This session will explore key elements of the EU General Pharmaceutical Legislation (GPL) that aim to foster innovation and accelerate patient access to new treatments. Key focus areas include Platform Technology approaches and Regulatory Sandboxes. 

By bringing together perspectives from patients, regulators, legislators, academia, and industry, the discussion will highlight how these regulatory tools can support cutting-edge pharmaceutical development and manufacturing while keeping the EU region competitive and attractive for innovation. 

This session aims to provide a comprehensive regulatory and scientific perspective on how these approaches can drive the future of pharmaceutical development in Europe, ensuring faster access to innovation while maintaining regulatory scientific robustness.  

Session Leaders:

Maren von Fritschen Head Regulatory Policy EU Moderna, the Netherlands

Stefan Vieths President  Paul-Ehrlich-Institut, Germany

Speakers will include:

 

Rainer Becker Director DG Health & Food Safety  European Commission, Belgium	Mihai Bilanin Global Regulatory Lead (Director), Vaccines Discovery and Development Vaccines  GSK, Belgium	Karl Broich President  Federal Institute for Drugs and Medical Devices (BfArM), Germany
Martin Hildebrandt CAR-T cell research, Clinic Hematology and Oncology TUM School of Medicine, Germany

 

The EU variation Regulation has been updated in March 2024 and the Detailed guideline for classification of variations dated from 2008 (last update 2013) has also been modified for a more operational vision. Nevertheless, this is only the first step, limited by the current legislation, and a second step is awaited after the new EU general pharmaceutical regulation is in force (expected 2028).
 
The current European Commission updates simplify the requirements and procedures, modernise the framework, adapt the rules for grouping and work-sharing, adapt the classification for some products, reduce administrative burden, and implement a risk-based approach. All these propositions align with stakeholders’ proposals for the Variations revision. 

This session will present an overview of the original goals of the revision, the new changes in the management of post-approval changes, including a comparison of the previous and proposed classifications with statistics and impact for both regulators and industries in term of volume of variations being generated. 

The session will also explore stakeholders’ responses to the proposed reforms and address the question - do these changes meet the needs and reduce the workload for all stakeholders in the complex European Medicines Regulatory Network? 

Now is the perfect timing to think differently and seek to innovate in the space of life-cycle management ahead of the planned second revision. This session will discuss opportunities to continue in re-inventing both submission policies and processes for post-approval changes in the EU for centrally and nationally registered products and seek to leverage opportunities to increase efficiencies for both industry and regulators. 

Session Leaders:

 

Agnès Dangy-Caye Global Regulatory Science and Policy Manager EU & AME  Sanofi, France	Cristina Dragan MTOPRA Associate Director Regulatory Policy and Intelligence Novartis, United Kingdom

Catering
Please visit one of the catering stands as indicated on the floorplan to enjoy a cup of coffee or tea during the networking break. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break. 

Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

 

 

 

This session will look into opportunities and challenges with application procedures and performing a combined 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. 

Multiple stakeholders (i.e. Pharmaceutical companies, device manufacturers, EMA, NCAs, Notified Bodies and academic institutions) are involved in the development of innovative drugs (using devices). The device regulation (MDR and IVDR) has introduced major changes and has been suggested as a contributing factor to the decrease in the number of clinical trials in Europe. 

The European Commission and EU Member States have launched the COMBINE initiative to propose solutions for combined trials (drug using a device in a clinical trial), specifically looking at the interplay of IVDR, MDR and CTR, also identified as one of “most important issues” by stakeholders ACT-EU workplan ‘25-’26. The panel discussion will explore whether the proposed solutions stemming from this highly welcomed initiative are already demonstrating benefits. It will also offer concrete strategies to ensure the European clinical trial ecosystem is well-suited to promote the conduct of clinical trials in Europe. 

Session Leaders:

 

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

Claudia Popp Head EU Regulatory Science & EMA Liaison Roche, Switzerland

Speakers will include:

Olga Tkachenko Policy Officer  European Commission, Belgium

This session will explore the transformative role of Artificial Intelligence (AI) in enhancing Chemistry, Manufacturing, and Controls (CMC) processes within regulatory affairs. As AI technologies continue to advance, their integration into CMC activities offers exciting opportunities to streamline development, optimize manufacturing, and improve regulatory decision-making. 

Session Leaders:

Janine Jamieson European Editor  International Pharmaceutical Quality, United Kingdom

Sandra Lourenço MTOPRA Director of Regulatory Affairs  Arriello, Ireland

Speakers will include:

Mark Birse Vice President, Technical Paraxel, United Kingdom

The Health Technology Assessment (HTA) legislation aims to harmonize the evaluation of new health technologies, including Advanced Therapy Medicinal Products (ATMPs), and to support evidence-based reimbursement decisions. 

With the implementation of the EU HTA Regulation (2021/2282) in 2025, a joint assessment process for clinical data will be introduced to avoid duplicate national evaluations and accelerate market access. However, this also presents challenges, as economic and healthcare policy decisions will continue to be made at the national level, and a fully harmonized reimbursement process is not guaranteed. 

Another key element of the HTA Regulation is the Joint Scientific Consultation, a long-awaited process for developers to learn at an early stage the expectations from regulators and HTA bodies in parallel via a joint scientific consultation. How are companies, agencies and HTA bodies preparing for this new process? 

Session Leaders:

 

Cristina Dragan MTOPRA Associate Director Regulatory Policy and Intelligence Novartis, United Kingdom

Carlos Langezaal FTOPRA Senior Director Regulatory Affairs I & I Nurix Therapeutics , United States of America

Speakers will include:

Regina Skavon Division Head  IQWiG, Germany

 

This session will focus on the regulatory implications and readiness strategies for the implementation of electronic Product Information (ePI) based on the HL7 FHIR® standard. As outlined in the EU pharmaceutical strategy and reinforced by EMA’s digital initiatives, the structured, interoperable ePI format will play a critical role in improving the accessibility, reliability, and lifecycle management of product information. Regulatory authorities and marketing authorisation holders must prepare for changes in submission formats, review procedures, and data governance models. The session will provide an overview of current status of the EU ePI project including linking to ePI from EU medicine packages, regulatory frameworks, and anticipated timelines. Practical insights will be shared on how regulatory professionals can adapt internal processes and evaluate IT infrastructure needs to ensure compliance and facilitate the seamless integration of FHIR-based ePI into existing regulatory operations. This is a key opportunity to engage in shaping the future of product information governance across the EU. 

Session Leaders:

Carlos Langezaal FTOPRA Senior Director Regulatory Affairs I & I Nurix Therapeutics , United States of America

Katja Peçjak Reven MTOPRA Director BD, Sales and Marketing; EU/UK QPPV Billev Pharma East Ltd., Slovenia

Speakers will include:

Niklas Jänich Global Regulatory Affairs Boehringer Ingelheim International GmbH, Germany

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 Leaders:

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

Speakers will include:

Nadine Kirsch-Stefan Head of DZIF Office for Scientific and Regulatory Advice (OSRA) Paul-Ehrlich-Institut, Germany

Catering
Please visit one of the catering stands as indicated on the floorplan to enjoy a cup of coffee or tea during the networking break. Various snacks will also be served during the break. Tables and seating can be found throughout the exhibition floor.

Exhibitors
Don't forget to visit our wonderful exhibitors located throughout the exhibition floor during the break.

Networking
Catch up with old colleagues and make new connections during the break. 

Poster Display
On the exhibition floor, TOPRA are delighted to present a collection of scientific posters submitted by our members – be sure to check them out during the session breaks!

The global market for ATMPs (based on genes, tissues or cells) is experiencing rapid growth, fueled by advancements in biotechnology. In the past decade, the number of ATMP-related clinical trials has multiplied tenfold, owing to the increasing number of trials in gene therapy. ATMPs can offer groundbreaking and transformative, potentially curative treatments, especially in rare diseases. While offering tremendous potential, ATMPs present several challenges, including high costs, limited data on long-term effects, and complex manufacturing and regulatory processes. Hear from regulators (from PEI & the EMA Committee for Advanced Therapies), Innovators and those representing the best interests of the patient for actionable insights for those developing ATMPs. 

Session Leaders:

Dr. Dima Al-Hadithi MTOPRA Partner – CMC/ Regulatory CMC Consultant RareGeniX Consulting/ Minaret Consulting Limited, United Kingdom	Christine Grew FTOPRA Director Canopy Life Sciences, United Kingdom

Speakers will include:

Keith Berelowitz Chair  Fulham Research Ethics Committee, United Kingdom	Jens Reinhardt Senior Assessor  Paul-Ehrlich-Institut, Germany	Valérie Salentey Regulatory Affairs and Quality Assurance Director  Sensorion, France
Ralf Sanzenbacher Senior Assessor  Paul-Ehrlich-Institut, Germany

 

With growing experience and coverage of the biosimilar market, regulatory strategies must evolve to balance scientific rigor with the need for efficient development. One of the currently most debated topics in the biosimilar arena is the potential waiver for traditional efficacy and safety studies, a move that could significantly reduce development timelines and costs. This session will focus on the increasing interest in shifting the emphasis to establish similarity mainly based on Chemistry, Manufacturing, and Controls (CMC) comparability data, as opposed to relying on results from comparative clinical efficacy trials. 

The session will explore the scientific rationale behind using robust CMC evidence as the cornerstone of biosimilar approval, while addressing concerns regarding the adequacy of clinical data. Experts in CMC will present their views on how advanced manufacturing technologies, analytical techniques, and product characterization can generate the necessary evidence to support a waiver for extensive efficacy and safety studies. These experts will share insights on how consistent manufacturing and comparability of biosimilars can be sufficiently demonstrated through state-of-the-art analytical methods, highlighting the potential for regulatory flexibility in this area. 

On the other hand, clinical specialists will provide arguments from a clinical point of view, discussing the feasibility and concerns about the lack of efficacy and safety data in these developments. They will examine the implications of waiving clinical trials, particularly in terms of patient safety, real world outcomes, and public confidence in biosimilars. 

By bringing together experts from both the CMC and clinical fields, this session aims to provide a comprehensive, balanced view of the challenges and opportunities in biosimilar development. The audience will gain a deeper understanding of the evolving regulatory landscape and how it could shape the future of biosimilar medicines. Ultimately, this discussion will help set the stage for a more nuanced, tailored approach to regulatory requirements, ensuring that biosimilars are both scientifically robust and clinically safe for patient use. 

Please note, this meeting is a parallel session and therefore has limited capacity. 

Session Leaders:

 

Andrea Laslop Experienced Regulatory Affairs Professional Austria

Sandra Lourenço MTOPRA Director of Regulatory Affairs  Arriello, Ireland

Speakers will include:

Nils Jost Paul-Ehrlich-Institut, Germany	Cecil Nick Vice President Paraxel, United Kingdom	Martina Weise Experienced Regulatory Affairs Professional  Germany

 

This session will explore the evolving landscape of European clinical trials, focusing on efforts to enhance competitiveness and drive innovation within the region. Industry experts and regulatory authorities will share insights drawn from the implementation of the Clinical Trial Regulation (CTR) and progress made under the Accelerating Clinical Trials in the EU (ACT EU) Workplan.

Session Leaders:

 

Michelle Blake MTOPRA Senior Regulatory Consultant and Team Leader DLRC Ltd, United Kingdom	Andreas Bonertz Head of Section Test and Therapy Allergens Paul-Ehrlich-Institut, Germany

Speakers will include:

Claudia Riedel Head of Clinical Trial Department Federal Institute for Drugs and Medical Devices (BfArM), Germany

 
In an era where environmental concerns are increasingly critical, the pharmaceutical industry faces a crucial challenge. The need to balance continuing medicines access for patients with cross-sectoral environmental and sustainability initiatives. This 90-minute panel session will explore the multifaceted impacts of environmental and sustainability initiatives for medicinal products, the impacts for regulatory affairs and patients and explore topics such as: 

•  Cumulative Impact Assessment of Green-Related Files – an overview of the potential legislative files for the pharmaceutical sector, resource implications for impacted stakeholders and potential for risks of contradictions in legislative goals. 
•  Sustainable Market Initiative (SMI) Health Systems Task Force - launched at COP26, this public-private partnership aims to accelerate the delivery of net-zero, patient-centric health systems. Speaker will discuss patient care pathways decarbonization and the development of science-based targets for Lifecycle Assessment (LCA) and clinical trials. 

This session will adopt a forward-thinking approach, exploring how EU environmental initiatives are poised to impact the industry while also discussing how the industry is proactively acting on sustainability goals. Key questions include: 

•  What impacts will sustainability and environmental initiatives have for medicines supply? 
•  Will the implementation of green practices require greater oversight by regulatory professionals? 
•  How can we balance moving to a sustainable medicines sector and decarbonised health system while minimising impacts for patients? 

Please note, this meeting is a parallel session and therefore has limited capacity. 

Session Leaders:

 

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