See below for the 2022 programme for the TOPRA Annual Symposium. The programme for the 2023 Symposium in Lisbon will be published in the near future.

Human Medicines Symposium 2023

23 October

  12:00 - 12:30  Registration and welcome to the Human Medicines Symposium

   12:30 - 12.40  Welcome from the Human Medicines Working Party Chair, Francesca Buttigieg, overall Symposium Chair, Margareth Jorvid and the president of Infarmed, Rui Santos Ivo

  12:40 – 14:10

HM1: Update on EU new regulatory legislation and a view from different angles (European Medicines Agency (EMA), industry, others)

Session Leaders:

  • Marta Marcelino - Head of Medicines Evaluation Department PT CMDh member, Infarmed, Portugal
  • Julie Taccoen - Senior Director, Regulatory Affairs, EU, PTC Therapeutics France, France

    In 2020 the European Commission published a Pharmaceutical Strategy for Europe, as a patient-centered strategy aiming to ensure the quality and safety of medicines, while boosting the sector’s global competitiveness. The European Pharmaceutical Legislation framework is being reshaped in an effort to streamline it, keep it adapted to scientific and technological advances, and to address the most important recent challenges and the lessons learned from the Covid-19 pandemic, such as reducing the environmental impact of drugs and enhancing security of supply throughout European countries. The EC proposal should be bringing many changes to the regulatory landscape, aiming also to support the attractiveness of the EU region for competitiveness and innovation.

    During this session, the commission, regulatory authority and industry will share their vision and respective considerations on how this major revision of the EU regulatory landscape is impacting their activities, and how they are planning to adapt.

    Speakers will include:

  • Olga Solomon - Head of unit for medicines: policy, authorization and monitoring (B5), European Commission, Belgium
  • Dr. Paula Loekemeijer - Executive Director, Medicines Evaluation Board (MEB), the Netherlands
  • Valentin Plouchard - Healthcare Regulatory Affairs Manager, EuropaBio, Belgium

    Panellists will include:

  • María Jesús Lamas Díaz - Executive Director, Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)/ Spanish Agency of Medicines and Medical Products, Spain
  • Prof. Steffen Thirstrup - Chief Medical Officer of European Medicines Agency (EMA), the Netherlands


    14:10 – 14:50

    Networking break
      14:50 – 16:20

    HM2: Improving the Odds of Regulatory Success

    Session Leader and speaker:

  • Carlos Langezaal - Senior Director, Global Regulatory Affairs, Bristol Myers Squibb (BMS), USA

    Drug development is a lengthy, complex and costly process with a high degree of uncertainty in achieving successful outcomes.  Regulatory strategy can make all the difference!  We invite you to participate in an interactive session that will cover regulatory strategies under uncertain conditions.  We will take a deep dive into the appropriate steps to take to increase the probability of regulatory success. You will then work with your fellow delegates to analyse different scenarios. You can then compare your answers with a panel of industry and agency representatives, who will provide practical advice.

  • Other speakers will include:

  • Michael Berntgen - Head of Scientific Evidence Generation Department, EMA, the Netherlands
  • Fred Senatore - Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research, U.S. Food and Drug Administration (FDA), USA


    16:20 – 17:00

    Networking break
      17:00 – 18:30

    HM3: A spotlight on to the future - Fireside Chat

    Session Leader: 

  • Francesca Buttigieg - Director Regulatory Affairs, PTC Therapeutics International Limited, Switzerland
  • Sabine Haubenreisser - Principal Scientific Administrator - Stakeholders and Communication, EMA, the Netherlands

    Along with Steffen Thirstrup (EMA Chief Medical Officer), Bruno Sepodes (CHMP Vice-Chair), a formal Q&A session in the form of a fireside chat will be covering the current hot topics and more importantly the future of the regulatory landscape. The role and importance of international collaboration, patient involvement and artificial intelligence will be discussed amongst other topics.

    Speakers will include:

  • Prof. Steffen Thirstrup - Chief Medical Officer of European Medicines Agency (EMA), the Netherlands
  • Prof. Bruno Sepodes - Vice-Chair of CHMP (EMA), Infarmed/University of Lisbon, Portugal

  •    18:30 – 20:00  Networking dinner


    24 October

      All times GMT
      9:00 – 10:30

    HM4: The evolving clinical trial landscape

    Session Leader: 

  • Dr. Carlos Alves - Vice President, Infarmed, Portugal

    The European Clinical Trials Regulation was implemented on 31 January 2022 and in the first year after this date sponsors could choose to submit new clinical trials in the CTD or CTR framework. However, since 31 January 2023 all clinical trials have been submitted through CTIS. This huge change in the clinical trials regulatory environment has posed challenges to all stakeholders, but has also created opportunities and solutions developed by the regulatory network to enhance and facilitate the process. It is now time to look at  the state of play regarding the implementation of the European Regulation and the lessons learned.

    Alongside the new regulation, the European Union (EU) has maintained its focus on the competitiveness of the European platform and to leverage this opportunity ACT EU has been launched. It is now ongoing with different workstreams that together will further improve clinical investigation within the EU landscape.

    Speakers will include: 

  • Christine Didion - Desk Officer, European Commission, Belgium
  • Dr. Marianne Lunzer - CTCG Chair, Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH (AGES)/ Austrian Agency for Health and Food Safety, Austria
  • Olga Kholmanskikh - Clinical Assessor, Federal Agency for Medicines and Health Products (FAHMP), Belgium
  • Björn Eriksson - Director General, Läkemedelsverket/Medical Product Agency (MPA), Sweden

    Panellists will include:

  • Laura Pioppo - CTIS Business Expert, EMA, the Netherlands
  • Pierre-Frédéric Omnes - Executive Director, Life Sciences, Transperfect, France


    10:30 – 11:00

    Networking break
      11:00– 11:45

    TOPRA Annual Lecture - Opportunities and challenges for healthcare in the future


  • Dr Miguel Forte - Managing Director, mC4Tx and President-Elect ISCT, Belgium

      11:45 – 12:30

    TOPRA Annual Review - TBC

      12:30 – 13:30 Lunch break

      13:30 – 13:35 Welcome to the MD/IVD Symposium from Medical Devices and overall Symposium Chair, Margareth Jorvid

      13:35 – 14:00 Keynote presentation: The EU in IMDRF: Influence on EU regulations and Guidance

    Presented by Flora Giorgio - Head of Unit, European Commission, Belgium

      14:00 – 15:30

    HM5/MD1/IVD1: Process for regulations and implications of different legislation – how to follow and decide which regulation will impact your product development

    Session Leader:

  • Bjørg Hunter - Director, Regulatory Affairs Digital Health & IVD, Novo Nordisk, Denmark

    The future of disease management is moving from being drug centric to product centric and devices, digital tools and diagnostics are being developed for a complete treatment management solution. However, this can prove to be a challenge as regulators and pharma  have historically kep their primary focus on drug development. In order to provide safe and effective treatments for patients in the future, it is key to ensure shared language and pathways in the interface of technologies. The session will include perspectives from the EMA, FDA and industry. 

  • Speakers will include:

  • Barr Weiner - Associate Director, Office of Combination Products, U.S. Food and Drug Administration (FDA), USA
  • Claudia Popp - Head of EU Regulatory Science and EMA Liaison, Roche, Switzerland
  • Stiina Aarum - Senior Scientific Specialist, EMA, the Netherlands

  • Panellists will include:

  • Dr. Lena Björk - Director Supervision, Läkemedelsverket/Medical Products Agency (MPA), Sweden
  • Lorraine Nolan - Chief Executive, Health Products Regulatory Authority (HPRA), Ireland
  • Flora Giorgio - Head of Unit, European Commission - DG Sante, Belgium


    15:30 – 16:00

    Networking break
      16:00 – 17:30

    HM6: Real world evidence (RWE) and the use of big data for regulatory decision making; DARWIN EU 

    Session Leaders:

  • Dr. Marén Koban - Director Global Regulatory and Scientific Policy, Merck Healthcare KGaA, Germany
  • Àlmath Spooner - Head of Europe, Regulatory Policy and Intelligence, Abbvie, Ireland

    In 2022, key global regulators have further paved the way for the use of real-world data (RWD) in regulatory decision making by publishing multiple RWD-relevant documents for consultation. DARWIN EU provides a tool to regulators allowing analysis of real-world data  upon request by EMA committees to help answer procedure-related questions. DARWIN EU is also intended as pathfinder for the proposed European Health Data Space which will make available RWD for secondary use from a very broad range of data sources across the healthcare data ecosystem. This session looks to provide further clarificationon how EU regulators will use real-world evidence (RWE) generated via DARWIN EU, and the expectations of key global regulators to accept RWD provided by sponsors.

    Speakers will include:

  • Meritxell Sabidó - Director Epidemiology, Merck Healthcare KGaA, Germany
  • Andrej Segec - Scientific Administrator, EMA, the Netherlands
  • Dr. Kimberly Smith - Medical Officer, U.S. Food and Drug Administration (FDA), USA

    Panellists will include:

  • Cláudia Furtado - Head of the Health Technology Assessment (HTA), Pricing and Reimbursement Division (DATS), Infarmed, Portugal
  • Prof. Peter Rijnbeek - Head of the Department of Medical Informatics, Erasmus Medical Center, The Netherlands

  •    17:30 – 19:30  Networking drinks  


    25 October

      All times GMT
       9:00 – 10:30  HM7: Paediatric Investigational Plans

    Session Leaders:

  • Dr. Andrea Laslop - Head of Scientific Office, Austrian Medicines and Medical Devices Agency (MEA), Austria
  • Sandra Lourenço - Head of Regulatory Affairs, Arriello, Ireland

    Since the paediatric legislation in the EU came into effect in the EU more than 15 years ago, much has been accomplished to improve the development and availability of medicines for children.

    In this session we will discuss how these achievements can be continuously expanded by addressing further disease areas and treatment modalities where unmet medical needs currently persist.

    The regulatory procedures for establishment of paediatric investigation plans are expected to benefit
    from a revised approach that will be tailored in a step-wise process to actual stages of development.

    Finally, we will address how global development of paediatric medicines can be facilitated by
    strengthening the collaboration and alignment of regulatory requirements for paediatric
    clinical trials and investigation plans on an international level.

  • Speakers will include:

  • Prof. Ignacio Malagon - Prof. of Paediatric Anaesthesia, Radboud UMC, the Netherlands
  • Karl-Heinz Huemer - Consultant, KHH Consultancy, Austria
  • Dr. Martine Dehlinger-Kremer - Vice President Scientific Affairs, Pediatric Subject Matter Expert, Icon-PLC & President EUCROF, Germany

  • Panellists will include:

  • Chrissi Pallidis - Senior Scientific Specialist, EMA, the Netherlands
  • Solange Corriol-Rohou - Senior Director Regulatory Affairs & Policy, AstraZeneca, France
      10:30 – 11:00  Networking break
      11:00 – 12:30 HM8: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME)

    Session Leaders:

  • Marie Uguen - Senior VP, Regulatory Affairs & Quality Assurance, SparingVision, France

  • Timely access to safe and effective therapies for patients is the essence of drug development. Regulators, often supported and sometimes prompted by third parties, have been creative in designing and testing regulatory mechanisms to expedite drug development and patient access.  

    In this session, regulators and senior industry representatives will provide an overview of existing regulatory mechanisms supporting streamlined drug development and patient access, illustrated by concrete case studies.

    Speakers will include:

  • Laurence Campion - Regulatory Affairs Director, PTC Therapeutics France, France
  • Dr Christian K. Schneider - Vice President, Head of Biopharma Excellence, Chief Medical Officer (Biopharma), PharmaLex, Denmark
  • Dr. Valérie Denux - Head of Europe & Innovation Division, ANSM, France
  • Bettina Ziegele - Head Innovation Office, Paul-Ehrlich-Institut, Germany

  • Panellists will include:

  • Momir Radulović - Executive Director, Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)/ Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Slovenia
  • Dr. Kevin Cunningham - EMA PRIME Scientific Coordinator, EMA, the Netherlands
  •   PS1: Health Technology Assessments – the new EU regulation 

    Session Leaders: 

  • Mariane Cossito - Head of Medicines Evaluation and Access Management Unit, Infarmed, Portugal
  • Carlos Langezaal - Senior Director, Global Regulatory Affairs, Bristol Myers Squibb (BMS), USA
  • The Regulation on Health Technology Assessment (HTA) was adopted in December 2021, entered into force in January 2022, and it will be applied in a three year timeframe (January 2025).  In this three year delayed application period, the intention is to set up the organisational framework of the HTA Regulation, and to adopt the implementation and delegated acts and methodological guidance documents. In this session, an overview of the progress and plans of the Coordination Group and Stakeholder Network will be provided. 

    Speakers will include:

  • Roisin Adams - Head at HTA Strategy and External Engagement National centre for Pharmacoeconomics, National Centre for Pharmacoeconomics (NCPE), Ireland
  • Dr. Tina Wang - Senior Manager, HTA Strategic Partnership, Centre for Innovation in Regulatory Science (CIRS), UK
  • Rui Santos Ivo - President, Infarmed, Portugal

  • Panellists will include:

  • Michael Berntgen - Head of Scientific Evidence Generation Department, EMA, the Netherlands
       12:30 – 14:00  Lunch      
       14:00 – 15:30 HM9: Patient engagement in the regulatory lifecycle of medicines

    Session Leaders:

  • Fred Senatore - Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research, U.S. Food and Drug Administration (FDA), USA
  • Sabine Haubenreisser - Principal Scientific Administrator - Stakeholders and Communication, EMA, the Netherlands

    In this session, we will illustrate how patients are involved throughout the development of medicines until the decision is made on the marketing authorisation application and post-authorisation both in the EU and in the US. Interaction with patients have evolved constantly, with patients being represented in the European Medicines Agency Management Board, Scientific Committees and patients contributing to Scientific Advice, Expert meetings and Committee discussions. FDA is holding listening sessions and patient focus drug development meetings and asking concrete questions on study designs and patients’ expectations.

    Hear from various stakeholders how patients have successfully contributed to decision making of regulators and how this process will be further strengthened.


    Speakers will include:

  • Maria Mavris - Patient Relations, EMA
  • Andrea Furia-Helms - Director, Patient Affairs, U.S. Food and Drug Administration (FDA), USA
  • Dr. Maren von Fritschen - Head Regulatory Policy Europe, Moderna, Germany
  • Dr. Kieran Breen - Research Advisor, Parkinson‘s Europe, United Kingdom
  • Dr. Joao Oliveira - M.D., Instituto Português de Oncologia de Lisboa, Portugal
  •   PS2: ATMP innovations and clinical trials with GMOs

    Session Leader:

  • Jayne Hunt - Principal Regulatory Affairs Consultant, Ariello, Ireland

  • In May 2023 members of the TOPRA Biotech and Clinical Trial SPIN groups published an article in the Regulatory Rapporteur on the topic of ‘Evolution of GMO requirements for innovative investigational medicinal products upon transition to the EU CTR’. As many SMEs work in the area of innovative medicinal products, this session will consider some of the new innovative development areas including off-the-shelf ATMPs. We are very fortunate to have Maria Isabel Borba Vieira (INFARMED & alternate CAT member) to provide some considerations on innovation from the Committee for Advanced Therapies perspective, as well as providing some thoughts on the use of non-clinical studies to support innovative clinical studies. Finally, we take some considerations from the TOPRA article with a case study relating to the GMO regulation and the impact of this on innovative clinical trial registration via the Clinical Trial Information System (CTIS).

    Speakers will include:

  • Dr. Patrick Ginty - Senior Director, Regulatory Affairs, Boyds, UK
  • Maria Isabel de Medeiros Borba Vieira - Non-clinical Assessor, Infarmed, Portugal
  • Pierre-Frédéric Omnes - Executive Director, Life Sciences ,TransPerfect, France
         End of the Human Medicines Symposium


    No content found

    No content found

    No content found

    TOPRA Symposium 2022
    Hilton Vienna Park, Vienna, Austria
    Am Stadtpark 1, 1030

    Contact us
    +44 (0)207 510 2560


    Exhibition / Sponsorship
    Call +44 (0)2076 510 2573
    or email