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 Executive Director, Medicines Evaluation Board (MEB), the Netherlands

With ever evolving technology and science, we have to be at the pulse of innovation and ready to engage, to understand, guide, support, evaluate and communicate.

How do we ensure Regulatory Excellence throughout the system and across stakeholders?

What would one look for in a regulator today and in future?

Come with your thoughts, experience and join the debate with representatives from the European Commission, European Medicines Agency, Dutch Medicines Evaluation Board, Heads of Medicines Agencies, Industry and patient representatives.

Session Leaders:

Sabine Haubenreisser Principal Scientific Administrator - Stakeholders and Communication European Medicines Agency (EMA), Germany

Roelie Marinus Senior Policy Advisor Medicines Evaluation Board (MEB), the Netherlands

Speakers will include:

Emer Cooke Executive Director, EMA, the Netherlands

Aimad Torqui Head of Division Medicines Evaluation Board, Medicines Evaluation Board (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 (CTR).

Complex and inconsistent requirements across Europe, unnecessary red tape, and a 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:

Susan Bhatti MTOPRA Director EU Global Regulatory and Scientific Policy, Merck BV, The Netherlands

Helle Christiansen  Head of European Affairs, National Centre for Ethics, Denmark

Speakers will include:

Lada Leyens MTOPRA Senior Director - EUCAN regulatory TA head GI2, Takeda, Switzerland	Kit Roes Professor of Biostatistics, Radboud University Medical Centre, the Netherlands
Maren Koban Director, Global Regulatory and Scientific Policy, Merck, Germany	Katarina Nedog Associate Director, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium

Panellists will include:

Begonya Nafria Escalera Patient Engagement Research Coordinator, Hospital Sant Joan de Déu, Spain

Ana Zanoletty Head of Clinical Trials Transformation, EMA, The Netherlands

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 Health Technology Assesment 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 keeping up with the times and health agencies are no different. The European Medicines Agency (EMA) and U.S Food and Drug Administration (FDA) issued guidance relating to the use of AI in 2023. This year both Agencies and the EU regulatory network 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 EMA’s, the European Regulatory network and FDA's 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 European Medicines Agency (EMA), Germany

Francesca Buttigieg MTOPRA Director of Regulatory Affairs PTC Therapeutics, Switzerland

Speakers will include:

Professor Ton de Boer Chairman of Medicines Evaluation Board (MEB), the Netherlands

Steffen Thirstrup Chief Medical Officer, European Medicines Agency, the Netherlands

Peter Marks Center for Biologics Evaluation and Research (CBER), FDA, United States of America

 

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 European Medicines Agency (EMA)/Heads of Medicines Agencies (HMA) ePI Pilot Project.

Session Leaders:

Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Research, United States of America		Carlos Langezaal is Senior Director of Regulatory Affairs for Premier Consulting, a firm that provides strategic solutions and service to emerging biopharmaceutical companies from concept to commercialisation. With 30 years’ experience in regulatory affairs, Carlos has amassed a wealth of experience across all stages of global pharmaceutical development, from pre-investigational new drug application (IND) through to phase III registrational stages. He has been a member of TOPRA’s Symposium Working Party for many years, to which he has applied his knowledge and experience in regulatory strategy.
Katja Pečjak MTOPRA Director BD, Sales and Marketing, Industry Subject Matter Expert in EMA/HMA ePI Pilot Project, Billev Pharma East, Slovenia		Katja has a Master’s in Pharmacy and has been working in the pharmaceutical industry for 20 years. Her journey in Billev Pharma East Ltd. started in September 2008 as a Director of Regulatory Affairs and EU Qualified Person Responsible for Pharmacovigilance (QPPV).  Her expertise has been sought when she was called upon to assume the role of Subject Matter Expert in the European Medicines Agency’s (EMA) electronic patient information (ePI) pilot project  EMA ePI Pilot Project, representing the Pharmaceutical Industry perspective since July 2022. She is a member of Medicines for Europe working groups (RSAC, Telematics), TOPRA and an ePI Topic Group Lead in IRISS Forum.

Speakers will include:

Elizabeth Scanlan Scientific Communication Officer & ePI Product Owner, EMA, the Netherlands

Jasper-Hugo Brouwers Head of Corporate & Stakeholder Affairs, MEB, the Netherlands

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

 

Speaker:

Professor Ilona Kickbusch Founder and Chair of the Global Health Centre, Graduate Institute of International and Development Studies, Switzerland

 

Speakers will include:

Kevin Pay Chief Executive, TOPRA United Kingdom

Michael Kipping MTOPRA Director, Medical Technologies EMEAA, Element, 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 the Clinical Trials Information System (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

Margareth Jorvid is CEO for Regulatory Affairs and Quality Assurance at Methra Uppsala AB. With more than 30 years’ experience in regulatory affairs, she has worked at the Swedish Medical Products Agency (MPA) as well as small and large pharmaceutical and biotechnology companies. Since 2006, she has worked as a consultant in regulatory affairs and quality assurance for pharmaceuticals, advanced therapy medicinal products, medical devices and combination products through Methra Uppsala AB. She holds an MSc Pharm from Uppsala University, an MBA from the Stockholm School of Economics in Sweden, and an MSc MTRA from Cranfield University in the UK.

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

Panellists will include:

Silvy Da Rocha Head of Office for Expert Panels and Groups Office, EMA, The Netherlands

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

Artificial Intelligence (AI)/Machine Learning (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, Medicines Evaluation Board (MEB)/European Medicines Agency (EMA), the Netherlands

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

Speakers will include:

Florian Lasch Biostatistics Specialist, EMA, The Netherlands

Jay Nanavati Head of Advanced NLP, IQVIA, United Kingdom

Karen Philippe Generative Artificial Intelligence Regulatory Lead, Sanofi, France

Clinical evidence generation for healthcare products has advanced to include a range of approaches. Although clinical trials (CTs) remain the research modality most relied upon by regulatory authorities for establishing clinical safety and efficacy, the lifecycle of evidence generation for medicines and vaccines increasingly embrace a combination of approaches which includes real-world evidence (RWE).   

Over the last two decades, the EU clinical trials environment has undergone significant changes intended to simplify and harmonize the administrative provisions governing EU clinical trials but obstacles persist that hamper the conduct of multinational trials in the EU. Progress continues to be made to work in partnership to optimize the implementation of the EU CTR and the related launch of the single EU portal and clinical trial database, the Clinical Trials Information System (CTIS).  The Accelerating Clinical Trials in the EU (ACT EU) initiative aims to support further transformation of the clinical trials environment in the EU. With several priority actions covering different aspects of clinical trials, the main goal of ACT EU is to contribute to the health of EU citizens through faster access to innovative medicines and optimized use of medicines on the market.  

Enabling access to innovative new medicines requires a range of approaches to evidence generation over the lifecycle of this product. This session will broaden the conversation on clinical evidence generation beyond traditional silos of clinical trials and real-world evidence generation to consider how we can holistically work in collaboration to generate evidence that meets the needs of decision makers through the product lifecycle.  The session will probe the interface between the European Medicines Agency (EMA)/Heads of Medicines Agencies (HMA), ACT EU and Big Data Initiatives and how these link into a broader strategic vision for the EU medicines regulatory network. The panel will consider not only how science is evolving but also the complexity of clinical trial execution in a rapidly changing landscape. 

Session Lead:

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

Denise Umuhire Pharmacoepidemiology & RWE Specialist, European Medicines Agency (EMA), the Netherlands

Speakers will include:

Alexandra Pacurariu  Scientific Administrator, EMA, the Netherlands

Gracy Crane International Regulatory Policy Lead for RWD, Roche Products Limited, United Kingdom

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

Margareth Jorvid is CEO for Regulatory Affairs and Quality Assurance at Methra Uppsala AB. With more than 30 years’ experience in regulatory affairs, she has worked at the Swedish Medical Products Agency (MPA) as well as small and large pharmaceutical and biotechnology companies. Since 2006, she has worked as a consultant in regulatory affairs and quality assurance for pharmaceuticals, advanced therapy medicinal products, medical devices and combination products through Methra Uppsala AB. She holds an MSc Pharm from Uppsala University, an MBA from the Stockholm School of Economics in Sweden, and an MSc MTRA from Cranfield University in the UK.

Speakers will include:

Anna Koptina Gültekin Head of Regulatory Affairs, Mendus, Sweden

Leonor Enes Scientific Officer - SME Office, EMA, The Netherlands

Marjon Pasmooij Head of Science Department, Medicines Evaluation Board (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 Health Technology Assessment (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		Sigrid Klaar is a former regulator and health technology assessment medical advisor. She holds an MD and a PhD in oncology, both from Uppsala University in Sweden. She currently works in consultancy at the NDA Group and has extensive experience in oncology, from drafting guidelines for industry to obtaining drug approvals under the European Medicines Agency’s (EMA) centralised procedure. She has previously specialised in HTA, having worked with national reimbursement applications as well as EUnetHTA and FINOSE joint clinical assessments.
Carlos Langezaal FTOPRA  Senior Director Regulatory Affairs, Premier Research, United States of America		Carlos Langezaal is Senior Director of Regulatory Affairs for Premier Consulting, a firm that provides strategic solutions and service to emerging biopharmaceutical companies from concept to commercialisation. With 30 years’ experience in regulatory affairs, Carlos has amassed a wealth of experience across all stages of global pharmaceutical development, from pre-investigational new drug application (IND) through to phase III registrational stages. He has been a member of TOPRA’s Symposium Working Party for many years, to which he has applied his knowledge and experience in regulatory strategy.

Speakers will include:

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

Michael Berntgen  Head of Scientific Evidence Generation Department, EMA, The Netherlands

Anne Willemsen Co-chair of the HTAR subgroup on Joint Clinical Assessment, Zorginstituut Nederland, 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 the European Medicines Agency (EMA), national regulatory agencies and Health Technology Assessment (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 Scientific Advice Working Party (SAWP)/Committee for Medicinal Products for Human Use (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		Andrea Laslop is Head of the Scientific Office at the Austrian Medicines and Medical Devices Agency, a business unit of the Austrian Agency for Health and Food Safety (AGES). Her focus in regulatory affairs falls on different types of centralised European procedures during drug development, marketing authorisation and lifecycle management. She has been a member of the European Medicines Agency (EMA) Scientific Advice Working Party since 2003, and served as a delegate in the the Committee for Medicinal Products for Human Use at the EMA between 2007 and 2022. Prior to this, she worked as a professor of pharmacology and toxicology at the Medical University of Innsbruck.
Sandra Lourenço MTOPRA Director of Regulatory Affairs Arriello, Ireland		Sandra Lourence holds a Bachelor of Science degree in Chemistry from Oporto University, Science College, and has more than 20 years’ experience in the pharmaceutical and management consultancy Industries. She started her career as a scientific investigator in the wine industry and moved into pharmaceutical development in 2003 as a pharmaceutical research and development scientist. In this role, she interacts and contributes at the earliest stage of the medicinal lifecycle. She has submitted more than 500 new abridged marketing authorisations in the EU through national and European procedures. These included the development of Modules 1, 2 and 3, management and response to deficiency letters and the consequent lifecycle maintenance of those products after approval.

Speakers will include:

 

Mireille Muller  Regulatory Policy Executive Director, Novartis, Switzerland

Marianne Lunzer CTCG Chair, AGES, Austria

Jane Moseley  Scientific Administrator, EMA, The Netherlands

Panellists will include:

Jane Moseley  Scientific Administrator, EMA, The Netherlands

 

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 (CTR) post-transition in a global context. Experience will be shared from usage of the Clinicial Trials Information System (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

Speakers will include:

Pierre-Frédéric Omnes FTOPRA Executive Director, Transperfect , France	Seán Byrne Senior Manager, Legal & Regulatory Affairs, EUCOPE - European Confederation of Pharmaceutical Entrepreneurs, Belgium
Francesca Scotti CTIS – Transparency Lead, EMA, The Netherlands	Marianne Lunzer CTCG Chair, AGES, Austria

Panellists will include:

Andrea Seidel-Glatzer Head of Project Management, Universitätsklinikum Heidelberg, Germany

A topic which requires no introduction and now a Symposium staple, patient experience data and its use in the evaluation of medicinal products will be the focus of this year’s discussion. Following an EMA workshop held in recent years, the definition of what patient experience data includes was proposed. However, patient experience data (PED) is not yet used systematically as part of a medicine’s development and evaluation. This session will put this up for discussion, we will hear from EMA officers what the current thinking is in light of a forthcoming reflection paper to be issued in 2024 as well as from representatives of the industry and most importantly patient representatives themselves. Could patient experience data, i.e. data coming directly from patients, such as Patient Reported Outcomes (PROs), Patient preference studies (PPS), or data from Patient Engagement, become a key decision making factor in future medicine evaluations?

The session will provide an update of progress from EMA on this topic and we will discuss and hear the views and expectations from patients and industry representatives.

Session Leaders:

Francesca Buttigieg Director of Regulatory Affairs, PTC Therapeutics, Switzerland

Juan Garcia Burgos Head of Public and Stakeholder Engagement, European Medicines Agency (EMA), the Netherlands

Speakers will include:

Susan Bhatti Director EU Global Regulatory and Scientific Policy, Merck BV, The Netherlands

Kaisa Immonen Patient Liaison, EMA, The Netherlands

Maria Cavallier Patient Engagement & Therapeutic Development Director, EURODIS, Spain

 

 
Speakers will include:

Kevin Pay Chief Executive, TOPRA, United Kingdom

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