22.02.21 DI Life Science Nyheder

Join FDA and EMA in a 4-part virtual seminar series

This is a unique opportunity to hear directly from FDA and EMA officials at the same time - on the topics of regulatory developments and trends in medical products regulation.

The Danish Embassy in Washington, DC is pleased to announce an exciting series of virtual seminars led by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) - addressing regulatory developments and trends in the USA and Europe. In the 4-part series of focused sessions, FDA and EMA officials will present how they work together and where they are different in addressing innovation, advancements and approval of new medical products.  

Each session will focus on a specific theme addressing related topics and incorporate recent examples and relevant cases.

Each session will focus on a specific theme addressing related topics and incorporate recent examples and relevant cases. Sessions will be interactive with a Q&A period following each presentation. Session titles are shown below with detailed descriptions available via the link further below.

March 22: Transatlantic Cooperation in Medical Products Regulation

This introductory seminar will present global trends and challenges facing regulatory bodies in Europe and USA, and how these agencies cooperate to address innovation, advancements, and approvals of new medical products from drugs to vaccines and beyond. In this first session, participants will learn about the scope of FDA’s engagement in Europe as well as the FDA and EMA collaboration. Regulatory experts will present examples from pediatrics, rare diseases, advanced therapy challenges and recent developments of counter measures to COVID 19. This session will provide the foundation upon which the future sessions on oncology, patient engagement, and digital transformations are built.

April 19: What’s new in Oncology

Drug development for treating cancer is one of the fastest growing areas of regulatory science, and one that has had long had strong collaborations across the European Medicines Agency and the US Food and Drug Administration. Experts from the two agencies have been meeting monthly to discuss applications and challenging issues in cancer every month for a decade. In this session, FDA and EMA experts will share perspectives on novel approaches in oncology from both regions, showcasing their work together as well as sharing how perspectives are similar and not. Precision medicine, tissue independent cancer treatments, the challenges of advanced therapies, development and use of master protocols, and transforming activities like FDA’s Oncology Center of Excellence and other programs in Europe, including Denmark, and how program complement each other will be covered.

May 17: Patients in Drug Development & Regulatory Processes

Patient focus in drug development has been a long needed and major force in recent years, and regulatory agencies have led the charge for change, offering a variety of different approaches that serve to complement each other. In the United States, legislation like the 21st Century Cures Act has ensured that FDA develops strong programs to ensure robust programs included in a framework for Patient Focused Drug Development, focusing first on the experience of living with a disease as a way to guide clinical trial design and even product development. In Europe, patients, consumers, and their organizations have long been active participants in EMA’s activities, including  as members of scientific committees (orphan diseases, pharmacovigilance and others), being consulted during medicines life cycle, reviewing labelling and safety communications, and most recently as part of the EMA COVID-19 Task Force.  In this session, the agencies will share their approaches, learnings and continuing challenges, including how they are learning from each other though the FDA-EMA Patient Engagement Cluster.In Denmark, a Citizens’ Council within the DKMA remit has been established in order for citizens to provide the agency with their input, perspectives and experiences. Focus will be centered around tasks with a direct interest for citizens, such as side effects, PILs, compassionate use and the shift from biologicals to biosimilar medicines. How the agencies are advising companies and patient advocacy groups on how to optimize their work in this critical area, including the challenges, will be discussed. 

June 14: Innovations in Therapy & Digital Transformations

Transformational research in biomedical science is bringing new treatment opportunities and innovation across the lifecycle of medicines. Examples include the explosion of advances in cell and gene therapies, biomarkers and novel manufacturing technologies.  These are increasingly coupled with innovations in clinical trial design, conduct and analysis that strive to streamline ascertaining the safety and efficacy of new products.  Such advancements and innovations pose new regulatory and scientific challenges, calling for Agencies to be nimble and actively engage with innovators to ensure advances in product development are met with equally innovative regulatory science.  This session will offer insight to how these programs work with examples of how companies can prepare to take advantage of them.

 

Amplifying advances in biology and methodology, digital transformation in healthcare and research has catalyzed clinical trials operations, endpoint measurement and data assessment.  Here, too, it is essential for regulatory agencies to think strategically about how to adapt and respond rapidly and collectively, especially sharing learnings globally.  In this session, you will hear how the Danish Medicines Agency, EMA and FDA are seizing opportunities offered by digital transformation and collaborating to not only support innovative approaches in therapy, but build new tools for doing so, such as through the EMA’s Digital Business Transformation Task Force, the DKMA Data Analytic Center and FDA’s Digital Health Center of Excellence.

Why attend?

  •  Hear the latest developments in regulatory science directly from FDA & EMA
  • Follow current trends in adapting regulations in the development and innovation of drugs and medical technologies
  • Understand critical changes underway to create successful strategies in the USA & Europe
  • Benchmark your regulatory strategies against agency requirements
  • Reserve a brief private one on one meeting with FDA & EMA officials

Who should attend?

Professionals in Research & Development, Regulatory Affairs, Medical Affairs, Corporate Strategy & Business Development, Market Access & Policy, Health Technology and Patient Advocacy

HOW TO REGISTER

Registration deadline is March 18, 2021.

The registration fee of DKK 1500 per person includes participation in all sessions, materials, a certificate of participation, session recordings, and the opportunity for a brief 1:1 consultation with FDA/EMA officials. Registration for single sessions is not allowed. 

In this document, you will find additional details on session descriptions, registration materials, and the option to reserve a 1:1 meeting with FDA & EMA officials. You will also find the registration form to be filled out by you. 

Return completed registration form via email to Hans Magnussen hanmag@um.dk by March 18, 2021.

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