Speakers will include:

 

Dr. Samantha Atkinson Chief Executive Officer TOPRA, United Kingdom	Karl Broich President  Federal Institute for Drugs and Medical Devices (BfArM), Germany	Stefan Vieths President  Paul-Ehrlich-Institut, Germany

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 Regulatory Policy, University of Applied Sciences, the Netherlands

Stefan Vieths President  Paul-Ehrlich-Institut, Germany

Speakers will include:

 

Florian Schmidt Deputy Head of Unit, DG SANTE 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 Professor  TUM Universitätsklinikum, Germany	Falk Ehmann Head of Innovation and Development Accelerator  EMA, The Netherlands

Sponsored Session by Paraxel (13:45 – 14:30): Bridging Regulatory and Access: Strategies for success in the JCA era 

The Joint Clinical Assessment (JCA) implementation in Europe under Regulation (EU) 2021/2282 necessitates coordinated regulatory and market access strategies. To support preparation, this session will focus on:

• Phased JCA implementation: 2025 for oncology and ATMPs, expanding to orphan drugs (2028) and all products (2030) 

• Understanding EMA vs JCA roles 

• Developing a unified clinical evidence package for EMA, JCA, and EU member state HTA bodies 

• Aligning submissions, timing, and processes 

We'll explore how regulatory professionals can adapt to this evolving landscape, emphasizing early scientific advice and integrated planning to optimize commercial opportunities while meeting new EU-wide clinical assessment requirements. 

Speakers will include:

Sangeeta Budhia Senior Vice President, Pricing & Market Access Paraxel, United Kingdom	Sinan Sarac Senior Vice President, Head of Oncology Europe, Regulatory Consulting Paraxel, Denmark

Catering 
Please visit one of the catering stands as indicated on the floorplan to be served lunch. 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! 

TOPRA Stand 
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA Stand located near registration. This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA notepad. 

 

With a holistic approach to health, at the beginning of 2025 the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have further developed and updated their strategy up to 2028 with the aim to guide the network in addressing both current and possible future hurdles which lie on the horizon. Having five distinct challenging areas in mind the network is well armed and ready to push-forward and ensure that patients in the EU will have access to meaningful treatments whilst fostering innovation, safeguarding the environment and most importantly promoting Europe’s competitiveness. Join us for this year’s fireside chat during which we will be focussing on Innovation and Competitiveness and debating with representatives from the EMA and HMA, who have developed these aspects of the strategy, along  with the participation from other crucial stakeholders, including a patient representative and the pharmaceutical industry. 

Session Leaders:

Francesca Buttigieg MTOPRA Regulatory Affairs Director Independent Consultant, Switzerland	Dr. Samantha Atkinson Chief Executive Officer TOPRA, United Kingdom

Speakers will include:

Julian Isla Director, Foundation 29, Spain	Falk Ehmann Head of Innovation and Development Accelerator  EMA, The Netherlands	Alexander Natz Sectretary General  EUCOPE, Belgium
Karl Broich President  Federal Institute for Drugs and Medical Devices (BfArM), Germany

Catering 
Please visit one of the catering stands as indicated on the floorplan to be served lunch. 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! 

TOPRA Stand 
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA Stand located near registration. This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA notepad. 

 

By now Artificial Intelligence should not be a new concept to us. It has in fact been a hot topic in numerous workshops, conferences, symposia and more. But how is it actually being applied in pharmaceutical development and regulation? Where has it made the most impact in the field? During this session we will aim to put aside the high-level discussions on what is possible with AI and deliver real-life examples of where AI is already making a difference. Join us and share your examples. 

Session Leaders:

 

Francesca Buttigieg MTOPRA Regulatory Affairs Director Independent Consultant, Switzerland

Dr. Martin Huber Acting Head of Division Pharmacovigilance  Federal Institute for Drugs and Medical Devices (BfArM), Germany

Speakers will include:

Julian Isla Director, Foundation 29, Spain	Larissa Kopp Assessor in Pharmacovigilance Paul-Ehrlich-Institut, Germany	Meelis Lootus Founder & CEO,  Tehistark, United Kingdom
Florian Lasch Biostatistics Specialist  EMA, The Netherlands

 

 

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

Speakers

Kora Doorduyn-van der Stoep Chair person – CMDh MEB, the Netherlands	Alex Barbosa Correia Regulatory Affairs Officer EMA, The Netherlands	Brian Dooley Pharmaceutical Quality Senior Specialist EMA, The Netherlands
Estelle Massoubre  Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs  Karo Healthcare, United Kingdom

Catering 
Please visit one of the catering stands as indicated on the floorplan to be served lunch. 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! 

TOPRA Stand 
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA Stand located near registration. This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA notepad. 

 

 

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	Claudia Popp Head EU Regulatory Science & EMA Liaison Roche, Switzerland	Hilke Zander Clinical Assessor,  Paul-Ehrlich-Institut, Germany
Stiina Aarum Senior Scientific Specialist EMA, The Netherlands

Sponsored Session by IQVIA (13:00 – 13:45): The Future is Now: Transforming Regulatory Processes through AI, ML, NLP, and RPAs 

In today's rapidly evolving regulatory landscape, AI/ML, NLP, & RPA are revolutionizing regulatory activities in the biopharma industry. Discover how these advanced technologies are transforming regulatory workflows, enhancing efficiency, and ensuring compliance. Attendees will learn about leveraging AI and ML for proactive regulatory intelligence, informed decision-making, language translation, dynamic task management, knowledge institutionalization, resource optimization, and real-time compliance monitoring.  

This session aims to provide valuable insights into the future of regulatory processes and the strategic implementation of advanced technologies. 

Speakers include:

Michelle Gyzen Senior Director, Regulatory Innovation & Technology IQVIA, United Kingdom

Catering 
Please visit one of the catering stands as indicated on the floorplan to be served lunch. 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! 

TOPRA Stand 
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA Stand located near registration. This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA notepad. 

 

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 Senior Vice President -  Technical, Strategic Compliance Consulting Paraxel, United Kingdom	Luca Zanotti Fragonara Advanced Technologies Competence Centre Lead PQE, Italy	Daniel Markl Professor  University of Strathclyde, United Kingdom
Mónica Perea-Vélez CMC Advocacy and Policy Director GSK, Belgium	James Pound Interim Executive Director Innovation and Compliance  MHRA, United Kingdom	Dolores Hernan Senior Quality (CMC) Specialist - Product Team Leader  EMA, The Netherlands

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! 

TOPRA Stand 
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA Stand located near registration. This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA notepad. 

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 Experienced Regulatory Affairs Professional United States of America

Speakers will include:

Regina Skavron Division Head European HTA  IQWiG, Germany	Michael Berntgen Head of Scientific Evidence Generation Department EMA, The Netherlands	Alexander Natz Sectretary General  EUCOPE, Belgium

 

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 Experienced Regulatory Affairs Professional United States of America

Katja Peçjak Reven MTOPRA Director BD, Sales and Marketing Billev Pharma East Ltd., Slovenia

Speakers will include:

Niklas Jänich Global Regulatory Affairs Boehringer Ingelheim International GmbH, Germany	Kim Sherwood Senior Expert Product Information Assessor MPA, Sweden	Elizabeth Scanlan ePI Product Owner EMA, The Netherlands

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.

There will be opportunities to hear directly from the European Medicines Agency (EMA) and the Paul-Ehrlich-Institut (PEI), Germany, on the support they can offer, along with practical examples on navigating the regulatory system and extensive time to network with colleagues and regulators.

09.30-09.35: Introduction
Chair: Margareth Jorvid, Methra Uppsala AB, Sweden
 

09.35-09.55: European Medicines Agency - Support to SMEs and Academia
Leonor Enes, EMA, SME Office, the Netherlands

• Support to SMEs - SME Office
• Support to academia
• EMA support to innovation

 

09.55-10.15: Local support from PEI to Academia and Start-ups
Nadine Kirsh-Stefan, Paul-Ehrlich-Institut, Germany

• How to prepare for and contact the Agency
• National scientific advice
• Experience of national support

 

10.15-10.25: The regulatory experience of a SME, industry perspective
Elaine Morten, Actimed Therapeutics Ltd, United Kingdom 

• When to talk to the Regulators?
• Meetings with National Agencies, EMA and FDA
• Practical experiences

 

10.25-11.00: Panel discussion

Session Leaders:

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

Speakers will include:

Leonor Enes Senior Scientific Officer EMA, The Netherlands	Nadine Kirsch-Stefan Head of DZIF Office for Scientific and Regulatory Advice (OSRA) Paul-Ehrlich-Institut, Germany	Elaine Morten Head of Regulatory Affairs and Technical Development Actimed Therapeutics Ltd, United Kingdom

Catering 
Please visit one of the catering stands as indicated on the floorplan to be served lunch. 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! 

TOPRA Stand 
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA Stand located near registration. This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA notepad. 

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 RareGeniX Consulting/ Minaret Consulting Limited, United Kingdom	Christine Grew FTOPRA Director Canopy Life Sciences, United Kingdom

Speakers will include:

Keith Berelowitz Founder & CEO, prxEngage Inc., 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	Anna Tavridou Scientific Officer  EMA, The Netherlands

 

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 Regulatory Expert Austria

Sandra Lourenço MTOPRA Director of Regulatory Affairs  Arriello, Ireland

Speakers will include:

Nils Jost Paul-Ehrlich-Institut, Germany	Cecil Nick Vice President (Technical) Paraxel, United Kingdom	Thomas Stangler Director, Regulatory Affairs CMC  Sandoz, Austria
Martina Weise Former Head of the Licensing Division 2 Germany	Peter Richardson Senior Quality Specialist  EMA, The Netherlands

Sponsored Session by Clarivate (13:15 – 14:00): Key scientific developments and regulatory considerations for Cell and Gene Therapies 

The significant potential of cell and gene therapies is tempered by the mismatch between traditional regulatory paradigms and the nature of these therapies, along with the need for innovative clinical trial designs, ethical considerations, and manufacturing complexities. Consequently, regulatory agencies have adopted a cautious approach to the oversight of cell and gene therapies, shaped by respective public health priorities, economic conditions, and healthcare systems. This session will focus on the obstacles faced when navigating regulations worldwide. It aims to evaluate market dynamics and emerging trends, how regulatory authorities are providing guidance, fostering collaborations, and establishing dedicated review pathways to facilitate development, and what changes to regulations can be expected in the European Union. As a bonus, we will also take a closer look at how to realize the immense potential of gene editing within the regulatory landscape. 

Speakers include:

Sofia Ataide Senior Business Solution Consultant Clarivate, Spain

Catering 
Please visit one of the catering stands as indicated on the floorplan to be served lunch. 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! 

TOPRA Stand 
If you are interested in learning about the opportunities TOPRA offers or just fancy a chat, please be sure to come visit the TOPRA Stand located near registration. This is also where delegates can come and collect their souvenir TOPRA teddy bear and members can collect their TOPRA notepad. 

 

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 Associate Director and Senior Regulatory Consultant DLRC Ltd, United Kingdom	Andreas Bonertz Head of Section Test and Therapy Allergens Paul-Ehrlich-Institut, Germany

Speakers will include:

Bertrand Fournier Senior Director, Regulatory Policy & Intelligence  Shionogi Europe, The Netherlands	Claudia Riedel Head of Clinical Trial Department Federal Institute for Drugs and Medical Devices (BfArM), Germany	Ana Zanoletty Head of Clinical Trials Transformation  EMA, The Netherlands

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

Speakers will include:

Jose-Francisco Vallejo Carrera Head of Environment & Environmental Sustainability  Sanofi, France	Kirsty Reid Director Science Policy  EFPIA, Belgium	Veronika Jekerle Head of Pharmaceutical Quality EMA, The Netherlands