra Uppsala AB, Sweden

 

This session will look into opportunities and challenges with application procedures and performing a combination clinical trial in Europe, that involves a medicinal product and an in vitro diagnostic (IVD), or companion diagnostic (CDx) and/or a medical device (MD) component. The clinical trial application for the medicinal product is submitted under the Clinical Trial Regulation (CTR) via CTIS, while the device/diagnostic follow different national procedures. An update on the COMBINE project will be included.

Session Lead:

Margareth Jorvid FTOPRA CEO, Regulatory Affairs & Quality Assurance Methra Uppsala AB, Sweden

Speakers will include:

Vladimir Vujovic Director, IQVIA, Serbia

Olga Tkachenko Policy Officer, European Commission, Belgium

Elin Karlberg Head of Regulatory Group, Medical Products Agency/Läkemedelsverket, Sweden

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

AI/ML tools are impacting every aspect of the medicines lifecycle. But how is AI/ML being used by Regulatory Professionals, both within industry and health authorities, to support their work? How will its use be overseen? And will it shape the skills of the Regulatory Professional of the future?

Session Leaders:

Carla Jonker Senior Regulatory Project Leader / Scientific Administrator, CBG-MEB/EMA, the Netherlands

Rebecca Lumsden MTOPRA Head of Regulatory Science and Policy, EU/AMEE region, Sanofi, United Kingdom

Session Lead:

Álmath Spooner Head of Europe Regulatory Policy and Intelligence AbbVie, Ireland

Small and medium sized companies (SMEs), Academia and Start-ups meet different regulatory challenges when developing the life science products of the future to meet patients’ needs. This day is to explore regulatory news, to receive an update on recent changes and also to understand the support available and provided to SMEs, Academia and Start-ups.

Session Lead:

Margareth Jorvid FTOPRA CEO, Regulatory Affairs & Quality Assurance Methra Uppsala AB, Sweden

Speakers will include:

Anna Koptina Gültekin Head of Regulatory Affairs, Mendus, Sweden

Marjon Pasmooij Head of Science Department, MEB, the Netherlands

 

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!
 

How to successfully navigate the new EU HTA Regulation’s mandatory assessment of relative effectiveness occurring in parallel with MAA – earlier consideration of HTA evidence needs during clinical development and regulatory strategy will be key.

Session Lead:

Sigrid Klaar Medical Advisor and Advisory Board Member, NDA Group AB, Sweden

Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Research, United States of America

Speakers will include:

Chantal van Gils Vice President, Evidence & Value, SSI Strategy, the Netherlands

 

Scientific advice is a long-standing, well-established process in the regulatory network and brings a number of benefits to drug developers. Over the years, additional topics and procedures have been added to the existing core process, so as to support the requirements of an ever-expanding regulatory framework, e.g. through broad advice, qualification procedures, scientific advice for biosimilars or on medicine repurposing, etc. In this session we will discuss some recent procedures offered by EMA, national regulatory agencies and HTA bodies. Parallel consultations of regulators and HTA experts provide advice in order to streamline the development program not only for marketing authorisation but also for determining the value of a new treatment and may be very helpful in answering different questions within the same clinical trial. A new pilot project introduced at the centralised level aims at harmonising the scientific recommendations given by the SAWP/CHMP with the requirements for approval of clinical trials, which is in the remit of national authorities. This joint advice intends to avoid differing conclusions in regards of the acceptability of a certain study design or features. Finally, it will be interesting to hear about the usefulness of the simultaneous national scientific advice procedure as perceived by the pharmaceutical industry.

Session Leaders:

Andrea Laslop Head of Scientific Office AGES, Austria

Sandra Lourenço MTOPRA Head of Regulatory Affairs Arriello, Ireland

 

This is a valuable opportunity to explore our wide range of exhibitor stands and network with fellow delegates!

 

Focus of the session will be on practical implementation of the Clinical Trial regulation post transition in a global context. Experience will be shared from usage of CTIS including transparency and disclosure requirements. The session will discuss challenges in navigating between the different EU regulations in relation to clinical trials and elements to consider in navigating a global trial beyond the current fragmented environment.

Session Leaders:

Christine Grew MTOPRA Director of Regulatory Affairs, Canopy Life Sciences, United Kingdom

Maren Koban Director, Global Regulatory and Scientific Policy, Merck Group, Germany

 

Session Leaders:

Francesca Buttigieg Director of Regulatory Affairs, PTC Therapeutics, Switzerland

Juan Garcia Burgos Head of Public and Stakeholder Engagement, EMA, The Netherlands

 

 
Speakers will include:

Kevin Pay Chief Executive, TOPRA, United Kingdom

Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Research, United States of America